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Clinical trials
catalyst calendar across sponsors →Studies where BIIB is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
Of the 500 shown: 407 interventional · 93 observational · 127 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their BabiesNCT06628687observationalNumber of Major Congenital Malformations (MCMs) | — | Recruiting | Drug: Omaveloxolone | Friedreich Ataxia | 10 | 2035-04-30 | in 3,176 d | 2026-07-10 |
| A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)NCT07483632TP Cohort A and OLE Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment DiscontinuationRandomized · Quadruple-masked · Treatment | Phase 3 | Not yet recruiting | Drug: Diroximel Fumarate, Dimethyl Fumarate, Fingolimod, Placebo matching DRF, Placebo matching DMF, Placebo matching fingolimod | Relapsing Forms of Multiple Sclerosis | 185 | 2034-07-28 | in 2,900 d | 2026-03-19 |
| A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Participants With Superoxide Dismutase 1 (SOD-1) Amyotrophic Lateral Sclerosis (ALS)NCT07259980observationalBaseline Demographic: Age | — | Recruiting | Drug: Tofersen | Amyotrophic Lateral Sclerosis | 125 | 2033-12-30 | in 2,690 d | 2026-04-09 |
| A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)NCT05767736observationalNumber of Participants With Confirmed Serious Adverse Events (SAEs) in the Vumerity, Tecfidera, Other Selected DMTs (Teriflunomide, Beta-interferons, or Glatiramer Acetate), or Vumerity/Tecfidera Switch Cohorts | — | Active, not recruiting | Drug: Diroximel Fumarate, Dimethyl Fumarate, Disease-Modifying Therapies (DMTs) | Multiple Sclerosis | 10,500 | 2032-12-01 | in 2,296 d | 2025-10-16 |
| A Study to Learn How Nusinersen (Spinraza) Affects Participants With Spinal Muscular Atrophy (SMA) Who Took it Before or During Pregnancy And About The Health of Their BabiesNCT05789758observationalNumber of Pregnancy Terminations | — | Recruiting | Other: No Intervention | Muscular Atrophy, Spinal | 20 | 2032-10-31 | in 2,265 d | 2026-03-09 |
| Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)NCT05658497observationalNumber of Major Congenital Malformations (MCMs) | — | Recruiting | Drug: Diroximel Fumarate, Avonex, Dimethyl Fumarate · Biological: Tysabri | Multiple Sclerosis | 908 | 2032-07-06 | in 2,148 d | 2026-08-11 |
| A Study to Learn About the Safety of BIIB115 Injections and How BIIB115 is Processed in the Bodies of Healthy Adult Male Volunteers and of Pediatric Participants With Spinal Muscular Atrophy Who Previously Took Onasemnogene AbeparvovecNCT05575011Parts A, B, and B Long Term Extension (LTE): Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Quadruple-masked · Treatment | Phase 1 | Active, not recruiting | Drug: BIIB115, BIIB115-Matching Placebo | Healthy Volunteer, Muscular Atrophy, Spinal | 62 | 2031-11-14 | in 1,913 d | 2026-07-09 |
| A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) or Microvascular Inflammation (MVI) (TRANSCEND/TRANSPIRE LTE)NCT07444489Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)Open-label · Treatment | Phase 3 | Enrolling by invitation | Drug: Felzartamab | Antibody-mediated Rejection, Microvascular Inflammation | 201 | 2031-05-28 | in 1,743 d | 2026-08-06 |
| A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their BabiesNCT05688436observationalNumber of Major Congenital Malformations (MCMs) | — | Active, not recruiting | Drug: Diroximel Fumarate, Fingolimod, Glatiramer acetate, Ozanimod, Ponesimod, Siponimod · Biological: Alemtuzumab, Interferon beta, Natalizumab, Ocrelizumab, Ofatumumab, Peginterferon beta-1a | Multiple Sclerosis | 1,178 | 2031-01-17 | in 1,612 d | 2026-06-04 |
| An Extension Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus ErythematosusNCT05352919Number of Participants with Treatment Emergent Adverse Events (TEAEs)Randomized · Quadruple-masked · Treatment | Phase 3 | Enrolling by invitation | Drug: Litifilimab, Litifilimab-matching placebo | Systemic Lupus Erythematosus (SLE) | 864 | 2030-03-29 | in 1,318 d | 2026-08-13 |
| A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)NCT06962800Percentage of Participants who Achieve Complete Remission (CR) at Week 104Randomized · Open-label · Treatment | Phase 3 | Recruiting | Drug: Felzartamab, Tacrolimus, Standard of Care IST | Primary Membranous Nephropathy | 180 | 2030-01-28 | in 1,258 d | 2026-08-19 |
| A Study to Learn More About the Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Who Are Prescribed it by Their Own DoctorsNCT06623890observationalOmaveloxolone Naive Cohort: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) | — | Recruiting | Drug: Omaveloxolone | Friedreich Ataxia | 300 | 2029-10-01 | in 1,139 d | 2026-04-28 |
| A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Onasemnogene AbeparvovecNCT07444450Parts A: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Salanersen · Procedure: Sham Procedure | Muscular Atrophy, Spinal | 42 | 2029-07-27 | in 1,073 d | 2026-08-11 |
| A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus ErythematosusNCT06044337Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Open-label · Treatment | Phase 3 | Enrolling by invitation | Drug: BIIB059 (litifilimab) | Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus | 306 | 2029-06-26 | in 1,042 d | 2026-08-04 |
| A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety When Given Before Symptoms Appear in Babies With Genetically Diagnosed Spinal Muscular Atrophy (SMA)NCT07221669Part 1: Percentage of Participants with 2 Survival Motor Neuron 2 (SMN2) Copies Sitting Without Support (for at Least 10 Seconds)Open-label · Treatment | Phase 3 | Recruiting | Drug: Salanersen | Muscular Atrophy, Spinal | 30 | 2028-11-28 | in 832 d | 2026-08-18 |
| A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years With Spinal Muscular Atrophy (SMA) Who Are Either New to SMA Treatment or Were Previously Treated With RisdiplamNCT07444476Change From Baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE) Total Score in Treatment-Naïve CohortOpen-label · Treatment | Phase 3 | Recruiting | Drug: Salanersen | Spinal Muscular Atrophy | 90 | 2028-06-23 | in 674 d | 2026-04-21 |
| A Study to Learn More About the Safety of a Single Dose of BIIB144 and How it is Processed in the Body of Healthy Adult Participants Ages 18 to 55 Years Old as Compared to a PlaceboNCT07662148Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Randomized · Quadruple-masked · Treatment | Phase 1 | Recruiting | Drug: BIIB144, Placebo | Healthy Volunteer | 48 | 2028-06-19 | in 670 d | 2026-07-27 |
| Adult Spinal Muscular Atrophy (SMA) China RegistryNCT05618379observationalNumber of Participants Characterized by Natural History of 5q-SMA Observed Among Adult Chinese Participants | — | Active, not recruiting | — | Muscular Atrophy, Spinal | 200 | 2028-06-01 | in 652 d | 2026-08-04 |
| A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular InflammationNCT07219043Part A: Percentage of Participants Who Achieve Biopsy-proven Histologic Resolution (BPHR)Randomized · Quadruple-masked · Treatment | Phase 2 | Recruiting | Drug: Felzartamab, Placebo | Microvascular Inflammation | 81 | 2028-02-10 | in 540 d | 2026-07-31 |
| A Study to Learn About The Effects of Felzartamab on Thyroid Function and Its Safety in Adults With Graves' Disease Ages 18 to 75 Years OldNCT07722546Percentage of Participants who are Euthyroid and off Anti-Thyroid Drugs (ATD) at Week 24Randomized · Quadruple-masked · Treatment | Phase 2 | Recruiting | Drug: Felzartamab, Placebo | Graves' Disease | 60 | 2028-01-31 | in 530 d | 2026-08-11 |
| A Study to Learn More About the Effects and Long-Term Safety of Omaveloxolone (BIIB141) in Children and Teens With Friedreich's AtaxiaNCT06953583Part 1: Change From Baseline in Upright Stability Score (USS) Subscale E of Modified Friedreich's Ataxia Rating Scale (mFARS) at Week 52Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Omaveloxolone, Placebo | Friedreich Ataxia | 255 | 2027-11-16 | in 454 d | 2026-06-16 |
| A Study to Learn About the Effect of Higher Doses of Nusinersen (BIIB058) Given as Injections to Participants With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Risdiplam (ASCEND)NCT05067790Change in Total Revised Upper Limb Module (RULM) ScoreOpen-label · Treatment | Phase 3 | Active, not recruiting | Drug: Nusinersen | Spinal Muscular Atrophy | 45 | 2027-09-24 | in 401 d | 2026-05-22 |
| Pediatric Spinal Muscular Atrophy (SMA) China RegistryNCT05042921observationalNatural History and Utilization of Disease Modifying Therapy (DMT) Treatments Among Pediatric Chinese Participants With Spinal Muscular Atrophy Linked to Chromosome 5q (5q-SMA) | — | Active, not recruiting | — | Muscular Atrophy, Spinal | 600 | 2027-09-02 | in 379 d | 2025-09-03 |
| A Study of BIIB067 (Tofersen) Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 MutationNCT04856982Parts B and C: Percentage of Participants with Emergence of Clinically Manifest ALS Within 24 Months of Part B BaselineRandomized · Triple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: Tofersen, Placebo | Amyotrophic Lateral Sclerosis Associated With a SOD1 Gene Mutation | 158 | 2027-08-07 | in 353 d | 2026-03-30 |
| A Study to Find Out How Nusinersen is Processed in the Body When Given Through the ThecaFlex DRx™ System in Adult and Pediatric Participants With Spinal Muscular Atrophy (PIERRE-PK)NCT06555419Maximum Observed Concentration (Cmax) of Nusinersen Delivered via Standard LP and via ThecaFlex DRx SystemOpen-label · Treatment | Phase 1 | Recruiting | Drug: Nusinersen · Device: ThecaFlex DRx System | Muscular Atrophy, Spinal | 58 | 2027-06-25 | in 310 d | 2026-03-18 |
| A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)NCT06935357Percent Change From Baseline in Proteinuria as Measured by the Urine Protein: Creatinine Ratio (UPCR)Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Felzartamab, Placebo | Immunoglobulin A Nephropathy (IgAN) | 454 | 2027-05-31 | in 285 d | 2026-08-19 |
| A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Chinese Participants With SOD-1 Amyotrophic Lateral Sclerosis (ALS)NCT07223723Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Open-label · Treatment | Phase 4 | Active, not recruiting | Drug: Tofersen | Amyotrophic Lateral Sclerosis | 12 | 2027-05-26 | in 280 d | 2026-08-13 |
| A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisNCT03958877Part 1: Annualized Relapse Rate (ARR) at Week 48Randomized · Open-label · Treatment | Phase 3 | Active, not recruiting | Drug: BIIB017 (peginterferon beta-1a), Interferon beta type 1a | Multiple Sclerosis, Relapsing-Remitting | 152 | 2027-05-20 | in 274 d | 2025-09-11 |
| A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting ZuranoloneNCT07398469observationalChange From Baseline in the Edinburgh Postnatal Depression Scale (EPDS) Score at Day 15 | — | Recruiting | Drug: Zuranolone | Postpartum Depression | 200 | 2027-03-29 | in 222 d | 2026-02-10 |
| Observational, Postmarketing Surveillance Study of Spinraza Injection (Nusinersen Sodium)NCT04317794observationalNumber of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | — | Active, not recruiting | Drug: Nusinersen Sodium Injection | Muscular Atrophy, Spinal | 74 | 2027-02-05 | in 170 d | 2026-07-27 |
| A Study to Learn More About the Safety of BIIB145 and How it is Processed in the Body of Healthy Adult ParticipantsNCT07225517Parts A, B, and C: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Randomized · Quadruple-masked · Treatment | Phase 1 | Recruiting | Drug: BIIB145, Placebo | Healthy Volunteer | 104 | 2027-02-02 | in 167 d | 2026-02-06 |
| A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)NCT06685757Part A: Percentage of Participants Who Achieve Biopsy-proven Histologic Resolution (BPHR)Randomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: Felzartamab, Placebo | Antibody-mediated Rejection | 132 | 2026-12-01 | in 104 d | 2026-06-05 |
| A Study Utilising Data From European Union (EU) National Multiple Sclerosis (MS) Registries to Assess the Incidence of Anti-Natalizumab Antibody Among Participants Who Receive Subcutaneous Administration of Natalizumab for Treatment of Relapsing-remitting Multiple Sclerosis (RRMS)NCT05925049observationalPercentage of Participants in Natalizumab-Naive and Other MS mAb-Naive Cohort who Start Taking Natalizumab Injections and Develop Anti-Natalizumab Antibodies (ANAs) | — | Active, not recruiting | Drug: Natalizumab | Multiple Sclerosis | 400 | 2026-10-31 | in 73 d | 2026-05-13 |
| A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus ErythematosusNCT05531565Parts A: Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1Randomized · Quadruple-masked · Treatment | Phase 2/3 | Active, not recruiting | Drug: Litifilimab, Placebo | Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus | 450 | 2026-10-20 | in 62 d | 2026-08-13 |
| A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus ErythematosusNCT04895241Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52Randomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: Litifilimab, Placebo | Lupus Erythematosus, Systemic | 548 | 2026-09-30 | in 42 d | 2026-02-10 |
| A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus ErythematosusNCT04961567Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52Randomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: Litifilimab, Placebo | Lupus Erythematosus, Systemic | 562 | 2026-09-27 | in 39 d | 2026-01-29 |
| A Study to Learn More About How Zuranolone Affects Postpartum Depression Symptoms in Participants Who Took it Within 1 Year After The End of Their PregnancyNCT07047820observationalChange From Baseline in Edinburgh Postnatal Depression Scale (EPDS) at Day 15 | — | Recruiting | Drug: Zuranolone | Depression, Postpartum | 200 | 2026-08-24 | in 5 d | 2025-08-03 |
| A Study to Learn About the Safety of BIIB142 and How it is Processed in the Body of Healthy Adult Participants Aged 18 to 55 Years OldNCT07133828Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Randomized · Double-masked · Treatment | Phase 1 | Recruiting | Drug: BIIB142, BIIB142-Matching Placebo | Healthy Volunteer | 78 | 2026-08-06 | — | 2026-05-06 |
| A Study to Learn About the Safety of Diranersen (BIIB080) Injections and Whether They Can Improve Symptoms of Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD Dementia Between 50 to 80 Years of AgeNCT05399888Dose response in Change From Baseline to Week 76 on the CDR-SBRandomized · Quadruple-masked · Treatment | Phase 2 | Active, not recruiting | Drug: Diranersen, Diranersen-matching placebo | Mild Cognitive Impairment Due to Alzheimer's Disease, Alzheimer's Disease Dementia | 416 | 2026-03-11actual | — | 2026-06-30 |
| A Study to Find Out How BIIB141 (Omaveloxolone) is Processed in the Body and to Learn More About Its Safety in Participants With Friedreich's Ataxia Aged 2 to 15 Years OldNCT06054893Part 1: Apparent Clearance (CL/F) of OmaveloxoloneNon-randomized · Open-label · Treatment | Phase 1 | Active, not recruiting | Drug: Omaveloxolone | Friedreich Ataxia | 33 | 2025-09-30actual | — | 2026-05-11 |
| Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)NCT02428218Time to first multiple sclerosis (MS) relapseRandomized · Double-masked · Treatment | Phase 3 | Withdrawnsponsor's stated reason: Feasibility | Drug: dimethyl fumarate, Placebo | Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis | 0 | Jan 2027 | ≤ 165 d | 2016-04-13 |
| A Study to Learn About the Long-Term Safety of Higher Doses of Nusinersen (BIIB058) Given as Injections to Participants With Spinal Muscular Atrophy (SMA) Who Took Part in an Earlier Nusinersen Trial (ONWARD)NCT04729907Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Non-randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Nusinersen | Muscular Atrophy, Spinal | 115 | 2026-07-30actual | — | 2026-08-11 |
| A Study to Learn How the Body Processes BIIB141 (Omaveloxolone) When Taken as a Capsule or as a Tablet Dissolved in Liquid, and to Learn About Its Safety in Healthy Adults Ages 18 to 55NCT07297199Maximum Observed Plasma Concentration (Cmax) of OmaveloxoloneRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Omaveloxolone | Healthy Volunteer | 70 | 2026-05-01actual | — | 2026-05-14 |
| A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different WaysNCT06741657Part 1 and 2: Maximum Observed Concentration (Cmax) of LitifilimabRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Litifilimab · Device: AI, OBI, PFS | Healthy Volunteer | 404 | 2026-03-10actual | — | 2026-05-26 |
| A Study to Learn About the Safety of BIIB122 Tablets and Whether They Can Slow the Worsening of Early-Stage Parkinson's Disease in Adults Between the Ages of 30 and 80NCT05348785Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score Over the Treatment PeriodRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: BIIB122, BIIB122-Matching Placebo | Parkinson Disease | 650 | 2026-03-09actual | — | 2026-06-04 |
| A Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled Diranersen (BIIB080) Co-administered With Diranersen in Healthy AdultsNCT06454721CNS Biodistribution of [89Zr]Zr-DFO-Diranersen Assessed as the Percentage of Dose Taken up by Each Region of Interest (ROI)Open-label · Treatment | Phase 1 | Completed | Drug: [89Zr]Zr-DFO-Diranersen, Diranersen | Healthy Volunteer | 5 | 2026-03-05actual | — | 2026-07-10 |
| A Study to Learn About the Safety of BIIB091 and Its Effect on Brain Inflammation When Taken Alone or With Diroximel Fumarate (DRF) in Adults With Relapsing Forms of Multiple Sclerosis (MS)NCT05798520Part 1: Number of Participants With Adverse Events (AEs)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: BIIB091, DRF, Placebo | Relapsing Forms of Multiple Sclerosis | 127 | 2026-02-10actual | — | 2026-02-20 |
| A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's Safety in Healthy Adults Aged 18 to 55NCT07149415Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of OmeprazoleOpen-label · Treatment | Phase 1 | Completed | Drug: Omaveloxolone, Omeprazole | Healthy Volunteer | 22 | 2025-10-16actual | — | 2025-10-23 |
| 802NP301 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal NeuralgiaNCT03070132Percentage of Participants Classified as Responders at Week 12 of the Double-Blind PeriodRandomized · Double-masked · Treatment | Phase 3 | Withdrawnsponsor's stated reason: Sponsor Decision | Drug: BIIB074, Placebo | Trigeminal Neuralgia | 0 | 2025-10-14 | — | 2023-05-06 |
| A Study to Learn About the Effect of Nusinersen (BIIB058) Given as Injections to Children With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Onasemnogene Abeparvovec (RESPOND)NCT04488133Total Hammersmith Infant Neurological Examination (HINE) Section 2 Motor Milestones ScoreOpen-label · Treatment | Phase 4 | Completed | Drug: Nusinersen | Muscular Atrophy, Spinal | 46 | 2025-10-09actual | — | 2025-10-14 |
| A Study to Learn How BIIB141 (Omaveloxolone) is Processed in the Body When Taken as Capsules Compared to Sprinkled on Yogurt in Healthy Adults Aged 18 to 55NCT07019064Maximum Observed Plasma Concentration (Cmax) of OmaveloxoloneRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Omaveloxolone | Healthy Volunteer | 52 | 2025-08-19actual | — | 2025-09-22 |
| 802NP302 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal NeuralgiaNCT03637387Percentage of Participants Classified as Responders at Week 12 of the Double- Blind PeriodRandomized · Quadruple-masked · Treatment | Phase 3 | Withdrawnsponsor's stated reason: Sponsor Decision | Drug: BIIB074, Placebo | Trigeminal Neuralgia | 0 | 2025-08-18 | — | 2023-05-06 |
| Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)NCT02283853results2026-05-19Part 1: Proportion of Participants Free of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) ScansRandomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: dimethyl fumarate, Interferon β-1a | Relapsing-Remitting Multiple Sclerosis | 156 | 2025-07-08actual | — | 2026-05-19 |
| A Study to Evaluate the Efficacy and Safety of BIIB131 for Participants With Ischemic Stroke Between 4.5 and 24 Hours After Last Known WellNCT05764122Part 1: Percentage of Participants with Arterial RevascularizationRandomized · Quadruple-masked · Treatment | Phase 2 | Withdrawnsponsor's stated reason: Sponsor decision | Drug: BIIB131, Placebo | Ischemic Stroke | 0 | 2025-07-07 | — | 2024-02-12 |
| TOPIK Study: A Study to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections in Natalizumab Treated ParticipantsNCT05236777observationalNumber of Participants With Progressive Multifocal Leukoencephalopathy (PML) who are Taking Natalizumab | — | Completed | Drug: Natalizumab | Multiple Sclerosis | 675 | 2025-04-30actual | — | 2025-05-13 |
| A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in ChinaNCT05658484Annualized Relapse Rate (ARR)Open-label · Treatment | Phase 4 | Completed | Drug: Dimethyl fumarate | Multiple Sclerosis | 60 | 2025-03-27actual | — | 2025-05-16 |
| A Study to Find Out How Multiple Doses of BIIB091 Affect the Electrical Activity of the Heart in Healthy ParticipantsNCT06574828Change From Baseline in QT Interval Corrected for Heart Rate (QTc) for BIIB091Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: BIIB091, Moxifloxacin, BIIB091-matched Placebo, Moxifloxacin-matched Placebo | Healthy Volunteer | 69 | 2025-03-22actual | — | 2025-03-28 |
| A Study to Find Out How BIIB141 (Omaveloxolone) Moves From the Blood Into the Breastmilk of Healthy Women Who Are Breastfeeding or Pumping MilkNCT06612879Maximum Observed Concentration (Cmax) of Omaveloxolone in Breast MilkOpen-label · Treatment | Phase 1 | Completed | Drug: Omaveloxolone | Healthy Volunteer | 12 | 2025-03-11actual | — | 2025-04-22 |
| A Study to Find Out How Different Forms of BIIB091 is Processed in The Body With and Without Food in Healthy ParticipantsNCT06640933Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB091Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: BIIB091 | Healthy Volunteer | 25 | 2025-02-07actual | — | 2025-02-18 |
| A Study of Multiple Doses of Nusinersen (ISIS 396443) Delivered to Infants With Genetically Diagnosed and Presymptomatic Spinal Muscular AtrophyNCT02386553results2025-10-20Time to Death or Respiratory InterventionOpen-label · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Nusinersen | Spinal Muscular Atrophy | 25 | 2024-12-17actual | — | 2025-10-20 |
| A Study to Assess New Participant's Perspectives Beyond Clinical Efficacy of Monoclonal Antibody-Based Relapsing Remitting Multiple Sclerosis (RRMS) TreatmentsNCT06127095observationalNumber of Participants who Perceived the Treatment Added Value of Natalizumab Assessed by Likert's Scale | — | Completed | — | Multiple Sclerosis, Relapsing-Remitting | 474 | 2024-11-28actual | — | 2024-12-18 |
| A Study of RTA 901 (BIIB143) in Participants With Diabetic Peripheral Neuropathic PainNCT05895552results2025-12-15Change From Baseline in Weekly Average Pain Intensity Assessed by the Numeric Pain Rating Scale (NPRS) at Week 12Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Sponsor decision to close study early; not due to safety concerns. | Drug: RTA 901, RTA 901-Matching Placebo | Diabetic Peripheral Neuropathic Pain | 209 | 2024-11-15actual | — | 2025-12-15 |
| Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)NCT05655507Plasma Concentrations of ZuranoloneOpen-label · Treatment | Phase 1 | Completed | Drug: Zuranolone | Major Depressive Disorder | 19 | 2024-10-18actual | — | 2025-03-26 |
| A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male ParticipantsNCT06262477results2025-10-06Maximum Observed Serum Concentration (Cmax) of TocilizumabRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: BIIB800, Actemra | Healthy Volunteer | 300 | 2024-09-25actual | — | 2025-10-06 |
| Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-β1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS)NCT04079088Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Double-masked · Treatment | Phase 2 | Withdrawnsponsor's stated reason: Decision to discontinue BIIB061 program was based on lack of stronger preclinical effects of BIIB061 on remyelination relative to opicinumab, that showed limited clinical efficacy in phase 2 clinical studies. This was not related to safety concerns. | Drug: Placebo, BIIB061, Glatiramer acetate · Biological: Interferon-beta1 | Relapsing Multiple Sclerosis | 0 | 2024-09-18 | — | 2023-06-01 |
| A Study of Diroximel Fumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis (RMS)NCT05083923results2025-10-24Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Diroximel fumarate | Relapsing Forms of Multiple Sclerosis | 136 | 2024-09-11actual | — | 2025-10-24 |
| A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic MutationNCT04494256results2025-10-09Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Terminatedsponsor's stated reason: Sponsor's decision | Drug: BIIB105, Placebo | Amyotrophic Lateral Sclerosis | 99 | 2024-08-13actual | — | 2025-10-09 |
| Long-Term Evaluation of BIIB067 (Tofersen)NCT03070119results2025-08-29Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious AEs (TESAEs)Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Tofersen | ALS Caused by Superoxide Dismutase 1 (SOD1) Mutation | 139 | 2024-08-12actual | — | 2025-08-29 |
| A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's DiseaseNCT05310071results2025-04-23Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 78Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Sponsor's Decision | Drug: Aducanumab, Placebo | Alzheimer's Disease | 1,027 | 2024-08-12actual | — | 2025-04-23 |
| A Study of End of Dose Phenomena in Subcutaneous Natalizumab Treated Multiple Sclerosis (MS) ParticipantsNCT05701423observationalPercentage of Participants who Develop End of Dose Symptoms (EOD) Under NTZ | — | Terminatedsponsor's stated reason: Due to low enrolment the sponsor decided to terminate the study | Drug: Natalizumab | Multiple Sclerosis | 34 | 2024-07-31actual | — | 2024-09-19 |
| A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205NCT04241068results2025-02-21Core Treatment Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Sponsor's Decision | Drug: Aducanumab | Alzheimer's Disease | 1,696 | 2024-07-22actual | — | 2025-02-21 |
| Virtual Reality for the Mitigation of Anxiety During Intrathecal Administration in Participants With Spinal Muscular AtrophyNCT05354414Visual Analog Scale for Anxiety (VAS-A) Score During IT as Evaluated by the Participant Just After ITRandomized · Open-label · Supportive care | Not applicable | Completed | Device: Virtual reality · Procedure: Standard of Care | Spinal Muscular Atrophy (SMA) | 63 | 2024-07-12actual | — | 2025-04-02 |
| A Study to Assess the Potential for Gastric-pH Dependent Drug-Drug Interactions of BIIB122 With a Proton Pump Inhibitor in Healthy ParticipantsNCT06264440Maximum Observed Concentration (Cmax) of BIIB122Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: BIIB122, Rabeprazole | Healthy Volunteer | 18 | 2024-06-18actual | — | 2024-07-19 |
| A Study to Look at How a Single Oral Dose of Carbon-14-Labelled [14C] BIIB091 Moves Through and is Processed by the Body in Healthy Male ParticipantsNCT06311786Amount of BIIB091 Excreted per Sampling Interval in Urine (Aeu)Open-label · Treatment | Phase 1 | Completed | Drug: [14C]-BIIB091 | Healthy Volunteer | 8 | 2024-05-11actual | — | 2024-05-23 |
| A Study for Tysabri Participant PreferenceNCT05304520observationalNumber of Participants by Their Preferred Method of Natalizumab Administration at Month 6 | — | Completed | Drug: Natalizumab | Relapsing-Remitting Multiple Sclerosis (RRMS) | 318 | 2024-04-30actual | — | 2024-05-17 |
| A Study to Explore Association Patterns Between Digital Outcome Assessments From the Konectom™ Platform and Magnetic Resonance Imaging (MRI) Measures of Brain Tissue DamageNCT05106465observationalCorrelation Between Konectom Tests and MRI Measures of Brain Tissue Damage | — | Completed | Device: Konectom platform | Multiple Sclerosis (MS) | 200 | 2024-04-03actual | — | 2024-05-17 |
| Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB107 in Healthy Adult ParticipantsNCT04593121Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs): Single Ascending Dose (SAD)Randomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: BIIB107, Placebo | Healthy Volunteers | 84 | 2024-03-05actual | — | 2024-04-15 |
| Study of Nusinersen (BIIB058) in Participants With Spinal Muscular AtrophyNCT04089566results2025-06-05Part B Infantile-onset SMA: Change From Baseline in CHOP-INTEND Total Score for 50/28mg Nusinersen Versus CS3B Matched Sham Control GroupRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Nusinersen | Muscular Atrophy, Spinal | 145 | 2024-02-21actual | — | 2025-06-05 |
| A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered Subcutaneously to Japanese Participants With Relapsing-Remitting Multiple SclerosisNCT05265728results2025-11-25Part 1: Cumulative Number of New Active Lesions up to Week 24 Identified Using Brain Magnetic Resonance Imaging (MRI) ScansOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Due to sponsor decision, not for efficacy or safety reasons. | Drug: Natalizumab | Multiple Sclerosis, Relapsing-Remitting | 21 | 2024-01-18actual | — | 2025-11-25 |
| Tysabri Observational Cohort Study - Multiple Sclerosis (MS) RegistriesNCT03399981observationalProspective and Retrospective Analyses: Number of Participants with Confirmed Progressive Multifocal Leukoencephalopathy (PML) | — | Completed | Biological: Tysabri | Progressive Multifocal Leukoencephalopathy | 80,327 | 2023-12-31actual | — | 2024-03-19 |
| Non-Interventional, Postmarketing Surveillance Study of Nusinersen Sodium InjectionNCT04419233observationalNumber of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | — | Completed | Drug: Nusinersen Sodium Injection | Muscular Atrophy, Spinal | 50 | 2023-11-21actual | — | 2023-12-07 |
| Tysabri Observational ProgramNCT00493298observationalNumber of Participants with Serious Adverse Events (SAE) | — | Completed | Drug: Tysabri | Relapsing-Remitting Multiple Sclerosis | 6,620 | 2023-11-01actual | — | 2024-04-08 |
| A Study to Investigate the Radiological Onset of Action After Treatment Initiation With Subcutaneous (SC) Natalizumab in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)NCT05532163Cumulative Number of Active Lesions (CUALs) Through Week 24Open-label · Treatment | Phase 4 | Terminatedsponsor's stated reason: Sponsor's decision | Drug: Natalizumab | Multiple Sclerosis, Relapsing-Remitting | 1 | 2023-10-09actual | — | 2024-06-21 |
| Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis ParticipantsNCT04832399observationalOverall Disease-Free Status at Month 12 | — | Completed | Drug: Natalizumab | Relapsing Remitting Multiple Sclerosis | 60 | 2023-10-02actual | — | 2024-02-05 |
| Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2)-Related Multiple Sclerosis (MS) Vaccination StudyNCT05197699observationalNumber of Participants who Developed an Immune Response to Their Last SARS-CoV-2-Vaccination | — | Terminatedsponsor's stated reason: Sponsor's decision | — | Multiple Sclerosis (MS) | 160 | 2023-09-30actual | — | 2024-04-17 |
| An Observational Study Using Multimodal Sensors to Measure Cognitive Health in Adults and Distinguish Mild Cognitive Impairment From Normal AgingNCT05058950observationalSensitivity and Specificity of the Classifier in Distinguishing Between Individuals With and Without MCI | — | Terminatedsponsor's stated reason: Study was terminated early as part of Biogen's ongoing research and development portfolio management efforts. | — | Mild Cognitive Impairment, Normal Aging | 22,720 | 2023-09-19actual | — | 2023-09-21 |
| A TQTc Study for OmaveloxoloneNCT05927649Change from baseline in placebo-corrected QTcF (∆∆QTcF)Randomized · Triple-masked · Basic science | Phase 1 | Completed | Drug: Omaveloxolone, Moxifloxacin | Health Adult Subjects | 30 | 2023-09-01actual | — | 2025-05-30 |
| An Open-label DDI Study of Omaveloxolone in Healthy SubjectsNCT05909644Maximum concentration (Cmax) of omaveloxoloneOpen-label · Treatment | Phase 1 | Completed | Drug: Omaveloxolone, Efavirenz | Healthy Adult Subjects | 20 | 2023-08-30actual | — | 2025-05-30 |
| A Natural History Study of Participants With Potassium Sodium-Activated Channel Subfamily T Member 1 (KCNT1)-Related EpilepsyNCT04924153observationalNumber of Seizures in Participants with KCNT1-Related Epilepsy, Assessed by Type | — | Completed | Other: No Intervention | KCNT1-Related Epilepsy | 35 | 2023-08-29actual | — | 2024-02-28 |
| An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)NCT03749447results2024-03-19Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Discontinuation of all bardoxolone chronic kidney disease programs | Drug: Bardoxolone methyl | Chronic Kidney Diseases, Alport Syndrome, Autosomal Dominant Polycystic Kidney | 270 | 2023-08-23actual | — | 2025-06-03 |
| A Study for Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in Nusinersen (ISIS 396443) Investigational StudiesNCT02594124results2024-10-22Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: nusinersen | Spinal Muscular Atrophy | 292 | 2023-08-21actual | — | 2024-10-22 |
| A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCONNCT03918447results2024-06-11Off-treatment Period: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 108Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Discontinuation of all bardoxolone chronic kidney disease programs | Drug: Bardoxolone methyl oral capsule, Placebo oral capsule | Autosomal Dominant Polycystic Kidney, ADPKD | 667 | 2023-08-08actual | — | 2025-06-03 |
| A Study to Assess if BIIB122 Tablets Are Safe and Can Slow Worsening of Early-Stage Parkinson's Disease in Participants With Specific LRRK2 Genetic Variants Between the Ages of 30 and 80 Using the Movement Disorder Society-Unified Parkinson's Disease Rating ScaleNCT05418673results2024-06-26Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and IIIRandomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Sponsor Decision | Drug: BIIB122, BIIB122-Matching Placebo | Parkinson Disease | 7 | 2023-07-27actual | — | 2024-06-26 |
| A Pharmacokinetics and Safety Study of BIIB132 in Adults With Spinocerebellar Ataxia 3NCT05160558Number of Participants with Adverse Events (AEs)Randomized · Quadruple-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: Sponsor's Decision | Drug: BIIB132, BIIB132-Matching Placebo | Spinocerebellar Ataxia Type 3 | 8 | 2023-07-25actual | — | 2023-08-04 |
| A Study to Assess the Clinical Validity of Konectom™ in Adults Living With Neuromuscular DisordersNCT05109637Type of Correlation of Konectom DOAs Versus Hammersmith Functional Motor Scale-Expanded (HFMSE) Total Score in PwSMANon-randomized · Open-label · Other | Not applicable | Completed | Device: Konectom NMD Application | Spinal Muscular Atrophy | 93 | 2023-07-10actual | — | 2024-02-06 |
| A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics, With Target Occupancy Study of BIIB113 in Healthy ParticipantsNCT05195008Parts A, B and C: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: BIIB113, BIIB113-Matching Placebo, 11^C]BIO-1819578 | Healthy Volunteer | 72 | 2023-07-10actual | — | 2024-02-05 |
| A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)NCT03864614results2024-07-18Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan: Part A: Statistical Analysis Plan ↗ · Statistical Analysis Plan: Part B: Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: SAGE-217 | Major Depressive Disorder | 1,515 | 2023-06-22actual | — | 2024-08-27 |
| Study of Diroximel Fumarate in the Real-World SettingNCT04746976observationalPercentage of Participants on Treatment with DRF at 1 Year | — | Terminatedsponsor's stated reason: Sponsor's Decision | Drug: Diroximel Fumarate | Relapsing Forms of MS | 75 | 2023-04-14actual | — | 2023-05-26 |
| Exploring Diroximel Fumarate Real-world Experience in Canada and IsraelNCT04948606observationalPercentage of Participants on Treatment with DRF | — | Terminatedsponsor's stated reason: Sponsor Decision | Drug: Diroximel Fumarate | Relapsing Forms of MS | 64 | 2023-04-14actual | — | 2023-05-10 |
| A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab AdministrationNCT03689972results2024-06-12Part 1: Mean Number of New or Newly Enlarging T2 Hyperintense Lesions at Week 72Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Natalizumab, Natalizumab | Multiple Sclerosis, Relapsing-Remitting | 585 | 2023-01-31actual | — | 2024-06-12 |
| MS PATHS Normative Sub-StudyNCT02996084observationalBrain volume | — | Completed | — | Healthy Volunteer | 246 | 2022-12-31actual | — | 2023-02-24 |
| Feasibility of the Multiple Sclerosis Performance Test in Participants With Multiple SclerosisNCT03926637observationalPercentage of Participants Completing All Modules | — | Terminatedsponsor's stated reason: Biogen will stop any further development of the MSPT. The data collected thus far in the MSPT Feasibility Study allow us to answer the primary study objectives that are associated with assessing the feasibility of the MSPT in a clinical care setting. | Other: Multiple Sclerosis Performance Test (MSPT) | Multiple Sclerosis | 3,073 | 2022-12-05actual | — | 2023-01-30 |
| Dimethyl Fumarate (DMF) Observational StudyNCT02047097observationalThe number of participants that experience Adverse Events (AEs) that lead to discontinuation of dimethyl fumarate (DMF) | — | Completed | Drug: dimethyl fumarate | Multiple Sclerosis | 5,487 | 2022-10-31actual | — | 2023-05-24 |
| Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEPNCT04221191observationalPercentage of Participants with Oral Dimethyl Fumarate (DMF) Persistence at 6 Months | — | Completed | Drug: Dimethyl Fumarate · Other: PSP | Multiple Sclerosis, Relapsing-Remitting | 353 | 2022-09-14actual | — | 2023-08-01 |
| Study of BIIB091 Formulations in Healthy ParticipantsNCT04564612Parts 1 and 1B: Time Prior to the First Measurable Concentration (Tlag) of BIIB091Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: BIIB091, Rabeprazole, Itraconazole | Healthy Volunteers | 59 | 2022-09-07actual | — | 2023-04-18 |
| A Study to See How BIIB122 Works in the Human Body, and to Evaluate it's Safety, and Tolerability in Healthy Adult Japanese, Chinese, and Caucasian ParticipantsNCT05229562Maximum Observed Plasma Concentration (Cmax) of BIIB122Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: BIIB122 | Healthy Volunteer | 84 | 2022-09-07actual | — | 2023-04-18 |
| A Study to Assess the Pharmacokinetic (PK) Comparability of 2 Fixed Subcutaneous (SC) Doses of Aducanumab (BIIB037) With a Single, Weight-Based Intravenous (IV) Dose in Healthy VolunteersNCT05216887Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of AducanumabRandomized · Open-label · Treatment | Phase 1 | Completed | Biological: Aducanumab | Healthy Volunteer | 123 | 2022-07-27actual | — | 2023-04-18 |
| Validation of DigiCog and Konectom Tools to Support Digitalized Clinical Assessment in Multiple SclerosisNCT04756700Raw Score of the Computerized Speed Cognitive Test (CSCT) using DigiCog (BCCAMS app)Randomized · Open-label · Treatment | Not applicable | Completed | Diagnostic test: DigiCog (BCCAMS app), Konectom Application | Multiple Sclerosis | 158 | 2022-07-26actual | — | 2023-04-18 |
| Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric ParticipantsNCT03870763results2023-05-16Time to First RelapseRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Decision to stop the trial was based on long-term difficulties in fulfilling our enrolment commitments and changes in paediatric MS landscape which no longer support placebo-controlled trials.Decision to stop study was not based on safety concerns. | Drug: Dimethyl Fumarate, Peginterferon Beta-1a, Placebo | Multiple Sclerosis, Relapsing-Remitting | 11 | 2022-07-21actual | — | 2023-06-15 |
| One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort StudyNCT03662919observationalPercentage of Participants who are Still Treated with Either Flixabi or Imraldi at 12 Months | — | Completed | Drug: Infliximab, Adalimumab | Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, Crohn's Disease, Colitis, Ulcerative | 2,274 | 2022-06-30actual | — | 2022-10-18 |
| A Safety Study of Retinal Gene Therapy for Choroideremia With Administration of BIIB111NCT03507686results2023-09-18Mean Best-Corrected Visual Acuity (BCVA) as Measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) Chart in Letters at Month 12Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: BIIB111 | Choroideremia | 66 | 2022-06-29actual | — | 2024-02-23 |
| A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (DRF) in Chinese and Caucasian Adult Healthy ParticipantsNCT05127564Maximum Observed Concentration (Cmax) of Monomethyl Fumarate (MMF)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Diroximel fumarate | Healthy Volunteers | 32 | 2022-06-09actual | — | 2022-07-05 |
| An Observational Study of Aducanumab-avwa in Participants With Alzheimer's Disease in the USNCT05097131observationalChange from Baseline in Quick Dementia Rating Scale Informant Version & Patient Version (QDRS-IV/PV) Score | — | Terminatedsponsor's stated reason: As a result of the national policy for coverage, it is expected there will be limited aducanumab-avwa prescription and usage in routine clinical practice making the study not feasible for enrollment. | — | Alzheimers Disease | 29 | 2022-05-20actual | — | 2023-04-18 |
| Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults C9ORF72-Associated Amyotrophic Lateral Sclerosis (ALS)NCT04288856Number of Participants with Adverse Events (AEs)Non-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: There was no evidence of benefit across efficacy endpoints in the randomized trial, 245AS101. Accordingly, Biogen has made the difficult decision to discontinue the BIIB078 program including this open label extension trial, 245AS102. | Drug: BIIB078 | Amyotrophic Lateral Sclerosis | 75 | 2022-05-03actual | — | 2023-04-18 |
| A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)NCT03745820results2023-04-18Change From Baseline in Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Working Memory Domain Score at Week 12Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: BIIB104 · Other: Placebo | Cognitive Impairment Associated With Schizophrenia | 195 | 2022-03-23actual | — | 2023-04-18 |
| A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)NCT04442503results2023-06-22Change From Baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: SAGE-217, Placebo | Depression, Postpartum | 200 | 2022-03-15actual | — | 2023-11-30 |
| Biogen Multiple Sclerosis Pregnancy Exposure RegistryNCT01911767observationalPregnancy Loss | — | Completed | Drug: Dimethyl fumarate, Peginterferon beta-1a | Multiple Sclerosis, Exposure During Pregnancy | 408 | 2022-02-10actual | — | 2022-06-21 |
| A Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB104 and Assess the Effect of Food on the Pharmacokinetics of BIIB104 Following Administration of a Single, Fixed, Oral Dose of BIIB104 in Healthy ParticipantsNCT05152485Area Under the Plasma Concentration-Time Curve from Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB104Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: BIIB104 Reference Formulation, BIIB104 Test Formulation | Healthy Volunteers | 36 | 2022-01-31actual | — | 2023-04-18 |
| A Study to Evaluate Safety and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese ParticipantsNCT05148481Maximum Observed Concentration (Cmax) of BIIB104Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: BIIB104, Placebo | Healthy Volunteer | 31 | 2022-01-30actual | — | 2023-04-18 |
| Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic PolyneuropathyNCT04106050Change in Nerve Excitability from Baseline (Day 1) to Last Treatment Visit (Day 8) as Determined by Compound Muscle Action Potential Threshold Tracking (CMAP-TT) in the Median Nerve of Healthy ParticipantsRandomized · Triple-masked · Treatment | Phase 1 | Withdrawnsponsor's stated reason: Sponsor Decision | Drug: BIIB095, BIIB074, Placebo, Lidocaine | Healthy Volunteers, Diabetic Neuropathies | 0 | 2022-01-21 | — | 2021-03-22 |
| Plegridy Observational ProgramNCT02230969observationalSafety as measured by the incidence proportion of SAEs | — | Completed | Drug: peginterferon beta-1a | Relapsing Forms of Multiple Sclerosis | 1,208 | 2022-01-20actual | — | 2022-09-26 |
| Angelman Syndrome (AS) Biomarker StudyNCT04103333Ubiquitin-Protein Ligase E3A (UBE3A) Protein Levels in Each Age GroupNon-randomized · Open-label · Diagnostic | Early Phase 1 | Completed | Procedure: Lumbar Puncture, Blood Collection | Angelman Syndrome, Chromosome 15q Duplication (dup15q) Syndrome | 20 | 2022-01-02actual | — | 2022-01-28 |
| A Real-world Study of Imraldi® UseNCT04089514observationalCandidate Predictors of Persistence on Adalimumab | — | Completed | Drug: Adalimumab | Arthritis, Rheumatoid (RA), Axial Spondyloarthritis (axSpA), Arthritis, Psoriatic (PsA), Crohn's Disease (CD), Colitis, Ulcerative (UC) | 1,000 | 2021-11-30actual | — | 2023-04-18 |
| A Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB078 in Adults With C9ORF72-Associated Amyotrophic Lateral SclerosisNCT03626012Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: BIIB078, Placebo | Amyotrophic Lateral Sclerosis | 106 | 2021-11-17actual | — | 2022-01-14 |
| A Study of Mass Balance, Pharmacokinetics, Metabolite Profile, and Metabolite Identification of BIIB122/DNL151 in Healthy Male SubjectsNCT05119790Mass balance (total recovery) following oral administration of a single dose of [14C] BIIB122 ([14C]-DNL151)Open-label · Treatment | Phase 1 | Completed | Drug: [14C] BIIB122 ([14C] DNL151) | Healthy Volunteers | 7 | 2021-11-05actual | — | 2021-12-07 |
| A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive DisorderNCT04476030results2023-11-07Change From Baseline in the HAMD-17 Total Score at Day 3Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: SAGE-217, Matching Placebo, Sertraline, Escitalopram, Citalopram, Duloxetine, Desvenlafaxine | Depressive Disorder, Major | 440 | 2021-10-25actual | — | 2023-12-22 |
| A Trial of Bardoxolone Methyl in Patients With CKD at Risk of Rapid Progression (MERLIN)NCT04702997results2022-12-01Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Bardoxolone methyl oral capsule, Placebo oral capsule | Chronic Kidney Diseases | 81 | 2021-10-20actual | — | 2025-06-03 |
| Study to Investigate Pregnancy Outcomes in Female Participants Exposed to Subcutaneous (SC) Peginterferon Beta-1a and Intramuscular (IM) Interferon Beta-1a Reported in a German Participant Support ProgramNCT04655222observationalPercentage of Participants With Live Births Without Congenital Anomalies | — | Completed | Drug: Interferon Beta Therapy | Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting | 470 | 2021-10-15actual | — | 2023-04-18 |
| MS PATHS COVID-19 Questionnaire Data Linkage Sub-StudyNCT05058729observationalNumber of Completed COVID-19 Questionnaires Able to be Linked to a MS PATHS Participant Identifier (ID) | — | Completed | — | Multiple Sclerosis (MS) | 1,507 | 2021-10-08actual | — | 2023-04-18 |
| A Study to Assess Absolute Bioavailability of Aducanumab in Healthy VolunteersNCT04924140Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of AducanumabRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Aducanumab | Healthy Volunteers | 30 | 2021-10-01actual | — | 2023-04-13 |
| A Study to Assess Choroideremia (CHM) Health OutcomesNCT04750785observationalTime to Disease Progression by Age in Participants with CHM | — | Completed | Other: No Intervention | Choroideremia | 46 | 2021-09-27actual | — | 2021-10-14 |
| A Study to Determine the Absolute Bioavailability of BIIB122/DNL151 in Healthy SubjectsNCT05005338PK Parameter: The first time to maximum observed concentration (Tmax) of BIIB122 (DNL151) in plasma following oral administrationOpen-label · Treatment | Phase 1 | Completed | Drug: BIIB122 (DNL151), [14C] BIIB122 ([14C] DNL151) | Healthy Volunteers | 8 | 2021-09-23actual | — | 2021-11-17 |
| Phase 2 Study of BIIB092 in Participants With Early Alzheimer's DiseaseNCT03352557results2022-11-08PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan: Placebo-Controlled Period ↗ · Statistical Analysis Plan: Long-Term Extension Period ↗ | Phase 2 | Terminatedsponsor's stated reason: The study (NCT03352557) was terminated based on lack of efficacy following the placebo-controlled period readout. | Drug: BIIB092, Placebo | Alzheimer's Disease | 654 | 2021-08-30actual | — | 2022-11-08 |
| An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 (Tofersen) in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)NCT02623699results2023-07-28Parts A and B: Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Tofersen, Placebo | Amyotrophic Lateral Sclerosis | 176 | 2021-07-16actual | — | 2023-07-28 |
| A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB100 Administered Orally to Adults With Amyotrophic Lateral SclerosisNCT03945279Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: BIIB100, Placebo | Amyotrophic Lateral Sclerosis | 49 | 2021-06-21actual | — | 2023-04-18 |
| Real World Analysis on Lymphocyte Reconstitution After Lymphopenia in Participants Treated by TecfideraNCT04756687observationalTime to ALC Reconstitution After DMF Discontinuation | — | Completed | Drug: Dimethyl fumarate | Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting | 1,507 | 2021-06-15actual | — | 2023-10-23 |
| A Study to Evaluate Safety, Tolerability, and Distribution of a Microdose of Radiolabeled BIIB067 (99mTc-MAG3-BIIB067) Co-administered With BIIB067 (Tofersen) to Healthy AdultsNCT03764488BIIB067 Concentrations Throughout the CNSNon-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: Tofersen, 99mTc-MAG3-BIIB067 | Healthy Volunteers | 8 | 2021-06-10actual | — | 2023-06-22 |
| A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1NCT02634307results2022-06-24Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: ALKS 8700 | Multiple Sclerosis | 1,057 | 2021-06-01actual | — | 2022-07-26 |
| Natural Disease Progression in Participants With ChoroideremiaNCT04795206observationalPercentage of Participants with Progression of Best Corrected Visual Acuity (BCVA) in Relation to Age | — | Completed | Other: No Intervention | Choroideremia | 1,178 | 2021-05-07actual | — | 2021-09-08 |
| A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Participants With Parkinson's DiseaseNCT03716570Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Triple-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: Affiliated study NCT03318523 did not meet its primary outcome measure of change from baseline measured by Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and did not demonstrate efficacy on secondary outcome measures | Drug: BIIB054, Placebo | Parkinson's Disease | 24 | 2021-04-23actual | — | 2021-05-25 |
| Efficacy and Safety Study of BIIB074 in Participants With Small Fiber NeuropathyNCT03339336Change from Baseline in Weekly Mean Average Daily Pain (ADP) ScoreRandomized · Quadruple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Sponsor decision to close study early; not due to safety concerns | Drug: BIIB074, Placebo | Small Fiber Neuropathy, Diabetes Mellitus | 265 | 2021-04-12actual | — | 2021-05-05 |
| A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB133 (Dapirolizumab Pegol) in Healthy Japanese and Caucasian ParticipantsNCT04571424Number of Participants with Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: BIIB133 (Dapirolizumab pegol), Placebo | Healthy Volunteers | 33 | 2021-04-08actual | — | 2023-04-18 |
| A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD)NCT04442490results2023-12-05Change From Baseline in the 17-item HAM-D Total Score at Day 15Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: SAGE-217, Placebo | Depressive Disorder, Major | 543 | 2021-03-26actual | — | 2023-12-22 |
| Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)NCT03222973results2022-04-28Part 1: Overall Response ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: The top-line results from the Part 1 did not meet the pre-specified primary endpoint nor the key secondary endpoints. The decision to discontinue study 215MS202 Part 2 was not based on safety concerns. | Drug: BIIB033 (opicinumab), Placebo | Multiple Sclerosis | 263 | 2021-02-12actual | — | 2022-04-28 |
| Study to Evaluate DNL151 in Subjects With Parkinson's DiseaseNCT04056689Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: DNL151, Placebo | Parkinson's Disease | 36 | 2020-12-02actual | — | 2023-04-18 |
| Efficacy and Safety of BIIB111 for the Treatment of ChoroideremiaNCT03496012results2023-12-07Percentage of Participants With a ≥15 -Letter Improvement From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 as Measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) ChartRandomized · Single-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Genetic: BIIB111 | Choroideremia | 169 | 2020-12-01actual | — | 2023-12-07 |
| A Clinical Trial of Retinal Gene Therapy for X-linked Retinitis Pigmentosa Using BIIB112NCT03116113results2024-01-18Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Biological: BIIB112 | X-Linked Retinitis Pigmentosa | 50 | 2020-11-18actual | — | 2024-01-18 |
| A Study to Explore Pharmacodynamic Effects of BIIB104 on Brain Circuitry in Healthy ParticipantsNCT04068532Change From Baseline in Faces Versus Shapes Emotional Faces Task Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Contrasts to Day 4 Within a Priori Defined Regions of InterestRandomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: Placebo, BIIB104 | Healthy Volunteers | 30 | 2020-11-11actual | — | 2021-03-22 |
| Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current TherapyNCT03177083Combined Counts of Adverse Events (AEs) of Flu-Like Symptoms (FLS)Randomized · Open-label · Treatment | Phase 4 | Completed | Drug: peginterferon beta-1a, interferon beta-1a, interferon beta-1b | Relapsing Remitting Multiple Sclerosis | 80 | 2020-10-26actual | — | 2020-11-25 |
| Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's DiseaseNCT03318523results2021-11-23Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: SPARK did not meet it's primary outcome measure for year 1 and failed to meet secondary outcome measures resulting in the development of BIIB054 (cinpanemab) for Parkinson's disease to be discontinued and SPARK study was closed. | Drug: Placebo, BIIB054 | Parkinson's Disease | 357 | 2020-10-26actual | — | 2022-02-28 |
| A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINALNCT03019185results2023-10-11Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 12 Weeks of Treatment (Phase 2)Randomized · Triple-masked · TreatmentStudy Protocol: US Protocol ↗ · Study Protocol: US Protocol Addendum ↗ · Study Protocol: Europe Protocol ↗ · Study Protocol: Germany Protocol ↗ · Study Protocol: France Spain UK Protocol ↗ · Study Protocol: France Spain UK Protocol Addendum ↗ · Statistical Analysis Plan: Phase 2 SAP ↗ · Statistical Analysis Plan: Phase 3 SAP ↗ | Phase 2/3 | Completed | Drug: Placebo Oral Capsule, Bardoxolone Methyl | Alport Syndrome | 187 | 2020-10-06actual | — | 2025-06-11 |
| Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGERNCT03068130results2023-10-12Long Term Safety as Measured by Incidence and Severity of Adverse Events During the Duration of the StudyOpen-label · TreatmentStudy Protocol: US Protocol ↗ · Study Protocol: Japan Protocol ↗ · Study Protocol: UK Protocol ↗ · Study Protocol: Germany Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: The company determined that continued exposure of these high-risk PH patients to clinic or in-person visits during the COVID pandemic presented an unacceptable risk. | Drug: Bardoxolone methyl | Pulmonary Hypertension | 261 | 2020-09-30actual | — | 2025-06-11 |
| Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYSTNCT02657356results2023-05-19Change From Baseline in Six-minute-walk Distance (6MWD) Relative to Placebo at Week 24Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Exposure of these high-risk patients to clinic or in-person visits during the pandemic presented an unacceptable risk to their health | Drug: Placebo capsules, Bardoxolone methyl capsules | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension | 202 | 2020-05-07actual | — | 2025-06-04 |
| Quantitative Magnetic Resonance Imaging (MRI) Sub-Study of MS PATHSNCT04145284observationalRadiologist Assessment of the Performance of the MS MRI Metrics Software Prototype by the Number of Approve or Reject Decision | — | Completed | — | Multiple Sclerosis | 6 | 2020-04-30actual | — | 2021-03-24 |
| Extension Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PSP) Who Participated in CN002003NCT02658916Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, DeathsNon-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: 251PP301(NCT03068468) primary endpoint was not met;further development of Gosuranemab BIIB092 in progressive supranuclear palsy will not be pursued. | Drug: BIIB092 | Supranuclear Palsy, Progressive | 47 | 2020-03-31actual | — | 2020-05-18 |
| Single-Ascending-Dose Study of BIIB076 in Healthy Volunteers and Participants With Alzheimer's DiseaseNCT03056729Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: BIIB076, Placebo | Alzheimer's Disease, Healthy Volunteer | 46 | 2020-03-03actual | — | 2020-03-24 |
| A Pharmacokinetic Study of Omaveloxolone in Subjects With Hepatic Impairment and Normal Hepatic FunctionNCT03902002Maximum concentration (Cmax) of omaveloxolone in plasmaNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Omaveloxolone 50 mg capsules | Hepatic Impairment | 48 | 2020-01-27actual | — | 2025-05-30 |
| Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal EpilepsyNCT03283371results2021-04-27Change From Baseline in Log-Transformed Seizure Frequency During Weeks 8 to 24 of TreatmentRandomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Natalizumab · Other: Placebo | Epilepsy, Focal Seizures, Partial Seizures | 67 | 2020-01-11actual | — | 2021-12-14 |
| A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult ParticipantsNCT03943056Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: BIIB091, Placebo | Healthy Volunteer | 64 | 2020-01-10actual | — | 2021-03-22 |
| A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive DisorderNCT04007367results2022-10-03Time to Relapse During the DB PhaseRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Internal company decision | Drug: SAGE-217, Placebo | Major Depressive Disorder | 53 | 2020-01-06actual | — | 2023-11-29 |
| Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese ParticipantsNCT04079101Maximum Observed Concentration of BIIB104Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: BIIB104, Placebo | Healthy Volunteers | 31 | 2019-12-27actual | — | 2021-03-24 |
| A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and InsomniaNCT03771664results2022-10-20Average Change From Baseline in Sleep Efficiency (SE) as Assessed by Polysomnogram (PSG) at Days 13 and 14Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: internal company decision | Drug: SAGE-217, Placebo | Major Depressive Disorder, Insomnia | 87 | 2019-12-20actual | — | 2023-11-29 |
| An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary FibrosisNCT03573505results2020-11-20Change From Baseline in Forced (Expiratory) Vital Capacity (FVC) at Week 52Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Study was stopped because of safety concerns. | Drug: BG00011, Placebo | Idiopathic Pulmonary Fibrosis | 109 | 2019-11-14actual | — | 2020-12-11 |
| BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)NCT00835770results2020-12-31Number of Participants With Treatment-Emergent Adverse Events (AEs)Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: dimethyl fumarate, Placebo | Relapsing-Remitting Multiple Sclerosis | 1,736 | 2019-11-08actual | — | 2020-12-31 |
| A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's AtaxiaNCT02255435results2022-11-29Change From Baseline in Peak Work (in Watts/kg) During Exercise Testing at Week 12 in Part 1Randomized · Double-masked · TreatmentStudy Protocol: Main Protocol ↗ · Study Protocol: United Kingdom Protocol ↗ · Statistical Analysis Plan: Part 1 ↗ · Statistical Analysis Plan: Part 2 ↗ · Statistical Analysis Plan: Part 2 Addendum ↗ | Phase 2 | Completed | Drug: Omaveloxolone Capsules, 2.5 mg, Omaveloxolone Capsules, 5 mg, Omaveloxolone Capsules, 10 mg, Placebo, Omaveloxolone Capsules, 20 mg, Omaveloxolone Capsules, 40 mg, Omaveloxolone Capsules, 80 mg, Omaveloxolone Capsules, 160 mg, Omaveloxolone Capsules, 300 mg, Omaveloxolone Capsules, 150 mg | Friedreich Ataxia | 172 | 2019-10-31actual | — | 2026-01-23 |
| A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive DisorderNCT03672175results2022-11-10Change From Baseline in the 17-item HAM-D Total Score at Day 15Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: SAGE-217, Placebo | Major Depressive Disorder | 581 | 2019-09-24actual | — | 2023-11-29 |
| Cognitive, Behavioral, and Functional Change in Behavioral Variant Frontotemporal Dementia (bvFTD)NCT03088956observationalAnnualized rate of change in International Shopping List Test (ISLT) - Immediate Recall | — | Completed | Other: Assessments | Frontotemporal Dementia, Behavioral Variant Frontotemporal Dementia | 47 | 2019-09-23actual | — | 2020-06-16 |
| Study of BIIB092 in Participants With Progressive Supranuclear PalsyNCT03068468results2020-12-21Change From Baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) at Week 52Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: 251PP301(PASSPORT) primary endpoint was not met;Biogen decision to close the study early. There were no safety concerns with the PASSPORT study. | Drug: BIIB092, Placebo | Supranuclear Palsy, Progressive | 490 | 2019-09-06actual | — | 2020-12-21 |
| Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)NCT02847598results2023-05-15Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: BIIB059 (litifilimab), Placebo | Systemic Lupus Erythematosus, Active Cutaneous Lupus Erythematosus | 264 | 2019-08-28actual | — | 2023-11-07 |
| A Clinical Drug-Drug Interaction (DDI) Study With OmaveloxoloneNCT04008186Part 1 - Maximum concentration (Cmax) of probe drugs co-administered with omaveloxolone (midazolam, repaglinide, metformin, rosuvastatin, and digoxin)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Omaveloxolone, Midazolam oral solution, Repaglinide 1 MG, MetFORMIN 500 Mg Oral Tablet, Rosuvastatin, Digoxin tablet, Gemfibrozil Tablets, Itraconazole capsule, Verapamil Pill | Healthy Adult Subjects | 61 | 2019-08-18actual | — | 2025-05-30 |
| 221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's DiseaseNCT02477800results2021-09-02Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score at Week 78Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Study was discontinued based on futility analysis done and not based on safety concerns. Follow-up visits and closing out study activities are completed | Drug: Aducanumab (BIIB037), Aducanumab (BIIB037), Placebo | Alzheimer's Disease | 1,653 | 2019-08-08actual | — | 2021-09-02 |
| 221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's DiseaseNCT02484547results2021-09-02Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 78Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Study was discontinued based on futility analysis done and not based on safety concerns. Follow-up visits and closing out study activities are completed | Drug: Aducanumab (BIIB037), Aducanumab (BIIB037), Placebo | Alzheimer's Disease | 1,643 | 2019-08-05actual | — | 2021-09-02 |
| Multiple Dose Study of Aducanumab (BIIB037) (Recombinant, Fully Human Anti-Aβ IgG1 mAb) in Participants With Prodromal or Mild Alzheimer's DiseaseNCT01677572Number of Participants with Adverse EventsRandomized · Triple-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: Study was discontinued based on futility analysis conducted on Phase 3 trials (NCT02477800 and NCT02484547) and not based on safety concerns. | Drug: Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb), Placebo | Alzheimer's Disease | 197 | 2019-07-31actual | — | 2020-08-03 |
| Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple SclerosisNCT02472938Mean number of cumulative combined unique active (CUA) lesions (registered from week 4 to 24)Randomized · Quadruple-masked · Treatment | Phase 4 | Withdrawnsponsor's stated reason: Sponsor Decision | Drug: dimethyl fumarate · Other: Placebo | Relapsing Remitting Multiple Sclerosis | 0 | Jul 2019 | — | 2015-12-28 |
| A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple SclerosisNCT03347370observationalPercentage of Participants with at Least one Injection Site Reaction (ISR) as Reported by the Participants | — | Completed | Drug: SC Peginterferon beta-1a, SC interferon beta-1a, SC interferon beta-1b | Multiple Sclerosis, Relapsing-Remitting | 626 | 2019-07-31actual | — | 2019-09-25 |
| A Study of Aducanumab in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Participants With Asymptomatic Amyloid-Related Imaging AbnormalitiesNCT03639987results2021-09-16Number of Participants With Clinically Impactful Amyloid-related Imaging Abnormalities (ARIA)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Study was discontinued based on futility analysis conducted on Phase 3 trials (NCT02477800 and NCT02484547) and not based on safety concerns. | Drug: Aducanumab, Placebo | Cognitive Dysfunction, Alzheimer's Disease | 52 | 2019-07-30actual | — | 2021-09-16 |
| Safety and PK/PD of RTA 1701 in Healthy AdultsNCT03579030Incidence of treatment-emergent adverse eventsRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: Placebo oral capsule, RTA 1701 capsules | Healthy | 90 | 2019-06-28actual | — | 2025-05-29 |
| A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2NCT03093324results2020-07-14Number of Days With Any Individual Gastrointestinal Symptom and Impact Scale (IGISIS) Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and BRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: ALKS 8700, Dimethyl Fumarate | Relapsing Remitting Multiple Sclerosis | 506 | 2019-06-27actual | — | 2020-07-14 |
| A Human AME Study for OmaveloxoloneNCT03931590Maximum concentration (Cmax) of omaveloxoloneOpen-label · Treatment | Phase 1 | Completed | Drug: [14C]-Omaveloxolone | Healthy Male Subjects | 8 | 2019-05-31actual | — | 2025-05-30 |
| A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive EpisodeNCT03692910results2022-04-20Part A: Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: SAGE-217, Placebo | Bipolar Disorder I, Bipolar Disorder II, Major Depressive Episode | 35 | 2019-05-21actual | — | 2023-12-13 |
| Evaluating the Safety, Tolerability, and Pharmacokinetics of BIIB095 in Healthy ParticipantsNCT03454126Percentage of Participants with Serious Adverse Events (SAEs)Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: BIIB095, Placebo | Healthy Volunteer | 80 | 2019-04-30actual | — | 2019-05-16 |
| An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical PracticeNCT01480063observationalNumber of Participants with Adverse Events | — | Completed | Drug: Fampridine | Multiple Sclerosis | 4,734 | 2019-02-08actual | — | 2019-06-05 |
| Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074NCT02957617Number of Participants experiencing Adverse Events(AE) and Serious Adverse Events (SAEs)Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: The parent study did not meet its primary or secondary efficacy endpoints and therefore Sponsor decision to discontinue development in this indication. | Drug: BIIB074 | Neuropathic Pain From Lumbosacral Radiculopathy | 302 | 2019-02-07actual | — | 2019-02-25 |
| A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIXNCT03366337results2022-01-18Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Bardoxolone methyl capsules | IgA Nephropathy, CKD Associated With Type 1 Diabetes, Focal Segmental Glomerulosclerosis, Autosomal Dominant Polycystic Kidney | 103 | 2019-01-02actual | — | 2025-06-03 |
| Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From EnbrelNCT03100734observationalChange from transition point in Disease Activity Score (DAS-28 score) | — | Completed | Biological: Benepali, Enbrel | Rheumatoid Arthritis, Axial Spondyloarthritis | 585 | 2018-11-30actual | — | 2021-02-05 |
| Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative ParticipantsNCT01485003observationalProportion of Participants who are overall disease activity-free at Months 12 and 24 | — | Completed | Biological: natalizumab | Relapsing-Remitting Multiple Sclerosis | 231 | 2018-11-26actual | — | 2019-02-12 |
| A Pharmacokinetic Study of Omaveloxolone in Healthy VolunteersNCT03664453Determine the effect of food on the pharmacokinetics of omaveloxolone in healthy adult subjects by measuring maximum observed concentration (Cmax)Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: omaveloxolone | Healthy | 32 | 2018-11-20actual | — | 2025-05-30 |
| A Study to Evaluate SAGE-217 in Participants With Severe Postpartum DepressionNCT02978326results2021-12-16Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: SAGE-217 15/20 mg Oral Solution, Placebo, SAGE 217 30 mg Capsules | Postpartum Depression | 276 | 2018-11-15actual | — | 2023-12-15 |
| Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019NCT01797965results2019-12-04Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Study terminated because of differences in the participant population under study compared with indicated Zinbryta use in most countries. | Drug: BIIB019 (Daclizumab) | Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis | 1,501 | 2018-09-24actual | — | 2019-12-04 |
| A Study to Assess the Safety and Tolerability of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA).NCT02462759results2020-01-27Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Quadruple-masked · TreatmentStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 2 | Terminatedsponsor's stated reason: The study was terminated early to roll over participants to open label extension study NCT02594124. | Drug: Nusinersen · Procedure: Sham Procedure | Spinal Muscular Atrophy | 21 | 2018-09-24actual | — | 2021-02-17 |
| Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)NCT02555215results2019-11-22Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: dimethyl fumarate | Multiple Sclerosis, Relapsing-Remitting | 20 | 2018-09-24actual | — | 2019-11-22 |
| Efficacy and Safety of Daclizumab in Participants With RRMS Switching From NatalizumabNCT02881567results2019-09-24Percentage of Participants Relapse-free at Month 6Open-label · TreatmentStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 3 | Terminatedsponsor's stated reason: Study terminated in line with Biogen decision to withdraw Zinbryta from the market and not to pursue further studies of daclizumab in MS. | Drug: Daclizumab | Relapsing-Remitting Multiple Sclerosis (RRMS) | 41 | 2018-09-12actual | — | 2019-09-27 |
| Study to Evaluate the Efficacy and Safety of BIIB074 in Neuropathic Pain From Lumbosacral RadiculopathyNCT02935608Change from Baseline to Week 14 in the weekly average of the daily neuropathic pain score on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: BIIB074, Placebo | Lumbosacral Radiculopathy | 502 | 2018-08-06actual | — | 2018-08-15 |
| Methodology Study of Novel Outcome Measures to Assess Progression of ALSNCT02611674observationalLongitudinal standardized mean change in electrophysiological measures as assessed by electrical impedance myography (EIM) | — | Completed | — | Amyotrophic Lateral Sclerosis | 138 | 2018-07-27actual | — | 2019-10-24 |
| Benepali® PEN Patient Satisfaction SurveyNCT03327454observationalPercentage of Participants that are "Very Satisfied (4)" or "Satisfied (3)" with the Benepali Pre-Filled Pen | — | Completed | Biological: Benepali | Rheumatoid Arthritis, Spondyloarthropathies | 500 | 2018-06-21actual | — | 2018-10-23 |
| Safety, Tolerability, and Pharmacokinetics of Single Doses of BIIB059 in Healthy Japanese Subjects.NCT03224793Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: BIIB059, Placebo | Healthy Subjects | 32 | 2018-06-12actual | — | 2018-08-31 |
| RTA 408 Capsules in Patients With Melanoma - REVEALNCT02259231results2021-06-24Measure of Efficacy of the Phase 2 Dose of RTA 408 in Combination With Nivolumab Using Overall Response Rate (ORR; Complete Plus Partial Responses) According to RECIST Version 1.1 CriteriaNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: Omaveloxolone Capsules (2.5 mg/capsule), Ipilimumab (3 mg/kg), Nivolumab (240 mg), Omaveloxolone Capsules (10 mg/capsule), Omaveloxolone Capsules (50 mg/capsule) | Melanoma, Unresectable (Stage III) Melanoma, Metastatic (Stage IV) Melanoma | 41 | 2018-05-09actual | — | 2025-06-04 |
| A Drug Interaction Study of BIIB074 and an Oral Contraceptive RegimenNCT03324685Area Under the Concentration-Time Curve from Hour 0 to Hour 8 (AUC8) for BIIB074Open-label · Treatment | Phase 1 | Completed | Drug: BIIB074, OC (ethinyl estradiol and levonorgestrel) | Drug Interactions | 36 | 2018-03-15actual | — | 2018-09-25 |
| Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Participants Treated With NatalizumabNCT02386566observationalCompare EDSS change categories with changes in MusiQoL | — | Completed | Drug: natalizumab | Multiple Sclerosis | 48 | 2018-01-28actual | — | 2018-09-13 |
| Effects of Vitamin K on Redness Associated With Injection Site Reactions in Participants Treated With PlegridyNCT03091569Change in Clinician's Erythema Assessment (CEA) scale from pre-application of topical cream to 24 hours post-applicationRandomized · Double-masked · Supportive care | Phase 4 | Completed | Other: Vitamin K Cream, Placebo Cream | Relapsing-Remitting Multiple Sclerosis | 23 | 2018-01-27actual | — | 2018-04-05 |
| Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIATNCT02036970results2021-07-23Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to PlaceboRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Bardoxolone methyl, Placebo | Pulmonary Arterial Hypertension, Pulmonary Hypertension, Interstitial Lung Disease, Idiopathic Interstitial Pneumonia, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Respiratory Bronchiolitis Associated Interstitial Lung Disease, Desquamative Interstitial Pneumonia, Cryptogenic Organizing Pneumonia, Acute Interstitial Pneumonitis, Idiopathic Lymphoid Interstitial Pneumonia, Idiopathic Pleuroparenchymal Fibroelastosis | 166 | 2018-01-19actual | — | 2025-06-10 |
| Ireland Natalizumab (TYSABRI) Observational ProgramNCT01943526observationalNumber of participants experiencing Serious Adverse Events (SAEs) | — | Completed | Biological: natalizumab | Relapsing-Remitting Multiple Sclerosis | 191 | 2017-12-31actual | — | 2018-05-04 |
| A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia ModelNCT03284931Sleep efficiency, as determined by polysomnography (PSG)Randomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: SAGE-217 high dose, Placebo, SAGE-217 low dose | Healthy | 45 | 2017-12-04actual | — | 2023-11-29 |
| A Study to Evaluate SAGE-217 in Participants With Essential TremorNCT02978781results2021-02-17Part A: Change From Baseline in Accelerometer-based Kinesia Kinetic Tremor Combined Score at Day 7Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: SAGE-217, SAGE-217, Placebo | Essential Tremor | 34 | 2017-11-22actual | — | 2023-11-28 |
| Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's DiseaseNCT02459886Adverse events/serious adverse events (AEs/SAEs),Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: BIIB054, Placebo | Parkinson's Disease, Healthy | 66 | 2017-11-20actual | — | 2019-08-08 |
| Safety and Efficacy of Intravenous Natalizumab in Acute Ischemic StrokeNCT02730455results2019-01-08Percentage of Participants With Composite Global Measure of Functional Disability Excellent Outcome at Day 90Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: natalizumab, Placebo | Acute Ischemic Stroke | 277 | 2017-11-20actual | — | 2019-01-08 |
| Effect of Itraconazole on the Pharmacokinetics of Bardoxolone Methyl in Healthy AdultsNCT03264079Area under the plasma concentration-time curve of bardoxolone methyl from time 0 to the last measurable time point (AUC0-t).Open-label · Treatment | Phase 1 | Completed | Drug: Bardoxolone methyl capsules 10 mg, Itraconazole capsules 100 mg | Healthy Volunteers | 16 | 2017-11-13actual | — | 2025-05-29 |
| RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTORNCT02255422results2020-09-17Change of Peak Workload (in Watts/kg) During Exercise TestingRandomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Omaveloxolone capsules, 2.5 mg, omaveloxolone capsules, 5 mg, omaveloxolone capsules, 10 mg, Placebo capsules, omaveloxolone capsules, 20 mg, omaveloxolone capsules, 40 mg, omaveloxolone capsules, 80 mg, omaveloxolone capsules, 160 mg | MItochondrial Myopathies | 53 | 2017-11-02actual | — | 2025-06-05 |
| Study to Evaluate Fatigue in Participants With Relapsing Remitting Multiple Sclerosis When Treated With Dimethyl FumarateNCT02090348Mean change from baseline in MS-related fatigue as assessed by FSMC at 12 months in participants receiving DMFOpen-label · Treatment | Phase 4 | Withdrawnsponsor's stated reason: The study was withdrawn for business reasons. The decision to stop the TECNERGY study was not a result of any safety or efficacy concerns. | Drug: dimethyl fumarate | Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis | 0 | Oct 2017 | — | 2015-09-07 |
| Study to Evaluate the Effect of UGT Inhibition by Valproic Acid on the Pharmacokinetics of BIIB074NCT03385525Maximum Observed Concentration (Cmax) of BIIB074Open-label · Treatment | Phase 1 | Completed | Drug: BIIB074, Valproic Acid | Drug Interaction | 30 | 2017-10-13actual | — | 2018-04-20 |
| A Study to Evaluate SAGE-217 in Participants With Moderate to Severe Major Depressive DisorderNCT03000530results2020-12-02Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - Part ARandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: SAGE-217, Placebo | Major Depression | 102 | 2017-10-04actual | — | 2023-11-28 |
| Plegridy Satisfaction Study in ParticipantsNCT02587065results2020-01-13Change From Baseline in Convenience Satisfaction Score of Treatment Satisfaction Questionnaire to Medication (TSQM-9) at Week 12Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: peginterferon beta-1a | Relapsing-Remitting Multiple Sclerosis (RRMS) | 193 | 2017-10-02actual | — | 2023-08-31 |
| A Study to Evaluate SAGE-217 in Participants With Parkinson's DiseaseNCT03000569results2020-11-23Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - Part ANon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan: Version 2 ↗ · Statistical Analysis Plan: Version 1 ↗ | Phase 2 | Completed | Drug: SAGE-217, Levodopa, Antiparkinsonian Agent(s) | Parkinson Disease | 29 | 2017-09-11actual | — | 2023-11-29 |
| A Longitudinal, Observational Biomarker Study in Participants With Primary Sjogren's SyndromeNCT02422407observationalGene expression levels in immune cells (innate and adaptive) in salivary gland biopsy samples from participants with and without pSS including healthy volunteers | — | Completed | Procedure: Biopsy | Healthy, Sicca Syndrome, Sjögren's Syndrome | 100 | 2017-08-22actual | — | 2018-01-19 |
| A Study to Assess the Efficacy, Safety and Pharmacokinetics of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy (SMA)NCT01839656results2018-10-30Percent of Participants Who Achieved Improvement in Motor Milestones as Assessed by Section 2 of the HINE at the Last VisitNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: nusinersen | Spinal Muscular Atrophy | 21 | 2017-08-21actual | — | 2021-02-17 |
| A Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of RTA 901 in Healthy AdultsNCT02666963Safety and tolerability will be assessed by monitoring adverse events, physical examinations, clinical laboratory tests, 12-lead ECGs, and vital signsRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: RTA 901 Capsules, 10 or 40 mg, Placebo | Healthy | 78 | 2017-07-23actual | — | 2025-05-29 |
| Tecfidera and the Gut MicrobiotaNCT02471560Comparison of the change in gut microbiota composition in participants pre vs. post initiation of DMF treatment.Non-randomized · Open-label · Other | Phase 4 | Completed | Drug: dimethyl fumarate, injectable MS DMT | Multiple Sclerosis, Relapsing-Remitting | 36 | 2017-06-12actual | — | 2021-09-05 |
| Scan-Rescan Sub-Study of MS PATHSNCT04123353observationalOverall Reproducibility of Brain Volume | — | Completed | — | Multiple Sclerosis | 30 | 2017-05-09actual | — | 2019-10-10 |
| Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).NCT02525874results2019-06-27Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: dimethyl fumarate | Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis | 218 | 2017-04-24actual | — | 2019-06-27 |
| STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)NCT01371305results2020-02-28Number of Participants With Adverse Events (AEs)Randomized · Quadruple-masked · TreatmentStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 2 | Completed | Drug: BG00011, Placebo | Idiopathic Pulmonary Fibrosis (IPF) | 41 | 2017-03-31actual | — | 2020-02-28 |
| Systemic Sclerosis Clinical and Biomarker StudyNCT02531009observationalChange in University of California at Los Angeles Scleroderma Clinical Trial Consortium GI Tract (UCLA-SCTC GIT) instrument score in participants with SSc | — | Withdrawn | — | Healthy, Systemic Sclerosis | 0 | Mar 2017 | — | 2015-11-02 |
| Study of Utilization Patterns of Dimethyl Fumarate in GermanyNCT02969304observationalProportion of dimethyl fumarate use that is prescribed "on-label" versus "off-label" in Germany | — | Completed | Drug: dimethyl fumarate | Multiple Sclerosis | 930 | 2017-03-02actual | — | 2017-07-19 |
| Transition to Peginterferon Beta-1a (BIIB017) From Subcutaneous Interferon TherapyNCT02234869Combined Counts of adverse events (AEs) of flu-like symptoms, injection site reactions or injection site reaction painRandomized · Open-label · Treatment | Phase 4 | Withdrawnsponsor's stated reason: Due to a change in Biogen Idec's medical research plans. | Drug: Interferon Beta, BIIB017 (Peginterferon beta-1a) | Relapsing Multiple Sclerosis | 0 | Feb 2017 | — | 2014-11-17 |
| PK and Safety Study of BIIB074 in Healthy Japanese and Caucasian ParticipantsNCT02831517Part 1: PK of BIIB074 single oral dose as assessed by maximum observed concentration (Cmax )Randomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: BIIB074, Placebo | Healthy, Trigeminal Neuralgia | 64 | Feb 2017actual | — | 2017-03-09 |
| New Formulation and Food Effect Study of BIIB074NCT02951221PK of BIIB074 DCF to RCF as assessed by maximum observed concentration (Cmax)Randomized · Open-label · Basic science | Phase 1 | Completed | Drug: BIIB074 Treatment A, BIIB074 Treatment B, BIIB074 Treatment C, BIIB074 Treatment D | Trigeminal Neuralgia (TN), Other Neuropathic Pain | 28 | Feb 2017actual | — | 2017-02-27 |
| A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Participants With Later-onset Spinal Muscular Atrophy (SMA)NCT02292537results2018-02-22Change From Baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE) Score at Month 15Randomized · Quadruple-masked · TreatmentStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 3 | Completed | Drug: Nusinersen · Procedure: Sham procedure | Spinal Muscular Atrophy | 126 | 2017-02-20actual | — | 2021-02-17 |
| Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving TecfideraNCT02410278results2018-07-24Percentage of Participants With a Worsening in Severity of Gastrointestinal (GI) Adverse Events (AEs) on the GSRS From Day 0 to Day 10Randomized · Triple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: dimethyl fumarate, montelukast, Placebo | Multiple Sclerosis | 102 | 2017-02-16actual | — | 2020-03-31 |
| An Open-label Safety and Tolerability Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in ISIS 396443-CS2 (NCT01703988) or ISIS 396443-CS10 (NCT01780246)NCT02052791Number of participants that experience Adverse Events (AEs) and Serious Adverse EventsOpen-label · Treatment | Phase 1 | Completed | Drug: nusinersen | Spinal Muscular Atrophy | 47 | 2017-01-31actual | — | 2021-02-16 |
| Long-Term Assessment of Remyelinating TherapyNCT02657915results2019-09-23FF-VEP Latency of the Affected Eye as Compared to the Baseline of the Fellow Eye at 2 Years (+ up to 12 Months) After the Last Study Visit Assessment (Week 32) in RENEW Study (NCT01721161)Randomized · Triple-masked · OtherStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 2 | Completed | Drug: Placebo, BIIB033 100mg/Kg | Acute Optic Neuritis | 52 | 2017-01-23actual | — | 2019-09-23 |
| Multiple Dose Study Of BIIB118 (PF-05251749) In Healthy VolunteersNCT02691702results2018-10-15Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16 - AlertnessRandomized · Double-masked · Basic science | Phase 1 | Completed | Drug: BIIB118, Melatonin | Healthy Adult Subjects, Healthy Elderly Subjects | 97 | 2017-01-12actual | — | 2021-02-17 |
| Controlled High Risk AVONEX® Multiple Sclerosis Prevention Study In Ongoing Neurological SurveillanceNCT01156298observationalEDSS | — | Terminatedsponsor's stated reason: low enrollment | — | Multiple Sclerosis | 383 | Dec 2016 | — | 2012-08-03 |
| Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis (RRMS)NCT02776072observationalProportion of participants relapsed at 12 months in participants treated with DMF | — | Completed | — | Multiple Sclerosis | 2,978 | Dec 2016actual | — | 2017-03-23 |
| A Phase 1, Single-Ascending-Dose, Safety, Tolerability, Pharmacokinetic(PK), and Pharmacodynamic(PD) Study of BIIB068 in Healthy ParticipantsNCT02829541Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: BIIB068, Placebo | Systemic Lupos Erythematosus, SLE | 36 | Dec 2016actual | — | 2017-03-15 |
| A Phase 2a Study of BIIB074 in the Treatment of ErythromelalgiaNCT02917187Weekly average severity of paroxysmsRandomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: BIIB074, Placebo | Primary Inherited Erythromelalgia | 8 | 2016-12-27actual | — | 2018-01-10 |
| Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012NCT02579681Proportion of patients with worsening in cognitive improvement over 2 years.Open-label · Treatment | Phase 3 | Completed | Drug: dimethyl fumarate | Multiple Sclerosis, Relapsing-Remitting | 221 | 2016-12-21actual | — | 2017-04-27 |
| Single and Multiple Ascending Dose Study of Aducanumab (BIIB037) in Japanese Participants With Alzheimer's DiseaseNCT02434718Incidence and nature of adverse events (AE) / serious adverse events(SAE)Randomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: Aducanumab, Placebo | Alzheimer's Disease | 21 | 2016-12-09actual | — | 2020-08-21 |
| Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab in Healthy ParticipantsNCT02782975PK parameter of SC dose of aducanumab: Absolute BioavailabilityRandomized · Open-label · Basic science | Phase 1 | Completed | Drug: aducanumab | Alzheimer's Disease | 28 | Nov 2016actual | — | 2017-01-13 |
| Pharmacokinetics, Safety and Tolerability of Single Doses of BIIB033 (Opicinumab) Produced by 2 Manufacturing ProcessesNCT02833142PK parameter of BIIB033: Area under the concentration-time curve from time 0 to infinity (AUC0-inf)Randomized · Triple-masked · Basic science | Phase 1 | Completed | Drug: BIIB033 (opicinumab) | Multiple Sclerosis, Acute Optic Neuritis | 28 | Nov 2016actual | — | 2016-12-08 |
| A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Infants With Spinal Muscular AtrophyNCT02193074results2017-07-28Percentage of Motor Milestones RespondersRandomized · Quadruple-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: After a positive interim analysis, the decision was made to terminate the study early to allow for participants to enroll into an open label study | Drug: nusinersen · Procedure: Sham procedure | Spinal Muscular Atrophy | 122 | 2016-11-21actual | — | 2021-02-17 |
| Multiple Ascending Dose Study of Intravenously Administered BMS-986168 (BIIB092) in Patients With Progressive Supranuclear PalsyNCT02460094Safety and Tolerability as Measured by Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: BIIB092, Placebo | Progressive Supranuclear Palsy | 48 | 2016-10-19actual | — | 2018-09-04 |
| Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BIIB033 in Healthy Japanese ParticipantsNCT02641041Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Quadruple-masked · Basic science | Phase 1 | Completed | Biological: BIIB033 · Other: Placebo | Central Nervous System (CNS) Demyelinating Disease, Multiple Sclerosis | 24 | Sep 2016actual | — | 2016-10-10 |
| A Study To Evaluate The Safety And Efficacy Of PF-04958242 In Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)NCT02855411results2017-10-04Change From Baseline in the MCCB (MATRICS Consensus Cognitive Battery) Working Memory Domain to Week 12Randomized · Triple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Terminated prematurely Sept 22, 2016 following an internal portfolio prioritization. It is not due to any safety concern or change in benefit:risk assessment. | Drug: PF-04958242, placebo | Cognitive Impairment Associated With Schizophrenia (CIAS) | 35 | 2016-09-26actual | — | 2020-01-09 |
| Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMSNCT02410200results2017-04-28Change in the Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans From the Baseline Period to On-Treatment Assessment PeriodOpen-label · Treatment | Phase 2 | Completed | Drug: dimethyl fumarate | Multiple Sclerosis, Relapsing-Remitting | 22 | 2016-09-23actual | — | 2017-10-23 |
| Pilot Tape Harvesting StudyNCT02125695observationalRNA expression of genes suspected to be associated with skin disease in affected versus unaffected skin in participants with skin disease | — | Completed | Procedure: Skin Taping, Blood Sampling, Skin Biopsy | Atopic Dermatitis, Healthy, Discoid Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus | 37 | Aug 2016actual | — | 2016-09-28 |
| Brimonidine Tartrate for the Treatment of Injection Related ErythemaNCT02568111Change in either Clinician's Erythema Assessment (CEA) or Patient Erythema Self-Assessment (PSA) scale measured as at least 1-grade improvement on CEA and/or at least 1-grade improvement on PSA scale assessed by the physician and participantRandomized · Triple-masked · Supportive care | Phase 4 | Withdrawn | Drug: peginterferon beta-1a, brimonidine tartrate, Vehicle Gel | Relapsing-Remitting Multiple Sclerosis (RRMS) | 0 | Aug 2016 | — | 2016-04-25 |
| Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) (BIIB019) in Participants Who Have Completed Study 205MS202 (NCT00870740) to Treat Relapsing Remitting Multiple SclerosisNCT01051349results2018-11-09Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEsOpen-label · Treatment | Phase 2 | Completed | Biological: BIIB019 (Daclizumab), trivalent seasonal influenza vaccine | Relapsing-Remitting Multiple Sclerosis | 410 | 2016-08-25actual | — | 2018-11-09 |
| Clinical Disease Activity With Long Term Natalizumab TreatmentNCT02677077observationalChange over time in the number of participants free of new or enlarging FLAIR lesions | — | Completed | Drug: natalizumab | Relapsing-Remitting Multiple Sclerosis | 277 | 2016-08-18actual | — | 2019-01-04 |
| Study to Evaluate the Interaction Between a Drug and CNV1014802 in Healthy SubjectsNCT02551497AUC(0-tau) of CNV1014802 and a drugRandomized · Triple-masked · Other | Phase 1 | Completed | Drug: CNV1014802 | Healthy | 36 | 2016-08-16actual | — | 2017-10-16 |
| Single Ascending Doses of BIIB063 in Healthy VolunteersNCT02555085Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Quadruple-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: Clinical study terminated due to preclinical safety findings in non-human primates. | Biological: BIIB063 · Other: Placebo | Healthy | 29 | 2016-06-01actual | — | 2017-04-18 |
| Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult VolunteersNCT02228707Number of participants experiencing AEsRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: BIIB061 · Other: Placebo | Healthy | 56 | May 2016actual | — | 2016-06-15 |
| Absorption, Metabolism, and Excretion Study of BIIB074NCT02751905Urinary amount excreted per sampling interval (Aeu)Open-label · Treatment | Phase 1 | Completed | Drug: BIIB074 | Neuropathic Pain | 6 | May 2016actual | — | 2016-06-16 |
| Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 (Litifilimab) in Healthy Volunteers and Participants With Systemic Lupus ErythematosusNCT02106897Number of Participants that Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: BIIB059 (litifilimab), Placebo | Systemic Lupus Erythematosus, Healthy Volunteers | 109 | 2016-05-24actual | — | 2023-01-31 |
| Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) ParticipantsNCT02342704results2017-06-09Cumulative Number of ≥ 6-Month Confirmed T1-Hypointense Lesions Arising From New On-Treatment T1-Gadolinium-Enhancing (Gd+) LesionsRandomized · Open-label · Treatment | Phase 4 | Terminatedsponsor's stated reason: Business Decision | Drug: natalizumab, fingolimod | Relapsing-Remitting Multiple Sclerosis | 111 | 2016-05-18actual | — | 2017-06-09 |
| Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.NCT02097849results2017-06-02Percentage of Tetanus Responders (≥ 2-Fold Rise) at Day 28 Compared to Prevaccination LevelNon-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: dimethyl fumarate, non-pegylated interferon · Biological: tetanus diphtheria toxoids vaccine, 23-valent pneumococcal polysaccharide vaccine, meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent) | Relapsing Forms of Multiple Sclerosis | 71 | 2016-05-02actual | — | 2017-06-02 |
| Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis After Failure on Other TherapiesNCT02241785results2017-06-05Proportion of Participants With No Evidence of Disease Activity (NEDA) From Reset Baseline (Week 8) to Week 56Open-label · Treatment | Phase 4 | Terminatedsponsor's stated reason: Business Decision | Drug: natalizumab | Relapsing Multiple Sclerosis | 47 | 2016-05-02actual | — | 2017-06-05 |
| A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of Intravenously Administered BMS-986168 in Healthy SubjectsNCT02294851Safety and tolerability, as measured by incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, and physical and neurological examinations.Randomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: BMS-986168, BMS-986168 Placebo | Tauopathies | 65 | 2016-04-30actual | — | 2017-11-06 |
| MSPT Device Usability StudyNCT02664324observationalNumber of study participants successfully completing all modules of the MSPT device | — | Completed | — | Multiple Sclerosis | 60 | Apr 2016actual | — | 2016-05-04 |
| Effect of Itraconazole on the Pharmacokinetics of BIIB074NCT02698267Maximum observed concentration (Cmax) of BIIB074Open-label · Treatment | Phase 1 | Completed | Drug: BIIB074, Itraconazole | Neuropathic Pain | 16 | Apr 2016actual | — | 2016-06-09 |
| Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.NCT02343159results2017-05-16Overall Adherence Rates at Month 12: Arm 3 vs. Arm 1Randomized · Open-label · Health services research | Phase 4 | Terminatedsponsor's stated reason: Sponsor Decision | Drug: dimethyl fumarate · Device: Medication Event Monitoring System (MEMS) · Behavioral: Adherence counseling | Multiple Sclerosis | 84 | 2016-04-15actual | — | 2017-05-16 |
| A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported OutcomesNCT01930708Annualized Relapse Rate (ARR)Open-label · Treatment | Phase 4 | Completed | Drug: dimethyl fumarate | Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis | 1,114 | 2016-03-31actual | — | 2020-03-19 |
| Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve)NCT02323269observationalAnnualized Relapse Rate (ARR) at month 12 | — | Terminatedsponsor's stated reason: 109MS415 ImPROve study was terminated due to patient enrollment challenges and feasibility . The decision was not a result of safety concerns. | Drug: dimethyl fumarate | Multiple Sclerosis, Relapsing-Remitting, Relapsing-Remitting Multiple Sclerosis | 24 | Mar 2016actual | — | 2016-04-08 |
| Fampridine Pregnancy Exposure RegistryNCT01532154observationalSpontaneous abortions | — | Terminatedsponsor's stated reason: Due to low enrollment, registration closed in agreement with the Regulatory Agency | Drug: Fampridine | Multiple Sclerosis, Pregnancy | 1 | Feb 2016actual | — | 2016-10-18 |
| Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMSNCT01903291observationalAnnualized Relapse Rate | — | Completed | Drug: dimethyl fumarate | Relapsing Forms of Multiple Sclerosis | 333 | Feb 2016actual | — | 2016-07-25 |
| Tolerability and Quality of Life Study in Participants Who Switched to Avonex PenNCT02076841observationalChange from baseline to month 4 in injection site tolerability as measured on a composite visual analogue scale (VAS) score ranging from 0-100 | — | Completed | Device: interferon beta-1a | Relapsing-Remitting Multiple Sclerosis, Clinical Isolated Syndrome (CIS), Multiple Sclerosis | 40 | Feb 2016actual | — | 2017-01-27 |
| Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In GermanyNCT02125604results2017-04-18Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Overall Gastrointestinal Symptom Scale (MOGISS)Open-label · Treatment | Phase 4 | Completed | Drug: dimethyl fumarate | Relapsing-Remitting Multiple Sclerosis | 214 | Feb 2016actual | — | 2017-04-18 |
| Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple SclerosisNCT02219932results2017-03-27Proportion of Participants Achieving a Mean Improvement of ≥ 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 24 WeeksRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: fampridine, Placebo | Multiple Sclerosis | 646 | Feb 2016actual | — | 2017-03-27 |
| Tecfidera Lymphocyte Chart ReviewNCT02519413observationalEstimated absolute lymphocyte count (ALC) change from baseline following Tecfidera initiation | — | Completed | Drug: dimethyl fumarate | Multiple Sclerosis | 483 | Feb 2016actual | — | 2016-08-26 |
| An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple SclerosisNCT01462318results2017-03-14Number of Participants With Anti-DAC HYP Binding Antibodies (ADAbs): Electrochemiluminescent (ECL) Anti-Drug Antibody (ADA) AssayOpen-label · Other | Phase 3 | Completed | Drug: Midazolam, S-warfarin, Omeprazole, Dextromethorphan · Other: Caffeine, Vitamin K · Biological: BIIB019 (Daclizumab) | Relapsing-Remitting Multiple Sclerosis | 133 | Jan 2016actual | — | 2017-03-14 |
| BIIB023 Long-Term Extension Study in Subjects With Lupus NephritisNCT01930890results2017-01-18Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)Randomized · Triple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Results from pre-specified criteria in study NCT01499355 (211LE201) did not demonstrate sufficient efficacy to warrant continuation of the study | Biological: BIIB023 · Drug: mycophenolate mofetil, oral corticosteroids | Lupus Nephritis | 87 | Jan 2016actual | — | 2017-01-18 |
| BG00012 and Delay of Disability Progression in Secondary Progressive Multiple SclerosisNCT02430532results2017-03-27Time to Disability Progression Independent of RelapseRandomized · Triple-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: Sponsor Decision | Drug: dimethyl fumarate · Other: Placebo | Multiple Sclerosis, Secondary Progressive | 58 | Jan 2016actual | — | 2017-04-26 |
| BIIB023 Proof-of-Concept Study in Participants With Lupus NephritisNCT01499355results2017-01-18Percentage of Participants Who Achieve a Complete or Partial Renal Response at Week 52Randomized · Double-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Results from pre-specified criteria did not demonstrate sufficient efficacy to warrant continuation of the study. | Biological: BIIB023, Placebo · Drug: mycophenolate mofetil, oral corticosteroids | Lupus Nephritis | 276 | Dec 2015actual | — | 2017-01-18 |
| Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With AvonexNCT01864148results2017-05-03Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent EndpointRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: BIIB033, Avonex · Other: Placebo | Multiple Sclerosis | 419 | Dec 2015actual | — | 2017-05-03 |
| Tecfidera Slow-Titration StudyNCT02428231results2017-05-05Proportion of Participants With a Worsening in Severity of Gastrointestinal (GI) Adverse Events (AEs) on the Gastrointestinal Symptom Rating Scale (GSRS)Randomized · Double-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: Sponsor decision | Drug: dimethyl fumarate | Multiple Sclerosis | 62 | Dec 2015actual | — | 2017-05-05 |
| JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With NatalizumabNCT01070836observationalDemonstrate that the incidence of PML in natalizumab-treated participants who do not have detectable antibodies to JC virus (JCV) (antibody negative) is lower than in patents who have detectable antibodies to JCV (antibody positive) | — | Completed | Drug: natalizumab | Relapsing Multiple Sclerosis | 35,895 | Nov 2015actual | — | 2016-09-29 |
| Long-Term Safety and Efficacy Study of Peginterferon Beta-1aNCT01332019results2017-01-13Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEsNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: peginterferon beta-1a | Relapsing Multiple Sclerosis | 1,077 | Oct 2015actual | — | 2017-01-13 |
| A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants With Multiple SclerosisNCT01917019The proportion of participants who show a consistent improvement in walking speedRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Placebo, BIIB041 (fampridine) | Multiple Sclerosis, Remittent Progressive, Multiple Sclerosis, Primary Progressive, Relapsing-Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Multiple Sclerosis | 101 | Oct 2015actual | — | 2017-03-21 |
| Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017)NCT01939002results2017-01-25Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Overall PopulationRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: BIIB017, naproxen | Relapsing Multiple Sclerosis | 251 | Oct 2015actual | — | 2017-01-25 |
| Safety and Efficacy in Pediatric MS Patients Prescribed TysabriNCT02137109observationalIncidence of all serious adverse events (SAEs) | — | Completed | Drug: natalizumab | Multiple Sclerosis | 400 | Oct 2015actual | — | 2015-10-20 |
| Safety, Tolerability and Pharmacokinetics of BIIB118 (PF-05251749)NCT02443740results2018-05-17Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)Randomized · Double-masked · Basic science | Phase 1 | Completed | Drug: BIIB118, BIIB118, BIIB118 | Healthy | 32 | 2015-10-31actual | — | 2021-02-17 |
| Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis ParticipantsNCT01706107observationalChange from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) | — | Terminatedsponsor's stated reason: Due to on-going enrollment challenges | — | Relapsing-Remitting Multiple Sclerosis | 73 | 2015-10-02actual | — | 2024-06-03 |
| RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVERNCT02029729Dose DeterminationOpen-label · Treatment | Phase 1 | Completed | Drug: omaveloxolone | Metastatic or Incurable Non-small Cell Lung Cancer, Relapsed, Refractory Melanoma | 11 | 2015-10-01actual | — | 2025-05-29 |
| Observational Study to Establish Patient-Matched Population Norms for the Multiple Sclerosis Cognition Assessment BatteryNCT02283918observationalSelective Reminding Test (SRT) Score | — | Completed | — | Healthy | 467 | Aug 2015actual | — | 2015-10-05 |
| Single-Dose Study of a New Formulation of BIIB061NCT02521545PK parameter - area under the concentration-time curve from time 0 to infinity (AUCinf)Open-label · Treatment | Phase 1 | Completed | Drug: BIIB061 | Multiple Sclerosis | 8 | Aug 2015actual | — | 2015-09-07 |
| A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple SclerosisNCT01416181results2017-06-27Part 1: Percentage of Participants With Confirmed Progression of Disability in One or More of the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), or 9-Hole Peg Test (9HPT)Randomized · Triple-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: The ASCEND Study did not achieve statistical significance on the primary or secondary endpoints. | Drug: natalizumab, Placebo | Secondary Progressive Multiple Sclerosis | 889 | 2015-07-28actual | — | 2017-09-11 |
| An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)NCT01838668Total number of new Gadolinium-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24.Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Placebo, dimethyl fumarate | Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis | 225 | 2015-06-16actual | — | 2018-11-20 |
| Natalizumab Subcutaneous Immunogenicity and Safety StudyNCT02142192Proportion of participants with persistent anti-natalizumab antibodiesOpen-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Sponsor's decision. | Drug: natalizumab | Relapsing Multiple Sclerosis | 2 | 2015-06-04actual | — | 2024-06-03 |
| TYSABRI Global Observational Program in SafetyNCT00477113observationalNumber of participants with serious infections, malignancies, and other SAEs | — | Completed | — | Multiple Sclerosis | 2,207 | May 2015actual | — | 2015-06-22 |
| CD INFORM: Investigating Natalizumab Through Further Observational Research and MonitoringNCT00707512observationalRate of serious and/or clinically significant infections, malignancies, and other SAEs in participants with Crohn's Disease treated with natalizumab | — | Terminatedsponsor's stated reason: Sponsor's decision. | Drug: natalizumab | Crohn's Disease | 87 | 2015-05-28actual | — | 2024-06-03 |
| RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSENCT02142959results2023-05-06Time-averaged Effect on Radiation Dermatitis Grade Measured With Common Terminology Criteria for Adverse Events (CTCAE, v 4.03) Following 3D Conformal Radiation Therapy to the Breast Following Topical Application of Omaveloxolone Lotion or Lotion VehicleRandomized · Triple-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Omaveloxolone Lotion 0.5%, Omaveloxolone Lotion 3%, Vehicle Lotion · Radiation: 3D conformal radiation therapy | Breast Cancer | 187 | 2015-04-30actual | — | 2025-06-03 |
| PK & Tolerability of CNV1014802 in Young and Elderly Healthy VolunteersNCT02359344Maximum ConcentrationRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: CNV1014802, Placebo | Trigeminal Neuralgia | 32 | 2015-04-20actual | — | 2017-10-12 |
| Multiple Ascending Doses of PF-04958242 in Subjects With Stable SchizophreniaNCT02332798results2016-06-14Maximum Observed Plasma Concentration (Cmax) (Single Dose)Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: PF-04958242, Placebo | Schizophrenia | 39 | 2015-04-15actual | — | 2021-10-25 |
| Functional MRI in Lupus NephritisNCT01731054observationalThe test-retest reliability and sensitivity of renal functional magnetic resonance imaging (MRI) measurements to detect renal inflammatory activity or damage in normal healthy volunteers (NHV) and participants with lupus nephritis (LN). | — | Completed | — | Healthy, Lupus Nephritis | 50 | Mar 2015actual | — | 2015-04-27 |
| BG00010 (Neublastin) Phase 2 Multiple Dose Adaptive Design in Participants With Painful Lumbar RadiculopathyNCT01873404Change from Baseline in the mean 24-hour average general pain intensity (AGPI) scoreRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: BG00010, Placebo | Painful Lumbar Radiculopathy, Sciatica, Radiculopathy | 183 | Mar 2015actual | — | 2015-09-10 |
| A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of PF-04958242 in Healthy SubjectsNCT02341482results2016-06-30Area Under the Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval, Where Tau = 12 Hours (AUCtau) of PF-04958242Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: PF-04958242, Itraconazole | Healthy | 13 | 2015-03-31actual | — | 2020-01-09 |
| Effect of Natalizumab on Infarct Volume in Acute Ischemic StrokeNCT01955707results2016-07-01Change in Infarct Volume From Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR])Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: natalizumab, Placebo | Acute Ischemic Stroke | 161 | Feb 2015actual | — | 2016-07-01 |
| Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple SclerosisNCT02090413results2016-12-28Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)Randomized · Double-masked · Treatment | Phase 4 | Completed | Drug: dimethyl fumarate, acetylsalicylic acid, ASA-Placebo | Relapsing-Remitting Multiple Sclerosis | 241 | Feb 2015actual | — | 2016-12-28 |
| RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARDNCT02128113results2023-05-26Change From Baseline in Central Corneal Endothelial Cell CountsRandomized · Double-masked · Prevention | Phase 2 | Completed | Drug: Vehicle Ophthalmic Solution, Omaveloxolone Ophthalmic Suspension 0.5%, Omaveloxolone Ophthalmic Suspension 1% | Corneal Endothelial Cell Loss, Ocular Pain, Ocular Inflammation, Cataract Surgery | 307 | 2015-02-28actual | — | 2025-06-03 |
| An Open-label Safety, Tolerability and Dose-Range Finding Study of Multiple Doses of Nusinersen (ISIS 396443) in Participants With Spinal Muscular AtrophyNCT01703988results2017-03-13Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuations Due to AEs, and Highest Severity of AEsNon-randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: Nusinersen | Spinal Muscular Atrophy | 34 | 2015-01-31actual | — | 2021-04-13 |
| Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab)NCT02159573observationalKaplan-Meier Estimates for the Proportion of Participants relapsed at 12 months after initiation of treatment with Tecfidera | — | Completed | Biological: natalizumab · Drug: dimethyl fumarate | Relapsing-Remitting Multiple Sclerosis | 530 | Jan 2015actual | — | 2016-06-07 |
| Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple SclerosisNCT01416155results2016-01-14Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEsOpen-label · Treatment | Phase 2 | Completed | Drug: natalizumab | Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis | 97 | Dec 2014actual | — | 2016-01-14 |
| A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy AdultsNCT02201849Safety and tolerability will be measured by incidence of adverse eventsRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: Study Drug, Active Control, Placebo | Multiple Sclerosis | 104 | Dec 2014actual | — | 2019-11-26 |
| Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy VolunteersNCT02269930Cumulative area under the concentration-time curve (AUC), as measured by area under the concentration-time curve from time zero to 336 hours post dose (AUC0-336h)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: peginterferon beta-1a, Rebif | Multiple Sclerosis | 30 | Dec 2014actual | — | 2015-02-02 |
| TYGRIS - ROW: TYSABRI Global Observational Program in Safety - Rest of WorldNCT00483847observationalNumber of participants with serious infections, malignancies, and other serious adverse events (SAEs) | — | Completed | — | Multiple Sclerosis | 4,296 | Nov 2014actual | — | 2015-04-13 |
| Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-04958242 In Healthy VolunteersNCT02228395results2015-12-17Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-BaselineRandomized · Double-masked · Basic science | Phase 1 | Completed | Drug: PF-04958242, Placebo | Healthy | 12 | 2014-11-13actual | — | 2020-01-07 |
| Canadian Avonex PEN Productivity StudyNCT01489748observationalChange from Baseline in work capacity | — | Completed | — | Multiple Sclerosis | 111 | Oct 2014actual | — | 2015-02-20 |
| BIIB033 In Acute Optic Neuritis (AON)NCT01721161results2016-06-30Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) PopulationRandomized · Double-masked · Treatment | Phase 2 | Completed | Biological: BIIB033 (anti-LINGO-1 mAb) · Drug: Placebo | Acute Optic Neuritis | 82 | Oct 2014actual | — | 2016-06-30 |
| Avonex-evaluation of Quality of Life and Convenience in Belgian Participants - The AVAIL StudyNCT01272128observationalChange from Baseline in EuroQol 5D (EQ-5D) Visual Analog Scale (VAS) at 12 months | — | Completed | Drug: Interferon beta-1a | Multiple Sclerosis | 100 | Sep 2014actual | — | 2015-10-20 |
| PK and PD Study of Natalizumab in Pediatric Subjects With RRMSNCT01884935predose (trough) concentrations from multiple dosing (Cpredose)Open-label · Treatment | Phase 1 | Completed | Biological: Natalizumab | Relapsing-Remitting Multiple Sclerosis | 13 | Sep 2014actual | — | 2016-06-23 |
| RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular SurgeryNCT02065375results2023-04-19Absence of Anterior Chamber Cells at Day 15 (Visit 5)Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Omaveloxolone Ophthalmic Suspension 1.0%, Omaveloxolone Opthalmic Suspension 0.5%, Placebo | Inflammation and Pain Following Ocular Surgery | 109 | 2014-09-30actual | — | 2025-06-03 |
| Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food EffectNCT02071121Number of participants that experience adverse events (AEs) and Serious Adverse Events (SAEs)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: BIIB061, Placebo, 14C-BIIB061 | Healthy | 39 | Sep 2014actual | — | 2015-02-02 |
| Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal LeukoencephalopathyNCT01211639observationalto examine host genetic variation and possible genetic susceptibility to PML | — | Terminatedsponsor's stated reason: Due to lack of enrollment. | — | Progressive Multifocal Leukoencephalopathy | 24 | Aug 2014actual | — | 2015-01-19 |
| Phase 1 Subcutaneous Single and Multiple Ascending Dose Study of BG00010 (Neublastin)NCT01842126The number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs)Randomized · Double-masked · Treatment | Phase 1 | Completed | Biological: BG00010 IV, BG00010 SC · Drug: Placebo IV, Placebo SC | Painful Lumbar Radiculopathy, Healthy | 54 | Aug 2014actual | — | 2015-02-09 |
| A Healthy Volunteer Study to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial ManufacturersNCT02171208Area under the concentration-time curve from time 0 to infinity (AUCinf) of BG00012Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: dimethyl fumarate - Reference form, dimethyl fumarate - Test form | Healthy | 80 | Jul 2014actual | — | 2015-01-09 |
| Natalizumab (Tysabri) Re-Initiation of DosingNCT00297232results2015-05-29Time to 24-week Confirmed Expanded Disability Status Scale (EDSS) ProgressionOpen-label · Treatment | Phase 3 | Terminated | Drug: Natalizumab | Relapsing-Remitting Multiple Sclerosis | 1,094 | Apr 2014actual | — | 2016-07-15 |
| Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS)NCT01405820results2015-07-29Cumulative Number of Combined Unique Active LesionsRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: natalizumab IV, natalizumab SC, IV Placebo, SC Placebo | Relapsing-Remitting Multiple Sclerosis | 290 | Apr 2014actual | — | 2015-08-21 |
| BG00012 Regional Absorption StudyNCT01924832The maximum observed concentration: CmaxNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: dimethyl fumarate | Healthy | 32 | Apr 2014actual | — | 2015-02-16 |
| RTA 408 Lotion in Healthy VolunteersNCT02029716Skin changes or redness following topical application of RTA 408 lotion or lotion vehicleRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: RTA 408 Lotion 0.5%, 1%, 3%, Lotion vehicle/placebo | Healthy | 109 | 2014-04-01actual | — | 2025-05-28 |
| Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple SclerosisNCT01064401results2016-07-11Adjusted Annualized Relapse Rate (ARR)Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Biological: BIIB019 (Daclizumab High Yield Process), Interferon beta-1a · Drug: Interferon beta-1a Placebo, Daclizumab High Yield Process Placebo | Relapsing-Remitting Multiple Sclerosis | 1,841 | Mar 2014actual | — | 2016-07-11 |
| A Phase IIa Withdrawal Study of CNV1014802 in Patients With Trigeminal NeuralgiaNCT01540630The number of failures on CNV1014802 vs. number of failures on placebo during the double-blind treatment period will be the primary outcome of the study.Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: CNV1014802, Placebo | Trigeminal Neuralgia | 67 | 2014-03-31actual | — | 2019-01-10 |
| Daclizumab Japanese PK StudyNCT01929746Area under the concentration-time curve from time 0 to infinity (AUCinf)Randomized · Single-masked · Treatment | Phase 1 | Completed | Biological: BIIB019 subcutaneous injection | Healthy | 56 | Mar 2014actual | — | 2014-05-02 |
| BIIB057 in Subjects With Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic DrugsNCT01652937Proportion of subjects achieving an ACR20 response (ACR20 = American College of Rheumatology 20% response criteria change from baseline)Randomized · Quadruple-masked · Treatment | Phase 2 | Withdrawn | Drug: BIIB057, Placebo | Rheumatoid Arthritis | 0 | Feb 2014 | — | 2013-09-16 |
| A Study To Examine The Effects Of PF-04958242 On Ketamine-Induced Cognitive Impairment In Healthy VolunteersNCT01749098Test score on the Hopkins Verbal Learning Test - Immediate RecallRandomized · Double-masked · Basic science | Phase 1 | Completed | Drug: PF-04958242, Ketamine, Placebo, Ketamine | Schizophrenia | 29 | Feb 2014actual | — | 2019-11-21 |
| An Open-label Safety and Tolerability Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy Who Previously Participated in ISIS 396443-CS1 (NCT01494701)NCT01780246Number of participants that experience Adverse Events (AEs) and Serious Adverse EventsOpen-label · Treatment | Phase 1 | Completed | Drug: nusinersen | Spinal Muscular Atrophy | 18 | 2014-02-28actual | — | 2021-02-16 |
| Pharmacokinetic Study of Peginterferon Beta-1a in Japanese and Caucasian Adult Healthy Participants.NCT01978652Area under the concentration-time curve from time zero to infinity (AUC0-∞)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Biological: Peginterferon Beta-1a | Healthy | 44 | Feb 2014actual | — | 2015-01-09 |
| A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Participants With Multiple SclerosisNCT01065090observationalChange of muscle strength | — | Completed | — | Exercise | 38 | Jan 2014actual | — | 2015-04-13 |
| A Study of the Effect of BIIB023 on Muscle Atrophy in Healthy Male VolunteersNCT01943513Percentage change in the magnitude of muscle atrophyRandomized · Double-masked · Treatment | Phase 1 | Completed | Biological: BIIB023, Placebo | Healthy | 34 | Jan 2014actual | — | 2014-09-03 |
| PeptoBismol® Use to Reduce Gastrointestinal Events in Healthy Volunteers Receiving DMF [Tecfidera®] Twice DailyNCT01915901Time to first gastrointestinal-related eventRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: bismuth subsalicylate (Pepto-Bismol®), matching placebo (bismuth subsalicylate), dimethyl fumarate (DMF) | Healthy | 175 | Dec 2013actual | — | 2014-03-03 |
| Safety and Efficacy of Natalizumab (BG00002, Tysabri®) in Russian Participants With Relapsing Remitting Multiple Sclerosis (RRMS)NCT02142205Number of participants that experience Serious Adverse Events (SAEs) and adverse events (AEs)Open-label · Treatment | Phase 4 | Completed | Biological: BG00002 | Relapsing-Remitting Multiple Sclerosis | 100 | Dec 2013actual | — | 2014-05-20 |
| Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United StatesNCT01873417results2014-11-11Worst Severity Score of Overall Gastrointestinal (GI) Events, Modified Overall GI Symptom Scale (MOGISS)Open-label · Treatment | Phase 4 | Completed | Drug: BG00012 (DMF) | Relapsing Forms of Multiple Sclerosis | 237 | Nov 2013actual | — | 2017-03-21 |
| Persistence, Adherence, Quality of Life, and Treatment Satisfaction With Avonex® PEN™.NCT01405872observationalPersistence with Avonex PEN therapy at Month 12/End of Study as measured by the percentage of patients remaining on therapy at Month 12/End of Study as reported by a physician. | — | Completed | Other: AVONEX PEN | Multiple Sclerosis | 270 | Sep 2013actual | — | 2014-09-09 |
| Single Ascending Dose Study of BIIB037 in Participants With Alzheimer's DiseaseNCT01397539Number of Participants with Adverse Events as a Measure of Safety and TolerabilityRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: BIIB037 · Other: Placebo | Alzheimer's Disease | 53 | Aug 2013actual | — | 2015-03-23 |
| Exploratory Study to Assess the Effect of Fampridine (BIIB041) on Walking Ability and Balance in Participants With Multiple Sclerosis.NCT01597297Change from baseline in self-assessed walking disability as reported on the Multiple Sclerosis Walking Scale-12 (MSWS-12)Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: BIIB041 (PR Fampridine) · Other: Placebo | Multiple Sclerosis | 132 | Aug 2013actual | — | 2017-01-09 |
| Biomarkers of Anti-TNF-α Therapy Efficacy in Rheumatoid Arthritis to Define Unresponsive PatientsNCT01211678observationalValidation of the ability of an 8-gene biomarker set to differentiate between participants who meet or do not meet EULAR DAS-28 Good response criteria after treatment with anti-TNF therapy | — | Completed | — | Arthritis, Rheumatoid | 301 | Jul 2013actual | — | 2014-06-09 |
| Open-Label Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) on Quality of Life as Reported by Participants With Multiple SclerosisNCT01480076results2016-11-04Change From Baseline in the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) At Months 3, 6, 9, and 12: RespondersOpen-label · Treatment | Phase 4 | Completed | Drug: Fampridine | Multiple Sclerosis | 901 | Jul 2013actual | — | 2017-03-21 |
| A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing LossNCT01518920Change from baseline to 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHzRandomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: PF-04958242, PF-04958242, Placebo | Hearing Loss, Sensorineural | 44 | Feb 2013actual | — | 2019-11-21 |
| An Open-label Safety, Tolerability, and Dose-range Finding Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA)NCT01494701Number of participants that experience Adverse Events (AEs) and Serious Adverse EventsNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: nusinersen | Spinal Muscular Atrophy | 28 | 2013-01-31actual | — | 2021-02-18 |
| A Study To Assess Effects Of PF-04958242 On Bold Functional Magnetic Resonance Imaging During Working Memory Activation And Arterial Spin Labeling At Rest In Healthy SubjectsNCT01365338Functional Magnetic Resonance Imaging Data During Working Memory TaskRandomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: Placebo, PF-04958242 | Healthy Volunteer | 112 | 2012-12-14actual | — | 2019-12-24 |
| Pharmacokinetic and Pharmacodynamic Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 DiabetesNCT01549769Area under the curveOpen-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: IDMC recommendation for safety concerns | Drug: Bardoxolone Methyl | Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2 | 24 | 2012-11-30actual | — | 2025-05-29 |
| Pilot Assessment of the Effects of Bardoxolone Methyl on Renal Perfusion, Systemic Haemodynamics and Cardiac Function in Patients With Chronic Kidney Disease and Type 2 DiabetesNCT01551446Change in renal perfusionOpen-label · Treatment | Phase 1 | Withdrawnsponsor's stated reason: IDMC recommendation for safety concerns | Drug: Bardoxolone Methyl | Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2 | 0 | 2012-11-30actual | — | 2025-05-29 |
| Single-Dose, Open-Label Pharmacokinetic Study of Bardoxolone Methyl in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic FunctionNCT01563562Area under the plasma concentration-time curveOpen-label · Treatment | Phase 1 | Completed | Drug: Bardoxolone Methyl | Hepatic Impairment, Healthy | 34 | 2012-11-30actual | — | 2025-05-29 |
| Multiple-Dose Study of Effect of Bardoxolone Methyl on QT/QTC Interval VolunteersNCT01689116Change in QT/QTc intervalRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: Bardoxolone Methyl 20mg, Bardoxolone Methyl 80mg, Bardoxolone Methyl Placebo, Moxifloxacin 400mg, Moxifloxacin Placebo | Healthy Volunteers | 179 | 2012-11-30actual | — | 2025-05-29 |
| A Pharmacodynamic Study of Measured Glomerular Filtration Rate in Patients With Chronic Kidney Disease and Type 2 DiabetesNCT01500798Measured GFR assessed by plasma clearance of Tc99m-DTPARandomized · Quadruple-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: IDMC recommendation for safety concerns | Drug: 20 mg bardoxolone methyl, Placebo | Chronic Kidney Disease, Type 2 Diabetes | 18 | 2012-11-01actual | — | 2023-10-27 |
| Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple SclerosisNCT00906399results2014-09-19Annualized Relapse Rate (ARR) at 1 YearRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: BIIB017 (peginterferon beta-1a), Placebo | Relapsing Multiple Sclerosis | 1,516 | Oct 2012actual | — | 2014-09-19 |
| Bardoxolone Methyl Evaluation in Patients With Chronic Kidney Disease and Type 2 DiabetesNCT01351675Time-to-first event of the composite endpointRandomized · Quadruple-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: IDMC recommendation for safety concerns | Drug: Placebo, Bardoxolone Methyl: 20 mg | Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2 | 2,185 | 2012-10-31actual | — | 2025-05-29 |
| Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl FumarateNCT01568112results2016-06-13Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS)Randomized · Quadruple-masked · Supportive care | Phase 3 | Completed | Drug: BG00012 (dimethyl fumarate), BG00012 placebo, ASA, ASA placebo | Healthy | 173 | Oct 2012actual | — | 2016-06-13 |
| A Double-Blind, Randomized, Placebo-Controlled Safety Study Evaluating the Effects of Residual Renal Function (RFF) in Patients With End-Stage Renal Disease and Type 2 Diabetes Mellitus on Peritoneal DialysisNCT01576887Number of Adverse EventsRandomized · Quadruple-masked · Treatment | Phase 2 | Withdrawnsponsor's stated reason: IDMC recommendation for safety concerns | Drug: Bardoxolone Methyl 20 mg, Placebo | End-Stage Renal Disease, Type 2 Diabetes Mellitus | 0 | 2012-10-31actual | — | 2025-05-29 |
| Peginterferon Beta-1a (BIIB017) Autoinjector Pharmacokinetic Study in Healthy VolunteersNCT01610310Area under the time-concentration curve for serum concentrations of peginterferon beta-1a from time zero to infinity post dose (AUC0-∞)Randomized · Open-label · Basic science | Phase 1 | Completed | Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS), BIIB017 (peginterferon beta-1a) Autoinjector | Healthy, Multiple Sclerosis | 55 | Oct 2012actual | — | 2014-06-13 |
| A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Effects of Bardoxolone Methyl on Body Composition in Patients With Stage 4 Chronic Kidney Disease and Type 2 Diabetes MellitusNCT01655186Mean change in body weight as measured by Dual Energy X-ray Absorptiometry (DXA)Randomized · Quadruple-masked · Treatment | Phase 2 | Withdrawnsponsor's stated reason: IDMC recommendation for safety concerns | Drug: Bardoxolone Methyl, Placebo | Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2 | 0 | 2012-10-31actual | — | 2025-05-29 |
| Study of the Safety, Tolerability, Pharmacokinetics and Safety of BG00010 (Neublastin) in Subjects With Sciatica.NCT01405833Number of Participants experiencing Adverse EventsRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: BG00010 (Neublastin), Placebo | Sciatica | 56 | Sep 2012actual | — | 2014-09-09 |
| Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.NCT01632449PK - Area under the plasma concentration curve.Randomized · Single-masked | Phase 1 | Completed | Drug: Test product, Reference product | Healthy Volunteers | 80 | Sep 2012actual | — | 2013-05-31 |
| Study Of The PF-04958242 Blood Concentrations Of A Capsule Formulation Of PF-04958242 Compared To A Solution FormulationNCT01646840Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)Randomized · Open-label · Basic science | Phase 1 | Completed | Drug: PF-04958242 capsule, PF-04958242 oral solution | Healthy | 12 | Sep 2012actual | — | 2019-11-21 |
| Natalizumab (BG00002, Tysabri) Study in Japanese Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)NCT01440101results2014-10-21Part A: Number of Participants With Adverse Events (AEs)Randomized · Quadruple-masked · Treatment | Phase 2/3 | Completed | Drug: Natalizumab (BG00002), Placebo | Multiple Sclerosis | 106 | Aug 2012actual | — | 2014-10-21 |
| Pregnancy Exposure Registry for Tysabri®NCT00472992observationalNumber of spontaneous abortions, fetal losses including stillbirths, and ectopic pregnancies | — | Completed | — | Crohn's Disease, Prenatal Exposure, Multiple Sclerosis, Pregnancy | 376 | Jul 2012actual | — | 2014-08-11 |
| A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) PatientsNCT00871780results2014-11-18Change From Baseline in the Timed 100-meter Walk Test (T100T)Open-label · Treatment | Phase 4 | Completed | Drug: BG00002 (natalizumab) | Relapsing Remitting Multiple Sclerosis (RRMS) | 224 | Jul 2012actual | — | 2017-03-21 |
| An Open-Label Study of the Effect of Bardoxolone Methyl on the Single Dose Pharmacokinetics of Digoxin and Rosuvastatin in Healthy VolunteersNCT01598363Maximum observed concentrationRandomized · Open-label · Basic science | Phase 1 | Completed | Drug: Digoxin, Rosuvastatin | Healthy Volunteers | 32 | 2012-07-31actual | — | 2025-05-29 |
| JC-Virus (JCV) Antibody ProgramNCT01070823observationalPrevalence of serum anti-JC virus (JCV) antibody | — | Completed | Drug: Tysabri® (natalizumab) | Multiple Sclerosis | 1,096 | Jun 2012actual | — | 2016-10-05 |
| Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-Sustained Release (SR) in Canadian Participants With Multiple Sclerosis Who Participated in Acorda Extension Trials.NCT01235221Adverse events (AEs) and serious adverse events (SAEs) as well as Changes in vital signs and clinical laboratory assessmentsOpen-label · Treatment | Phase 3 | Completed | Drug: BIIB041 (Fampridine-SR) | Multiple Sclerosis | 38 | Jun 2012actual | — | 2014-07-04 |
| Crossover Study of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral RadiculopathyNCT01561027Change in Average Daily Neuropathic Pain Score from BaselineRandomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: CNV1014802, Placebo | Lumbosacral Radiculopathy | 82 | 2012-06-30actual | — | 2017-10-13 |
| Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple SclerosisNCT00870740results2016-08-30Number of Participants With Treatment-emergent Adverse Events (AEs)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Biological: BIIB019 (Daclizumab High Yield Process) · Drug: Placebo | Relapsing-Remitting Multiple Sclerosis | 517 | May 2012actual | — | 2016-08-30 |
| JC-virus (JCV) Epidemiology in Multiple Sclerosis (MS)NCT01185717observationalPrevalence of anti-JCV antibodies | — | Completed | — | Multiple Sclerosis | 7,726 | May 2012actual | — | 2014-06-02 |
| Avonex PEN Satisfaction and Patients Experience Clinical TrialNCT01366040observationalPatient satisfaction | — | Completed | — | Multiple Sclerosis | 89 | May 2012actual | — | 2013-09-16 |
| Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple SclerosisNCT01058005results2014-08-13Incidence of Treatment-emergent Serious Adverse Events (SAEs)Randomized · Open-label | Phase 3 | Terminatedsponsor's stated reason: Due to significantly slower than expected enrollment, the Sponsor decided to terminate the study. | Drug: BG00002 (natalizumab), interferon beta-1a, glatiramer acetate | Relapsing Remitting Multiple Sclerosis | 84 | Apr 2012actual | — | 2014-09-03 |
| Safety Study of BIIB033 in Subjects With Multiple SclerosisNCT01244139Evaluate safety and tolerability profile of two IV infusions of BIIB033 in subjects with MSRandomized · Triple-masked | Phase 1 | Completed | Drug: BIIB033, Placebo | Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis | 47 | Apr 2012actual | — | 2017-01-09 |
| Phase 1 Study to Evaluate the PK, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Healthy VolunteersNCT01453426AUC of BG00012Randomized · Open-label · Basic science | Phase 1 | Completed | Drug: BG00012 Dose 1, BG00012 Dose 2 | Healthy | 71 | Apr 2012actual | — | 2013-09-16 |
| Demonstrate the Bioequivalence of Interferon Beta-1a (INFB) Manufactured by Two Different Processes in Healthy VolunteersNCT01500408Area under the serum concentration-time curve (AUC) as a measure of PK.Randomized · Single-masked | Phase 1 | Completed | Drug: Interferon beta-1a (current approved manufacturing process invloving FBS), Interferon beta-1a (new process, manufactured without FBS) | Multiple Sclerosis | 110 | Apr 2012actual | — | 2012-11-19 |
| BG00012 Phase 2 Combination Study in Participants With Multiple SclerosisNCT01156311results2015-06-09Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period)Non-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: dimethyl fumarate | Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis | 108 | Mar 2012actual | — | 2017-03-21 |
| A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Psychiatrically Stable Subjects With SchizophreniaNCT01518894Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24 hours after dosing on Day 1Randomized · Double-masked · Basic science | Phase 1 | Completed | Drug: PF-04958242, PF-04958242, PF-04958242, Placebo | Schizophrenia | 30 | Mar 2012actual | — | 2019-11-21 |
| Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica ParticipantsNCT00961766Number of participants experiencing Adverse Events (AEs)Randomized · Single-masked · Treatment | Phase 1 | Completed | Drug: BG00010 (Neublastin), Placebo | Sciatica | 48 | Feb 2012actual | — | 2014-10-28 |
| Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS)NCT01211665results2014-08-13Time Course Change in Functional Status Based on Karnofsky Performance Status Index Through 6 Months Following Completion of Plasma Exchange (PLEX)Non-randomized · Open-label · Treatment | Phase 4 | Terminatedsponsor's stated reason: This study was stopped prematurely due to lack of enrollment within a 1-5-year period. | Drug: Methylprednisolone, Prednisolone | Immune Reconstitution Inflammatory Syndrome, Leukoencephalopathy, Progressive Multifocal | 3 | Feb 2012actual | — | 2014-09-05 |
| Phase 1 Study to Evaluate the PK, Safety, Tolerability of BIIB023 in Chinese, Japanese, and Caucasian Healthy VolunteersNCT01407406AUC of BIIB023Randomized · Quadruple-masked · Basic science | Phase 1 | Completed | Drug: BIIB023 - low dose IV Dose, BIIB023 - high dose IV Dose | Healthy Volunteers | 48 | Feb 2012actual | — | 2013-09-16 |
| COMPliance With Avonex® PS in Patients With Relapsing-Remitting MSNCT00675883observationalCompliance with therapy in the prospective arm | — | Completed | — | Multiple Sclerosis, Relapsing-Remitting | 1,000 | Dec 2011actual | — | 2012-01-30 |
| A Single-Dose, Open-Label, Randomized, Food Effect and Blinded, Randomized, Dose Proportionality Study in Healthy Volunteers With Bardoxolone MethylNCT01461161Effect of food on Pharmacokinetics of a 20 mg single dose of bardoxolone methylRandomized · Quadruple-masked · Basic science | Phase 1 | Completed | Drug: bardoxolone methyl | Healthy Volunteers | 32 | 2011-12-31actual | — | 2025-05-29 |
| A Phase I Study to Investigate the Absorption, Metabolism and Excretion in Healthy Male SubjectsNCT01503866area under curveOpen-label · Basic science | Phase 1 | Completed | Drug: bardoxolone methyl | Healthy | 6 | 2011-12-31actual | — | 2025-05-29 |
| Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)NCT00559702Maximum observed concentration (Cmax) of natalizumabRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: natalizumab · Other: standard of care | Relapsing-Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis | 76 | Nov 2011actual | — | 2014-09-09 |
| Treatment Interruption of NatalizumabNCT01071083results2013-01-30Time Course to Return of Radiological and/or Clinical Evidence of Multiple Sclerosis Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) and/or Clinical Relapse Rescue Criteria.Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: natalizumab, interferon beta 1-a, methylprednisolone, glatiramer acetate · Other: IV placebo | Relapsing Remitting Multiple Sclerosis | 175 | Nov 2011actual | — | 2013-09-19 |
| Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Repeated Doses of PF-04958242 in Healthy VolunteersNCT01511510Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24 hours after dosing on Day 1Randomized · Double-masked · Basic science | Phase 1 | Completed | Drug: PF-04958242, PF-04958242, PF-04958242, PF-04958242, Placebo | Schizophrenia | 39 | Nov 2011actual | — | 2019-11-21 |
| Administration of BIIB028 to Subjects With Solid TumorsNCT00725933Safety and Tolerability of BIIB028Open-label · Treatment | Phase 1 | Completed | Drug: BIIB028 | Advanced Solid Tumors | 43 | Oct 2011actual | — | 2017-01-09 |
| Hormone Receptor Positive Metastatic Breast Cancer (HR+ mBC) BIIB021 Plus Aromasin Schedule FindingNCT01004081The primary objective of this study is to assess the efficacy of 2 dosing regimens of BIIB021 in combination with exemestane in women whose HR+ breast cancer had progressed following treatment with a nonsteroidal AI.Randomized · Open-label · Treatment | Phase 2 | Completed | Drug: BIIB021, BIIB021, exemestane (Aromasin) | Breast Cancer | 54 | Oct 2011actual | — | 2015-10-02 |
| BIIB033 Single Ascending Dose Study in Healthy Volunteer SubjectsNCT01052506Safety as measured by adverse event monitoring, laboratory assessments and MRIRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: BIIB033, Placebo | Healthy | 72 | Oct 2011actual | — | 2017-01-09 |
| Avonex Safety and Tolerability in Chinese Subjects With Relapsing Multiple Sclerosis (MS)NCT01181115The number and proportion of subjects with adverse events (AEs)Open-label · Treatment | Phase 3 | Completed | Drug: Avonex | Multiple Sclerosis | 60 | Oct 2011actual | — | 2013-09-16 |
| A Multiple-Dose, Open-Label, Phase 1, Pharmacokinetic, Pharmacodynamic, and Safety Study of Avonex® in Chinese Healthy Volunteer SubjectsNCT01416207CmaxOpen-label · Basic science | Phase 1 | Completed | Drug: Avonex | Healthy | 24 | Oct 2011actual | — | 2011-11-04 |
| MATRIX: Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and ColombiaNCT01556685Neutralizing antibodies to Interferon beta 1a IM (Avonex) or IFN beta 1a IM biosimilarNon-randomized · Treatment | Phase 4 | Completed | Other: clinical and neurological evaluation, Blood Sample · Genetic: Blood Sample | Multiple Sclerosis | 180 | Oct 2011actual | — | 2013-09-16 |
| Pregnancy Exposure Registry for Avonex (Interferon Beta-1a)NCT00168714observationalRecord and analyze birth defects and spontaneous fetal losses | — | Completed | Drug: BG9418 (interferon beta-1a) | Prenatal Exposure Delayed Effects, Multiple Sclerosis, Pregnancy | 329 | Sep 2011actual | — | 2014-06-09 |
| A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung CancerNCT00970580To evaluate the safety and tolerability of BIIB022 in combination with paclitaxel and carboplatinOpen-label · Treatment | Phase 1 | Completed | Drug: BIIB022 With Paclitaxel and Carboplatin | Non-Small Cell Lung Cancer | 18 | Sep 2011actual | — | 2013-09-16 |
| Study in Healthy Volunteers to Establish the BioEquivalence of Two Formulations of BG00012NCT01420458Area under the plasma concentration curve as a measure of PK.Randomized · Open-label | Phase 1 | Completed | Drug: Experimental | Healthy Volunteers | 80 | Sep 2011actual | — | 2011-11-04 |
| Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple SclerosisNCT00451451results2014-06-02Annualized Relapse RateRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: BG00012, Placebo, Glatiramer Acetate | Relapsing-Remitting Multiple Sclerosis | 1,417 | Aug 2011actual | — | 2015-01-26 |
| A Single-Dose, Pharmacokinetic/Pharmacodynamic (PK/PD), & Safety Study of BIIB017 in Participants With Renal Impairment & Healthy VolunteersNCT01119781Area under the time-concentration curve (AUC) for serum concentrations of peginterferon beta-1aNon-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: BIIB017(peginterferon beta-1a) | Healthy, Renal Insufficiency | 35 | Aug 2011actual | — | 2014-06-02 |
| A Phase I Study of BIIB015 in Relapsed/Refractory Solid TumorsNCT00674947To evaluate safetyNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: BIIB015 | Solid Tumors | 55 | Jun 2011actual | — | 2013-09-16 |
| Effects of Tysabri (BG00002) Over 12 Months on MS Related Fatigue in Participants With RRMSNCT00884481observationalTo investigate the MS related fatigue during treatment with Tysabri as measured by changes in the fatigue scale for motor and cognitive functions (FMSC) over the course of 12 months. | — | Completed | Other: Natalizumab | Relapsing-Remitting Multiple Sclerosis, Fatigue | 195 | 2011-06-30actual | — | 2018-11-08 |
| Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple SclerosisNCT00390221results2016-07-11Adjusted Annualized Relapse Rate Between Baseline and Week 52Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Biological: BIIB019 (Daclizumab High Yield Process) · Drug: Placebo | Relapsing-Remitting Multiple Sclerosis | 621 | May 2011actual | — | 2016-07-11 |
| Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PF-04958242 in Healthy Adult VolunteersNCT01238679Number of Participants Experiencing Adverse Events and Serious Adverse EventsRandomized · Triple-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: See termination reason in detailed description. | Drug: PF-04958242, Placebo | Healthy Volunteers | 20 | 2011-05-03actual | — | 2019-12-24 |
| CNF2024 (BIIB021) HER2- (QD) HER2+ (BIW w/Herceptin) PK/PD StudyNCT00412412Clinical and laboratory safety assessmentsNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: CNF2024, CNF2024 + trastuzumab | Breast Cancer | 34 | Apr 2011actual | — | 2012-06-08 |
| BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid ArthritisNCT00771329Determine the safety and tolerability of single doses of BIIB023 administered intravenously (IV) to subjects with RA.Randomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: BIIB023 · Other: Placebo (sterile normal saline) | Rheumatoid Arthritis | 53 | Apr 2011actual | — | 2013-09-16 |
| Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)NCT00956436To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC.Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: BIIB022, Sorafenib | Hepatocellular Carcinoma | 40 | Apr 2011actual | — | 2013-09-16 |
| A Safety Study in Healthy Volunteers of the Single-Use Autoinjector Containing Placebo of BG9418 Interferon Beta-1a With a 25-Gauge × 1-Inch NeedleNCT01313364Incidence of treatment-emergent AEs reported when using the single-use autoinjector with a 25G x 1" needleOpen-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: The objective of the study has been achieved with fewer subjects than planned. | Device: 25G x 1" Needle Autoinjector | Healthy | 80 | Apr 2011actual | — | 2011-08-12 |
| A Proof of Concept Study to Evaluate the Effectiveness of Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) Patient Bladder FunctionNCT00818038observationalChange in bladder function as measured by UDI-6 compared to baseline over 6 months of TYSABRI treatment. | — | Completed | Drug: BG0002 (natalizumab) | Relapsing-Remitting Multiple Sclerosis | 30 | Mar 2011actual | — | 2014-06-27 |
| Alternate Dosing Regimens of BG00012 in Healthy VolunteersNCT01281111• incidence of treatment emergent AEsRandomized · Double-masked · Basic science | Phase 1 | Completed | Drug: Dimethyl Fumarate (BG00012), Aspirin, BG00012 matching placebo, ASA matching placebo | Healthy | 56 | 2011-03-18actual | — | 2023-08-23 |
| Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple SclerosisNCT00420212results2014-06-02Proportion of Subjects RelapsedRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: BG00012, Placebo | Relapsing-Remitting Multiple Sclerosis | 1,234 | Feb 2011actual | — | 2015-01-26 |
| Phase II Pharmacodynamic Trial to Determine the Effects of Bardoxolone Methyl on eGFR in Patients With Type 2 Diabetes and Chronic Kidney DiseaseNCT01053936To assess a trend in mean change from baseline to Day 29 in eGFR (as estimated by the 4-component MDRD formula) with increasing doses of bardoxolone methyl (amorphous dispersion) in patients with Type 2 diabetes and CKD (eGFR 15-45 mL/min/1.73m2).Randomized · Open-label · Treatment | Phase 2 | Completed | Drug: Bardoxolone methyl (amorphous dispersion) | Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2 | 129 | 2010-12-31actual | — | 2025-05-29 |
| Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's LymphomaNCT00651443Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL.Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: A company's strategic decision to focus on areas whereit believes it can be competitive and decided to exit Oncology | Drug: Galiximab | Lymphoma, Non-Hodgkin's | 20 | Nov 2010actual | — | 2011-01-07 |
| Study to Explore the Effect of Mefloquine in Participants With Progressive Multifocal Leukoencephalopathy (PML)NCT00746941results2014-07-31Change From Baseline to Week 4 in JC Virus (JCV) Load in Cerebrospinal Fluid (CSF)Randomized · Single-masked · Treatment | Phase 1/2 | Terminatedsponsor's stated reason: Primary endpoint not achieved | Drug: mefloquine | Progressive Multifocal Leukoencephalopathy | 37 | Nov 2010actual | — | 2014-07-31 |
| A Pharmacokinetics (PK) and Safety Study of Oral Fampridine-PR 10 mg in Chinese, Japanese, and Caucasian Adult Healthy VolunteersNCT01215084Percentage of participants with treatment-emergent adverse events in each ethnic groupNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: BIIB041 (Fampridine-PR) | Healthy | 36 | Nov 2010actual | — | 2014-07-09 |
| A Study of Avonex to Determine the Effects of Dose Titration on the Incidence of Flu Like Symptoms in Healthy VolunteersNCT01119677To determine whether titration of Avonex reduces the incidence of flu like symptomsRandomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: Avonex | Healthy Volunteers | 120 | 2010-10-23actual | — | 2017-11-17 |
| First-in-Human Study of PF-04958242 in Healthy VolunteersNCT01159483Number of Participants Experiencing Adverse EventsRandomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: PF-04958242, Placebo | Healthy Volunteer | 24 | 2010-10-16actual | — | 2019-12-24 |
| Effect of Food and Antacid on BIIB021 With Advanced Solid TumorsNCT01017198The primary objective of the study is to assess the pharmacokinetics of BIIB021 taken under fed conditions compared to BIIB021 taken under fasting conditions in subjects with advanced solid tumors.Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: BIIB021 and Food, BIIB0121 and Antacid | Advanced Solid Tumors | 20 | Aug 2010actual | — | 2013-09-16 |
| Lumiliximab With Fludarabine, Cyclophosphamide, and Rituximab (FCR) Versus FCR Alone in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)NCT00391066Complete Response (CR) rateRandomized · Open-label · Treatment | Phase 2 | Terminated | Drug: FCR + Lumiliximab, FCR | Chronic Lymphocytic Leukemia | 627 | Jul 2010actual | — | 2015-10-02 |
| Evaluation of Natalizumab for thE Relief of MS Associated FatiGueNCT00464074observationalVisual Analog Scale for Fatigue (VAS-F) | — | Completed | — | Multiple Sclerosis | 89 | 2010-07-31actual | — | 2023-08-22 |
| Once or Twice Daily Administration of BIIB021 to Subjects With Advanced Solid TumorsNCT00618735Safety and tolerability of BIIB021Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: BIIB021, BIIB021 | Advanced Solid Tumors | 68 | Jul 2010actual | — | 2016-12-29 |
| Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis SubjectsNCT00828204results2011-08-09Percentage of Participants in the Main Subset With Overall Success Using the Avonex Single-Use AutoinjectorOpen-label | Phase 3 | Completed | Device: single-use autoinjector with a prefilled liquid Avonex syringe, Avonex prefilled syringe via manual IM injection · Drug: BG9418 (interferon beta-1a) | Multiple Sclerosis | 95 | Jul 2010actual | — | 2014-06-03 |
| Evaluation of Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) +/- Lumiliximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia (CLL)NCT00801060To evaluate the safety and tolerability of FCR+L compared with FCR alone in subjects with previously untreated CLL.Randomized · Open-label · Treatment | Phase 2 | Terminated | Drug: Lumiliximab + FCR, FCR | Chronic Lymphocytic Leukemia | 40 | Jun 2010actual | — | 2015-10-02 |
| BIIB014 Effects on the Pharmacokinetics (PK) of Rosiglitazone, Warfarin, and MidazolamNCT01017666Pharmacokinetic profile of rosiglitazone (Cohort 1), midazolam & metabolites and s-warfarin (Cohort 2) during steady state exposure to BIIB014 or placeboRandomized · Double-masked · Other | Phase 1 | Completed | Drug: BIIB014, Placebo | Healthy | 28 | 2010-06-02actual | — | 2023-08-23 |
| Study of Tysabri (Natalizumab) in Patients Who Failed Anti-TNF-α TherapyNCT00801125Proportion (%) achieving a clinical response at Week 12, defined as a reduction in the CDAI score from baseline (Week 0) of ≥ 70 points.Open-label · Treatment | Phase 4 | Withdrawnsponsor's stated reason: Study sponsor decided to withdraw the current study prior to enrollment of first participant. | Drug: natalizumab | Crohn's Disease | 0 | May 2010 | — | 2016-06-16 |
| Trial to Determine the Effects of Bardoxolone Methyl on eGFR in Patients With Type 2 Diabetes and Chronic Kidney DiseaseNCT00811889To determine the change in eGFR from baseline in patients with type 2 diabetes and CKD (baseline eGFR = 20 - 45 mL/min/1.73m2) after receiving bardoxolone methyl for 6 months (24 weeks) following randomizationRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Other: Placebo · Drug: Bardoxolone Methyl (RTA 402) | Chronic Kidney Disease, Type 2 Diabetes, Diabetic Nephropathy | 227 | 2010-05-31actual | — | 2025-05-29 |
| Safety Study of RP-1127 (Glyburide for Injection) in Healthy VolunteersNCT01132703Number of Participants with Adverse Events and Serious Adverse EventsRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: Glyburide for Injection, Placebo | Traumatic Brain Injury, Stroke | 34 | 2010-05-07actual | — | 2021-06-21 |
| Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple SclerosisNCT00492765The time to first documented relapseRandomized · Quadruple-masked · Treatment | Phase 4 | Completed | Drug: Interferon-beta-1a, Simvastatin, Placebo | Multiple Sclerosis | 380 | Apr 2010actual | — | 2010-10-15 |
| Phase 1 Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Relapsed/Refractory Solid TumorsNCT00555724To evaluate the safety and tolerability of BIIB022Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: BIIB022 | Solid Tumors | 40 | Apr 2010actual | — | 2017-01-09 |
| An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST)NCT00618319Changes in FDG-PET imagingOpen-label · Treatment | Phase 2 | Completed | Drug: BIIB021 | GIST | 20 | Apr 2010actual | — | 2015-10-02 |
| BIIB014 Cardiovascular Monitoring StudyNCT01035515Supine Blood pressureRandomized · Double-masked | Phase 1 | Completed | Drug: Placebo, BIIB014 50mg, BIIB014 100mg | Healthy | 24 | Apr 2010actual | — | 2010-06-22 |
| A Phase 2 Study of Interferon Beta-1a (Avonex®) in Ulcerative ColitisNCT00616434results2014-08-13Percentage of Participants With a Clinical ResponseRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: BG9418 (Interferon beta-1a), Placebo | Active Ulcerative Colitis | 123 | Mar 2010actual | — | 2014-08-13 |
| Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid ArthritisNCT00810836The primary objective is the proportion of subjects with ACR20 response in their RA at Week 12.Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: BG00012, BG00012, placebo | Rheumatoid Arthritis | 153 | Feb 2010actual | — | 2013-09-16 |
| Lumiliximab in Combination With FCR in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)NCT00103558Characterize the safety profileNon-randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: Lumiliximab with FCR | Chronic Lymphocytic Leukemia | 31 | Jan 2010actual | — | 2015-10-02 |
| A Study of Galiximab + Rituximab Versus Rituximab + Placebo in Follicular Non-Hodgkin's Lymphoma (NHL)NCT00363636To assess efficacy as measured by progression free survival (PFS), and determine whether rituximab plus galiximab compared to rituximab plus placebo may extend PFS.Randomized · Triple-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: Enrollment challenges due to changes in standards of care resulted in premature termination. No safety or efficacy events factored into this action. | Drug: Galiximab in combination with rituximab, Rituximab in combination with placebo | Lymphoma, Non-Hodgkin's | 340 | Jan 2010actual | — | 2015-10-02 |
| Retreatment Study of Galiximab + Rituximab in Follicular Non-Hodgkin's Lymphoma (NHL)NCT00384150Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodiesNon-randomized · Open-label · Treatment | Phase 3 | Terminatedsponsor's stated reason: Enrollment challenges due to changes in standards of care resulted in premature termination. No safety or efficacy events factored into this action. | Drug: galiximab in combination with rituximab | Lymphoma, Non-Hodgkin's | 16 | Jan 2010actual | — | 2015-11-26 |
| Oral Tonapofylline (BG9928) in Patients With Heart Failure and Renal InsufficiencyNCT00745316To assess the safety and tolerability of BG9928 administered to subjects with heart failure and renal insufficiency.Randomized · Triple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Company Decision | Drug: Tonapofylline, Placebo | Renal Insufficiency, Heart Failure | 34 | Jan 2010actual | — | 2023-09-11 |
| Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon BetaNCT00493116return of bioavailability of AVONEX (interferon-beta-1a) as measured by induction of MxA mRNAOpen-label · Treatment | Phase 4 | Completed | Drug: Interferon-beta-1a, methylprednisolone | Relapsing-Remitting Multiple Sclerosis | 20 | Dec 2009actual | — | 2013-09-16 |
| Study of Natalizumab in Relapsed/Refractory Multiple MyelomaNCT00675428results2014-09-19Number of Participants With Dose Limiting Toxicities (DLTs)Randomized · Open-label · Treatment | Phase 1/2 | Terminatedsponsor's stated reason: Sponsor decision due to low enrollment and not safety concerns. | Drug: BG00002 (natalizumab) | Multiple Myeloma | 6 | Dec 2009actual | — | 2014-09-19 |
| Study to Investigate the Effect of GSK1014802 on Ambulatory Blood PressureNCT00955396Change in 24 h average SBP and DBP from Baseline to Day 36.Randomized · Double-masked · Other | Phase 1 | Completed | Drug: GSK1014802, Placebo | Healthy Volunteer | 60 | 2009-12-31actual | — | 2017-10-16 |
| The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple SclerosisNCT00536120results2011-07-29Percentage of Keyhole Limpet Hemocyanin (KLH) Responders at Day 28 Post-VaccinationRandomized · Open-label | Phase 4 | Completed | Biological: BG00002 (natalizumab), keyhole limpet hemocyanin (KLH), tetanus diphtheria toxoid vaccine (Td) | Multiple Sclerosis | 60 | Nov 2009actual | — | 2017-02-15 |
| Effect of GSK1014802 on Electrical Hyperalgesia and Threshold Tracking in Healthy SubjectsNCT00964288To determine the effect of single oral doses of GSK1014802 on area of flare evoked by cutaneous electrical stimulation.Randomized · Quadruple-masked · Treatment | Phase 1 | Terminatedsponsor's stated reason: During treatment session 3, a subject had a pattern of AEs of severe intensity, suggestive of brainstem toxicity/encephalopathy during lidocaine/saline infusion | Drug: GSK1014802 low dose, Lidocaine, GSK1014802 high dose, Placebo | Pain, Neuropathic, Neuropathic Pain | 16 | 2009-11-30actual | — | 2017-10-26 |
| Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic CancerNCT00529113Phase I - To determine the maximum tolerated dose (MTD) of RTA 402 in combination with gemcitabine in patients with locally advanced or metastatic pancreatic cancer.Randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: To pursue other indications | Drug: Bardoxolone methyl, Bardoxolone methyl, Bardoxolone methyl, Bardoxolone methyl, Bardoxolone methyl, Bardoxolone methyl, Bardoxolone methyl, Gemcitabine, Placebo, Bardoxolone methyl | Pancreatic Neoplasms, Pancreatic Cancer | 33 | 2009-11-01actual | — | 2025-05-29 |
| A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MSNCT00837785To establish a PK profile of MMF during a 24-hour BG00012 dosing period in subjects with RRMSRandomized · Open-label · Basic science | Phase 1 | Completed | Drug: BG00012, BG00012 | Relapsing Remitting Multiple Sclerosis | 48 | 2009-10-31actual | — | 2018-02-15 |
| Pharmacokinetics Profile Study of BG00012 Standard Formulation and BG00012 Active Pharmaceutical IngredientNCT01069913PK profiles of the current BG00012 standard formulation and the BG00012 API formulation in healthy volunteers. Primary PK parameter will be the area under the plasma concentration curveRandomized · Open-label | Phase 1 | Completed | Drug: BG00012 | Healthy | 14 | Oct 2009actual | — | 2010-02-17 |
| Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal InsufficiencyNCT00709865Assess the safety andtolerability of intravenous tonapofylline, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency.Randomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: tonapofylline, Placebo | Renal Insufficiency, Congestive Heart Failure | 420 | 2009-10-30actual | — | 2023-09-11 |
| BG9928 in Subjects With Hepatic ImpairmentNCT00858156The comparative effect of hepatic function on the pharmacokinetics of a single oral dose of BG9928 in subjects with mild and moderate hepatic impairment as compared to subjects with normal hepatic functionNon-randomized · Open-label | Phase 1 | Completed | Drug: BG9928 | Hepatic Impairment | 23 | Aug 2009actual | — | 2010-01-27 |
| A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-aNCT00771043Changes in average RNFL thickness as measured by OCT of affected eyes across treatment groups.Randomized · Open-label · Treatment | Phase 4 | Withdrawnsponsor's stated reason: Sponsor decision to withdraw study at this time. | Drug: TYSABRI and AVONEX | Relapsing-remitting Multiple Sclerosis | 0 | 2009-08-01 | — | 2024-06-03 |
| Phase IIa Trial to Determine the Effects of Bardoxolone Methyl on Renal Function in Patients With Diabetic NephropathyNCT00664027To determine the effects of RTA 402 administered orally at three dose strengths on the glomerular filtration rate (as estimated by the MDRD formula) in patients with diabetic nephropathy (stratum 1).Randomized · Open-label · Treatment | Phase 2 | Completed | Drug: RTA 402 (Bardoxolone Methyl) | Diabetic Nephropathy | 80 | 2009-05-31actual | — | 2025-05-29 |
| Safety and Tolerability of Rituxan With Methotrexate and Etanercept or Methotrexate and Adalimumab in Patients With Active Rheumatoid ArthritisNCT00298272results2010-11-17Proportion of Participants With at Least One Serious Infection Through Week 24Randomized · Triple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Sponsor decided to end long term extension phase for business reasons unrelated to safety. | Biological: IDEC-C2B8 (rituximab) · Drug: Placebo, Methotrexate, Etanercept, Adalimumab, Methylprednisolone · Dietary supplement: Folate | Rheumatoid Arthritis | 54 | Apr 2009actual | — | 2015-09-28 |
| Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's DiseaseNCT00438607Number and proportion of subjects with adverse eventsRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: BIIB014, Placebo | Parkinson's Disease | 83 | Apr 2009actual | — | 2009-07-13 |
| Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) PatientsNCT00784836results2014-05-07Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta)Open-label · Treatment | Phase 3 | Terminatedsponsor's stated reason: Terminated early by Sponsor for business reasons unrelated to safety. | Drug: BG9418 (interferon beta 1-a) | Multiple Sclerosis | 3 | Feb 2009actual | — | 2014-05-07 |
| Dose-Finding Safety Study of BIIB014 in Early-Stage Parkinson's DiseaseNCT00442780Number and proportion of subjects with adverse eventsRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: BIIB014, Placebo | Parkinson's Disease | 36 | Dec 2008actual | — | 2009-01-09 |
| ATP Expression in Lymphocytes of MS Patients by Means of "ImmuKnow®" Assay.NCT00618267observationalThe primary objective of this study is to determine the effects of various therapies (immunomodulatory as well as immunosuppressive) on ATP levels in CD4+ cells. | — | Completed | — | Multiple Sclerosis | 100 | Dec 2008actual | — | 2010-03-05 |
| A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady StateNCT00744679Pharmacokinetic (PK) Profile of NatalizumabNon-randomized · Open-label · Basic science | Phase 4 | Completed | Drug: Natalizumab | Multiple Sclerosis | 20 | Dec 2008actual | — | 2015-02-10 |
| Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802.NCT00908154Safety and tolerability will be evaluated by monitoring AEs and concomitant medication, ECG, Lead II monitoring, Holter monitoring, vital signs, and laboratory parameters.Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Placebo, GSK1014802 | Bipolar Depression, Bipolar Disorder | 51 | 2008-12-31actual | — | 2017-10-30 |
| A Safety Study of RTA 744 in Patients With Recurrent High-Grade GliomasNCT00526812To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of RTA 744 Injection in the patient population studied and to determine the qualitative and quantitative toxic effects of RTA 744 Injection.Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: RTA 744, RTA 744 injection | Glioma | 54 | 2008-12-01actual | — | 2025-05-28 |
| A Safety Study of RTA 744 in Recurrent, Progressive or Refractory Neoplastic MeningitisNCT00527410Determine the tolerability of RTA 744 Injection in patients with leptomeningeal disease (LMD) secondary to any type of primary tumor.Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Business Decision | Drug: RTA 744 | Leptomeningeal Carcinomatosis | 9 | 2008-12-01actual | — | 2025-05-30 |
| RTA 402 in Patients With Advanced Solid Tumors or Lymphoid MalignanciesNCT00529438To determine the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of Bardoxolone methyl CapsulesOpen-label · Treatment | Phase 1 | Completed | Drug: Bardoxolone methyl | Advanced Solid Tumors, Lymphoid Malignancies | 47 | 2008-12-01actual | — | 2025-05-28 |
| RTA 744 in Breast Cancer Patients With Progression of Previously Irradiated Brain MetastasesNCT00538343To evaluate the efficacy of RTA 744 in reducing intracranial tumor on contrast-enhanced MRI of breast cancer patients with progression of brain metastases following whole brain radiotherapy (WBRT).Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Business Decision | Drug: berubicin hydrochloride (RTA 744) | Brain Metastases | 14 | 2008-12-01actual | — | 2025-05-29 |
| Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MSNCT00168766To estimate the effect interferon-beta-1a in combination with methylprednisolone vs interferon-beta-1a in combination with placebo on the time to onset of disability progression sustained over at least 6 months based on change from randomization in EDSSRandomized · Double-masked · Treatment | Phase 4 | Completed | Drug: Interferon-beta-1a (Avonex) plus methylprednisolone | Relapsing-remitting Multiple Sclerosis | 345 | Nov 2008actual | — | 2013-09-16 |
| BG9924 in Combination With Methotrexate for Participants With Active Rheumatoid ArthritisNCT00458861Evaluate efficacy of BG9924 in combination with methotrexate in RA participants who have had an inadequate response to anti-TNF therapyRandomized · Triple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Interim analysis of data failed to meet primary endpoint. | Biological: BG9924 · Other: Placebo Comparator | Rheumatoid Arthritis | 115 | Oct 2008actual | — | 2016-01-21 |
| BG9924 in Combination With Methotrexate Extension of Study 104RA203 (NCT 00458861)NCT00523328To observe the long-term treatment with BG9924 when administered to participants with RA who previously participated in a Biogen Idec Study.Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Analysis of data from 104RA203 failed to meet primary endpoint. | Drug: BG9924 | Rheumatoid Arthritis | 72 | Oct 2008actual | — | 2016-01-21 |
| 104RA204 Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) ParticipantsNCT00664573To Observe The Long-Term treatment with BG9924 When Administered to Participants with RA who Previously Participated in a Biogen Idec StudyRandomized · Double-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Analysis of data from 104RA202 failed to meet primary endpoint | Biological: Baminercept alfa (BG9924) | Rheumatoid Arthritis | 339 | Oct 2008actual | — | 2016-01-21 |
| Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) ParticipantsNCT00664716Evaluate efficacy of BG9924 in combination with methotrexate (MTX) in RA participants who have had an inadequate response to DMARD therapyRandomized · Double-masked · Treatment | Phase 2 | Completed | Biological: Baminercept alfa 1, Placebo, Baminercept alfa 2, Baminercept alfa 3, Baminercept alfa 4, Baminercept alfa 5 | Rheumatoid Arthritis | 391 | Oct 2008actual | — | 2016-01-21 |
| Phase 1, Dose-Escalation Study of Oral CNF2024(BIIB021) in CLLNCT00344786Safety and toxicity (maximum tolerated dose (MTD))Non-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Sponsor's decision | Drug: CNF2024 (BIIB021) | B-Cell Chronic Lymphocytic Leukemia | 15 | Jul 2008actual | — | 2009-06-05 |
| Study of Oral CNF2024 (BIIB021) in Advanced Solid TumorsNCT00345189To determine the maximum tolerated dose (MTD)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: CNF2024 | Tumors, Lymphoma | 70 | Jul 2008actual | — | 2009-07-14 |
| GSK Drug Single Dose Escalation And Their Effect On Resting Motor Threshold In Healthy VolunteersNCT00488566Part1:AEs for the duration of the study;Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: GSK drug · Other: Placebo, Lamictal | Bipolar Disorder | 50 | 2008-05-31actual | — | 2017-10-26 |
| A Multiple Dose Safety Study of PEG-IFN in Healthy VolunteersNCT02125578The number of participants that experience Adverse Events (AEs)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: BIIB017 (PEGylated Interferon Beta-1a), Placebo | Healthy | 69 | May 2008actual | — | 2014-04-29 |
| Using PET Scans to Study Brain Receptor Occupancy of BIIB014 in Healthy Male VolunteersNCT00531193PET scanning with [11C]SCH442416 of the putamen, caudate, nucleus accumbens, thalamus, and cerebellum.Non-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: BIIB014 · Other: [11C]SCH442416 | Healthy | 32 | Apr 2008actual | — | 2008-07-30 |
| How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full DoseNCT00574041To assess the mean severity of episodes of FLS during the 4 week titration phaseRandomized · Single-masked · Treatment | Phase 4 | Terminatedsponsor's stated reason: Terminated due to poor recruitment | Drug: Interferon beta-1a | Relapsing Remitting Multiple Sclerosis | 19 | Feb 2008actual | — | 2008-09-04 |
| Natalizumab Re-Initiation of DosingNCT00306592results2010-01-26Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)Open-label · Treatment | Phase 3 | Completed | Biological: BG00002 (natalizumab) | Multiple Sclerosis, Relapsing-Remitting | 404 | Dec 2007actual | — | 2017-03-21 |
| Study to Assess the Safety, Tolerability, and Pharmacodynamics of RTA 402 in Patients With Hepatic DysfunctionNCT00550849To evaluate the safety and tolerability of multiple-dose oral administration of RTA 402 in patients with hepatic dysfunction.Randomized · Triple-masked · Treatment | Phase 1/2 | Terminatedsponsor's stated reason: Enrollment discontinued after second cohort completed. | Drug: RTA 402, RTA 402, RTA 402 | Liver Disease | 16 | 2007-11-30actual | — | 2025-05-30 |
| A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)NCT00424788Non-randomized · Open-label · Treatment | Early Phase 1 | Completed | Procedure: Plasma exchange · Drug: natalizumab treatment | Relapsing Forms of Multiple Sclerosis | 12 | Oct 2007actual | — | 2009-09-04 |
| GER-009-06-AVX Early Therapy in Multiple SclerosisNCT00492570observational | — | Completed | — | Relapsing-Remitting Multiple Sclerosis | 230 | Oct 2007actual | — | 2009-06-16 |
| Natalizumab High Titer Immunogenicity and SafetyNCT00516893results2009-08-13Number of Participants With Anti-Natalizumab Antibody Negative, Transient Positive, and Persistent Positive StatusOpen-label | Phase 2 | Completed | Biological: BG00002-E (natalizumab high titer) | Multiple Sclerosis | 113 | Oct 2007actual | — | 2014-05-15 |
| Effect of Rituximab on Immunological Recall Response to Specific Antigens in the Treatment of Non-Hodgkin's LymphomaNCT00090038To determine whether treatment with rituximab causes a clinically significant effect on immunological recall response to tetanus vaccine in NHL patientsNon-randomized · Open-label · Treatment | Phase 4 | Completed | Drug: rituximab | Non-Hodgkin's Lymphoma | 168 | Jun 2007actual | — | 2009-10-20 |
| Dose-Escalating Study of BG9924 in Combination With Methotrexate in Active Rheumatoid ArthritisNCT00292422To evaluate the safety and tolerability of BG9924 when administered in combination with MTX to subjects with active RA who have had an inadequate response to DMARD therapyRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: BG9924 | Rheumatoid Arthritis | 50 | May 2007actual | — | 2007-12-31 |
| Safety and Tolerability of hCBE-11 in Subjects With Advanced Solid TumorsNCT00105170To evaluate the safety and tolerability of hCBE-11 in advanced solid tumorsNon-randomized · Open-label · Treatment | Phase 1 | Terminated | Drug: hCBE-11 | Tumors | 13 | Aug 2006actual | — | 2013-04-26 |
| Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing AntibodiesNCT00492466Reduction in the proportion of patients being neutralizing antibody (NAb) positive (titre>20)Open-label · Treatment | Phase 4 | Completed | Drug: Interferon-beta-1a, methylprednisolone | Relapsing-Remitting Multiple Sclerosis | 14 | Aug 2006actual | — | 2008-01-30 |
| AVONEX® Combination Trial - "ACT"NCT00112034Brain MRI lesion activity measured by the combined number of T2-hyperintense lesions at Month 12 that are new or enlarged since BaselineRandomized · Double-masked | Phase 4 | Completed | Drug: Methotrexate, IV methylprednisolone | Multiple Sclerosis, Relapsing-Remitting | 350 | Jun 2006actual | — | 2008-05-09 |
| Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta TherapyNCT00493077neutralizing antibody levels will be followedOpen-label · Treatment | Phase 4 | Completed | Drug: low immunogenic interferon-beta-1a | Multiple Sclerosis | 3 | May 2006actual | — | 2008-01-30 |
| Patient Satisfaction Study of Single-Use Autoinjector for the Delivery of Pre-Filled Avonex SyringeNCT00915577The primary objective of the study is to determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled AVONEX® syringeOpen-label | Phase 3 | Completed | Drug: Interferon beta-1a · Device: Single-use autoinjector | Multiple Sclerosis | 74 | Apr 2006actual | — | 2009-06-08 |
| Efficacy and Safety of BG00012 in MSNCT00168701The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24.Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: BG00012 | Multiple Sclerosis | 260 | 2006-03-31actual | — | 2023-08-28 |
| Safety and Efficacy of Avonex in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)NCT00099489The primary endpoint for the efficacy analyses is the total IVIg dose (g/Kg) administered after Visit 5 and through Visit 9 (Week 32, End of Study).Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Interferon Beta-1a | Chronic Inflammatory Demyelinating Polyradiculoneuropathy | 67 | Feb 2006actual | — | 2010-03-05 |
| Safety and Activity of 90Y-Labeled IDEC-159 in Subjects With Metastatic Colorectal AdenocarcinomaNCT00102024To characterize the safety profile and determine the MTD of 90Y-IDEC-159 in subjects with metastatic colorectal cancer.Non-randomized · Open-label · Treatment | Phase 1/2 | Terminated | Drug: Unconjugated IDEC-159, 111In-IDEC-159, 90Y-IDEC-159 | Colorectal Cancer, Metastases | 30 | Jan 2006actual | — | 2010-08-27 |
| Open-Label Natalizumab Safety Extension StudyNCT00276172The safety endpoints under consideration will be the incidence of adverse events, changes in laboratory evaluations, vital signs, and physical examinations. The incidence of development of antibodies to natalizumab will also be assessed.Non-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: Natalizumab | Multiple Sclerosis | 1,615 | Oct 2005actual | — | 2009-06-22 |
| Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple SclerosisNCT00030966Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS.Randomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Natalizumab, Placebo | Multiple Sclerosis, Relapsing-Remitting | 1,200 | Apr 2005actual | — | 2009-06-18 |
| A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's DiseaseNCT00078611Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: natalizumab | Crohn's Disease | 462 | Mar 2005actual | — | 2016-06-16 |
| Natalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving MethotrexateNCT00083759results2009-06-02American College of Rheumatology (ACR)20.Randomized · Double-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: The biological effect seen with natalizumab was not sufficient to warrant further development in RA. | Drug: natalizumab, placebo | Rheumatoid Arthritis | 299 | Feb 2005actual | — | 2016-07-18 |
| A Phase II, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Natalizumab in Subjects With Rheumatoid Arthritis Who Have Previously Participated in Study ELN100226-RA201NCT00831649The number and proportion of subjects with AEsOpen-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: The biological effect seen with natalizumab was not sufficient to warrant further development in RA. | Drug: natalizumab | Rheumatoid Arthritis | — | Feb 2005actual | — | 2016-06-16 |
| Immunogenicity and Safety Study of Serum-Free AvonexNCT00912860To evaluate the immunogenicity of a serum-free pre-formulated solution of AVONEX®Open-label · Basic science | Phase 2 | Completed | Drug: Interferon beta-1a | Multiple Sclerosis | 155 | Dec 2004actual | — | 2009-06-10 |
| Safety and Efficacy of Natalizumab in the Treatment of Multiple SclerosisNCT00027300The primary objectives of this study are to determine whether natalizumab, when compared with placebo, is effective in reducing the rate of clinical relapses at 1 year and, in slowing the progression of disability at 2 years.Randomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Natalizumab, Placebo | Multiple Sclerosis, Relapsing-Remitting | 900 | Nov 2004actual | — | 2017-01-09 |
| Open Label Natalizumab Safety Extension Study for Subjects With Crohn's DiseaseNCT00280956To evaluate the safety of natalizumab by the number and proportion of subjects with adverse events, and by assessing clinical laboratory parameters and vital signs.Non-randomized · Open-label | Phase 4 | Completed | Drug: natalizumab | Crohn's Disease | 2,000 | Sep 2004actual | — | 2016-06-16 |
| Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's DiseaseNCT00055367Non-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: natalizumab | Crohn's Disease | 30 | May 2004actual | — | 2016-06-16 |
| Safety and Efficacy of IDEC-152 in the Treatment of Chronic Lymphocytic Leukemia (CLL)NCT00046488Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLLRandomized · Open-label | Phase 1 | Completed | Drug: IDEC-152 | Chronic Lymphocytic Leukemia | 70 | Apr 2004actual | — | 2013-09-16 |
| Safety and Efficacy of Natalizumab in the Treatment of Crohn's DiseaseNCT00032786Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: natalizumab | Crohn's Disease | — | Mar 2004actual | — | 2016-06-16 |
| Safety and Efficacy of IDEC-114 in Combination With Rituxan in the Treatment of Non-Hodgkin's LymphomaNCT00048555To characterize the safety profile and to define the dose of galiximab to be used for the Phase II portion of the studyNon-randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: IDEC-114 | Non-Hodgkin's Lymphoma | 90 | Mar 2004actual | — | 2013-09-16 |
| Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple SclerosisNCT00097760Rate of development of new active lesions on MRI scans.Randomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: Natalizumab, Natalizumab, Placebo | Multiple Sclerosis, Relapsing-Remitting | 110 | Mar 2004actual | — | 2009-06-18 |
| Safety and Efficacy of Natalizumab in the Treatment of Crohn's DiseaseNCT00032799Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: natalizumab | Crohn's Disease | 905 | Sep 2003actual | — | 2016-06-16 |
| Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's DiseaseNCT00055536Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: natalizumab | Crohn's Disease | 60 | Jul 2003actual | — | 2016-06-16 |
| Open-Label Safety Extension Study of AvonexNCT00915460The primary objective of this study is to collect data on serious adverse events which occur during extended treatment with AVONEX in subjects at high risk for developing MS and in subjects with secondary progressive MS.Non-randomized · Open-label | Phase 4 | Completed | Drug: Interferon beta-1a (Avonex) | Multiple Sclerosis | 408 | Jun 2003actual | — | 2009-06-08 |
| Safety and Efficacy of IDEC-114 in the Treatment of Non-Hodgkin's LymphomaNCT00575068To characterize the safety profile of IDEC-114 and to define their duration and reversibilityNon-randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: IDEC-114 | Non-Hodgkin's Lymphoma | 42 | Sep 2002actual | — | 2012-06-08 |
| Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV GliomasNCT00031083Non-randomized · Open-label · Treatment | Phase 1 | Completed | Genetic: Interferon-beta | Glioblastoma Multiforme, Anaplastic Astrocytoma, Oligoastrocytoma, Mixed, Gliosarcoma | 12 | — | — | 2020-11-17 |
| Safety and Efficacy of Zevalin in the Treatment of Non-Hodgkin's LymphomaNCT00057343Event-free survivalRandomized · Open-label · Treatment | Phase 3 | Terminated | Drug: Zevalin (ibritumomab tiuxetan), Rituxan (rituximab) | Non-Hodgkin's Lymphoma | 400 | — | — | 2006-09-12 |
| Interferon-Beta Gene Transfer (Ad.hIFN-β) as Treatment for Refractory Colorectal Carcinoma With Liver MetastasesNCT00107861- Evaluate the safety of a single IV administration of Ad.hIFN-β.Non-randomized · Open-label · Treatment | Phase 1/2 | Completed | Drug: Ad.hIFN-β (BG00001, IDEC-201) | Colorectal Carcinoma, Metastases | 44 | — | — | 2009-07-14 |
| Zevalin® Followed by Rituxan® Maintenance in Previously Treated Low Grade Non-Hodgkin's LymphomaNCT00168727Determine overall response rate, event-free survival, time-to-progression, time-to-next-therapy, and freedom-from-relapse in pts with low-grade lymphoma in first or second relapse treated with Zevalin® followed by 2 yrs of Rituxan maintenance therapyNon-randomized · Open-label · Treatment | Phase 4 | Completed | Drug: ibritumomab tiuxetan (Zevalin®) | Lymphoma, Non-Hodgkin, Lymphoma, Low-Grade | 12 | — | — | 2023-08-23 |
| Treatment of Relapsed Low-Grade or Follicular Lymphoma With Rituximab (Also Known as Rituxan, IDEC-C2B8, IDEC-102)NCT00168740overall response rateNon-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: rituximab | Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma | 150 | — | — | 2005-09-15 |
| Safety and Tolerability of Repeat Courses of IM AlefaceptNCT00233662Incidence of infections, malignancies, serious adverse events, adverse events leading to discontinuation of study drug, dose withholding (due to infection or decreased T cells), and changes in lymphocyte counts over time.Non-randomized · Open-label · Treatment | Phase 3 | Completed | Drug: Alefacept | Chronic Plaque Psoriasis | 400 | — | — | 2023-08-23 |
| A Serologic Study to Correlate Beta-IFN NAb Titers to Beta-IFN Induced Biomarker Response in Patients With Multiple SclerosisNCT00288990observational | — | Completed | — | Multiple Sclerosis | 300 | — | — | 2007-12-24 |
| Phase 1, Dose-Escalation, Pharmacodynamic Study of IV CNF1010 in ZAP-70 Positive CLLNCT00319930The minimal biologically active dose (MBAD)Non-randomized · Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Discontinuation of program | Drug: CNF1010 (17-AAG) | Chronic Lymphocytic Leukemia | 10 | — | — | 2010-03-08 |
| BIIB014 Phase 2a MonotherapyNCT00451815Randomized · Treatment | Phase 2 | Withdrawn | Drug: active drug (BIIB014) at 10, 30, 100, or 300 mg once daily., placebo | Parkinson's Disease | 0 | — | — | 2023-08-23 |
| Avonex 15 Year Long Term Follow-up StudyNCT00525343observationalTo determine the impact of early versus delayed initiation of treatment on the long-term disability status of patients with relapsing forms of multiple sclerosis (MS) measured by the self-reported EDSS. | — | Completed | — | Multiple Sclerosis | 122 | — | — | 2010-03-08 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19