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4151.T JP Equity

Kyowa Kirin Co.,Ltd.Health Care · FY ends Dec 31
JPY 2,541.50
-38.00 (-1.47%)
JPY · as of 2026-08-17 · marketstack
195 registered studies · 17 active

Studies where 4151.T 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.

187 interventional · 6 observational · 2 expanded access · 28 with posted results

government filings 180d: none disclosed

StudyPhaseStatusInterventionsConditionsEnrollmentPrimary completionReadout inUpdated
Phase I Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Other Hematologic Malignancies.NCT06812104Dose-limiting toxicity (Part 1:Dose escalation)Non-randomized · Open-label · TreatmentPhase 1RecruitingDrug: KK2845_1, KK2845_2, KK2845_3, KK2845_4, KK2845_5, KK2845_6, KK2845_7, KK2845_8, KK2845_alternative_1, KK2845_alternative_2Relapsed or Refractory AML and Other Hematologic Malignancies1562031-11-30in 1,929 d2026-07-01
Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With MogamulizumabNCT04014374observationalAssess toxicities or complications of transplant among patients who were treated with mogamulizumab, alone or in combinationRecruitingLeukemia/Lymphoma, Cutaneous T Cell Lymphoma, ATLL150Feb 2030≤ 1,289 d2024-07-24
A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid TumorsNCT06248411Dose-limiting toxicity (Only in Part 1a)Randomized · Open-label · TreatmentPhase 1RecruitingDrug: KK2260, KK2260Advanced or Metastatic Solid Tumors1892029-10-31in 1,169 d2026-05-27
Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia(AOBA Study)NCT06926491Change from baseline in annualized height velocityOpen-label · TreatmentPhase 3RecruitingDrug: KK8398Achondroplasia62029-05-31in 1,016 d2025-04-29
A Study of KK2269 in Adult Participants With Solid TumorsNCT06266299Number of Subjects Experiencing Dose-limiting ToxicityNon-randomized · Open-label · TreatmentPhase 1RecruitingDrug: KK2269, DocetaxelAdvanced Solid Tumor, Metastatic Solid Tumor, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma, Non Small Cell Lung Cancer101Mar 2029≤ 955 d2026-01-28
A First-in-Human Study of KK2223 in Participants With Relapsed or Refractory T Cell Non-Hodgkin LymphomaNCT07192471Assess the incidence of treatment-emergent adverse events and determine the maximum tolerated dose (MTD) of KK2223 in patients with relapsed or refractory peripheral or cutaneous T cell lymphoma (PTCL/CTCL).Non-randomized · Open-label · TreatmentPhase 1Not yet recruitingDrug: KK2223T-cell NHL (PTCL or CTCL)72Mar 2029≤ 955 d2026-07-01
Study of Longitudinal Observation for Patient With X-linked Hypophosphatemic Rickets/Osteomalacia in Collaboration With Asian PartnersNCT03745521observationalHeightActive, not recruitingOther: no interventionX-Linked Hypophosphatemia2262028-12-31in 865 d2025-09-05
Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result SurveillanceNCT07132567observationalSafety (Special situation, adverse event, symptom, or disease occurring during treatment with Poteligeo)RecruitingDrug: Poteligeo 20mgMycosis Fungoides, Sezary Syndrome15Sep 2028≤ 773 d2025-09-22
Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)NCT04533581Objective response rate (ORR)Open-label · TreatmentPhase 2Active, not recruitingDrug: ME-401Indolent B-cell Non-Hodgkin's Lymphoma612028-05-31in 651 d2025-09-11
A First-in-human Study of KK8123 in Adults With X-linked HypophosphatemiaNCT06525636Part 1: Number of participants with TEAEsNon-randomized · Open-label · TreatmentPhase 1/2RecruitingDrug: KK8123X-linked Hypophosphatemia242028-02-11in 541 d2025-11-14
Study of KK3910 in Healthy Volunteers and Patients With Essential HypertensionNCT06823947Number of participants with adverse events (AEs)Randomized · Triple-masked · TreatmentPhase 1RecruitingDrug: Placebo, KK3910Healthy Volunteers Essential Hypertension160Dec 2027≤ 499 d2026-07-01
A Phase 1/2 Study of KK2430 in Participants With Hematologic NeoplasmsNCT07629726Dose Level Toxicity (DLT)Open-label · TreatmentPhase 1/2RecruitingDrug: KK2430Hematologic Neoplasms72Apr 2027≤ 254 d2026-08-07
A Phase 2 Clinical Study of Ziftomenib in Patients With Relapsed or Refractory NPM1-Mutated Acute Myeloid LeukemiaNCT07623616CR+CRh rateOpen-label · TreatmentPhase 2RecruitingDrug: ziftomenibAcute Myeloid Leukemia (AML)6Mar 2027≤ 224 d2026-06-03
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular DegenerationNCT06116890Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baselineRandomized · Quadruple-masked · TreatmentPhase 2Active, not recruitingDrug: KHK4951, Aflibercept InjectionNeovascular Age-Related Macular Degeneration (nAMD)1802026-08-31in 12 d2025-10-30
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular EdemaNCT06116916Reduction of 15 or more letters in BCVA (Best corrected visual acuity) as measured by ETDRS visual acuity chart from baselineRandomized · Quadruple-masked · TreatmentPhase 2Active, not recruitingDrug: KHK4951, Aflibercept InjectionDiabetic Macular Edema (DME)1502026-08-31in 12 d2025-10-30
A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus ErythematosusNCT05411016Number of participants with adverse events (AEs)Randomized · Quadruple-masked · TreatmentPhase 1Active, not recruitingDrug: Placebo, KK4277Healthy Volunteers, Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)1572024-12-10actual2025-09-19
Long Term Follow-up Observational Study After Clinical Trials of AMG531 (Romiplostim) in Patients With Untreated Aplastic AnemiaNCT04870346observationalHematological response at 2 years after the start of romiplostim treatment in Study 531-003/531-004Active, not recruitingAplastic Anemia362024-08-31actual2025-09-11
Mogamulizumab Q4week Dosing in Participants With R/R CTCLNCT04745234Number, percentage and severity of treatment emergent adverse eventsOpen-label · TreatmentPhase 2Unknown statusDrug: MogamulizumabCutaneous T-Cell Lymphoma, Relapsed, Cutaneous T-Cell Lymphoma Refractory34May 20252024-04-25
Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's LymphomaNCT03985189Number of participants with treatment-emergent adverse events (TEAEs)Open-label · TreatmentPhase 1CompletedDrug: ME-401Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma142025-01-15actual2025-12-19
Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Pediatric Chinese Patients With XLHNCT04842032Change from Baseline (CFB) in mean serum phosphorus level at the end of the dose cycleOpen-label · TreatmentPhase 4CompletedDrug: KRN23X-linked Hypophosphatemia (XLH)282023-12-18actual2024-07-09
Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With TIONCT05357573Change from Baseline in mean serum phosphorus level at the end of the dosing cycle.Open-label · TreatmentPhase 4CompletedDrug: KRN23Tumor-Induced Osteomalacia (TIO)92023-11-22actual2024-07-09
Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With XLHNCT04842019Change from Baseline (CFB) in mean serum phosphorus level at the end of the dose cycleOpen-label · TreatmentPhase 4CompletedDrug: KRN23X-linked Hypophosphatemia (XLH)182023-08-17actual2024-07-09
KW-3357 Study in Patients With Early Onset Severe PreeclampsiaNCT04182373Days of maintaining pregnancyRandomized · Double-masked · TreatmentPhase 3CompletedDrug: Antithrombin gamma, physiological salinePreeclampsia1812023-05-17actual2023-11-15
A Phase 3 Study of Bardoxolone Methyl in Patients With Diabetic Kidney Disease; AYAME StudyNCT03550443Time to onset of a ≥ 30% decrease in eGFR from baseline or ESRDRandomized · Double-masked · TreatmentPhase 3Terminatedsponsor's stated reason: Based on results of double-blind parts, it was determined that it would be difficult to submit a marketing authorization application for RTA 402 for diabetic kidney disease.Drug: Bardoxolone methyl, PlaceboDiabetic Kidney Disease1,3232022-11-30actual2023-09-26
KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects With Advanced Bladder CancerNCT03915405Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0Open-label · TreatmentPhase 1Terminatedsponsor's stated reason: Termination was based on the business decisionDrug: KHK2455, AvelumabUrothelial Carcinoma162022-11-15actual2024-04-25
A Study of KRN125 in Patients With Multiple Myeloma and Malignant LymphomaNCT05007652Achievement of a target of ≥ 2*10^6 CD34+ cells/kg collected during apheresis period in patients with multiple myeloma.Randomized · Open-label · TreatmentPhase 2CompletedDrug: KRN125(pegfilgrastim), PLR001(plerixafor), KRN8601(filgrastim), PLR001(plerixafor)Multiple Myeloma and Malignant Lymphoma642022-10-25actual2023-02-21
A Safety Study of KHK4951 in Healthy Volunteers and Patients With Wet Age-Related Macular DegenerationNCT04594681Number of participants with adverse eventsRandomized · Quadruple-masked · TreatmentPhase 1Terminatedsponsor's stated reason: The Sponsor judged that the objectives of this Phase 1 study were satisfied, and the study was terminated after the completion of Cohort 3 Step 3.Drug: Placebo, KHK4951Healthy Volunteers, Wet Age-related Macular Degeneration1162022-08-26actual2023-05-18
Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on HemodialysisNCT04771780Incidence rates of all adverse events and adverse drug reactions that occurred or worsened after the initiation of KHK7791 treatment for 52 weeks.Open-label · TreatmentPhase 3CompletedDrug: KHK7791Hyperphosphatemia2132022-06-27actual2023-08-02
A Phase 4 Study of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque PsoriasisNCT04614298To evaluate the proportion of subjects achieving 75% improvement from baseline in Psoriasis Area and Severity Index (PASI; PASI 75) at Week 12Randomized · Quadruple-masked · TreatmentPhase 4Withdrawnsponsor's stated reason: Due to the reconsideration of KHK4827's business in China, it. was decided to withdraw this clinical trial prior to enrollment of first participant.Drug: KHK4827-Active, KHK4827-PlaceboModerate to Severe Plaque Psoriasis0Feb 20222021-09-30
Study to Assess Bioequivalence and Adhesion Properties Between Two Granisetron Transdermal Patches.NCT05027646Area under the plasma concentration versus time curve AUC (0-t)Randomized · Open-label · PreventionPhase 1CompletedDrug: Sancuso - Part 1, Sancuso - Part 2Healthy Volunteers1342021-12-22actual2024-06-14
Clinical Study of KHK7791 in Hyperphosphatemia Patients on Peritoneal DialysisNCT04766385Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration.Open-label · TreatmentPhase 3CompletedDrug: KHK7791Hyperphosphatemia542021-12-01actual2022-01-11
Study of AMG531 (Romiplostim) in Patients With Aplastic AnemiaNCT04095936Rate of achievement of complete response (CR) or partial response (PR)Open-label · TreatmentPhase 2/3CompletedDrug: RomiplostimAplastic Anemia242021-10-07actual2022-05-26
Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients on HemodialysisNCT04766398Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration.Randomized · Double-masked · TreatmentPhase 3CompletedDrug: KHK7791, PlaceboHyperphosphatemia1692021-09-27actual2021-10-28
Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in AsiaNCT03822507Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation periodRandomized · Double-masked · TreatmentPhase 3CompletedDrug: KHK7580, Cinacalcet HydrochlorideSecondary Hyperparathyroidism4042021-09-23actual2022-04-25
A Study of KHK4827 in Subjects With Palmoplantar PustulosisNCT04061252Change from baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) total score at Week 16Randomized · Double-masked · TreatmentPhase 3CompletedDrug: KHK4827, PlaceboPalmoplantar Pustulosis1262021-08-11actual2023-02-14
Clinical Study of KHK7791 in Hyperphosphatemia Patients on HemodialysisNCT04767581Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration.Randomized · Double-masked · TreatmentPhase 3CompletedDrug: KHK7791, PlaceboHyperphosphatemia1652021-08-10actual2021-09-08
Pharmacokinetic Study of KHK7580 in Healthy Adult VolunteersNCT04206657Plasma KHK7580 concentration at each time pointNon-randomized · Open-label · TreatmentPhase 1CompletedDrug: 1mg KHK7580, 3mg KHK7580, 6mg KHK7580, 12mg KHK7580, 6mg KHK7580 for 8daysHealthy Volunteer422021-06-17actual2021-09-08
A Study of KRN23 in Adult and Pediatric Patients With X-linked Hypophosphatemic Rickets/OsteomalaciaNCT04308096Number of subjects for each adverse eventsOpen-label · TreatmentPhase 3CompletedDrug: KRN23XLH272020-12-04actual2022-09-06
Study of AMG531(Romiplostim) in Patients With Aplastic AnemiaNCT03957694Achievement of complete response (CR) or partial response (PR)Open-label · TreatmentPhase 2/3CompletedDrug: RomiplostimAplastic Anemia172020-11-05actual2022-05-26
Study of KHK2375 in Subjects With Advanced or Recurrent Breast CancerNCT02623751Number and percentage of subjects with treatment-emergent adverse events including dose-limiting toxicities and serious adverse eventsOpen-label · TreatmentPhase 1CompletedDrug: KHK2375, ExemestaneBreast Cancer15Oct 2020actual2022-06-21
A Phase 3 Study of KHK4827 in Patients With Systemic SclerosisNCT03957681Change in modified Rodnan skin score (mRSS) from baseline at Week 24Randomized · Double-masked · TreatmentPhase 3CompletedDrug: KHK4827, PlaceboModerate to Severe Systemic Sclerosis1002020-10-16actual2025-07-11
A Through QT/QTc Study of KW-6356NCT04342273Change from baseline in QTc interval [QTcF] (ΔQTcF)Randomized · Quadruple-masked · TreatmentPhase 1CompletedDrug: KW-6356, KW-6356, Placebo, MoxifloxacinParkinson's Disease1282020-09-05actual2020-09-18
KRN125 for Mobilization of Hematopoietic Stem CellsNCT03993639Achievement of >20 cells/μL positive for CD34 in peripheral blood from baseline to Day 7Open-label · TreatmentPhase 2CompletedDrug: PegfilgrastimPeripheral Blood Stem Cell Transplantation352020-07-21actual2021-01-22
A Study of RTA 402 in Obese AdultsNCT04018339Changes from baseline in weight measured by Bioelectrical Impedance AnalysisRandomized · Single-masked · OtherPhase 1CompletedDrug: Bardoxolone methyl, PlaceboObese Adult Male222020-05-28actual2020-06-23
A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing PreparationsNCT03703570Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) part III scoreRandomized · Double-masked · TreatmentPhase 2CompletedDrug: KW-6356, PlaceboParkinson's Disease5022020-04-15actual2020-09-07
Single-dose Study to Investigate the Plasma PK of KW-6356 and Its Major MetaboliteNCT04190654CmaxNon-randomized · Open-label · OtherPhase 1CompletedDrug: KW-6356Hepatic Impairment262020-03-20actual2024-04-25
A Study of KRN23 in Pediatric Patients With X-linked Hypophosphatemic Rickets/OsteomalaciaNCT03233126Number of subjects for each adverse eventsOpen-label · TreatmentPhase 3CompletedDrug: KRN23X-linked Hypophosphatemic Rickets/Osteomalacia162020-02-17actual2022-09-06
Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic DermatitisNCT03703102results2022-06-09Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) ScoreRandomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis PlanPhase 2CompletedDrug: KHK4083, PlaceboAtopic Dermatitis2742020-02-06actual2024-04-26
KHK2455 Alone and in Combination With Mogamulizumab in Subjects With Locally Advanced or Metastatic Solid TumorsNCT02867007Number of Participants with Adverse Events as a Measure of Safety and TolerabilityOpen-label · TreatmentPhase 1CompletedDrug: KHK2455, MogamulizumabSolid Tumor, Cancer, Carcinoma362019-12-15actual2024-04-25
Study of KHK 4323 in Healthy Volunteers and Subjects With Atopic DermatitisNCT03846466Number of participants with adverse eventsRandomized · Triple-masked · TreatmentPhase 1Terminatedsponsor's stated reason: The study terminated for safety reasons.Drug: KHK4323 IV/S, KHK4323 SC/S, KHK4323 IV/M, Placebo IV/S, Placebo IV/M, Placebo SC/SAtopic Dermatitis52019-12-11actual2020-01-28
Dose-finding Study of KHK7791 in Hyperphosphatemia PatientsNCT03864458To investigate the clinically recommended dose by comparing changes in serum phosphorus levels from baseline values at Week 6.Randomized · Double-masked · TreatmentPhase 2CompletedDrug: KHK7791, PlaceboHyperphosphatemia2072019-12-10actual2024-03-07
Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia PatientsNCT03864445Comparing changes in serum phosphorus levels between hemodialysis patients taking KHK7791 in combination with phosphate binders and those taking placebo in combination with phosphate binders.Randomized · Double-masked · TreatmentPhase 2CompletedDrug: KHK7791, PlacebpHyperphosphatemia472019-12-03actual2024-03-07
A Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on HDNCT03831607Percentage of subjects who reduce the total number of taking phosphate binder tablets at the last assessment from baseline.Open-label · TreatmentPhase 2CompletedDrug: KHK7791Hyperphosphatemia672019-11-26actual2024-03-07
A Drug Interaction Study of KW-6356 and Clarithromycin or RifampicinNCT04070495Geometric mean ratio of the pharmacokinetic parameter (AUC0-t) of KW-6356 in combination with or without a perpetrator drugNon-randomized · Open-label · TreatmentPhase 1CompletedDrug: KW-6356, Clarithromycin, RifampicinParkinson's Disease202019-11-19actual2019-11-29
A Study of Single and Multiple Doses of KW-6356 in Healthy SubjectsNCT03830528Part A Number and percentage of subjects with treatment-emergent adverse eventsRandomized · Quadruple-masked · TreatmentPhase 1CompletedDrug: KW-6356 Low Dose, KW-6356 Middle Dose, KW-6356 High Dose, KW-6356 X Dose, KW-6356 Y Dose, PlaceboParkinson's Disease482019-10-10actual2019-11-29
Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-KW-6356NCT04147910CmaxOpen-label · OtherPhase 1CompletedDrug: KW-6356Healthy Male Subjects82019-10-02actual2024-04-25
A Study of Brodalumab in Subjects With Axial Spondyloarthritis (axSpA)NCT02985983Percentage of ASAS 40 in axSpA subjectsRandomized · Double-masked · TreatmentPhase 3CompletedDrug: Brodalumab, PlaceboAxial Spondyloarthritis1592019-09-23actual2024-07-16
A Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or RosuvastatinNCT03970798Geometric mean ratio of the major pharmacokinetic parameter (AUC0-t) of the index substrates in combination with or without KW-6356Open-label · TreatmentPhase 1CompletedDrug: Midazolam, Caffeine, Rosuvastatin, KW-6356Parkinson's Disease502019-07-31actual2019-11-29
A Clinical Pharmacology Study of Bardoxolone Methyl in Healthy AdultsNCT04023903CmaxRandomized · Open-label · OtherPhase 1CompletedDrug: Bardoxolone methyl, Bardoxolone methylHealthy Subject362019-06-14actual2020-02-05
A Study of KW-0761 in Subjects With HTLV-1 Associated Myelopathy (HAM)NCT03191526Improvement in Osame's motor disability scoreRandomized · Double-masked · TreatmentPhase 3Terminatedsponsor's stated reason: Due to not achieving the primary outcome.Drug: KW-0761 0.3 mg/kg IV, Placebo (saline)HTLV-1 Associated Myelopathy662019-06-06actual2022-04-14
Study of KHK2823 in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)NCT02181699Number of Participants with Adverse Events as a Measure of Safety and Tolerability.Open-label · TreatmentPhase 1Terminatedsponsor's stated reason: Failed treatment responseDrug: KHK2823Acute Myeloid Leukemia, Myelodysplastic Syndrome392019-05-10actual2024-04-29
Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary HyperparathyroidismNCT03280264results2021-05-27The Number and Percentage of Patients Who Achived a Serum Corrected Ca Concentration of Under 10.3 mg/dL for at Least 2weeks During Titration Phase.Open-label · TreatmentStudy Protocol and Statistical Analysis PlanPhase 3CompletedDrug: KHK7580Parathyroid Carcinoma, Primary Hyperparathyroidism182019-04-09actual2021-05-27
Phase 2 Study of KHK2375 in Subjects With Advanced or Recurrent Breast CancerNCT03291886Progression Free Survival(PFS) defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1)Randomized · Quadruple-masked · TreatmentPhase 2CompletedDrug: Entinostat, Entinostat(Placebo), ExemestaneAdvanced or Recurrent Breast Cancer1332019-04-04actual2022-06-21
A Study of KHK4827 in Patients With Systemic SclerosisNCT04368403serum KHK4827 concentrationOpen-label · TreatmentPhase 1CompletedDrug: KHK4827Systemic Sclerosis82019-01-31actual2025-07-11
Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH)NCT02312687results2019-12-16Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or DeathOpen-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2CompletedBiological: KRN23X-Linked Hypophosphatemia202018-11-30actual2024-05-06
Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH)NCT02163577results2019-05-22Change From Baseline in RSS Total Score Over TimeRandomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2CompletedBiological: burosumabX-linked Hypophosphatemia522018-10-30actual2024-05-06
Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative ColitisNCT02647866results2020-03-05Number of Subjects With Treatment-related Adverse EventsRandomized · Quadruple-masked · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2CompletedDrug: KHK4083, PlaceboUlcerative Colitis, Digestive System Diseases, Colitis, Ulcerative, Colitis, Gastrointestinal Diseases, Inflammatory Bowel Diseases, Intestinal Diseases, Colonic Diseases, Autoimmune Disease, Abdominal Pain66Sep 2018actual2024-04-26
Study of Mogamulizumab + Nivolumab in Subjects w/Locally Advanced or Metastatic Solid TumorsNCT02705105results2020-06-04Maximum Tolerated Dose (MTD)Non-randomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 1/2CompletedBiological: Mogamulizumab + NivolumabSolid Tumor, Cancer, Carcinoma, Hepatocellular Carcinoma, HCC1142018-08-22actual2024-04-25
Efficacy and Safety of Burosumab Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With XLHNCT02915705results2019-04-11Radiographic Global Impression of Change (RGI-C) Global Score at Week 40Randomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 3CompletedBiological: burosumab · Drug: Oral Phosphate Supplement, active vitamin DX-Linked Hypophosphatemia612018-02-12actual2024-08-29
Study of Combination Therapy With Mogamulizumab (KW-0761) and Nivolumab (ONO-4538/BMS-936558) in Subjects With Advanced Solid TumorsNCT02476123Number of subjects reporting adverse eventsOpen-label · TreatmentPhase 1CompletedBiological: Mogamulizumab: KW-0761, Nivolumab: (ONO-4538/BMS-936558)Solid Tumor1182018-02-07actual2019-06-11
A Phase 1 Study of KHK4083 in Subjects With Atopic DermatitisNCT03096223Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their natureOpen-label · TreatmentPhase 1CompletedDrug: KHK4083Dermatitis, Atopic262018-02-07actual2018-03-27
A Phase 1 Study of KHK4083 in Healthy Volunteers and Subjects With Ulcerative ColitisNCT02985593Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their natureRandomized · Single-masked · TreatmentPhase 1CompletedDrug: KHK4083, PlaceboHealthy Men and Subjects With Ulcerative Colitis1552017-12-26actual2023-08-30
Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's DiseaseNCT02610231results2019-12-13Evaluation of the Long-term Safety and Tolerability of Oral Istradefylline (20mg or 40mg/Day [mg/d])Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 3CompletedDrug: Istradefylline 20 mg or 40 mgIdiopathic Parkinson's Disease2392017-12-20actual2024-04-25
Study of Mogamulizumab + MEDI4736 (Durvalumab) and Mogamulizumab + Tremelimumab in Subjects w/ Advanced Solid TumorsNCT02301130Number of subjects reporting adverse eventsRandomized · Open-label · TreatmentPhase 1CompletedBiological: mogamulizumab, MEDI4736 (Durvalumab), tremelimumabAdvanced Solid Tumors642017-12-08actual2024-04-25
A Repeated Dose Study of KHK6640 in Japanese Patients With Alzheimer's DiseaseNCT03093519Number of Participants with Adverse EventsRandomized · Double-masked · TreatmentPhase 1CompletedDrug: KHK6640, PlaceboAlzheimer Disease212017-12-06actual2018-03-20
A Study of KW-6356 in Subjects With Early Parkinson's DiseaseNCT02939391Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partⅢ scoreRandomized · Double-masked · TreatmentPhase 2CompletedDrug: KW-6356, KW-6356, PlaceboParkinson's Disease1752017-11-22actual2018-03-20
Study of Romiplostim(AMG531) in Subjects With Aplastic AnemiaNCT02773290Proportion of subjects achieving a hematological response (any of the platelet response, erythroid response, and neutrophil response) at Week 27Open-label · TreatmentPhase 2/3CompletedBiological: RomiplostimAplastic Anemia462017-11-14actual2024-07-16
A Randomized Double-blind, Placebo-controlled Japanese Phase III Trial of ARQ 197 in Hepatocellular Carcinoma (HCC)NCT02029157Progression-free survival (PFS)Randomized · Quadruple-masked · TreatmentPhase 3CompletedDrug: ARQ197, PlaceboLiver Cancer386Aug 2017actual2017-10-09
Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)NCT02537431results2018-09-25Percent Change From Baseline in OV/BV at Week 48Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 3CompletedBiological: burosumabX-linked Hypophosphatemia142017-08-30actual2024-06-18
A Study of KRN23 in Subjects With Tumor-Induced Osteomalacia or Epidermal Nevus SyndromeNCT02722798serum phosphorus concentration at each test time pointOpen-label · TreatmentPhase 2CompletedDrug: KRN23Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome14Jul 2017actual2022-09-06
Study of Burosumab (KRN23) in Adults With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)NCT02304367results2020-07-30Percentage of Participants Achieving Mean Serum Phosphorus Levels Above 2.5 mg/dL at the Mid-Point of the Dose Intervals Between Baseline and Week 24Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2CompletedBiological: BurosumabTumor Induced Osteomalacia (TIO), Epidermal Nevus Syndrome (ENS)172017-07-27actual2024-05-06
A Study of Single and Multiple Doses of KHK6640 in Subjects With Prodromal or Mild to Moderate Alzheimer's DiseaseNCT02127476Number of Participants with Adverse Events as a Measure of Safety and TolerabilityRandomized · Quadruple-masked · TreatmentPhase 1CompletedDrug: KHK6640, Matching PlaceboAlzheimer's Disease57May 2017actual2024-06-17
Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)NCT02750618results2018-06-19Change From Baseline at Week 40 in Serum PhosphorusOpen-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 2CompletedBiological: BurosumabX-Linked Hypophosphatemia132017-04-20actual2024-05-06
Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCLNCT01728805results2019-04-11Progression Free SurvivalRandomized · Open-label · TreatmentStudy Protocol · Statistical Analysis PlanPhase 3CompletedBiological: KW-0761 · Drug: VorinostatCutaneous T-Cell Lymphoma372Mar 2017actual2024-04-25
Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic RhinosinusitisNCT02772419The change from baseline in nasal polyp score at Week 12Randomized · Double-masked · TreatmentPhase 2CompletedDrug: benralizumab, benralizumab, PlaceboEosinophilic Chronic Rhinosinusitis632017-03-27actual2018-04-23
A Phase 4 Clinical Study of BrodalumabNCT04183881Incidence and types of adverse events and adverse reactionsOpen-label · TreatmentPhase 4CompletedDrug: Brodalumab 210mg SCPsoriasis Vulgaris, Psoriatic Arthritis, Pustular; Psoriasis, Palmaris Et Plantaris, Psoriatic Erythroderma1382017-01-10actual2019-12-09
Study of Mogamulizumab + Docetaxel in Subjects With Non-small Cell Lung CancerNCT02358473results2018-11-30Number of Subjects Reporting Adverse EventsOpen-label · TreatmentPhase 1CompletedBiological: mogamulizumab · Drug: DocetaxelNon-Small Cell Lung Cancer13Dec 2016actual2024-09-19
Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH)NCT02526160results2021-02-05Percentage of Participants Achieving Mean Serum Phosphorus Levels Above the LLN (2.5 mg/dL [0.81 mmol/L]) at the Mid-Point of the Dose Interval, as Averaged Across Dose Cycles Between Baseline and Week 24Randomized · Quadruple-masked · TreatmentPhase 3CompletedBiological: burosumab · Other: PlaceboX-linked Hypophosphatemia1342016-12-22actual2024-06-18
Phase 3 Study of KHK7580NCT02549417Percentage of subjects in the evaluation period achieving a mean intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mLOpen-label · TreatmentPhase 3CompletedDrug: KHK7580Secondary Hyperparathyroidism392016-12-22actual2017-07-05
Phase 3 Study of KHK7580NCT02549404Number of participants with adverse eventsOpen-label · TreatmentPhase 3CompletedDrug: KHK7580Secondary Hyperparathyroidism1372016-12-06actual2017-07-05
Phase 3 Study of KHK7580NCT02549391Percentage of subjects in the evaluation period achieving a mean intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mLRandomized · Double-masked · TreatmentPhase 2/3CompletedDrug: KHK7580, KRN1493Secondary Hyperparathyroidism634Nov 2016actual2017-03-24
A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's DiseaseNCT01968031results2020-11-20Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12Randomized · Quadruple-masked · TreatmentPhase 3CompletedDrug: Istradefylline 40 mg, Istradefylline 20 mg, PlaceboIdiopathic Parkinson's Disease613Oct 2016actual2024-04-25
A Single Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease.NCT02377713Number of Participants with Adverse Events as a Measure of Safety and TolerabilityRandomized · Double-masked · TreatmentPhase 1CompletedDrug: KHK6640, PlaceboAlzheimer's Disease20Sep 2016actual2016-12-07
A Study to Evaluate Abuse Potential of IstradefyllineNCT02609477Drug Liking VASRandomized · Quadruple-masked · OtherPhase 1CompletedDrug: Istradefylline, Phentermine 45 mg · Other: PlaceboDrug Abuse42Jul 2016actual2024-04-25
Observational Study for Non-motor Symptoms and Treatment in Parkinson's Disease PatientsNCT02073981observationalChanging of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)CompletedParkinson Disease1,021May 2016actual2023-08-07
The Phase II Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes; TSUBAKI StudyNCT02316821Safety: Number and types of adverse eventsRandomized · Double-masked · TreatmentPhase 2CompletedDrug: RTA 402, PlaceboChronic Kidney Disease, Type 2 Diabetes216May 2016actual2017-10-27
Study of KRN951 in Patients With Solid TumorsNCT00970411To define the maximum tolerated dose (MTD) of KRN-951 when administered orally for 21 days followed by a 7-day rest period.Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: KRN951Solid Tumors12Apr 2016actual2017-01-05
A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus ErlotinibNCT01377376Overall survivalRandomized · Double-masked · TreatmentPhase 3TerminatedDrug: ARQ 197 and Erlotinib, Placebo and ErlotinibNon-small-cell Lung CancerNov 2015actual2016-12-07
KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)NCT01626664results2018-06-15Overall Response RateRandomized · Open-label · TreatmentPhase 2CompletedBiological: KW-0761 · Drug: Pralatrexate, gemcitabine plus oxaliplatin, DHAPAdult T-cell Leukemia-Lymphoma71Aug 2015actual2024-04-25
A Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/OsteomalaciaNCT02181764Number and types of adverse eventsOpen-label · TreatmentPhase 1CompletedDrug: KRN23X-linked Hypophosphatemic Rickets/Osteomalacia15Jun 2015actual2017-03-03
Phase 1 Study of KHK2898 in Subjects With Advanced Solid TumorsNCT01516645Adverse Event collection and assessmentOpen-label · TreatmentPhase 1TerminatedDrug: KHK2898Solid Tumour14May 2015actual2017-03-16
Study of KW-0761 (Mogamulizumab) in Subjects With Previously Treated Peripheral T-cell Lymphoma (PTCL)NCT01611142Overall Response RateOpen-label · TreatmentPhase 2CompletedBiological: KW-0761 (mogamulizumab)Peripheral T-Cell Lymphoma38May 2015actual2024-06-17
ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung CancerNCT01580735Objective Response RateOpen-label · TreatmentPhase 2CompletedDrug: ARQ 197Non-small-cell Lung Cancer40Apr 2015actual2015-08-18
A Phase 3 Clinical Study of KHK4827NCT01782924Incidence and types of adverse events and adverse reactionsRandomized · TreatmentPhase 3CompletedDrug: KHK4827Psoriasis145Feb 2015actual2015-02-16
Phase 2 Study of KHK7580NCT02216656The percent changes in intact Parathyroid hormone levels from baselineRandomized · Triple-masked · TreatmentPhase 2CompletedDrug: Placebo, KHK7580 low dose, KHK7580 middle dose, KHK7580 high dose, KRN1493Secondary Hyperparathyroidism201Feb 2015actual2018-07-10
Phase 1 Study of CEP-37250/KHK2804 in Subjects With Advanced Solid TumorsNCT01447732Adverse Event collection and assessment will be done for all 74 potentially treated subjects.Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: CEP-37250/KHK2804Solid Tumour, Adenocarcinoma of the Colorectal, Adenocarcinoma of the Pancreas71Jan 2015actual2024-04-29
A Phase 3 Clinical Study of KHK 4827NCT02052609Incidence and types of adverse events and adverse reactionsNon-randomized · Open-label · TreatmentPhase 3CompletedDrug: KHK4827 140mg SC, KHK4827 210mg SCPsoriasis Vulgaris, Psoriatic Arthritis, Pustular; Psoriasis, Palmaris Et Plantaris, Psoriatic Erythroderma1552015-01-28actual2023-08-25
An Open-label, Non-controlled Study of KHK4827 in Subjects With PsoriasisNCT01782937Clinical Global Impression (CGI)Open-label · TreatmentPhase 3CompletedDrug: KHK4827Psoriasis30Dec 2014actual2015-02-16
Phase 2 Study of KHK4577NCT02004119Percent improvement from baseline in Eczema Area and Severity Index (EASI)Randomized · Quadruple-masked · TreatmentPhase 2CompletedDrug: KHK4577, PlaceboAtopic Dermatitis93Dec 2014actual2018-09-11
Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal DialysisNCT02143271Number and types of adverse eventsOpen-label · TreatmentPhase 1CompletedDrug: KHK7580Secondary Hyperparathyroidism13Dec 2014actual2015-03-05
Effect of Mild Hepatic Impairment on the Pharmacokinetics of IstradefyllineNCT02256033Comparison of pharmacokinetic parameter istradefylline (Area under the concentration-time curve [AUC]) between subjects with hepatic impairment and healthy subjects with normal hepatic function using an analysis of variance modelOpen-label · Basic sciencePhase 1CompletedDrug: IstradefyllineHepatic Impairment20Dec 2014actual2024-04-25
The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.NCT02174250Area under the concentration-time curve from time zero to infinity (AUC0 ∞) and Observed maximum plasma concentration (Cmax) of istradefyllineNon-randomized · Open-label · Basic sciencePhase 1CompletedDrug: Istradefylline 40 mg, Rifampin 300mg BID + istradefylline 40mg Day 8 onlyParkinson's Disease20Aug 2014actual2024-04-25
Study of ARQ 197 in Hepatocellular Carcinoma (HCC)NCT01656265Number of participants with dose-limiting toxicity (DLT), as a measure of safety and tolerabilityOpen-label · TreatmentPhase 1CompletedDrug: ARQ 197Advanced Hepatocellular Carcinoma24Mar 2014actual2017-03-03
Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving HemodialysisNCT01935856The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examinationOpen-label · TreatmentPhase 1/2CompletedDrug: KHK7580Hyperparathyroidism20Mar 2014actual2017-03-03
A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic SyndromeNCT01497145The proportion of subjects achieving a erythroid responseRandomized · Open-label · TreatmentPhase 2CompletedDrug: KRN321MDS45Feb 2014actual2015-03-04
A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple MyelomaNCT01063907results2014-11-05To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).Non-randomized · Open-label · TreatmentPhase 1/2CompletedDrug: KW-2478, BortezomibMultiple Myeloma95Nov 2013actual2024-04-25
A Glomerular Filtration Rate (GFR) Measuring Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes MellitusNCT01572610Efficacy: glomerular filtration rate measured by inulin clearanceOpen-label · TreatmentPhase 2TerminatedDrug: RTA 402Chronic Kidney Disease, Type 2 Diabetes11Nov 2013actual2017-03-03
A Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes MellitusNCT01574365Efficacy:Changes in eGFRRandomized · Open-label · TreatmentPhase 2TerminatedDrug: RTA 402Chronic Kidney Disease, Type 2 Diabetes53Nov 2013actual2017-03-03
An Extension Study of KRN23 in Adults With X-Linked HypophosphatemiaNCT01571596results2021-02-17Safety and Efficacy of Repeated SC Injections of KRN23.Open-label · TreatmentPhase 1/2CompletedDrug: KRN23X-linked Hypophosphatemia23Sep 2013actual2024-06-18
A Phase 2 Clinical Study of KHK4827NCT01748539Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12Randomized · Double-masked · TreatmentPhase 2CompletedDrug: KHK4827, PlaceboModerate to Severe Plaque Psoriasis140Sep 2013actual2013-09-05
A Phase IIa Study of KHK4563NCT01412736evaluation of the effect of multiple-dose subcutaneous(SC) administration of benralizumab on the annual asthma exacerbation rate in adult subjects with uncontrolled, suspected eosinophilic asthma.Randomized · Double-masked · TreatmentPhase 2CompletedDrug: KHK4563, KHK4563, KHK4563, PlaceboUncontrolled and Suspected Eosinophilic Asthma106Jul 2013actual2014-12-23
A Comparative Study of KHK6188NCT01544296Change of pain intensity scoreRandomized · Double-masked · TreatmentPhase 2CompletedDrug: KHK6188, PlaceboPostherpetic Neuralgia42Jun 2013actual2013-10-10
A Repeated Study of KRN23 in Adults With X-Linked HypophosphatemiaNCT01340482results2020-10-26Safety and Efficacy of Repeated SC Injections of KRN23Open-label · TreatmentPhase 1/2CompletedDrug: KRN23X-linked Hypophosphatemia29May 2013actual2024-06-18
An Open-label Study of KW-3357NCT01384903DIC resolutionRandomized · Open-label · TreatmentPhase 3CompletedDrug: KW-3357, Plasma-derived antithrombinDisseminated Intravascular Coagulation (DIC)221May 2013actual2017-03-24
A Clinical Study of KW-3357 in Patients With DICNCT01384396SafetyOpen-label · TreatmentPhase 3CompletedDrug: KW-3357Disseminated Intravascular Coagulation (DIC)15Apr 2013actual2017-03-24
An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary HyperparathyroidismNCT01460030Corrected serum calciumTreatmentPhase 3CompletedDrug: Cinacalcet HClParathyroid Carcinoma, Hypercalcemia, Primary HyperparathyroidismFeb 2013actual2017-03-03
A Study of LY2523355 in Patients With Solid CancerNCT01358019Dose limiting toxicity based on the Common Terminology Criteria for Adverse Events v4.0Open-label · TreatmentPhase 1CompletedDrug: LY2523355Solid Tumors18Jan 2013actual2013-01-28
Safety, Tolerability, and Efficacy Study in Subjects With Advanced or Metastatic Breast CancerNCT01199367To establish the safety, tolerability, and recommended Phase 2 dose of KW-2450 administered in combination with lapatinib and letrozole in subjects with previously treated or untreated advanced breast cancer.Open-label · TreatmentPhase 1Terminatedsponsor's stated reason: The results of the dose escalation phase did not identify a well-tolerated dose that would permit further study in Phase 2.Drug: KW-2450 in combination with lapatinib and letrozoleBreast Cancer11Dec 2012actual2024-04-25
A Study of ARQ 197 in Combination With ErlotinibNCT01251796Dose-Limiting Toxicity in the combination of tivantinib and erlotinibTreatmentPhase 1CompletedDrug: ARQ 197 and ErlotinibAdvanced/Recurrent Non-small-cell Lung Cancer9Nov 2012actual2017-03-15
Study of Anti-HB-EGF Antibody KHK2866 in Subjects With Advanced Solid Tumors and Ovarian CancerNCT01279291Number of Participants with Adverse Events as a Measure of Safety and TolerabilityNon-randomized · Open-label · TreatmentPhase 1Terminatedsponsor's stated reason: The study was stopped due to the inability to determine an acceptable dose with the potential for further studyBiological: KHK2866 · Drug: Gemcitabine and Carboplatin, paclitaxel, pegylated liposomal doxorubicinNeoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Primary Peritoneal Neoplasm22Nov 2012actual2024-04-26
A Phase 3 Clinical Study of KW-3357 in Patients With DICNCT01384409SafetyOpen-label · TreatmentPhase 3TerminatedDrug: KW-3357Disseminated Intravascular Coagulation (DIC)5Oct 2012actual2017-03-24
Safety Study to Evaluate Monoclonal Antibody KW-0761 in Subjects With Peripheral T-cell LymphomaNCT00888927results2020-12-29Maximum Tolerated DoseNon-randomized · Open-label · TreatmentPhase 1/2CompletedBiological: KW-0761Peripheral T-Cell Lymphoma42Sep 2012actual2024-04-25
Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001NCT01226472results2020-12-29Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT ImagingOpen-label · TreatmentPhase 2CompletedBiological: KW-0761Peripheral T-cell Lymphoma, Cutaneous T-cell Lymphoma1Sep 2012actual2024-04-25
A Clinical Pharmacology of KHK4827 in Healthy Volunteers and Subject With Moderate to Severe PsoriasisNCT01488201SafetyRandomized · Single-masked · TreatmentPhase 1CompletedDrug: Placebo, KHK4827Psoriasis48Sep 2012actual2012-11-02
Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal CancerNCT00838578results2015-03-23Number of Participants With Serious and Other (Non-Serious) Adverse Events According to the CTCAE v.3.0Open-label · TreatmentPhase 1/2Terminatedsponsor's stated reason: Per protocol, the study was terminated based on interim analysis resultsBiological: KRN330 · Drug: IrinotecanColorectal Cancer65Jul 2012actual2024-04-26
A Comparative Study of KW-2246NCT01326689Pain intensity differenceRandomized · Double-masked · TreatmentPhase 3CompletedDrug: KW-2246, PlaceboCancer Related Pain (Breakthrough Pain)42Jun 2012actual2017-03-08
Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell LymphomaNCT01192984Antitumor effect (best overall response)TreatmentPhase 2CompletedBiological: KW-0761Peripheral T/NK-cell Lymphoma38May 2012actual2017-03-03
Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15NCT01173887Complete response rate in the best overall response assessment for antitumor effectRandomized · Open-label · TreatmentPhase 2CompletedDrug: VCAP/AMP/VECP(mLSG15) · Biological: KW-0761Adult T-cell Leukemia-Lymphoma44Apr 2012actual2017-03-30
A Phase 3 Study of OPC-262 in Patients With Type 2 DiabetesNCT01193179Adverse events, clinical laboratory testsOpen-label · TreatmentPhase 3CompletedDrug: OPC-262Diabetes, Type 2450Apr 2012actual2014-01-08
A Study of KRN23 in X-linked HypophosphatemiaNCT00830674Safety and tolerabilityRandomized · Triple-masked · TreatmentPhase 1CompletedDrug: Placebo, KRN23X-linked Hypophosphatemia42Dec 2011actual2024-06-17
A Phase 1 Study of ARQ 197 in Patients With Solid TumorsNCT00609921Determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197Open-label · TreatmentPhase 1CompletedDrug: ARQ197Cancer42Sep 2011actual2012-09-07
Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease PatientsNCT00957203Adverse eventsOpen-label · TreatmentPhase 3CompletedDrug: IstradefyllineParkinson's Disease308Sep 2011actual2012-08-31
A Study of ARQ 197 in Combination With ErlotinibNCT01069757Dose-Limiting Toxicity in the combination of tivantinib and erlotinibOpen-label · TreatmentPhase 1CompletedDrug: ARQ 197 and ErlotinibNon-small-cell Lung Cancer16Sep 2011actual2017-03-15
Extended Long-Term Safety Study of KW-6500NCT01063621Adverse events and related adverse eventsOpen-label · TreatmentPhase 3CompletedDrug: KW-6500Parkinson's Disease27Aug 2011actual2017-03-15
Study of ARQ 197 MonotherapyNCT01152645Antitumor effectOpen-label · TreatmentPhase 2CompletedDrug: ARQ 197Gastric Cancer31Aug 2011actual2017-03-15
Open Label Extension Study of AMG 531 in Japanese Subjects With ITPNCT00440037results2020-01-21Percentage of Participants With Adverse Events Including Clinically Significant Changes in Laboratory Values.Open-label · TreatmentPhase 2/3CompletedBiological: AMG 531Immune (Idiopathic) Thrombocytopenic Purpura (ITP)44Jul 2011actual2020-01-21
A Study of OPC-262 in Patients With Type 2 DiabetesNCT01046318Changes in HbA1C from baseline to each visit (OC) and Week 52 (LOCF)Non-randomized · Open-label · TreatmentPhase 3CompletedDrug: OPC-262Type 2 Diabetes100Jul 2011actual2014-01-08
Along-term Study of OPC-262 in Patients With Type 2 DiabetesNCT01634282Change in HBA1c form baselineOpen-label · TreatmentPhase 3CompletedDrug: OPC-262Diabetes, Type 2222Jun 2011actual2014-01-08
Phase 1/2 Study of Anti GM-2 Monoclonal Antibody To Treat Multiple MyelomaNCT00775502Serum M protein levelsOpen-label · TreatmentPhase 1Terminatedsponsor's stated reason: lack of efficacy in Multiple myelomaDrug: BIW-8962Multiple Myeloma23May 2011actual2024-04-25
Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking LevodopaNCT00955526Reducing the mean total hours of awake time per day spent in the OFF stateRandomized · Double-masked · TreatmentPhase 3CompletedDrug: Istradefylline, Istradefylline, PlaceboParkinson's Disease373Feb 2011actual2012-08-29
Mineral and Bone Disorders Outcomes in Stage 5D of Chronic Kidney DiseaseNCT00995163observationalall-cause mortalityCompletedEnd Stage Renal Disease, Hyperparathyroidism, Secondary8,020Jan 2011actual2012-08-23
Long-Term Safety Study of KW-6500 in Patients With Parkinson's DiseaseNCT00955318The incidence of adverse events after administration of KW-6500Open-label · TreatmentPhase 3CompletedDrug: KW-6500Parkinson's Disease58Dec 2010actual2017-03-15
A Study of KW-3357 in Congenital Antithrombin DeficiencyNCT00938288To evaluate the pharmacokinetic profile of a single dose (50 IU/kg) of KW 3357 in subjects with congenital AT deficiencyOpen-label · OtherPhase 1CompletedDrug: KW-3357Congenital Antithrombin Deficiency162010-12-22actual2024-10-17
A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes MellitusNCT01162876PharmacokineticsOpen-label · OtherPhase 3CompletedDrug: saxaglipitinDiabetes20Nov 2010actual2017-03-09
A Study of OPC-262 in Patients With Type 2 DiabetesNCT00997282Changes in HbA1C from baselineRandomized · Quadruple-masked · TreatmentPhase 2/3CompletedDrug: OPC-262 2.5 mg, OPC-262 5 mg, PlaceboDiabetes Type 2255Oct 2010actual2014-01-08
Placebo-Controlled Double-Blind Crossover Comparative Study of KW-6500NCT01058291The raw score change in UPDRS part III scoreRandomized · Double-masked · TreatmentPhase 3CompletedDrug: KW-6500, KW-6500 PlaceboParkinson's Disease31Oct 2010actual2017-03-03
A Phase I Safety, PK and PD Study of KW-2478 in Patients With Multiple Myeloma, Chronic Lymphocytic Leukaemia or B-cell Non-Hodgkin's LymphomaNCT00457782To determine Safety & Tolerability by adverse event rates in order to determine recommended Phase II doseOpen-label · TreatmentPhase 1CompletedDrug: KW-2478Multiple Myeloma, Chronic Lymphocytic Leukaemia, B-cell Non-Hodgkin's Lymphoma27Aug 2010actual2024-04-25
Safety Study to Evaluate KW-2450 in Subjects With Advanced Solid TumorNCT00921336To establish the safety, tolerability, and recommended Phase 2 dose of KW 2450 administered orally in subjects with advanced solid tumor who have not responded to standard therapy or for whom no standard therapy is availableOpen-label · TreatmentPhase 1CompletedDrug: KW-2450Solid Tumor13Aug 2010actual2024-04-25
Phase II Study of KW-0761 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphomaNCT00920790results2012-09-25Overall Response Rate (ORR)Open-label · TreatmentPhase 2CompletedBiological: KW-0761Adult T-cell Leukemia-lymphoma28Jul 2010actual2017-03-29
Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Study of KW-2449 in Acute Myelogenous Leukemia (AML) (Protocol Number: 2449-US-002)NCT00779480Safety as determine by adverse event rate and dose limiting toxicityOpen-label · TreatmentPhase 1Terminatedsponsor's stated reason: Failure to demonstrate a tolerable dose that had potential for efficacy.Drug: KW-2449Acute Myelogenous Leukemia (AML)14Apr 2010actual2024-04-25
Effect of External Heat on a Transdermal Granisetron Patch in Pharmacokinetics (PK) of Healthy SubjectsNCT01073696Pharmacokinetic profile of the granisetron patch in healthy subjects when heat is appliedNon-randomized · Open-label · TreatmentPhase 1CompletedDrug: granisetron IV, granisetron patchHealthy16Apr 2010actual2024-06-17
A Phase 2 Study of OPC-262 in Patients With Type 2 DiabetesNCT00857558changes in HbA1C from baselineRandomized · Quadruple-masked · TreatmentPhase 2CompletedDrug: saxagliptin, saxagliptin, saxagliptin, placeboDiabetes, Type 2350Mar 2010actual2017-03-09
Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal CancerNCT00575562The primary objective of this study is to assess the safety and tolerability of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer.Non-randomized · Open-label · TreatmentPhase 1CompletedDrug: KRN330Colorectal Cancer42Jan 2010actual2024-04-29
An Investigation on the Effect of Age and BMI on the Pharmacokinetics of Transdermal GranisetronNCT00868764Pharmacokinetic profile of the granisetron patch in elderly subjects (Part 1) and in underweight and obese subjects (Part 2)Open-label · OtherPhase 1CompletedDrug: granisetronPharmacokinetics60Sep 2009actual2024-07-24
Safety Study of Electrocardiogram (ECG) Effects of Sancuso® (Granisetron TDS)NCT00890565Time-matched, placebo-corrected change from baseline in QTc based on the Fridericia correction (QTcF).Randomized · Single-masked · OtherPhase 1CompletedDrug: granisetronHealthy240Aug 2009actual2024-06-17
A Phase III Clinical Study of KW-2246NCT00683995Open-label · TreatmentPhase 3CompletedDrug: KW-2246 (fentanyl citrate)Pain, Cancer43Jul 2009actual2020-08-28
PK, Tolerability and Safety of the Co-administration of Sancuso® (Transdermal Granisetron) and IV GranisetronNCT00873197Pharmacokinetic profile of the co-administration of IV granisetron and the Sancuso® patchOpen-label · OtherPhase 1CompletedDrug: granisetronHealthy12May 2009actual2024-06-17
A Phase III Clinical Study of KW-2246 for Breakthrough Pain in Cancer PatientsNCT00684632Randomized · Quadruple-masked · Supportive carePhase 3CompletedDrug: Placebo, KW-2246 (fentanyl citrate)Pain, Cancer51Apr 2009actual2020-08-28
Efficacy and Safety of Sublingual Fentanyl Tablets in Treatment of Breakthrough Pain in Cancer Patients.NCT00262678Randomized · Double-masked · TreatmentPhase 3CompletedDrug: EN3267Pain, CancerDec 2008actual2009-06-04
Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer PatientsNCT00263575results2020-11-19Evaluate the Long-term Safety and Effectiveness of EN3267Open-label · TreatmentPhase 3CompletedDrug: EN3267Pain, Cancer139Dec 2008actual2024-06-18
An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001NCT00199381results2013-07-30Safety as Measured by Adverse EventsOpen-label · TreatmentPhase 3Terminatedsponsor's stated reason: Additional long-term safety data no longer neededDrug: IstradefyllineParkinson's Disease504Oct 2008actual2024-05-17
Phase I Study of KW-0761 in Relapsed Patients With CCR4-Positive ATL and PTCLNCT00355472results2012-09-07Incidence of Dose-Limiting Toxicities (DLTs)Open-label · TreatmentPhase 1CompletedDrug: KW-0761Adult T-Cell Leukemia and Lymphoma (ATL), Adult Peripheral T-Cell Lymphoma (PTCL)16Oct 2008actual2012-10-18
Phase 2 Clinical Study of KW-6500 in Parkinson's Disease Patients With Motor Response Complication on Levodopa TherapyNCT00610103The change (response ratio, raw score change, percent score change) in UPDRS (Unified Parkinson's Disease Rating Scale ) Part 3 score at the maintenance dose levelRandomized · Quadruple-masked · TreatmentPhase 2CompletedDrug: apomorphine hydrochlorideParkinson's Disease16Oct 2008actual2020-08-28
A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking LevodopaNCT00455507To establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with Parkinson's disease (PD) treated with levodopa/dopa-decarboxylase inhibitor.Randomized · Quadruple-masked · TreatmentPhase 2CompletedDrug: Istradefylline, Istradefylline, PlaceboParkinson's Disease363Aug 2008actual2012-08-29
An Ascending Dose Study of KW-2449 in Acute Leukemias, Myelodysplastic Syndromes, and Chronic Myelogenous LeukemiaNCT00346632results2016-08-12Safety of KW-2449 - Number of Participants With Treatment-related Adverse Events (TEAEs) as Assessed by NCI-CTCAE v3.0Open-label · TreatmentPhase 1Terminatedsponsor's stated reason: Terminated due to suboptimal dosing scheduleDrug: KW-2449Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, Chronic Myelogenous Leukemia37Apr 2008actual2024-05-17
Dose Finding Study of KRN125 (Pegfilgrastim) for Treatment of Neutropenic PatientsNCT00364468To compare the duration of severe neutropeniaRandomized · Open-label · TreatmentPhase 2CompletedDrug: pegfilgrastimNeutropenia107Mar 2008actual2017-03-03
A Dose Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid TumorNCT00359840To compare the effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin responseRandomized · Double-masked · TreatmentPhase 2CompletedDrug: darbepoetin alfaAnemia120Sep 2007actual2012-08-31
Clinical Study of KW-2246 in Patients With Cancer PainNCT00355628Safety and TolerabilityOpen-label · TreatmentPhase 2CompletedDrug: KW-2246 (fentanyl citrate)Pain, Cancer40Jul 2007actual2012-08-31
A Double-blind Study of KRN321 for the Treatment of Anemia in Cancer PatientsNCT00344409To compare the proportion of subjects who reach red blood cell transfusion triggerRandomized · Double-masked · TreatmentPhase 3CompletedDrug: darbepoetin alfaAnemia200May 2007actual2012-08-31
An Extension of Istradefylline in Parkinson's Disease Patients Who Have Completed Studies 6002-EU-007, 6002-US-013 or 6002-US-018NCT00199368SafetyNon-randomized · Open-label · TreatmentPhase 3CompletedDrug: Istradefylline ( KW-6002)Parkinson's Disease1,100Mar 2007actual2024-04-25
Safety Study of AMG 531 in Japanese Subjects With ITPNCT00305435Incidence of all adverse events including evaluation of antibody statusOpen-label · TreatmentPhase 2CompletedDrug: Romiplostim (AMG-531)Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)12Nov 2006actual2024-07-05
A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's DiseaseNCT00250393To establish the efficacy of 40mg/d doses of istradefylline for the change in UPDRS part-III (Motor examination) score in patients with Parkinson's disease (PD).Randomized · Double-masked · TreatmentPhase 2CompletedDrug: Istradefylline (KW-6002)Parkinson's Disease64Oct 2006actual2012-08-29
Study of Istradefylline (KW-6002) for the Treatment of Restless Legs SyndromeNCT00199446Change from baseline in an RLS rating scale score at endpoint (6 weeks of treatment or early discontinuation).Randomized · Double-masked · TreatmentPhase 2CompletedDrug: Istradefylline (KW-6002)Sleep Disorder, Restless Legs Syndrome160Aug 2006actual2024-04-25
A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) PatientsNCT00199433Change from baseline in the UPDRS subscale III at endpoint.Randomized · Double-masked · TreatmentPhase 2CompletedDrug: Istradefylline (KW-6002)Parkinson's Disease, Movement Disorder Syndrome160Jul 2006actual2024-04-25
A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking LevodopaNCT00199355To establish the efficacy of 20 mg/d and 40mg/d doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/DCI.Randomized · Double-masked · TreatmentPhase 2CompletedDrug: Istradefylline (KW-6002)Parkinson's Disease75Mar 2006actual2014-05-23
A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking LevodopaNCT00199407To establish the efficacy of a 20 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/carbidopa.Randomized · Double-masked · TreatmentPhase 3CompletedDrug: Istradefylline (KW-6002)Parkinson's Disease230Nov 2005actual2024-04-25
A Study of Istradefylline (KW-6002) in Treating Patients With Parkinson's Disease on LevodopaNCT00199420To establish the efficacy of 10, 20 and 40 mg/d istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/carbidopa.Randomized · Double-masked · TreatmentPhase 3CompletedDrug: Istradefylline (KW-6002)Parkinson's Disease580Nov 2005actual2024-04-25
A Study of a Monoclonal Antibody, KW-2871, in Patients With Advanced MelanomaNCT00199342To determine the MTD and a recommended Phase II dose of KW-2871 administered with a specified premedication regimen (rantidine, diphenhydramine, and dexamethasone) in patients with Stage IV melanoma.Non-randomized · Open-label · TreatmentPhase 1/2Terminatedsponsor's stated reason: Occurrence of 2 dose-limiting toxicities at the initial dose level (60 mg/m2) in Part I.Drug: KW-2871Stage IV Melanoma5Oct 2005actual2024-05-03
A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's DiseaseNCT00199394OFF time assessed by patient diaries at endpoint.Randomized · Double-masked · TreatmentPhase 3CompletedDrug: Istradefylline (KW-6002)Parkinson's Disease405Oct 2005actual2024-04-25
12-Week, Double-Blind, Placebo-Controlled Study of 20 and 60 mg/Day Istradefylline in Parkinson's Disease Patients on Levodopa/CarbodopaNCT00456794Change from Baseline to Endpoint in percentage of awake time per day in an OFF state based on the subjects' valid ON/OFF Parkinson's disease diary data.Randomized · Double-masked · TreatmentPhase 2CompletedDrug: Istradefylline (KW-6002)Parkinson's Disease325Oct 2003actual2024-04-25
A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa TherapyNCT00955045Phase 2/3CompletedDrug: istradefyllineParkinson's DiseaseOct 2003actual2024-04-25
12-Week, Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy of 40 mg/Day KW-6002 in Parkinson's Disease Patients on Levodopa/CarbidopaNCT00456586To evaluate the safety and efficacy of 40 mg/day istradefylline for reducing OFF time in subjects with Parkinson's disease (PD) treated with levodopa/carbidopa.Randomized · Double-masked · TreatmentPhase 2CompletedDrug: KW-6002 (istradefylline)Parkinson's Disease180May 2003actual2024-04-25
To Study the Safety and Effectiveness of a Granisetron Patch to Treat Chemotherapy-Induced Nausea and Vomiting (CINV)NCT00273468Percentage of patients achieving Complete Control of CINV from the first administration until 24 h after the last administration of the moderately or highly emetogenic chemotherapyRandomized · Double-masked · TreatmentPhase 3CompletedDrug: GranisetronChemotherapy-induced Nausea and Vomiting6302024-06-17
Expanded Access to BurosumabNCT03775187expanded accessAvailableBiological: BurosumabX-linked Hypophosphatemia, Tumor-Induced Osteomalacia2025-03-05
Expanded Access for KHK2455NCT04321694expanded accessNo longer availableDrug: KHK2455Glioblastoma Multiforme2024-04-25

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