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September 2027 biotech catalysts

registry pull 2026-08-31

100 trial readouts estimated for September 2027.

Primary-completion dates that listed drug and biotech companies filed with ClinicalTrials.gov. They are the sponsor's own estimated windows, revised as a study runs — not announcement or FDA approval dates. A month-only filing counts to the last day it can mean, which is what the “≤” on a countdown says. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-31

Readouts filed for September 2027

soonest first
ReadoutStudySponsorPhaseConditionStatus
2027-09-01in 365 dA Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors4568.TDaiichi SankyoPhase 2Solid TumorsRecruiting
2027-09-01in 365 dREDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood VesselsNVONovo Nordisk A/SPhase 3Cardiovascular DiseaseActive, not recruiting
2027-09-01in 365 dA Study to Learn How Different Amounts of the Study Medicine Called PF-08065010 Are Tolerated and Act in the Body of Healthy AdultsPFEPfizerPhase 1HealthyRecruiting
2027-09-01in 365 dPAP-NAP Device Clinical StudyRMDResMedNot applicableObstructive Sleep ApneaNot yet recruiting
2027-09-02in 366 dPediatric Spinal Muscular Atrophy (SMA) China RegistryBIIBBiogenMuscular Atrophy, SpinalActive, not recruiting
2027-09-02in 366 dIBRX-042 In Participants With HPV-Associated TumorsIBRXImmunityBio, Inc.Phase 1HPV-Related CarcinomaActive, not recruiting
2027-09-03in 367 dA Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 DiabetesNVONovo Nordisk A/SPhase 2Type 2 DiabetesRecruiting
2027-09-10in 374 dStudy of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of AgeSNYSanofiPhase 3Pneumococcal DiseaseActive, not recruiting
2027-09-13in 377 dA Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese AdultsAZNAstraZenecaPhase 1Staphylococcus Aureus Bloodstream InfectionRecruiting
2027-09-13in 377 dIsatuximab in Combination With Novel Agents in RRMM - Master ProtocolSNYSanofiPhase 1/2Plasma Cell Myeloma RefractoryRecruiting
2027-09-15in 379 dSafety Follow-up Study of Participants Dosed With INV-347 in Study INV-CL-108NVONovo Nordisk A/SPhase 1ObesityRecruiting
2027-09-17in 381 dA First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes MellitusARWRArrowhead PharmaceuticalsPhase 1/2ObesityRecruiting
2027-09-20in 384 dA Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)AZNAstraZenecaPhase 3Breast CancerActive, not recruiting
2027-09-21in 385 dEfficacy and Safety of MET097 Once-Weekly in People With Overweight or ObesityPFEPfizerPhase 3ObesityActive, not recruiting
2027-09-22in 386 dA Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis SuppurativaSNYSanofiPhase 2Hidradenitis SuppurativaRecruiting
2027-09-23in 387 dStudy to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell DisordersINCYIncyte CorporationPhase 2Immune ThrombocytopeniaRecruiting
2027-09-23in 387 dA First-in-human Research Study on How NNC0721-8060 Works in People Living With Overweight or ObesityNVONovo Nordisk A/SPhase 1OverweightNot yet recruiting
2027-09-24in 388 dPhase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC)AMGNAmgenPhase 3Lung CancerRecruiting
2027-09-24in 388 dA 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)BIIBBiogenPhase 3Spinal Muscular AtrophyActive, not recruiting
2027-09-24in 388 dStudy to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney DiseaseREGNRegeneron PharmaceuticalsPhase 2Diabetic Kidney Disease (DKD)Recruiting
2027-09-26in 390 dLong-Term Real-World Safety of Cobenfy in Adults With SchizophreniaBMYBristol-Myers SquibbSchizophreniaActive, not recruiting
2027-09-27in 391 dA Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely ImmunocompromisedPFEPfizerPhase 3COVID-19Recruiting
2027-09-28in 392 dA Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host DiseaseINCYIncyte CorporationPhase 3Graft-Versus-Host DiseaseRecruiting
2027-09-28in 392 dPhase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid TumorsONCBeOne MedicinesPhase 1Solid TumorsRecruiting
2027-09-28in 392 dA Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)REGNRegeneron PharmaceuticalsPhase 2/3Lung CancerActive, not recruiting
2027-09-29in 393 dACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile InfectionACXPAcurx Pharmaceuticals Inc.Phase 2Clostridium Difficile Infection RecurrenceRecruiting
2027-09-29in 393 dMaridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure TherapyAMGNAmgenPhase 3ObesityRecruiting
2027-09-29in 393 dMaridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) TherapyAMGNAmgenPhase 3Obstructive Sleep ApneaRecruiting
2027-09-29in 393 dA Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or OverweightAMGNAmgenPhase 2Overweight or Obesity and Elevated Liver FatRecruiting
2027-09-29in 393 dA Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid MalignanciesAZNAstraZenecaPhase 1/2Breast CancerRecruiting
2027-09-30in 394 dA Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01)4568.TDaiichi SankyoPhase 2Solid TumorsActive, not recruiting
Sep 2027≤ 394 dA Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433ABBVAbbViePhase 3Crohn's DiseaseActive, not recruiting
Sep 2027≤ 394 dA Study to Assess Disease Activity in Adolescent and Adult Participants With Atopic Dermatitis Who Receive Oral Upadacitinib Tablets in a Real-World SettingABBVAbbVieAtopic DermatitisActive, not recruiting
Sep 2027≤ 394 dStudy to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400ABBVAbbViePhase 1Hepatocellular CarcinomaRecruiting
Sep 2027≤ 394 dA Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participants With Active Ulcerative ColitisABBVAbbViePhase 2Ulcerative ColitisActive, not recruiting
Sep 2027≤ 394 dA Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult ParticipantsABBVAbbViePhase 2/3HypothyroidismRecruiting
Sep 2027≤ 394 dStudy to Assess Real Life Effectiveness of Foslevodopa/Foscarbidopa in Adult German Participants at Initial Stages of Advanced Parkinson's Disease (EARLY-FOS)ABBVAbbVieParkinson's DiseaseRecruiting
Sep 2027≤ 394 dA Study to Assess Change in Disease Activity and Adverse Events of Oral Icalcaprant in Adult Participants With Major Depressive DisorderABBVAbbViePhase 2Major Depressive DisorderRecruiting
2027-09-30in 394 dExamination of Nociscan Impact on Discogenic Low Back Pain Surgical OutcomesACONAclarionDiscogenic Low Back PainRecruiting
Sep 2027≤ 394 dA Study of Botensilimab and Balstilimab for the Treatment of Colorectal CancerAGENAgenus Inc.Phase 2Colorectal CancerActive, not recruiting
Sep 2027≤ 394 dLong-term Safety Extension Study of OLZ/SAM in Pediatric SubjectsALKSAlkermes, Inc.Phase 3Bipolar DisorderEnrolling by invitation
2027-09-30in 394 dA Study to Evaluate ALN-BCAT in Patients With Hepatocellular CarcinomaALNYAlnylam PharmaceuticalsPhase 1Hepatocellular CarcinomaRecruiting
2027-09-30in 394 dRESTORE TRIAL: Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)ALTAltimmune, Inc.Phase 2Alcohol-associated Liver DiseaseActive, not recruiting
2027-09-30in 394 dA Non-interventional Prospective Study of Early HER2-negative High-risk Breast Cancer and BRCA1/2 Mutations Prevalence in RussiAAZNAstraZenecaBreast CancerActive, not recruiting
2027-09-30in 394 dSaruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal AgentsAZNAstraZenecaPhase 3Metastatic Castration-Sensitive Prostate CancerActive, not recruiting
2027-09-30in 394 dStudy That Will Evaluate the Brazilian Population With COPD.AZNAstraZenecaCOPDRecruiting
2027-09-30in 394 dStudy of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/TrixeoAZNAstraZenecaCOPDRecruiting
2027-09-30in 394 dLUNG-ROLL: Treatment Patterns and Cost of Illness of Lung Cancer in CanadaAZNAstraZenecaLung CancerRecruiting
2027-09-30in 394 dA 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)BIIBBiogenPhase 1Muscular Atrophy, SpinalRecruiting
2027-09-30in 394 dIC-8 Apthera IOL New Enrollment Post Approval StudyBLCOBausch & Lomb IncorporatedCataract, Presbyopia, Posterior Capsule OpacificationRecruiting
Sep 2027≤ 394 dA Study to Investigate the Safety and Effectiveness of the Technolas® TENEO 317 Model 2 Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Myopia or Myopic AstigmatismBLCOBausch & Lomb IncorporatedNot applicableMyopic AstigmatismNot yet recruiting
2027-09-30in 394 dImmune Modulation During Palynziq® Treatment in Adults (IMPALA)BMRNBioMarin PharmaceuticalPhase 4PhenylketonuriaRecruiting
2027-09-30in 394 dA Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese PopulationBSXBoston Scientific CorporationCarotid Artery StenosisNot yet recruiting
2027-09-30in 394 dA Phase 1b Study of CLN-049 in Combination With Azacitidine and Venetoclax in AML PatientsCGEMCullinan Therapeutics Inc.Phase 1Acute Myeloid LeukemiaNot yet recruiting
Sep 2027≤ 394 dA Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular CarcinomaCHRSCoherus Oncology, Inc.Phase 2Hepatocellular CarcinomaActive, not recruiting
Sep 2027≤ 394 dA Phase 1b/2a Study of Budoprutug in Systemic Lupus Erythematosus (SLE)CLYMClimb Bio, Inc.Phase 1/2Systemic Lupus ErthematosusRecruiting
Sep 2027≤ 394 dRelacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic AdenocarcinomaCORTCorcept TherapeuticsPhase 2Pancreatic CancerRecruiting
Sep 2027≤ 394 dStudy With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection FractionCYTKCytokineticsPhase 3Heart FailureRecruiting
2027-09-30in 394 dA Phase 1 Study of FT819 in B-cell Mediated Autoimmune DiseaseFATEFate TherapeuticsPhase 1Systemic SclerosisRecruiting
Sep 2027≤ 394 dEvaluate the Safety and Feasibility of Same-Day Bilateral Epithelium-On Corneal Cross-Linking for KeratoconusGKOSGlaukos CorporationPhase 4KeratoconusRecruiting
2027-09-30in 394 dStudy of IMC-P115C in Advanced PRAME-Positive CancersIMCRImmunocore LtdPhase 1PRAME Positive, Cancer, HLA-A*02:01-positiveRecruiting
2027-09-30in 394 dAn Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of RuxolitinibINCYIncyte CorporationPhase 2Pancreatic CancerActive, not recruiting
Sep 2027≤ 394 dStudy to Evaluate the Safety, Tolerability, and Pharmacokinetics of ION464 Administered to Adults With Multiple System Atrophy (HORIZON)IONSIonis Pharmaceuticals, Inc.Phase 1Multiple System AtrophyRecruiting
Sep 2027≤ 394 dATTUNE: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally-Administered ION440 in Participants With Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome (MDS)IONSIonis Pharmaceuticals, Inc.Phase 1/2Methyl CpG Binding Protein 2 (MECP2) Duplication SyndromeRecruiting
Sep 2027≤ 394 dA Study to Assess the Safety, Tolerability and Efficacy of ION775IONSIonis Pharmaceuticals, Inc.Phase 2Hypertriglyceridemia, Severe HypertriglyceridemiaRecruiting
Sep 2027≤ 394 dA Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung CancerIOVAIovance Biotherapeutics, Inc.Phase 1/2MelanomaRecruiting
2027-09-30in 394 dStudy of Cabozantinib as Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment.IPN.PAIpsenRenal Cell CarcinomaActive, not recruiting
Sep 2027≤ 394 dA Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated CardiomyopathyKARDKardigan, Inc.Phase 2/3Symptomatic Genetic Dilated CardiomyopathyRecruiting
Sep 2027≤ 394 dPAS-004 in Adults Who Have Neurofibromatosis Type 1 With Plexiform NeurofibromasKTTAPasithea Therapeutics Corp.Phase 1NF1 Mutation, Neurofibroma Plexiform, Neurofibroma, Plexiform, Neurofibromatosis Type 1 (NF1)-Related Plexiform Neurofibromas (PNs), Neurofibromatosis Type 1 (NF1)Recruiting
Sep 2027≤ 394 dKYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia GravisKYTXKyverna TherapeuticsPhase 2/3Myasthenia GravisRecruiting
Sep 2027≤ 394 dA Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or OverweightLLYEli Lilly and CompanyPhase 2ObesityRecruiting
Sep 2027≤ 394 d[Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate CancerLLYEli Lilly and CompanyPhase 1Prostate CancerActive, not recruiting
Sep 2027≤ 394 dA Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening)LLYEli Lilly and CompanyPhase 3HypertensionActive, not recruiting
Sep 2027≤ 394 dA Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1LLYEli Lilly and CompanyPhase 3HypertensionActive, not recruiting
Sep 2027≤ 394 dA Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL2LLYEli Lilly and CompanyPhase 3HypertensionActive, not recruiting
Sep 2027≤ 394 dA Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back PainLLYEli Lilly and CompanyPhase 3ObesityActive, not recruiting
Sep 2027≤ 394 dA Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4066708 in Healthy ParticipantsLLYEli Lilly and CompanyPhase 1Healthy, CancerRecruiting
Sep 2027≤ 394 dA Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)LLYEli Lilly and CompanyPhase 2Irritable Bowel Syndrome, DiarrheaRecruiting
Sep 2027≤ 394 dA Study to Investigate Weight Management With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or OverweightLLYEli Lilly and CompanyPhase 2OverweightRecruiting
Sep 2027≤ 394 dClinical Course Of Disease In Participants With FA-CMLXEOLexeo TherapeuticsFriedreich Ataxia, CardiomyopathyRecruiting
2027-09-30in 394 dTHIO Sequenced With Cemiplimab in Advanced NSCLCMAIAMaia BiotechnologyPhase 2Lung CancerActive, not recruiting
2027-09-30in 394 dA Study to Investigate the Safety, Reactogenicity, and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adult ParticipantsMRNAModernaTX, Inc.Phase 1Ebola-Bundibugyo Virus Disease (Ebola-BDBV)Recruiting
2027-09-30in 394 dA Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid TumorsONCBeOne MedicinesPhase 1Solid TumorsRecruiting
2027-09-30in 394 dAn Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid TumorsONCBeOne MedicinesPhase 1Solid TumorsRecruiting
2027-09-30in 394 dEvaluating ABRYSVO Maternal Vaccine Effectiveness Among InfantsPFEPfizerRespiratory Syncytial VirusActive, not recruiting
2027-09-30in 394 dStudy of PTC844 in Participants With Active Rheumatoid ArthritisPTCTPTC TherapeuticsPhase 2Rheumatoid ArthritisNot yet recruiting
Sep 2027≤ 394 dClinical Study of DTX301 AAV-Mediated Gene Transfer for Ornithine Transcarbamylase (OTC) DeficiencyRAREUltragenyx Pharmaceutical IncPhase 3OTC DeficiencyActive, not recruiting
Sep 2027≤ 394 dStudy of AB598 Monotherapy and Combination Therapy in Participants With Advanced CancersRCUSArcus Biosciences, Inc.Phase 1Bladder CancerActive, not recruiting
2027-09-30in 394 dSafety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced MalignanciesREGNRegeneron PharmaceuticalsPhase 1Advanced MalignanciesActive, not recruiting
Sep 2027≤ 394 dLong Term Follow-Up for RGX-111RGNXREGENXBIO Inc.Mucopolysaccharidosis IEnrolling by invitation
2027-09-30in 394 dA Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary FibrosisRNTXRein TherapeuticsPhase 2Idiopathic Pulmonary FibrosisRecruiting
2027-09-30in 394 dA Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK InhibitorSNYSanofiPhase 3Atopic DermatitisActive, not recruiting
Sep 2027≤ 394 dSafety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery LesionsTFXTeleflexNot applicableCoronary Artery DiseaseRecruiting
Sep 2027≤ 394 dPressure Enabled Intrapancreatic Delivery of SD-101 With Checkpoint Blockade for Locally Advanced Pancreatic AdenocarcinomaTLSITriSalus Life Sciences, Inc.Phase 1Locally Advanced Pancreatic AdenocarcinomaActive, not recruiting
Sep 2027≤ 394 dThe Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)TRVITrevi TherapeuticsPhase 2Refractory Chronic CoughRecruiting
Sep 2027≤ 394 dA Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR)UPBUpstream Bio Inc.Phase 2AsthmaActive, not recruiting
2027-09-30in 394 dMotion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion SicknessVNDAVanda PharmaceuticalsPhase 3Motion SicknessActive, not recruiting
2027-09-30in 394 dEvaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and OlderVRTXVertex Pharmaceuticals IncorporatedPhase 3Cystic FibrosisActive, not recruiting
Sep 2027≤ 394 dA Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious InfectionsXFORX4 PharmaceuticalsPhase 3NeutropeniaRecruiting
Sep 2027≤ 394 dZimmer Trabecular Metal Total Ankle PMCFZBHZimmer BiometNot applicableRheumatoid ArthritisActive, not recruiting

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