JNJ-80202135
Sponsors
Janssen - Cilag International, Janssen Cilag International
Conditions
Active Idiopathic Inflammatory Myopathies (IIM)Chronic Inflammatory Demyelinating PolyneuropathyFetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)Generalized Myasthenia GravisHemolytic Disease of the Fetus and Newborn (HDFN)Myasthenia gravis (MG)Rheumatoid ArthritisSjögren's Disease
Phase 2
An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to less than 18 years with Generalized Myasthenia Gravis
RecruitingCTIS2022-502539-21-00
Start: 2022-10-21Target: 3Updated: 2026-01-04
A Phase 2a Multicenter, Randomized, Double Blind, Parallel-group, Proof of Concept Study Evaluating the Efficacy and Safety of Nipocalimab and Certolizumab Combination Therapy in Subjects with Active Rheumatoid Arthritis despite Prior Treatment with Advanced Therapies (bDMARD or tsDMARD)
CompletedCTIS2023-504045-31-00
Start: 2024-02-08End: 2024-10-29Target: 55Updated: 2024-10-16
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Nipocalimab in Participants with Active Idiopathic Inflammatory Myopathies
Active, not recruitingCTIS2023-505314-20-00
Start: 2023-01-20Target: 62Updated: 2025-10-22
Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension
Active, not recruitingCTIS2023-505321-14-00
Start: 2019-09-06Target: 51Updated: 2025-07-18
Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
RecruitingCTIS2023-508425-28-00
Start: 2022-10-24Target: 42Updated: 2026-01-07
Phase 3
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis
RecruitingCTIS2023-504152-97-00
Start: 2021-11-26Target: 125Updated: 2025-09-01
A Phase 3 Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN).
RecruitingCTIS2022-502629-16-00
Start: 2024-07-10Target: 26Updated: 2026-01-22
Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies
Not yet recruitingCTIS2023-504307-88-00
Start: 2024-02-20Target: 23Updated: 2026-01-12
A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults with Moderate to Severe Sjögren's Disease (SjD)
RecruitingCTIS2024-513965-38-01
Start: 2025-06-16Target: 309Updated: 2026-01-20
Efficacy and Safety of Nipocalimab vs Efgartigimod in a Randomized, Open-label, Phase 3b, Interventional Trial Including Within Class Switching From Efgartigimod to Nipocalimab
Not yet recruitingCTIS2025-521130-28-00
Target: 29Updated: 2025-12-14