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JNJ-80202135

DRUG10 trials

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
Janssen - Cilag InternationalMyasthenia gravis (MG)
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
Janssen - Cilag InternationalRheumatoid Arthritis
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
Janssen - Cilag InternationalActive Idiopathic Inflammatory Myopathies (IIM)
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
Janssen - Cilag InternationalWarm Autoimmune Hemolytic Anemia
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
Janssen Cilag InternationalChronic Inflammatory Demyelinating Polyneuropathy
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
Janssen - Cilag InternationalGeneralized Myasthenia Gravis
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
Janssen - Cilag InternationalHemolytic Disease of the Fetus and Newborn (HDFN)
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
Janssen - Cilag InternationalFetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
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
Janssen Cilag InternationalSjögren's Disease
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
Janssen Cilag Internationalgeneralized myasthenia gravis
Target: 29Updated: 2025-12-14