Product
Nipocalimab
Aliases
JNJ-80202135, JNJ-80202135, M281, M281
16 clinical trials
14 indications
Indication
Autoimmune Hemolytic AnemiaIndication
Myasthenia GravisIndication
HealthyIndication
ArthritisIndication
RheumatoidIndication
ThrombocytopeniaIndication
Neonatal AlloimmuneIndication
Lupus NephritisIndication
Systemic Lupus ErythematosusIndication
MyositisIndication
PolyradiculoneuropathyIndication
Chronic Inflammatory DemyelinatingIndication
Sjögren's syndromeClinical trial
A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)Status: Completed, Estimated PCD: 2023-10-23
Clinical trial
Nipocalimab Post-trial Access in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA) Who Are Experiencing Clinical Benefit After Complete 28-Weeks Open-label Extension in MOM-M281-006Status:
Clinical trial
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 GravisStatus: Recruiting, Estimated PCD: 2025-03-19
Clinical trial
A Phase 1, Open-Label Study to Investigate Drug-Drug Interaction (DDI) Potential of Nipocalimab With Coadministration of Etanercept or Hydroxychloroquine in Healthy ParticipantsStatus: Completed, Estimated PCD: 2022-05-27
Clinical trial
A Phase 1 Double-Blind, Placebo-Controlled, Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Nipocalimab in Healthy Male and Female ParticipantsStatus: Completed, Estimated PCD: 2022-05-26
Clinical trial
A Sequential, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of JNJ-80202135 Following a Single Intravenous Administration in Healthy Chinese Adult ParticipantsStatus: Completed, Estimated PCD: 2022-09-09
Clinical trial
A Randomized, Open-Label Study on the Effect of Nipocalimab on Vaccine Responses in Healthy ParticipantsStatus: Completed, Estimated PCD: 2023-10-04
Clinical trial
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants With Active Rheumatoid Arthritis Despite Standard TherapyStatus: Completed, Estimated PCD: 2022-08-10
Clinical trial
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 PregnanciesStatus: Recruiting, Estimated PCD: 2029-12-05
Clinical trial
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 GravisStatus: Recruiting, Estimated PCD: 2023-11-17
Clinical trial
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Nipocalimab in Adult Participants With Active Lupus NephritisStatus: Not yet recruiting, Estimated PCD: 2028-02-28
Clinical trial
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Nipocalimab in Adult Participants With Active Systemic Lupus ErythematosusStatus: Active (not recruiting), Estimated PCD: 2024-05-02
Clinical trial
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 MyopathiesStatus: Recruiting, Estimated PCD: 2026-03-02
Clinical trial
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)Status: Recruiting, Estimated PCD: 2027-08-05
Clinical trial
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)Status: Recruiting, Estimated PCD: 2027-05-14
Clinical trial
A Phase 2a Multicenter, Randomized, Double Blind, Parallel, Proof of Concept Study Evaluating the Efficacy and Safety of Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis Despite Prior Treatment With Advanced Therapies (bDMARD or tsDMARD)Status: Active (not recruiting), Estimated PCD: 2024-09-30