0.9% Sodium Chloride Solution for Injection
Sponsors
Janssen - Cilag International, Bristol-Myers Squibb Services Unlimited Company, Janssen Cilag International, Bristol Myers Squibb International Corporation, Sirius Therapeutics Inc.
Conditions
Active Idiopathic Inflammatory Myopathies (IIM)Advanced solid tumorsChronic Inflammatory Demyelinating PolyneuropathyFetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)Hemolytic Disease of the Fetus and Newborn (HDFN)Resectable Stage II-IIIB Non-small cell lung cancerRheumatoid Arthritisvenous thromboembolism
Phase 1
Phase 2
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
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
A Multicenter, Randomized, Open-Label, Blinded Endpoint Evaluation, Active-Controlled Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing Elective Primary Unilateral Total Knee Arthroplasty.
RecruitingCTIS2024-519688-16-00
Start: 2025-08-07Target: 450Updated: 2025-10-28
Phase 3
A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy plus Nivolumab versus Neoadjuvant Chemotherapy plus Placebo, followed by Surgical Resection and Adjuvant Treatment with Nivolumab or Placebo for Participants with Resectable Stage II-IIIB Non-small Cell Lung Cancer (CheckMate 77T, CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 77T)
Active, not recruitingCTIS2022-502658-15-00
Start: 2019-09-22Target: 252Updated: 2025-10-08
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