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Clinical Trial Summary

The purpose of this post-trial access (PTA) program is to provide nipocalimab for the treatment of participants with Warm Autoimmune Hemolytic Anemia (wAIHA) who are experiencing clinical benefit after completing 28-weeks open-label extension in MOM-M281-006 (NCT04119050) study.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05221619
Study type Expanded Access
Source Janssen Research & Development, LLC
Contact
Status Temporarily not available
Phase

See also
  Status Clinical Trial Phase
Recruiting NCT05786573 - A Study of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre) Phase 3
Withdrawn NCT03965624 - Efficacy and Safety of Ixazomib and Dexamethasone Refractory Autoimmune Cytopenia Phase 2
Recruiting NCT05922839 - Zanubrutinib in the Treatment of Relapsed/Refractory wAIHA Phase 2
Completed NCT01181154 - Rituximab in Auto-Immune Hemolytic Anemia Phase 3
Recruiting NCT05925023 - Sirolimus in the Treatment of Refractory/Relapsed wAIHA Phase 2
Recruiting NCT05757570 - An Open-label Study of Povetacicept in Subjects With Autoimmune Cytopenias Phase 1/Phase 2
Withdrawn NCT04256148 - ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia Phase 2
Terminated NCT03075878 - A Safety Study of SYNT001 in Participants With Warm Autoimmune Hemolytic Anemia (WAIHA) Phase 1/Phase 2
Withdrawn NCT04956276 - Subcutaneous ALXN1830 in Adult Participants With Warm Autoimmune Hemolytic Anemia Phase 2
Completed NCT03226678 - Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD) Phase 2
Recruiting NCT04119050 - Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia Phase 2/Phase 3
Terminated NCT04253236 - To Assess the Efficacy and Safety of RVT-1401 in the Treatment of Warm Autoimmune Hemolytic Anemia (ASCEND-WAIHA). Phase 2