Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)

• Conditions: Warm Autoimmune Hemolytic Anemia

• Registration Number: NCT05221619
• Lead Sponsor: Janssen Research & Development, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: TEMPORARILY_NOT_AVAILABLE
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

• Participants demonstrate clinical benefit (improvement of hemoglobin from baseline) at the Week 28 assessment in the open-label extension of the MOM-M281-006 (NCT04119050) study
• Participants does not have co-morbidities that would alter the risk-benefit of nipocalimab administration (determined by treating physician)
• Participants completed treatment in the 28-week open-label extension of the MOM-M281-006 (NCT04119050) study without receiving rescue treatment or discontinuation of the study prior to Week 28 visit

Exclusion Criteria

• Participants have a serious or clinically significant infection (example: pneumonia, biliary tract infection, diverticulitis, Clostridioides difficile infection) requiring parenteral anti-infectives and/or hospitalization
• Participants have a chronic infection (example: bronchiectasis, chronic osteomyelitis, chronic pyelonephritis) or require chronic treatment with anti-infectives (example: antibiotics, antivirals)

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified