Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)
- Sponsor
- Janssen Research & Development, LLC
- Study ID
- NCT05221619
- Status
- Temporarily Not Available
Conditions
- Warm Autoimmune Hemolytic Anemia
Eligibility Criteria
- Sex
- All
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nipocalimab — DRUGDepending on the dose received at their last administration in the MOM-M281-006 (NCT04119050) study, participants will continue to receive either nipocalimab dose-1 every 2 weeks (Q2W) or nipocalimab dose-2 every 4 weeks (Q4W) by intravenous (IV) infusion.
Study Details
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.
Key Dates
- Status verified
- Jan 2026