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Temporarily Not AvailableNCT05221619

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

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-M281-006

Status
Temporarily Not Available
Phase
Study type
Expanded Access
Enrollment
Sponsor
Janssen Research & Development, LLC · Industry
Sex
Age
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
DRUGNipocalimabDepending 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.

Timeline

First posted
2022-02-03
Last updated
2026-01-16

Source: ClinicalTrials.gov record NCT05221619. Inclusion in this directory is not an endorsement.

Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA) (NCT05221619) · Clinical Trials Directory