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.
Depending 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.
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) - Participants have received a live viral or bacterial vaccine within 3 months prior to signing the informed consent for this post-trial access (PTA) program, or there is a known need to receive a live viral or bacterial vaccine during this program or within at least 3 months after the last dose of nipocalimab - Participants have received a Bacille Calmette-Guerin (BCG) vaccination within 1 year prior to signing the informed consent for this PTA program, or there is a known need to receive a live BCG vaccination during this program or within at least 1 year after the last dose of nipocalimab
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC