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

Janssen (J&J Innovative Medicine)

Status

Conditions: Warm Autoimmune Hemolytic Anemia

Treatments: Drug: Nipocalimab

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT05221619

CR109152

80202135WHA4001 (Other Identifier)

Details and patient eligibility

About

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.

Sex

Volunteers: No Healthy Volunteers

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)