Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia

• Status: Recruiting
• Trial end date: 2024-10-15
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC; Momenta Pharmaceuticals, Inc.

Criteria

Inclusion criteria:

• Male or female ≥18 years of age

• Have been diagnosed with warm autoimmune hemolytic anemia (wAIHA) for at least 3 months, and are currently receiving treatment for wAIHA or have previously received treatment for wAIHA (treatment-naive patients are not eligible)

• Participants must be able to understand and voluntarily provide written informed consent to participate in the study and comply with all study procedures

Exclusion criteria:

• Participants must not be pregnant or breastfeeding

• Participants must not have other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate

• Have cold antibody autoimmune hemolytic anemia (AIHA), cold agglutinin syndrome, mixed type (that is, warm and cold) AIHA, or paroxysmal cold hemoglobinuria