Overview
The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).
Description
The study consists of a 24-week double-blind, placebo control period, a 144-week open-label extension period and follow-up period of 8 weeks after last study drug administration. Eligible participants will be randomized to placebo or nipocalimab (2 dose levels) during the double-blind period and nipocalimab (2 dose levels) during the open-label extension period.
Eligibility
Inclusion criteria:
- Participants greater than or equal to (>=)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 participants 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 been diagnosed with cold antibody autoimmune hemolytic anemia (AIHA), cold agglutinin syndrome, mixed type (that is, warm and cold) AIHA, or paroxysmal cold hemoglobinuria