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

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

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

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

Additional locations may be listed on ClinicalTrials.gov for NCT04119050.

See trial information on ClinicalTrials.gov for a list of participating sites.

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.

Trial PhasePhase II/III

Trial Typetreatment

Lead OrganizationJanssen Research & Development, LLC

Primary IDCR108987
Secondary IDsNCI-2020-01950, 2019-000720-17, 2023-505321-14-00, MOM-M281-006
ClinicalTrials.gov IDNCT04119050

Description