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

  • End date
    Apr 10, 2028
  • participants needed
  • sponsor
    Janssen Research & Development, LLC
Updated on 19 September 2023


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


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.

Condition Warm Autoimmune Hemolytic Anemia
Treatment Placebo, M281
Clinical Study IdentifierNCT04119050
SponsorJanssen Research & Development, LLC
Last Modified on19 September 2023


Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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