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Evaluating M281 for treating warm autoimmune hemolytic anemia in adults

Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study With a Long-term Open-label Extension

Phase2; Phase3 Interventional Janssen Research & Development, LLC · NCT04119050

This study is testing a new medication called M281 to see if it can help adults with warm autoimmune hemolytic anemia feel better and stay healthy.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment111 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsnipocalimab
Locations171 sites (Fountain Valley, California and 170 other locations)
Trial IDNCT04119050 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of M281 (nipocalimab) in adults diagnosed with warm autoimmune hemolytic anemia (wAIHA). It includes a 24-week double-blind, placebo-controlled phase followed by a 144-week open-label extension period. Participants will be randomized to receive either a placebo or one of two doses of nipocalimab during the initial phase, with all participants receiving nipocalimab during the extension. The study also includes an 8-week follow-up after the last administration of the study drug.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with wAIHA for at least three months and are currently receiving or have previously received treatment for the condition.

Not a fit: Patients who are pregnant, breastfeeding, or have other specific types of autoimmune hemolytic anemia may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from warm autoimmune hemolytic anemia.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific treatment and its methodology are being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Fountain Valley, California and 170 other locations

+121 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Warm Autoimmune Hemolytic AnemiaM281wAIHAJNJ-80202135
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.