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

  • STATUS
    Recruiting
  • End date
    Oct 15, 2024
  • participants needed
    111
  • sponsor
    Janssen Research & Development, LLC
Updated on 10 August 2022

Summary

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 6 weeks after last assessment. 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.

Details
Condition Warm Autoimmune Hemolytic Anemia
Treatment Placebo, M281
Clinical Study IdentifierNCT04119050
SponsorJanssen Research & Development, LLC
Last Modified on10 August 2022

Eligibility

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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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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