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Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Available
CT.gov ID
NCT05221619
Collaborator
(none)

Study Details

Study Description

Brief Summary

The purpose of this post-trial access (PTA) program is to provide nipocalimab for the treatment of participants with Warm Autoimmune Hemolytic Anemia (wAIHA) who are experiencing clinical benefit after completing 28-weeks open-label extension in MOM-M281-006 (NCT04119050) study.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Expanded Access
Official Title:
Nipocalimab Post-trial Access in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA) Who Are Experiencing Clinical Benefit After Complete 28-Weeks Open-label Extension in MOM-M281-006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Participants demonstrate clinical benefit (improvement of hemoglobin from baseline) at the Week 28 assessment in the open-label extension of the MOM-M281-006 (NCT04119050) study

    • Participants does not have co-morbidities that would alter the risk-benefit of nipocalimab administration (determined by treating physician)

    • Participants completed treatment in the 28-week open-label extension of the MOM-M281-006 (NCT04119050) study without receiving rescue treatment or discontinuation of the study prior to Week 28 visit

    Exclusion Criteria:

    • Participants have a serious or clinically significant infection (example: pneumonia, biliary tract infection, diverticulitis, Clostridioides difficile infection) requiring parenteral anti-infectives and/or hospitalization

    • Participants have a chronic infection (example: bronchiectasis, chronic osteomyelitis, chronic pyelonephritis) or require chronic treatment with anti-infectives (example: antibiotics, antivirals)

    • Participants have received a live viral or bacterial vaccine within 3 months prior to signing the informed consent for this post-trial access (PTA) program, or there is a known need to receive a live viral or bacterial vaccine during this program or within at least 3 months after the last dose of nipocalimab

    • Participants have received a Bacille Calmette-Guerin (BCG) vaccination within 1 year prior to signing the informed consent for this PTA program, or there is a known need to receive a live BCG vaccination during this program or within at least 1 year after the last dose of nipocalimab

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT05221619
    Other Study ID Numbers:
    • CR109152
    • 80202135WHA4001
    First Posted:
    Feb 3, 2022
    Last Update Posted:
    Feb 3, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Anemia
    Anemia, Hemolytic
    Anemia, Hemolytic, Autoimmune
    Hemolysis

    Study Results

    No Results Posted as of Feb 3, 2022