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

Primary Purpose

Warm Autoimmune Hemolytic Anemia

Status
Temporarily not available
Phase
Locations
Study Type
Expanded Access
Intervention
Nipocalimab
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Warm Autoimmune Hemolytic Anemia

Eligibility Criteria

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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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 5, 2022
    Last Updated
    November 15, 2022
    Sponsor
    Janssen Research & Development, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05221619
    Brief Title
    Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)
    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
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Temporarily not available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Janssen Research & Development, LLC

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Warm Autoimmune Hemolytic Anemia

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Nipocalimab
    Other Intervention Name(s)
    M281, JNJ-80202135
    Intervention Description
    Depending on the dose received at their last administration in the MOM-M281-006 (NCT04119050) study, participants will continue to receive either nipocalimab dose-1 every 2 weeks (Q2W) or nipocalimab dose-2 every 4 weeks (Q4W) by intravenous (IV) infusion.

    10. Eligibility

    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen Research & Development, LLC Clinical Trial
    Organizational Affiliation
    Janssen Research & Development, LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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