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
About this trial
This is an expanded access trial for Warm Autoimmune Hemolytic Anemia
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)
- 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
NCT ID
NCT05221619
First Posted
January 5, 2022
Last Updated
November 15, 2022
Sponsor
Janssen Research & Development, LLC
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
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Primary Completion Date
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Study Completion Date
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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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