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

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ClinicalTrials.gov Identifier: NCT05221619
Expanded Access Status : Temporarily not available
First Posted : February 3, 2022
Last Update Posted : January 23, 2024
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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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
Warm Autoimmune Hemolytic Anemia Drug: Nipocalimab

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Interventions
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Intervention Details:
  • Drug: Nipocalimab
    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.
    Other Names:
    • M281
    • JNJ-80202135
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05221619


Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT05221619    
Other Study ID Numbers: CR109152
80202135WHA4001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: February 3, 2022    Key Record Dates
Last Update Posted: January 23, 2024
Last Verified: January 2024
Additional relevant MeSH terms:
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Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Hemolysis
 Hematologic Diseases
Pathologic Processes
Autoimmune Diseases
Immune System Diseases