- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05221619
Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)
January 22, 2024 updated by: Janssen Research & Development, LLC
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
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.
Study Overview
Status
Temporarily not available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
January 5, 2022
First Submitted That Met QC Criteria
February 2, 2022
First Posted (Actual)
February 3, 2022
Study Record Updates
Last Update Posted (Actual)
January 23, 2024
Last Update Submitted That Met QC Criteria
January 22, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR109152
- 80202135WHA4001 (Other Identifier: Janssen Research & Development, LLC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Warm Autoimmune Hemolytic Anemia
-
Novartis PharmaceuticalsRecruitingWarm Autoimmune Hemolytic Anemia (wAIHA)China, Japan, Spain, Singapore, France, Germany, Taiwan, United States, Italy, India, Malaysia, Argentina, Hungary, Israel, Australia, Thailand, United Kingdom, Romania
-
Annexon, Inc.CompletedWarm Autoimmune Hemolytic Anemia (wAIHA)United States
-
Eugene NikitinUnknownAIHA - Warm Autoimmune Hemolytic AnemiaRussian Federation
-
SanofiActive, not recruitingWarm Autoimmune Hemolytic Anemia (wAIHA)United States, Austria, China, Denmark, Germany, Hungary, Italy, Spain, United Kingdom
-
SanofiTerminatedWarm Autoimmune Hemolytic Anemia (wAIHA)United Kingdom, Belgium, Netherlands, France, United States, Germany, Hungary, Italy
-
Incyte CorporationActive, not recruitingWarm Autoimmune Hemolytic Anemia (wAIHA)Spain, United States, Austria, Belgium, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Poland, United Kingdom
-
Peking Union Medical College HospitalRecruiting
-
Alexion PharmaceuticalsWithdrawnWarm Autoimmune Hemolytic AnemiaUnited States
-
Alexion PharmaceuticalsTerminatedWarm Autoimmune Hemolytic AnemiaUnited States, Jordan
-
Chen MiaoNot yet recruiting
Clinical Trials on Nipocalimab
-
Janssen Research & Development, LLCCompleted
-
Janssen Research & Development, LLCCompletedArthritis, RheumatoidUnited Kingdom, United States, Spain, Germany, Poland
-
Janssen Research & Development, LLCCompleted
-
Janssen Research & Development, LLCRecruitingMyasthenia GravisUnited States, Japan, Netherlands, Poland
-
Janssen Research & Development, LLCRecruitingWarm Autoimmune Hemolytic AnemiaUnited States, Israel, Korea, Republic of, Spain, Czechia, France, Brazil, China, United Kingdom, Malaysia, Hungary, Japan, Poland, Germany, Ukraine, Italy, Greece, Netherlands
-
Janssen Research & Development, LLCRecruitingHemolytic Disease of the Fetus and NewbornIsrael, Australia, United States, Brazil, United Kingdom
-
Janssen Research & Development, LLCRecruitingPolyradiculoneuropathy, Chronic Inflammatory DemyelinatingUnited States, China, Taiwan, Korea, Republic of, Japan, France, Czechia, Poland, United Kingdom
-
Janssen Research & Development, LLCRecruitingMyasthenia GravisUnited States, Korea, Republic of, Japan, Taiwan, Denmark, Germany, Czechia, China, Spain, Belgium, Canada, Mexico, Poland, Italy, France, Australia, Sweden
-
Janssen Research & Development, LLCActive, not recruitingSjogren's SyndromeUnited States, Germany, Netherlands, Japan, Taiwan, Italy, France, Spain, Poland, Portugal
-
Janssen Research & Development, LLCActive, not recruitingSystemic Lupus ErythematosusJapan, Taiwan, Spain, United States, Poland, Argentina, Ukraine, Germany, Hungary, Bulgaria, Colombia, South Africa