RECRUITING

Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia

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Conditions

Warm Autoimmune Hemolytic AnemiaM281 (Nipocalimab)wAIHAJNJ-80202135

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).

Official Title

Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study With a Long-term Open-label Extension

Quick Facts

Study Start:2019-08-15
Study Completion:2028-04-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04119050

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants greater than or equal to (\>=)18 years of age
  2. * Have been diagnosed with warm autoimmune hemolytic anemia (wAIHA) for at least 3 months, and are currently receiving treatment for wAIHA or have previously received treatment for wAIHA (treatment-naive participants are not eligible)
  3. * Participants must be able to understand and voluntarily provide written informed consent to participate in the study and comply with all study procedures
  1. * Participants must not be pregnant or breastfeeding
  2. * Participants must not have other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate
  3. * Have been diagnosed with cold antibody autoimmune hemolytic anemia (AIHA), cold agglutinin syndrome, mixed type (that is, warm and cold) AIHA, or paroxysmal cold hemoglobinuria

Contacts and Locations

Study Contact

Study Contact
CONTACT
844-434-4210
Participate-In-This-Study@its.jnj.com

Principal Investigator

Janssen Research & Development, LLC Clinical Trial
STUDY_DIRECTOR
Janssen Research & Development, LLC

Study Locations (Sites)

MemorialCare Medical Group
Fountain Valley, California, 92708
United States
University of Southern California
Los Angeles, California, 90033
United States
Compassionate Cancer Care
Riverside, California, 92501
United States
American Institute of Research
Whittier, California, 90603
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
GNP Research
Cooper City, Florida, 33024
United States
University of Florida College of Medicine
Gainesville, Florida, 32610
United States
21st Century Oncology
Jacksonville, Florida, 32204
United States
Lakes Research
Miami Lakes, Florida, 33014
United States
AdventHealth Cancer Institute
Orlando, Florida, 32804
United States
Children's Research Institute
Saint Petersburg, Florida, 33701
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Alliance for Multispeciality Research
Merriam, Kansas, 66204
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Henry Ford Medical Center
Detroit, Michigan, 48202
United States
Research Medical Center
Kansas City, Missouri, 64132
United States
Montefiore Medical Center
Lake Success, New York, 11042
United States
Monter Cancer Center
Lake Success, New York, 11042
United States
Hematology Oncology Associates of Rockland
Nyack, New York, 10960
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
East Carolina University
Greenville, North Carolina, 27834
United States
Taussig Cancer Insititute Cleveland Clinic
Cleveland, Ohio, 44195
United States
The Ohio State University- James Cancer Hospital
Columbus, Ohio, 43210
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
United States
University of Utah
Salt Lake City, Utah, 84132
United States
Northwest Medical Specialists
Tacoma, Washington, 98405
United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

  • Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, 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

Study Start Date2019-08-15
Study Completion Date2028-04-10

Study Record Updates

Study Start Date2019-08-15
Study Completion Date2028-04-10

Terms related to this study

Keywords Provided by Researchers

  • Warm Autoimmune Hemolytic Anemia
  • M281 (Nipocalimab)
  • wAIHA
  • JNJ-80202135

Additional Relevant MeSH Terms

  • Warm Autoimmune Hemolytic Anemia