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

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Warm Autoimmune Hemolytic Anemia

In brief

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

Key facts

Study ID

NCT04119050

Run by

Janssen Research & Development, LLC

People needed

118

Starts

2019-08-15

Expected to finish

2028-04-01

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants greater than or equal to (>=)18 years of age
• 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)
• Participants must be able to understand and voluntarily provide written informed consent to participate in the study and comply with all study procedures

You may not qualify if…

• Participants must not be pregnant or breastfeeding
• Participants must not have other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate
• 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

Where it is running

• University of Southern California — Los Angeles, California, United States
• Compassionate Cancer Care — Riverside, California, United States
• American Institute of Research — Whittier, California, United States
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
• GNP Research — Cooper City, Florida, United States
• University of Florida College of Medicine — Gainesville, Florida, United States
• 21st Century Oncology — Jacksonville, Florida, United States
• Lakes Research — Miami Lakes, Florida, United States
• AdventHealth Cancer Institute — Orlando, Florida, United States
• Children's Research Institute — St. Petersburg, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Alliance for Multispeciality Research — Merriam, Kansas, United States
• Tulane University School of Medicine — New Orleans, Louisiana, United States
• Henry Ford Medical Center — Detroit, Michigan, United States
• Research Medical Center — Kansas City, Missouri, United States
• Montefiore Medical Center — Lake Success, New York, United States
• Monter Cancer Center — Lake Success, New York, United States
• Hematology Oncology Associates of Rockland — Nyack, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• East Carolina University — Greenville, North Carolina, United States
• Taussig Cancer Insititute Cleveland Clinic — Cleveland, Ohio, United States
• The Ohio State University- James Cancer Hospital — Columbus, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• MemorialCare Medical Group — Fountain Valley, California, United States

Full record on ClinicalTrials.gov

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