Status:
RECRUITING
Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Warm Autoimmune Hemolytic Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).
Detailed Description
The study consists of a 24-week double-blind, placebo control period, a 144-week open-label extension period and follow-up period of 8 weeks after last study drug administration. Eligible participants...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 10 2028
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT04119050
Start Date
August 15 2019
End Date
April 10 2028
Last Update
December 19 2025
Active Locations (171)
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1
MemorialCare Medical Group
Fountain Valley, California, United States, 92708
2
University of Southern California
Los Angeles, California, United States, 90033
3
Compassionate Cancer Care
Riverside, California, United States, 92501
4
American Institute of Research
Whittier, California, United States, 90603