Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia (NCT04119050) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
United States118 participantsStarted 2019-08-15
Plain-language summary
The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Percentage of Participants Achieving Durable Response of Improvement in Hemoglobin (Hgb)
Timeframe: Up to Week 20 of the double-blind period