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 States, Brazil, China118 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is in a combined Phase 2/3 stage, what does that mean for how much is already known about M281's safety and effectiveness for warm autoimmune hemolytic anemia — and how does that compare to treatments already available to me?
2The trial is measuring whether people achieve a 'durable response' in hemoglobin levels — can you explain what that means in practical terms for how I might feel day-to-day, and how confident we can be in those results given where the study currently stands?
3This trial is active but no longer enrolling new participants, so is there any way I could still benefit from what's being learned here, such as through compassionate use or related studies?
4M281 appears to target a specific immune pathway — how does its mechanism compare to standard treatments I might already be eligible for, and would trying a standard therapy first make more sense before considering something still in trials?
5Given that managing warm autoimmune hemolytic anemia can require ongoing monitoring and treatment adjustments, how demanding would participating in or following the protocol of a trial like this be on my schedule and daily life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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