Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
Purpose
The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).
Condition
- Warm Autoimmune Hemolytic Anemia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental M281 administered every 4 weeks (double-blind period) |
Participants will receive M281 administered every 4 weeks alternating with placebo every 4 weeks during the 24 weeks double-blind period. |
|
Experimental M281 administered every 2 weeks (double-blind period) |
Participants will receive M281 administered every 2 weeks during the 24 weeks double-blind period. |
|
Experimental Placebo administered every 2 weeks (double-blind period) |
Participants will receive M281 matching placebo administered every 2 weeks during the 24 weeks double-blind period. |
|
Experimental M281 administered every 4 weeks (open-label extension period) |
Participants will receive M281 administered every 4 weeks during the 144 weeks open-label extension period. |
|
Experimental M281 administered every 2 weeks (open-label extension period) |
Participants will receive M281 administered every 2 weeks during the 144 weeks open-label extension period. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Janssen Research & Development, LLC
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 will be randomized to placebo or nipocalimab (2 dose levels) during the double-blind period and nipocalimab (2 dose levels) during the open-label extension period.