Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
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- STATUS
- Recruiting
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- End date
- Apr 10, 2028
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- participants needed
- 111
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- sponsor
- Janssen Research & Development, LLC
Summary
The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).
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.
Details
| Condition | Warm Autoimmune Hemolytic Anemia |
|---|---|
| Treatment | Placebo, M281 |
| Clinical Study Identifier | NCT04119050 |
| Sponsor | Janssen Research & Development, LLC |
| Last Modified on | 19 September 2023 |
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