drugset / Trial / NCT04119050
Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
RandomizedParallel-groupTriple-blindTreatment
Summary
The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).
Timeline
- Start
- 2019-08-15
- Primary completion
- 2025-02-02
- Completion
- 2028-04-01
Publications
- Fattizzo B, Murakhovskaya I, Ueda Y, Schlichting D, Sweet KM, Zelasky M, Craig J, Liva SG, Leu JH, Ling LE, Pease S, Anakor A, Shu C. Nipocalimab for warm autoimmune hemolytic anemia: results from the phase 2/3 randomized, double-blind ENERGY study. Blood. 2026 Aug 28:blood.2026034036. doi: 10.1182/blood.2026034036. Online ahead of print.
- Liu AP, Cheuk DK. Disease-modifying treatments for primary autoimmune haemolytic anaemia. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012493. doi: 10.1002/14651858.CD012493.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nipocalimab | Monoclonal antibody | — | Intravenous |