Clinical Trial

HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

Study acronym: wAIHA
Active, Not Recruiting Phase 2/3
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Summary
Phase II Study: To evaluate the safety and preliminary efficacy of HMPL-523 in adult patients with wAIHA. Phase III Study(Part A): Confirmation of Efficacy safety and of HMPL-523 in adult patients with wAIHA. Phase III Study (Part B): To further evaluate the long-term safety and tolerability of HMPL-523 in adult patients with wAIHA.
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-05-19
notable Sponsor changed: Hutchison Medipharma Limited -> Hutchmed 2026-05-19
Trial Details
NCT Number NCT05535933
Lead Sponsor Hutchmed
Conditions Warm Antibody Autoimmune Hemolytic Anemia
Enrollment 111 participants
Start Date 2022-09-30
Primary Completion 2025-11-25 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2026-05-18