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

• Status: Not yet recruiting
• Trial end date: 2026-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase II Study: To evaluate the safety and preliminary efficacy of HMPL-523 in adult patients with wAIHA

Phase III Studies: Confirmation of Efficacy safety and of HMPL-523 in Adult Patients With wAIHA

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hutchison Medipharma Limited

Criteria

Inclusion Criteria:

1. Voluntarily signed the informed consent form (ICF);

2. Males or females aged 18 to 75 years;

3. Patients diagnosed with primary wAIHA or secondary wAIHA whose underlying diseases are stable;

4. Organs in good function.

Exclusion Criteria:

1. Patients with other types of AIHA other than wAIHA;

2. Patients with secondary wAIHA with unstable underlying disease;

3. Patients with drug-induced secondary wAIHA;

4. Patients with infections requiring systemic treatment;

5. Patients previously treated with Syk inhibitors (e.g., fostamatinib);

6. Patients with known allergy to the active ingredients or excipients of the study drug;

7. Patients with serious psychological or mental disorder;

8. Alcoholic or drug abuser;

9. Female patients who are pregnant and lactating.