Active — Not RecruitingPhase 2/3

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

China110 participantsStarted 2022-09-30

Plain-language 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

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Voluntarily signed the informed consent form (ICF);
✓. Males or females aged 18 to 75 years;
✓. Patients diagnosed with primary wAIHA or secondary wAIHA whose underlying diseases are stable;
✓. Organs in good function.

Exclusion criteria

✕. Patients with other types of AIHA other than wAIHA;
✕. Patients with secondary wAIHA with unstable underlying disease;
✕. Patients with drug-induced secondary wAIHA;
✕. Patients with infections requiring systemic treatment;
✕. Patients previously treated with Syk inhibitors (e.g., fostamatinib);
✕. Patients with known allergy to the active ingredients or excipients of the study drug;
✕. Patients with serious psychological or mental disorder;
✕. Alcoholic or drug abuser;

What they're measuring

Phase II: overall Hb response rate

Timeframe: 24Weeks

Trial details

NCT IDNCT05535933

SponsorHutchison Medipharma Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-25

View on ClinicalTrials.gov More Warm Antibody Autoimmune Hemolytic Anemia trials