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

Phase 2

Recruiting

• Conditions: Warm Antibody Autoimmune Hemolytic Anemia
• Interventions: Drug: HMPL-523(300mg PO QD); Drug: Placebo

• Registration Number: NCT05535933
• Lead Sponsor: Hutchison Medipharma Limited

Brief 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

Detailed Description

Phase II Study: the proportion of patients with overall Hb response by Week 24

Phase III study: the proportion of patients who achieve a durable response by Week 24

Study Timeline

• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-10
• Study Start: 2022-09-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Primary Completion: 2026-09
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HMPL-523	HMPL-523(300mg PO QD)	Phase II: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 8 weeks and at least 16 weeks open-label treatment. Phase III: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 24 weeks and enter open-label phase in the opinion of the Investigator.
Placebo	Placebo	Phase II: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 8 weeks and at least 16 weeks open-label treatment. Phase III: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 24 weeks and enter open-label phase in the opinion of the Investigator.

Primary Outcome Measures

Name	Time	Method
Phase II: overall Hb response rate	24Weeks	Phase II: Overall Hb response rate: the proportion of patients with overall Hb response by Week 24

Secondary Outcome Measures

Name	Time	Method
Phase III: Durable Hb response rate	24Weeks	Phase III: Durable Hb response rate: the proportion of patients who achieve a durable response by Week 24

Trial Locations

Locations (5)

The First affiliated hospital of nanchang uiversity; 🇨🇳 Nanchang, Jiangxi, China

Bethune First Hospital Of Jilin University; 🇨🇳 Changchun, Jilin, China

Guangdong Provincial People's Hospital; 🇨🇳 Lanzhou, Gansu, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

Hematology Hospital of Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, China