HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
NCT ID: NCT05535933
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
110 participants
INTERVENTIONAL
2022-09-30
2026-11-30
Brief Summary
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Phase III Studies: Confirmation of Efficacy safety and of HMPL-523 in Adult Patients With wAIHA
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Detailed Description
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Phase III study: the proportion of patients who achieve a durable response by Week 24
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HMPL-523
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.
HMPL-523(300mg PO QD)
HMPL-523(300mg PO QD)
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.
Placebo
Placebo(300mg PO QD)
Interventions
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HMPL-523(300mg PO QD)
HMPL-523(300mg PO QD)
Placebo
Placebo(300mg PO QD)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Hutchison Medipharma Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Fengkui Zhang, professor
Role: PRINCIPAL_INVESTIGATOR
offices director
Locations
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Guangdong Provincial People's Hospital
Lanzhou, Gansu, China
The First affiliated hospital of nanchang uiversity
Nanchang, Jiangxi, China
Bethune First Hospital Of Jilin University
Changchun, Jilin, China
Peking Union Medical College Hospital
Beijing, , China
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Liansheng Zhang
Role: primary
Fei Li
Role: primary
Sujun Gao
Role: primary
Bing Han
Role: primary
Fengkui Zhang
Role: primary
References
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Zhao X, Sun J, Zhang Z, Chen M, Gong T, He G, Li Y, Liu H, Li F, Li X, Zhou H, Wang X, Hong M, Lei L, Yin H, Luo X, Li Y, Fan S, Guo X, Shi MM, Su W, Zhang L, Han B, Zhang F. Sovleplenib in patients with primary or secondary warm autoimmune haemolytic anaemia: results from phase 2 of a randomised, double-blind, placebo-controlled, phase 2/3 study. Lancet Haematol. 2025 Feb;12(2):e97-e108. doi: 10.1016/S2352-3026(24)00344-2. Epub 2025 Jan 9.
Other Identifiers
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2022-523-00CH1
Identifier Type: -
Identifier Source: org_study_id
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