HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
wAIHA
A Randomized, Double-Blind, Placebo-Controlled Phase II/III Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HMPL-523 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
1 other identifier
interventional
110
1 country
39
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2022
Typical duration for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2022
CompletedFirst Posted
Study publicly available on registry
September 10, 2022
CompletedStudy Start
First participant enrolled
September 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
ExpectedMarch 10, 2026
March 1, 2026
3.2 years
August 31, 2022
March 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Phase II: overall Hb response rate
Phase II: Overall Hb response rate: the proportion of patients with overall Hb response by Week 24
24Weeks
Secondary Outcomes (1)
Phase III: Durable Hb response rate
24Weeks
Study Arms (2)
HMPL-523
EXPERIMENTALPhase 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 COMPARATORPhase 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- Female patients who are pregnant and lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Fuyang Hospital Of Anhui Medical University
Fuyang, Anhui, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Nanfang hospital
Guangzhou, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
Guilin Medical College Affiliated Hospital
Guilin, Guangxi, China
Hainan General Hospital
Haikou, Hainan, China
Affiliated hospital of Hebei university
Baoding, Hebei, China
Affiliated hospital of chengde medical university
Chengde, Hebei, China
Harbin First Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University Of Science and Technology
Luoyang, Henan, China
Xinxiang Central Hospital
Xinxiang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangyang Center Hospital
Xiangyang, Hubei, China
The First People's Hospital of Changde City
Changde, Hunan, China
The third xiangya hospital of central south university
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Chenzhou First People's Hospital
Chenzhou, Hunan, China
Jiangsu province hospital
Nanjing, Jiangsu, China
Affiliated hospital of nantong university
Nantong, Jiangsu, China
Jiangxi Provincial people's Hospital
Nanchang, Jiangxi, China
The First affiliated hospital of nanchang uiversity
Nanchang, Jiangxi, China
Bethune First Hospital Of Jilin University
Changchun, Jilin, China
Qinghai provincial people's hospital
Xining, Qinghai Provincial, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
Affiliated Hospital of Binzhou Medical College
Binzhou, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Jinshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Heping Hospital Affiliated To Changzhi Medical College
Changzhi, Shanxi, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital of WMU
Wenzhou, Zhejiang, China
Peking Union Medical College Hospital
Beijing, China
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, China
Related Publications (1)
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.
PMID: 39799953DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Fengkui Zhang, professor
offices director
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2022
First Posted
September 10, 2022
Study Start
September 30, 2022
Primary Completion
November 25, 2025
Study Completion (Estimated)
November 1, 2026
Last Updated
March 10, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
The results of this study can be published in core journals or international scientific conferences, and the primary investigators who make significant contributions to the implementation and management of this study and the personnel who makes great contributions to the design, interpretation or analysis of this study (such as the staffs or consultants of the sponsor) can have their authorship attribution. The sponsor promises to provide the manuscript to the investigator for review before publication of any result of the study. Investigators have to obtain the approval of the sponsor before submitting academic articles or abstracts. The study personnel have the right to publish results of this study, however, the requirement of protecting confidential information must be met. The confidential information is the property of the sponsor only, cannot be disclosed to others without the written approval of the sponsor, and cannot be used for other purposes.