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

NCT05535933 · tracked via the Priya Life Science China tracker

Sponsor

Hutchmed

Phase

Phase 2/3

Started

2022-09-30

Last updated

2026-05-18

Condition(s) studied

Warm Antibody Autoimmune Hemolytic Anemia

Investigational drug(s) / intervention(s)

HMPL-523(300mg PO QD)Placebo

HMPL-523(300mg PO QD): HMPL-523(300mg PO QD)

Placebo: Placebo(300mg PO QD)

Study summary

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

Phase III Study(Part A): Confirmation of Efficacy safety and of HMPL-523 in adult patients with wAIHA.

Phase III Study (Part B): To further evaluate the long-term safety and tolerability of HMPL-523 in adult patients with wAIHA.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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.

Primary outcome measure(s)

Phase II: Overall Hb response rate — 24Weeks
Phase II: Overall Hb response rate: The proportion of patients with overall Hb response by Week 24
Phase III(Part A): Durable Hb response rate — 24Weeks
Phase III(Part A):Durable Hb response rate: The proportion of patients who achieve a durable response by Week 24 during Part A

Trial sites (39)

Facility	City	Region
Fuyang Hospital Of Anhui Medical University	Fuyang	Anhui
Fujian Medical University Union Hospital	Fuzhou	Fujian
Lanzhou University Second Hospital	Lanzhou	Gansu
Nanfang hospital	Guangzhou	Guangdong
Shenzhen Second People's Hospital	Shenzhen	Guangdong
Affiliated Hospital of Guangdong Medical University	Zhanjiang	Guangdong
Guilin Medical College Affiliated Hospital	Guilin	Guangxi
Hainan General Hospital	Haikou	Hainan
Affiliated hospital of Hebei university	Baoding	Hebei
Affiliated hospital of chengde medical university	Chengde	Hebei
Harbin First Hospital	Harbin	Heilongjiang
The First Affiliated Hospital of Henan University Of Science and Technology	Luoyang	Henan
Xinxiang Central Hospital	Xinxiang	Henan
Henan Cancer Hospital	Zhengzhou	Henan
The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
Xiangyang Center Hospital	Xiangyang	Hubei
The First People's Hospital of Changde City	Changde	Hunan
The third xiangya hospital of central south university	Changsha	Hunan
Xiangya Hospital of Central South University	Changsha	Hunan
Chenzhou First People's Hospital	Chenzhou	Hunan
Jiangsu province hospital	Nanjing	Jiangsu
Affiliated hospital of nantong university	Nantong	Jiangsu
Jiangxi Provincial people's Hospital	Nanchang	Jiangxi
The First affiliated hospital of nanchang uiversity	Nanchang	Jiangxi
Bethune First Hospital Of Jilin University	Changchun	Jilin
Qinghai provincial people's hospital	Xining	Qinghai Provincial
Shaanxi Provincial People's Hospital	Xi'an	Shaanxi
Affiliated Hospital of Binzhou Medical College	Binzhou	Shandong
Yantai Yuhuangding Hospital	Yantai	Shandong
Jinshan Hospital of Fudan University	Shanghai	Shanghai Municipality
Heping Hospital Affiliated To Changzhi Medical College	Changzhi	Shanxi
The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan
Xinjiang Uygur Autonomous Region People's Hospital	Ürümqi	Xinjiang
The Second Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
The First Affiliated Hospital of WMU	Wenzhou	Zhejiang
Peking Union Medical College Hospital	Beijing	China
Hematology Hospital of Chinese Academy of Medical Sciences	Tianjin	China

More Hutchmed trials in China

A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer Recruiting

Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2) Active, not recruiting

Study of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Relapsed/Refractory DLBCL Active, not recruiting

A Clinical Study of HMPL-506 in Patients With Hematological Malignancies Recruiting

Phase I Study of HMPL-306 for the Treatment of Gliomas With IDH1 and/or IDH2 Mutations Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05535933 on ClinicalTrials.gov ↗ ← All trials in China