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

Last updated: March 7, 2026
Sponsor: Hutchison Medipharma Limited
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Anemia

Treatment

HMPL-523(300mg PO QD)

Placebo

Clinical Study ID

NCT05535933
2022-523-00CH1
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 diseasesare stable;

  4. Organs in good function.

Exclusion

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 studydrug;

  7. Patients with serious psychological or mental disorder;

  8. Alcoholic or drug abuser;

  9. Female patients who are pregnant and lactating.

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: HMPL-523(300mg PO QD)
Phase: 2/3
Study Start date:
September 30, 2022
Estimated Completion Date:
November 30, 2026

Study 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

Connect with a study center

  • Fuyang Hospital Of Anhui Medical University

    Fuyang, Anhui
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Lanzhou, Gansu
    China

    Active - Recruiting

  • Lanzhou University Second Hospital

    Lanzhou, Gansu
    China

    Site Not Available

  • Nanfang hospital

    Guangzhou, Guangdong
    China

    Site Not Available

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong
    China

    Site Not Available

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong
    China

    Site Not Available

  • Guilin Medical College Affiliated Hospital

    Guilin, Guangxi
    China

    Site Not Available

  • Hainan General Hospital

    Haikou, Hainan
    China

    Site Not Available

  • Affiliated hospital of Hebei university

    Baoding, Hebei
    China

    Site Not Available

  • Affiliated hospital of chengde medical university

    Chengde, Hebei
    China

    Site Not Available

  • Harbin First Hospital

    Harbin, Heilongjiang
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University Of Science and Technology

    Luoyang, Henan
    China

    Site Not Available

  • Xinxiang Central Hospital

    Xinxiang, Henan
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Site Not Available

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei
    China

    Site Not Available

  • Xiangyang Center Hospital

    Xiangyang, Hubei
    China

    Site Not Available

  • The First People's Hospital of Changde City

    Changde, Hunan
    China

    Site Not Available

  • The third xiangya hospital of central south university

    Changsha, Hunan
    China

    Site Not Available

  • Xiangya Hospital of Central South University

    Changsha, Hunan
    China

    Site Not Available

  • Chenzhou First People's Hospital

    Chenzhou, Hunan
    China

    Site Not Available

  • Jiangsu province hospital

    Nanjing, Jiangsu
    China

    Site Not Available

  • Affiliated hospital of nantong university

    Nantong, Jiangsu
    China

    Site Not Available

  • Jiangxi Provincial people's Hospital

    Nanchang, Jiangxi
    China

    Site Not Available

  • The First affiliated hospital of nanchang uiversity

    Nanchang, Jiangxi
    China

    Site Not Available

  • Bethune First Hospital Of Jilin University

    Changchun, Jilin
    China

    Site Not Available

  • Qinghai provincial people's hospital

    Xining, Qinghai Provincial
    China

    Site Not Available

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi
    China

    Site Not Available

  • Affiliated Hospital of Binzhou Medical College

    Binzhou, Shandong
    China

    Site Not Available

  • Yantai Yuhuangding Hospital

    Yantai, Shandong
    China

    Site Not Available

  • Jinshan Hospital of Fudan University

    Shanghai, Shanghai Municipality
    China

    Site Not Available

  • Heping Hospital Affiliated To Changzhi Medical College

    Changzhi, Shanxi
    China

    Site Not Available

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan
    China

    Site Not Available

  • Xinjiang Uygur Autonomous Region People's Hospital

    Ürümqi, Xinjiang
    China

    Site Not Available

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Site Not Available

  • The First Affiliated Hospital of WMU

    Wenzhou, Zhejiang
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing,
    China

    Site Not Available

  • Hematology Hospital of Chinese Academy of Medical Sciences

    Tianjin,
    China

    Site Not Available

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