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

Last updated: March 13, 2025
Sponsor: Hutchison Medipharma Limited
Overall Status: Active - 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

  • Guangdong Provincial People's Hospital

    Lanzhou, Gansu
    China

    Active - Recruiting

  • The First affiliated hospital of nanchang uiversity

    Nanchang, Jiangxi
    China

    Active - Recruiting

  • Bethune First Hospital Of Jilin University

    Changchun, Jilin
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing,
    China

    Active - Recruiting

  • Hematology Hospital of Chinese Academy of Medical Sciences

    Tianjin,
    China

    Active - Recruiting

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