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Search / Trial NCT05535933

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

Launched by HUTCHISON MEDIPHARMA LIMITED · Sep 7, 2022

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HMPL-523 (also known as Sovleplenib) for adults with a condition called warm antibody autoimmune hemolytic anemia (wAIHA). This condition causes the immune system to mistakenly attack red blood cells, leading to anemia, which can make you feel weak and tired. The trial is currently looking for adult participants between the ages of 18 and 75 who have either primary or stable secondary wAIHA. To join, patients must have healthy organ function and be able to provide informed consent.

If you participate in this trial, you will receive HMPL-523 and be monitored for its safety and effectiveness. The researchers aim to see how well this treatment works and if it is safe for people with wAIHA. It's important to note that certain individuals, such as those with unstable medical conditions or other specific health issues, may not be eligible to participate. If you or a family member are considering joining this trial, it could be an opportunity to access a potentially helpful treatment while contributing to important medical research.

Gender

ALL

Eligibility criteria

  • 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.

About Hutchison Medipharma Limited

Hutchison Medipharma Limited is a leading biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapies for cancer and other serious diseases. With a commitment to advancing healthcare, the company leverages cutting-edge science and technology to create targeted treatments that address unmet medical needs. Hutchison Medipharma collaborates with global partners and utilizes a robust pipeline of novel compounds to drive clinical trials and bring effective solutions to patients worldwide. Their dedication to quality and excellence in research positions them at the forefront of the biopharmaceutical industry.

Locations

Beijing, , China

Beijing, Beijing, China

Changchun, Jilin, China

Lanzhou, Gansu, China

Nanchang, Jiangxi, China

Tianjin, , China

Patients applied

0 patients applied

Trial Officials

Fengkui Zhang, professor

Principal Investigator

offices director

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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