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

Warm Antibody Autoimmune Hemolytic Anemia Clinical Trial

— wAIHA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05535933
• Other study ID #: 2022-523-00CH1
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: September 30, 2022
• Est. completion date: November 2026

Study information

• Verified date: July 2023
• Source: Hutchmed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: November 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Hemolytic
• Anemia, Hemolytic, Autoimmune
• Hemolysis
• Warm Antibody Autoimmune Hemolytic Anemia

Intervention

Drug:
• HMPL-523(300mg PO QD)
No more than two doses will be explored
• Placebo
Placebo

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing
China	Bethune First Hospital Of Jilin University	Changchun	Jilin
China	Guangdong Provincial People's Hospital	Lanzhou	Gansu
China	The First affiliated hospital of nanchang uiversity	Nanchang	Jiangxi
China	Hematology Hospital of Chinese Academy of Medical Sciences	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Hutchison Medipharma Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Phase III: Durable Hb response rate	Phase III: Durable Hb response rate: the proportion of patients who achieve a durable response by Week 24	24Weeks