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

• ClinicalTrials.gov Identifier: NCT05535933
• Recruitment Status: Active, not recruiting
• First Posted: September 10, 2022
• Last Update Posted: July 11, 2023
• Sponsor: Hutchison Medipharma Limited
• Information provided by (Responsible Party): Hutchmed ( Hutchison Medipharma Limited )

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Warm Antibody Autoimmune Hemolytic Anemia	Drug: HMPL-523(300mg PO QD); Drug: Placebo	Phase 2; Phase 3

Detailed 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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: September 30, 2022
• Estimated Primary Completion Date: September 2026
• Estimated Study Completion Date: November 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: HMPL-523; Phase II: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 8 weeks and at least 16 weeks open-label treatment. Phase III: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 24 weeks and enter open-label phase in the opinion of the Investigator.	Drug: HMPL-523(300mg PO QD); No more than two doses will be explored; Other Name: Sovleplenib
Placebo Comparator: Placebo; Phase II: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 8 weeks and at least 16 weeks open-label treatment. Phase III: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 24 weeks and enter open-label phase in the opinion of the Investigator.	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures :

1. Phase II: overall Hb response rate [ Time Frame: 24Weeks ]
   Phase II: Overall Hb response rate: the proportion of patients with overall Hb response by Week 24

Secondary Outcome Measures :

1. Phase III: Durable Hb response rate [ Time Frame: 24Weeks ]
   Phase III: Durable Hb response rate: the proportion of patients who achieve a durable response by Week 24

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

China, Gansu

Guangdong Provincial People's Hospital

Lanzhou, Gansu, China

China, Jiangxi

The First affiliated hospital of nanchang uiversity

Nanchang, Jiangxi, China

China, Jilin

Bethune First Hospital Of Jilin University

Changchun, Jilin, China

China

Peking Union Medical College Hospital

Beijing, China

Hematology Hospital of Chinese Academy of Medical Sciences

Tianjin, China

Sponsors and Collaborators

Hutchison Medipharma Limited

Investigators

• Principal Investigator: Fengkui Zhang, professor; offices director

More Information

• Responsible Party: Hutchison Medipharma Limited
• ClinicalTrials.gov Identifier: NCT05535933
• Other Study ID Numbers: 2022-523-00CH1
• First Posted: September 10, 2022
• Last Update Posted: July 11, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Plan Description

The results of this study can be published in core journals or international scientific conferences, and the primary investigators who make significant contributions to the implementation and management of this study and the personnel who makes great contributions to the design, interpretation or analysis of this study (such as the staffs or consultants of the sponsor) can have their authorship attribution. The sponsor promises to provide the manuscript to the investigator for review before publication of any result of the study. Investigators have to obtain the approval of the sponsor before submitting academic articles or abstracts. The study personnel have the right to publish results of this study, however, the requirement of protecting confidential information must be met.

The confidential information is the property of the sponsor only, cannot be disclosed to others without the written approval of the sponsor, and cannot be used for other purposes.

• Supporting Materials: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Anemia; Anemia, Hemolytic; Anemia, Hemolytic, Autoimmune; Hemolysis; Hematologic Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases