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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Warm Antibody Autoimmune Hemolytic Anemia
• Intervention / Treatment: Drug: Placebo; Drug: HMPL-523(300mg PO QD)

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 Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Angela Niu; Phone Number: 86 18801196102; Email: angelan@hutch-med.com

Study Locations

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

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hutchison Medipharma Limited
• Investigators: Principal Investigator: Fengkui Zhang, professor, offices director

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 9, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Anemia; Hemolysis; Anemia, Hemolytic; Anemia, Hemolytic, Autoimmune
• Other Study ID Numbers: 2022-523-00CH1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• 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