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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05535933
Recruitment Status : Not yet recruiting
First Posted : September 10, 2022
Last Update Posted : September 10, 2022
Sponsor:
Information provided by (Responsible Party):
Hutchmed ( Hutchison Medipharma Limited )

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

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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
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : November 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

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




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05535933


Contacts
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Contact: Angela Niu 18801196102 ext 86 angelan@hutch-med.com

Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
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Principal Investigator: Fengkui Zhang, professor offices director
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Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT05535933    
Other Study ID Numbers: 2022-523-00CH1
First Posted: September 10, 2022    Key Record Dates
Last Update Posted: September 10, 2022
Last Verified: September 2022
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)

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