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

HUTCHMED

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Warm Antibody Autoimmune Hemolytic Anemia

Treatments: Drug: Placebo; Drug: HMPL-523(300mg PO QD)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05535933

2022-523-00CH1

Details and patient eligibility

About

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

Full 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

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups, including a placebo group

HMPL-523

Experimental group

Description:

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.

Treatment:

Drug: HMPL-523(300mg PO QD)

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo