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

NCT05535933 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2026-05-18

No results posted yet for this study

Summary

Phase II Study: To evaluate the safety and preliminary efficacy of HMPL-523 in adult patients with wAIHA.

Phase III Study(Part A): Confirmation of Efficacy safety and of HMPL-523 in adult patients with wAIHA.

Phase III Study (Part B): To further evaluate the long-term safety and tolerability of HMPL-523 in adult patients with wAIHA.

Conditions

  • Warm Antibody Autoimmune Hemolytic Anemia

Interventions

DRUG

HMPL-523(300mg PO QD)

HMPL-523(300mg PO QD)

DRUG

Placebo

Placebo(300mg PO QD)

Sponsors & Collaborators

  • Hutchmed

    lead INDUSTRY

Principal Investigators

  • Fengkui Zhang, professor · offices director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2025-11-25
Completion
2026-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05535933 on ClinicalTrials.gov