NCT05029635

Phase III Study on HMPL-523 for Treatment of ITP

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HMPL-523 in Treatment of Primary Immune Thrombocytopenia (ITP) in Adults(ESLIM-01 Study)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 272 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether HMPL-523 (sovleplenib) is safe and effective in the treatment of chronic Immune Thrombocytopenic Purpura (ITP).

Detailed description

This is a randomized, double-blind, placebo-controlled phase III clinical trial in adult patients with primary immune thrombocytopenia to determine whether HMPL-523 (sovleplenib) is safe and effective in the treatment of chronic Immune Thrombocytopenic Purpura (ITP)

Conditions

• Primary Immune Thrombocytopenia (ITP)

Interventions

Type	Name	Description
DRUG	HMPL-523	HMPL-523 will be oral administrated once daily for 24 weeks
DRUG	Placebo	HMPL-523 matching placebo will be oral administrated once daily for 24 weeks .

Timeline

• Start date: 2021-10-27
• Primary completion: 2025-03-31
• Completion: 2025-05-30
• First posted: 2021-08-31
• Last updated: 2025-03-17

Locations

37 sites across 1 country: China