Trials / Active Not Recruiting
Active Not RecruitingNCT05535933
HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
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
- Status
- Active Not Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- Sponsor
- Hutchison Medipharma Limited · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HMPL-523(300mg PO QD) | HMPL-523(300mg PO QD) |
| DRUG | Placebo | Placebo(300mg PO QD) |
Timeline
- Start date
- 2022-09-30
- Primary completion
- 2025-11-25
- Completion
- 2026-11-01
- First posted
- 2022-09-10
- Last updated
- 2026-03-10
Locations
39 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05535933. Inclusion in this directory is not an endorsement.