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

Warm Antibody Autoimmune Hemolytic Anemia Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Hemolysis
Warm Antibody Autoimmune Hemolytic Anemia

Clinical Trial Details

NCT number	NCT05535933
Study type	Interventional
Source	Hutchmed
Contact
Status	Active, not recruiting
Phase	Phase 2/Phase 3
Start date	September 30, 2022
Completion date	November 2026

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT04138927` - A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia	Phase 3
Active, not recruiting	`NCT04657094` - Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia	Phase 2
Completed	`NCT02612558` - A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)	Phase 2
Completed	`NCT03764618` - A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA	Phase 3