A Multicenter, Single-arm/Randomized, Double-blind, Active-controlled, Parallel-group Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR-1703 for Patients With EGPA

NCT05979051 Phase 2/Phase 3 RECRUITING

This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.

Details

Lead sponsor	Guangdong Hengrui Pharmaceutical Co., Ltd
Phase	Phase 2/Phase 3
Status	RECRUITING
Enrolment	166
Start date	2023-11-16
Completion	2028-12

Conditions

• Eosinophilic Granulomatosis With Polyangiitis

Interventions

• SHR-1703
• Mepolizumab Injection

Primary outcomes

• Change from baseline in oral glucocorticoid dose (OCS) — Up to week 12
  Phase 2
• The Proportion of subjects in EGPA remission — week 36 and week 48
  Phase 3

Countries

China