Phase 23 Study to Test the Safety and Effectiveness of SHR-1703 Injection in Adults With Eosinophilic Granulomatosis With Polyangiitis EGPA

What this Trial Is About

Researchers are evaluating the efficacy and safety of SHR-1703 in patients with Eosinophilic Granulomatosis with Polyangiitis EGPA, a condition characterized by inflammation of blood vessels. This phase 23 clinical trial aims to understand how well SHR-1703 works compared to other treatments, with a focus on improving patient outcomes and reducing the need for oral glucocorticoids. The study is sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd and includes patients diagnosed with EGPA for at least six months who have a history of relapsing or refractory disease. Participants will receive SHR-1703 via subcutaneous injection during both phase 2 and phase 3 of the trial. In phase 3, some participants may also receive Mepolizumab Injection or its matching placebo, also administered subcutaneously. The study design includes randomized allocation to treatment groups, with monitoring at various time points up to 48 weeks. The trial measures changes in oral glucocorticoid doses and the proportion of subjects achieving remission of EGPA, among other outcomes. During the study, participants will be regularly assessed for their oral glucocorticoid use, disease remission status, lung function through FEV1 measurements, and relapse occurrences. These evaluations occur at weeks 12, 24, 36, and 48. Researchers will track safety through clinical and laboratory tests, and participants health status will be monitored throughout the trial. The total study duration extends up to 48 weeks for each participant, with detailed follow-up on disease activity and treatment effects.

A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）