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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

About this trial

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

Eligibility criteria

Qualifiers

Male or female subjects age 18 years or older;

Diagnosed with EGPA for at least 6 months;

History of relapsing or refractory EGPA;

Stable dose of oral prednisone of ≥7.5 mg/day (but not >50 mg/day) for at least 4 weeks prior to randomization;

Disqualifiers

Subjects with other eosinophilic-related diseases;

Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).

Life-threatening EGPA within 3 months prior to randomization;

Malignancy history within 5 years prior to randomization;

Trial design

Treatments tested in this trial

  • SHR-1703
  • Mepolizumab Injection

Treatment groups

166 Participants
are divided into 2 treatment groups