Tests SHR-1703 against mepolizumab in adults with eosinophilic granulomatosis with polyangiitis
Tests SHR-1703 compared with mepolizumab in adults with eosinophilic granulomatosis with polyangiitis.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）
Key facts
- Where
- Beijing and Hangzhou, ChinaSee the 2 sites
- Phase
- Phase 2/3
Where in China
- Beijing HospitalBeijing, ChinaTaking people
- The Second Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Trial code
- NCT05979051
- Record updated
- 4 December 2025
- Original description
This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.Read full original descriptionShow less
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
This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.
Inclusion: 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; If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage must be stable within 4 weeks prior to randomization and during the study.
Exclusion: Life-threatening EGPA within 3 months prior to randomization; Malignancy history within 5 years prior to randomization; parasitic infection within 6 months prior to randomization; Active infectious disease requiring clinical treatment within 4 weeks prior to randomization; Subjects with a dose of oral prednisone of >50 mg/day within 4 weeks prior to randomization; Oral or intravenous cyclophosphamide therapy within 4 weeks prior to randomization; Intravenous or subcutaneous immunoglobulin within 12 weeks prior to randomization; Biological agents or TH2 cytokine inhibitors used within 12 weeks prior to randomization or within 5 half-lives of the drug; Rituximab used within 6 months prior to randomization；; Surgical plans that might affect the evaluation; History of drug or substance abuse or alcohol abuse within 1 year prior to screening; Subjects participated another clinical study and received active drug within 30 days or 5 half-lives of the drug prior to screening; Subjects have a known history of hypersensitivity or intolerance to anti-IL-5 mabs or other biological agents or previous failure of IL-5/IL-5R therapy; Subjects with other eosinophilic-related diseases; Uncontrolled hypertension；; Uncontrolled cerebrovascular and cardiovascular disease; Other conditions unsuitable for participation in the study per investigator judgement; Significant laboratory abnormalities；; Prolonged QTc interval or other electrocardiogram abnormalities with significant safety risk at screening; Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA); Immunodeficiency; Subjects is pregnant, lactating, or planning to be pregnant.