RecruitingPhase 2Phase 3NCT05979051

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

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

Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Enrollment

166 participants

Start Date

Nov 16, 2023

Study Type

INTERVENTIONAL

Conditions

Eosinophilic Granulomatosis With Polyangiitis

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria22

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;
Immunodeficiency;
Uncontrolled hypertension；
Uncontrolled cerebrovascular and cardiovascular disease;
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;
Significant laboratory abnormalities；
Prolonged QTc interval or other electrocardiogram abnormalities with significant safety risk at screening;
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 is pregnant, lactating, or planning to be pregnant;
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;
Other conditions unsuitable for participation in the study per investigator judgement.