Phase
Condition
Collagen Vascular Diseases
Connective Tissue Diseases
Treatment
SHR-1703
SHR-1703 Placebo
Mepolizumab Injection
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 4weeks prior to randomization;
If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage mustbe stable within 4 weeks prior to randomization and during the study.
Exclusion
Exclusion Criteria:
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 torandomization;
Subjects with a dose of oral prednisone of >50 mg/day within 4 weeks prior torandomization;
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 torandomization 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 significantsafety risk at screening;
History of drug or substance abuse or alcohol abuse within 1 year prior toscreening;
Subjects participated another clinical study and received active drug within 30 daysor 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 mabsor other biological agents or previous failure of IL-5/IL-5R therapy;
Other conditions unsuitable for participation in the study per investigatorjudgement.
Study Design
Connect with a study center
Beijing Hospital
Beijing, Beijing 100730
ChinaSite Not Available
Beijing Hospital
Beijing 1816670, Beijing Municipality 2038349 100730
ChinaActive - Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang 310009
ChinaSite Not Available
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou 1808926, Zhejiang 1784764 310009
ChinaActive - Recruiting

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