SHR-1703: SHR-1703 will be administered by Subcutaneous injection in Phase 2 and Phase 3.
Mepolizumab Injection: Mepolizumab Injection and Matching Placebo will be administered by Subcutaneous injection in Phase 3
Study summary
This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Male or female subjects age 18 years or older;
2. Diagnosed with EGPA for at least 6 months;
3. History of relapsing or refractory EGPA;
4. Stable dose of oral prednisone of ≥7.5 mg/day (but not \>50 mg/day) for at least 4 weeks prior to randomization;
5. If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage must be stable within 4 weeks prior to randomization and during the study.
Exclusion Criteria:
1. Subjects with other eosinophilic-related diseases;
2. Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
3. Life-threatening EGPA within 3 months prior to randomization;
4. Malignancy history within 5 years prior to randomization;
5. Immunodeficiency;
6. Uncontrolled hypertension;
7. Uncontrolled cerebrovascular and cardiovascular disease;
8. parasitic infection within 6 months prior to randomization;
9. Active infectious disease requiring clinical treatment within 4 weeks prior to randomization;
10. Subjects with a dose of oral prednisone of \>50 mg/day within 4 weeks prior to randomization;
11. Oral or intravenous cyclophosphamide therapy within 4 weeks prior to randomization;
12. Intravenous or subcutaneous immunoglobulin within 12 weeks prior to randomization;
13. Biological agents or TH2 cytokine inhibitors used within 12 weeks prior to randomization or within 5 half-lives of the drug;
14. Rituximab used within 6 months prior to randomization;
15. Surgical plans that might affect the evaluation;
16. Significant laboratory abnormalities;
17. Prolonged QTc interval or other electrocardiogram abnormalities with significant safety risk at screening;
18. History of drug or substance abuse or alcohol abuse within 1 year prior to screening;
19. Subjects participated another clinical study and received active drug within 30 days or 5 half-lives of the drug prior to screening;
20. Subjects is pregnant, lactating, or planning to be pregnant;
21. 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;
22. Other conditions unsuitable for participation in the study per investigator judgement.
Primary outcome measure(s)
Change from baseline in oral glucocorticoid dose (OCS) — Up to week 12 Phase 2
The Proportion of subjects in EGPA remission — week 36 and week 48 Phase 3
Trial sites (2)
Facility
City
Region
Status
Beijing Hospital
Beijing
Beijing Municipality
Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
Zhejiang
Recruiting
More Guangdong Hengrui Pharmaceutical Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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