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Clinical Trials in China / NCT05979051
Recruiting Phase 2/3

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

NCT05979051 · tracked via the Priya Life Science China tracker
Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Phase
Phase 2/3
Started
2023-11-16
Last updated
2025-12-04

Condition(s) studied

Eosinophilic Granulomatosis With Polyangiitis

Investigational drug(s) / intervention(s)

SHR-1703Mepolizumab Injection

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)

Trial sites (2)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT05979051 on ClinicalTrials.gov ↗ ← All trials in China