Status:
RECRUITING
A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）
Lead Sponsor:
Guangdong Hengrui Pharmaceutical Co., Ltd
Conditions:
Eosinophilic Granulomatosis With Polyangiitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
November 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT05979051
Start Date
November 16 2023
End Date
December 1 2028
Last Update
December 4 2025
Active Locations (2)
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1
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
2
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009