Actively Recruiting
A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2025-12-04
166
Participants Needed
2
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 67.5 mg/day (but not >50 mg/day) for at least 4 weeks prior to randomization
- Stable dose of immunosuppressive therapy (excluding cyclophosphamide) within 4 weeks prior to randomization and during the study
You will not qualify if you...
- 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
- Oral prednisone dose >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
- Participation in another clinical study with active drug within 30 days or 5 half-lives of the drug prior to screening
- Pregnant, lactating, or planning to be pregnant
- Known hypersensitivity or intolerance to anti-IL-5 monoclonal antibodies or other biological agents or previous failure of IL-5/IL-5R therapy
- Other conditions unsuitable for participation per investigator judgement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
2
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
S
Siai Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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