Last updated: December 8, 2023
Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Overall Status: Active - Recruiting
Phase
2/3
Condition
Collagen Vascular Diseases
Connective Tissue Diseases
Treatment
SHR-1703
SHR-1703 Placebo
Clinical Study ID
NCT05979051
SHR-1703-301
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 or alemtuzumab used within 12 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 to screening;
- 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 mabs orother biological agents;
- Other conditions unsuitable for participation in the study per investigator judgement.
Study Design
Total Participants: 112
Treatment Group(s): 2
Primary Treatment: SHR-1703
Phase: 2/3
Study Start date:
November 16, 2023
Estimated Completion Date:
May 16, 2027
Connect with a study center
Beijing Hospital
Beijing, Beijing 100730
ChinaActive - Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang 310009
ChinaActive - Recruiting
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