[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514480":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":70,"collaborators":25,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":25,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":25,"enrollmentInfo":81,"targetDuration":25,"studyType":84,"phases":85,"briefSummary":88,"conditions":89,"keywords":25,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Guangdong Hengrui Pharmaceutical Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group A","EXPERIMENTAL","SHR-1703",[13],"Drug: SHR-1703",{"label":15,"type":16,"description":17,"interventionNames":18},"Mepolizumab Injection","ACTIVE_COMPARATOR","SHR-1703 Placebo",[19],"Drug: Mepolizumab Injection",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","SHR-1703 will be administered by Subcutaneous injection in Phase 2 and Phase 3.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Mepolizumab Injection and Matching Placebo will be administered by Subcutaneous injection in Phase 3",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Siai Sun","CONTACT","0518-82342973","siai.sun@hengrui.com",[36,55],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Beijing Hospital","RECRUITING","Beijing","Beijing Municipality","100730","China","CN",{"type":45,"coordinates":46},"Point",[47,48],116.39723,39.9075,{"lat":48,"lon":47},[51],{"name":52,"role":32,"phone":53,"phoneExt":25,"email":54},"Xuan Zhang, Doctor","010-85132266","zxlab@outlook.com",{"facility":56,"status":38,"city":57,"state":58,"zip":59,"country":42,"countryCode":43,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"The Second Affiliated Hospital Zhejiang University School of Medicine","Hangzhou","Zhejiang","310009",{"type":45,"coordinates":61},[62,63],120.16142,30.29365,{"lat":63,"lon":62},[66],{"name":67,"role":32,"phone":68,"phoneExt":25,"email":69},"Huahao Shen, Doctor","0571-87783777","huahaoshen@163.com",{"type":71,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100514480","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-shr-1703-in-subjects-with-eosinophilic-granulomatosis-with-polyangiitis-egpa-100514480",false,"NCT05979051","A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）","A Multicenter, Single-arm\u002FRandomized, Double-blind, Active-controlled, Parallel-group Phase 2\u002F3 Clinical Study to Evaluate the Efficacy and Safety of SHR-1703 for Patients With EGPA","Inclusion Criteria:\n\n1. Male or female subjects age 18 years or older;\n2. Diagnosed with EGPA for at least 6 months;\n3. History of relapsing or refractory EGPA；\n4. Stable dose of oral prednisone of ≥7.5 mg\u002Fday (but not \\>50 mg\u002Fday) for at least 4 weeks prior to randomization;\n5. If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage must be stable within 4 weeks prior to randomization and during the study.\n\nExclusion Criteria:\n\n1. Subjects with other eosinophilic-related diseases;\n2. Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).\n3. Life-threatening EGPA within 3 months prior to randomization;\n4. Malignancy history within 5 years prior to randomization;\n5. Immunodeficiency;\n6. Uncontrolled hypertension；\n7. Uncontrolled cerebrovascular and cardiovascular disease;\n8. parasitic infection within 6 months prior to randomization;\n9. Active infectious disease requiring clinical treatment within 4 weeks prior to randomization;\n10. Subjects with a dose of oral prednisone of \\>50 mg\u002Fday within 4 weeks prior to randomization;\n11. Oral or intravenous cyclophosphamide therapy within 4 weeks prior to randomization;\n12. Intravenous or subcutaneous immunoglobulin within 12 weeks prior to randomization;\n13. Biological agents or TH2 cytokine inhibitors used within 12 weeks prior to randomization or within 5 half-lives of the drug;\n14. Rituximab used within 6 months prior to randomization；\n15. Surgical plans that might affect the evaluation;\n16. Significant laboratory abnormalities；\n17. Prolonged QTc interval or other electrocardiogram abnormalities with significant safety risk at screening;\n18. History of drug or substance abuse or alcohol abuse within 1 year prior to screening;\n19. Subjects participated another clinical study and received active drug within 30 days or 5 half-lives of the drug prior to screening;\n20. Subjects is pregnant, lactating, or planning to be pregnant;\n21. Subjects have a known history of hypersensitivity or intolerance to anti-IL-5 mabs or other biological agents or previous failure of IL-5\u002FIL-5R therapy;\n22. Other conditions unsuitable for participation in the study per investigator judgement.","ALL","18 Years",{"count":82,"type":83},166,"ESTIMATED","INTERVENTIONAL",[86,87],"PHASE2","PHASE3","This study is a phase 2\u002F3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.",[90],"Eosinophilic Granulomatosis With Polyangiitis","2025-11-26",{"date":93,"type":94},"2025-12-04","ACTUAL",{"date":96,"type":94},"2023-11-16",{"date":98,"type":83},"2028-12",{"name":5,"class":6},2]