Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 1:36 PM
Study NCT ID:
NCT05979051
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2023-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015267', 'term': 'Churg-Strauss Syndrome'}], 'ancestors': [{'id': 'D056648', 'term': 'Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis'}, {'id': 'D056647', 'term': 'Systemic Vasculitis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006099', 'term': 'Granuloma'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C434107', 'term': 'mepolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A single-arm/randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 clinical study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 166}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2023-07-30', 'studyFirstSubmitQcDate': '2023-07-30', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in oral glucocorticoid dose (OCS)', 'timeFrame': 'Up to week 12', 'description': 'Phase 2'}, {'measure': 'The Proportion of subjects in EGPA remission', 'timeFrame': 'week 36 and week 48', 'description': 'Phase 3'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in oral glucocorticoid dose', 'timeFrame': 'Up to week 24, week 48', 'description': 'Effectiveness Indicators (Phase 2)'}, {'measure': 'The proportion of subjects with OCS dosage ≤5 mg/d', 'timeFrame': 'week 12, week 24, week 48', 'description': 'Effectiveness Indicators (Phase 2)'}, {'measure': 'The proportion of subjects with at least 50% reduction of OCS dosage from baseline', 'timeFrame': 'week 12, week 24, week 48', 'description': 'Effectiveness Indicators (Phase 2)'}, {'measure': 'The Proportion of subjects with EULAR remission', 'timeFrame': 'week 12, week 24, week 48', 'description': 'Effectiveness Indicators (Phase 2)'}, {'measure': 'The Proportion of subjects achieving EULAR remission at week 12 and week 24 of treatment and maintaining it up to week 48', 'timeFrame': 'week 12, week 24, week 48', 'description': 'Effectiveness Indicators (Phase 2)'}, {'measure': 'The Proportion of subjects with EGPA remission', 'timeFrame': 'week 24, week 48', 'description': 'Effectiveness Indicators (Phase 2)'}, {'measure': 'The proportion of subjects achieving EGPA remission within 24 weeks of treatment and maintaining it up to week 48', 'timeFrame': 'week 24, week 48', 'description': 'Effectiveness Indicators (Phase 2)'}, {'measure': 'The proportion of subjects with EGPA relapse', 'timeFrame': 'week 12, week 24, week 48', 'description': 'Effectiveness Indicators (Phase 2)'}, {'measure': 'The time to the first relapse of EGPA', 'timeFrame': 'Up to week 48', 'description': 'Effectiveness Indicators (Phase 2)'}, {'measure': 'The proportion of subjects with Severe relapse of EGPA', 'timeFrame': 'week 12, week 24, week 48', 'description': 'Effectiveness Indicators (Phase 2)'}, {'measure': 'The time of the first Severe relapse of EGPA', 'timeFrame': 'Up to week 48', 'description': 'Effectiveness Indicators (Phase 2)'}, {'measure': 'Changes from baseline in Pre- and post-Bronchodilator FEV1', 'timeFrame': 'Up to week 48', 'description': 'Effectiveness Indicators (Phase 2)'}, {'measure': 'The Proportion of subjects with EULAR remission', 'timeFrame': 'week 36, week 48', 'description': 'Effectiveness Indicators (Phase 3)'}, {'measure': 'The Proportion of subjects with EGPA remission', 'timeFrame': 'week 36, week 48', 'description': 'Effectiveness Indicators (Phase 3)'}, {'measure': 'The Proportion of subjects achieving EULAR remission within 24 weeks of treatment and maintaining it up to week 48', 'timeFrame': 'week 24, week 48', 'description': 'Effectiveness Indicators (Phase 3)'}, {'measure': 'The proportion of subjects achieving EGPA remission within 24 weeks of treatment and maintaining it up to week 48', 'timeFrame': 'week 24, week 48', 'description': 'Effectiveness Indicators (Phase 3)'}, {'measure': 'Cumulative weeks of EGPA remission through week 48, categorized as 0 weeks; >0 to <12 weeks; 12 to <24 weeks; 24 to <36 weeks; or ≥36 weeks', 'timeFrame': 'week 0, week 12, week 24, week 36, week 48', 'description': 'Effectiveness Indicators (Phase 3)'}, {'measure': 'Change from baseline in OCS', 'timeFrame': 'Week 24, Week 48', 'description': 'Effectiveness indicators (Phase 3)'}, {'measure': 'The proportion of subjects with OCS dosage ≤5 mg/d', 'timeFrame': 'week 24, week 48', 'description': 'Effectiveness indicators (Phase 3)'}, {'measure': 'The proportion of subjects with at least 50% reduction of OCS dosage from baseline', 'timeFrame': 'week 24, week 48', 'description': 'Effectiveness indicators (Phase 3)'}, {'measure': 'The Proportion of subjects with EGPA relapse', 'timeFrame': 'week 24, week 48', 'description': 'Effectiveness indicators (Phase 3)'}, {'measure': 'The Proportion of subjects with Severe relapse of EGPA', 'timeFrame': 'week 24, week 48', 'description': 'Effectiveness indicators (Phase 3)'}, {'measure': 'The time to the first relapse of EGPA', 'timeFrame': 'Up to week 48', 'description': 'Effectiveness indicators (Phase 3)'}, {'measure': 'The time of the first Severe relapse occurred of EGPA', 'timeFrame': 'Up to week 48', 'description': 'Effectiveness indicators (Phase 3)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eosinophilic Granulomatosis With Polyangiitis']}, 'descriptionModule': {'briefSummary': 'This study is a phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/day (but not \\>50 mg/day) 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/day 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/IL-5R therapy;\n22. Other conditions unsuitable for participation in the study per investigator judgement.'}, 'identificationModule': {'nctId': 'NCT05979051', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangdong Hengrui Pharmaceutical Co., Ltd'}, 'officialTitle': 'A Multicenter, Single-arm/Randomized, Double-blind, Active-controlled, Parallel-group Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR-1703 for Patients With EGPA', 'orgStudyIdInfo': {'id': 'SHR-1703-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group A', 'description': 'SHR-1703', 'interventionNames': ['Drug: SHR-1703']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mepolizumab Injection', 'description': 'SHR-1703 Placebo', 'interventionNames': ['Drug: Mepolizumab Injection']}], 'interventions': [{'name': 'SHR-1703', 'type': 'DRUG', 'description': 'SHR-1703 will be administered by Subcutaneous injection in Phase 2 and Phase 3.', 'armGroupLabels': ['Treatment group A']}, {'name': 'Mepolizumab Injection', 'type': 'DRUG', 'description': 'Mepolizumab Injection and Matching Placebo will be administered by Subcutaneous injection in Phase 3', 'armGroupLabels': ['Mepolizumab Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuan Zhang, Doctor', 'role': 'CONTACT', 'email': 'zxlab@outlook.com', 'phone': '010-85132266'}], 'facility': 'Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huahao Shen, Doctor', 'role': 'CONTACT', 'email': 'huahaoshen@163.com', 'phone': '0571-87783777'}], 'facility': 'The Second Affiliated Hospital Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Siai Sun', 'role': 'CONTACT', 'email': 'siai.sun@hengrui.com', 'phone': '0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong Hengrui Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}