Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-01-26 @ 9:29 AM
Study NCT ID:
NCT05936268
Status:
COMPLETED
Last Update Posted:
2024-11-08
First Post:
2023-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D003078', 'term': 'Colchicine'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Acute gout patients with gout flare Group A: Genakumab 200mg single injection;Group B: Etoricorxib 120mg qd po.(until remission or intorlerance, no longer than 8 days)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-06', 'studyFirstSubmitDate': '2023-06-30', 'studyFirstSubmitQcDate': '2023-06-30', 'lastUpdatePostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '72hours target joint VAS change from baseline', 'timeFrame': '72h±2h', 'description': '72hours target joint VAS change from baseline'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '6hours, 24hours, 48hours, 72hours, Day 8,', 'description': 'target joint VAS Target joint VAS change from baseline Time to first VAS\\<=50% baseline VAS Time to first VAS\\<=30mm Time to first VAS\\<=10mm'}, {'measure': 'Recurrence of flare', 'timeFrame': '12 weeks after the last dose', 'description': 'Proportion of patients who have at least 1 flare Time to first flare'}, {'measure': 'Safety outcome', 'timeFrame': '12weeks', 'description': 'AE, laboratory examination, ECG, vital signs and physical examination'}, {'measure': 'immunogenic outcome', 'timeFrame': '12 weeks after the last dose', 'description': 'The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute gout', 'Gout flare'], 'conditions': ['Acute Gout', 'Gout Flare']}, 'referencesModule': {'references': [{'pmid': '40833487', 'type': 'DERIVED', 'citation': 'Kong N, Xue Y, Mao L, Qian L, Guo H, Hu J, Yuan F, Li R, Duan X, Yu J, Gou W, Yang L, Wei H, Li R, Xu Q, Luo T, Zhang X, Zou H. Efficacy and Safety of Firsekibart Compared to Etoricoxib for Gout Flares: A Phase 2, Multicenter, Open-label, Active-controlled, Randomized Non-inferiority Trial. Rheumatol Ther. 2025 Oct;12(5):975-990. doi: 10.1007/s40744-025-00790-6. Epub 2025 Aug 20.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of Genakumab for Injection in patients with gout flare as a first line therapy', 'detailedDescription': 'Phase 2， randomized, open lable, multi-center, active controlled study. Patients are randomized to Genakumab 200mg single injection group or Etoricorxib 120mg qd po.(until remission or intorlerance, no longer than 8 days) group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Male or female, 18 years ≤ age ≤ 75 years;\n2. BMI ≤ 40kg/m2\n3. Meeting ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout;\n4. Start of acute gout flare within 3 days prior to enrolled;\n5. History of ≥2 gout flare within 12 months prior to study start;\n6. Baseline pain intensity ≥ 50mm on the 0-100mm visual analog scale(VAS)'}, 'identificationModule': {'nctId': 'NCT05936268', 'acronym': 'Gensci 048-203', 'briefTitle': 'Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare', 'organization': {'class': 'INDUSTRY', 'fullName': 'Changchun GeneScience Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Randomized, Open Lable, Multi-center, Active Competitor Phase 2 Study for Evaluating Efficacy and Safety of Genakumab for Injection as First Line Therapy in Patients With Gout Flare', 'orgStudyIdInfo': {'id': 'GenSci048-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Genacumab group', 'description': 'Genakumab 200mg single injection', 'interventionNames': ['Drug: Genakumab for injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'cholchicine group', 'description': 'Colchicine 0.5mg qd po.for 12 weeks', 'interventionNames': ['Drug: Colchicine']}], 'interventions': [{'name': 'Genakumab for injection', 'type': 'DRUG', 'description': '150 mg/1ml/bottle', 'armGroupLabels': ['Genacumab group']}, {'name': 'Colchicine', 'type': 'DRUG', 'description': '0.5mg/table', 'armGroupLabels': ['cholchicine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan University Affiliated Huashan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Hejian Zou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University Affiliated Huashan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changchun GeneScience Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Huashan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}