[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647430":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":41,"collaborators":11,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":11,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":11,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":63,"whyStopped":11,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":11},{"fullName":5,"class":6},"Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.","INDUSTRY",[8,14,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"SSGJ-613 100 mg Q12W","EXPERIMENTAL",null,[13],"Drug: SSGJ-613 100 mg Q12W",{"label":15,"type":10,"description":11,"interventionNames":16},"SSGJ-613 200 mg Q12W",[17],"Drug: SSGJ-613 200 mg Q12W",{"label":19,"type":20,"description":11,"interventionNames":21},"Colchicine 0.5mg","ACTIVE_COMPARATOR",[22],"Drug: Colchicine 0.5 mg",{"label":24,"type":10,"description":11,"interventionNames":25},"SSGJ-613 100 mg Q4W",[26],"Drug: SSGJ-613 100 mg Q4W",[28,32,34,37],{"type":29,"name":9,"description":30,"armGroupLabels":31,"otherNames":11},"DRUG","Participants will receive one s.c. injection of SSGJ-613 on Day 1、W12",[9],{"type":29,"name":15,"description":30,"armGroupLabels":33,"otherNames":11},[15],{"type":29,"name":24,"description":35,"armGroupLabels":36,"otherNames":11},"Participants will receive one s.c. injection of SSGJ-613 on Day 1、W4、W8、W12",[24],{"type":29,"name":38,"description":39,"armGroupLabels":40,"otherNames":11},"Colchicine 0.5 mg","Participants will receive 0.5mg bid Colchicine for 24 weeks.",[19],{"type":42,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100647430","phase-2-a-study-of-ssgj-613-in-gout-participants-initiating-urate-lowering-treatment-100647430",false,"NCT07708181","A Study of SSGJ-613 in Gout Participants Initiating Urate-Lowering Treatment","A Phase 2, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Trial to Evaluate the Efficacy and Safety of SSGJ-613 for Prophylaxis Against Acute Gouty Arthritis Flares in Subjects Initiating Urate-Lowering Treatment.","Inclusion Criteria:\n\n* Must be 18 Years to 75 Years, both male and female.\n* BMI ≤40 kg\u002Fm2.\n* Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of gouty arthritis.\n* ≥4 acute gout flares within 1 year prior to screening\n\nExclusion Criteria:\n\n* Gout caused by radiotherapy\u002Fchemotherapy, organ transplantation, tumors, etc.\n* Evidence\u002Fsuspicion of infectious\u002Fseptic arthritis, or other acute inflammatory arthritis.\n* Presence of severe renal function impairment.\n* Intolerance of subcutaneous injection.\n* Known presence or suspicion of active or recurrent bacterial, fungal, or viral infection at the time of enrollment.\n* Live vaccinations within 8 weeks prior to the start of the study.\n* Use of forbidden therapy.","ALL","18 Years","75 Years",{"count":54,"type":55},200,"ESTIMATED","INTERVENTIONAL",[58],"PHASE2","The purpose of this study is to determine the efficacy and safety of recombinant anti-interleukin-1β humanized monoclonal antibody injection in Chinese gout participants Initiating Urate-Lowering Treatment",[61],"Gout Arthritis",[61],"NOT_YET_RECRUITING","2026-07-16",{"date":66,"type":67},"2026-07-20","ACTUAL",{"date":69,"type":55},"2026-08-02",{"date":71,"type":55},"2028-04-19",{"name":5,"class":6}]