[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610604":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":57,"collaborators":11,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":11,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":11,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Guangdong Hengrui Pharmaceutical Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR-2173 Injection Group","EXPERIMENTAL",null,[13],"Drug: SHR-2173 Injection",{"label":15,"type":16,"description":11,"interventionNames":17},"SHR-2173 Injection Placebo Group","PLACEBO_COMPARATOR",[18],"Drug: SHR-2173 Injection Blank Preparation",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","SHR-2173 Injection","SHR-2173 injection.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"SHR-2173 Injection Blank Preparation","SHR-2173 injection blank preparation.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Su Zhang","CONTACT","+86-0518-82342973","su.zhang.sz3@hengrui.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"The General Hospital of the Eastern Theater Command of the People's Liberation Army of China","RECRUITING","Nanjing","Jiangsu","210002","China","CN",{"type":45,"coordinates":46},"Point",[47,48],118.77778,32.06167,{"lat":48,"lon":47},[51,55],{"name":52,"role":32,"phone":53,"phoneExt":11,"email":54},"Zhihong Liu","+86-025-80862022","zhliunj@vip.163.com",{"name":52,"role":56,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":58,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100610604","phase-2-a-phase-ii-clinical-study-on-the-efficacy-and-safety-of-shr-2173-injection-in-the-treatment-of-patients-with-active-lupus-nephritis-100610604",false,"NCT07229742","A Phase II Clinical Study on the Efficacy and Safety of SHR-2173 Injection in the Treatment of Patients With Active Lupus Nephritis","A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-2173 Injection in Patients With Active Lupus Nephritis","Inclusion Criteria:\n\n1. Age 18-70 years (inclusive) at informed consent signing, regardless of sex;\n2. Body weight ≥ 40.0 kg and body mass index (BMI) ≥ 16 kg\u002Fm² to ≤ 28 kg\u002Fm² at screening;\n3. Diagnosed with systemic lupus erythematosus (SLE) per 1997 ACR criteria or 2019 EULAR\u002FACR classification criteria;\n4. Positive antinuclear antibody (titer ≥ 1:80) and\u002For anti-dsDNA antibody and\u002For anti-Sm antibody at screening;\n5. Histologically confirmed active lupus nephritis (LN) class III or IV ± class V by renal biopsy, per 2018 International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) standards within 1 year preceding or during screening.\n\nExclusion Criteria:\n\n1. Received renal dialysis within 12 months preceding screening, or anticipated requirement for dialysis\u002Frenal transplantation within 6 months post-enrollment;\n2. Renal biopsy demonstrating \\> 50% globally sclerosed glomeruli;\n3. Active severe\u002Funstable neuropsychiatric SLE (NPSLE);\n4. Catastrophic antiphospholipid syndrome (APS) within 12 months pre-screening, or APS-related thrombotic events (except non-catastrophic\u002Fmild APS cases with stable anticoagulation ≥12 weeks prior to screening);\n5. Non-LN renal diseases potentially confounding disease assessment (e.g., diabetic nephropathy per investigator judgment);\n6. Inflammatory\u002Fautoimmune diseases beyond SLE\u002FLN that may interfere with efficacy\u002Fsafety interpretation.","ALL","18 Years","70 Years",{"count":70,"type":71},51,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","The study is a Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in patients with lupus nephritis (LN). It adopts a randomized, double-blind, placebo-controlled, multicenter trial design.",[77],"Active Lupus Nephritis","2025-11-28",{"date":80,"type":81},"2025-12-01","ACTUAL",{"date":83,"type":81},"2025-11-22",{"date":85,"type":71},"2028-03",{"name":5,"class":6},1]