[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"active-lupus-nephritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:active-lupus-nephritis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"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":20,"type":21},51,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Active Lupus Nephritis","RECRUITING","2025-11-28",{"date":31,"type":32},"2025-12-01","ACTUAL",{"date":34,"type":32},"2025-11-22",{"date":36,"type":21},"2028-03",{"name":38,"class":39},"Guangdong Hengrui Pharmaceutical Co., Ltd","INDUSTRY"]