[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557230":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":11,"centralContacts":11,"locations":36,"responsibleParty":53,"collaborators":11,"id":55,"slug":11,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":11,"studyType":67,"phases":68,"briefSummary":71,"conditions":72,"keywords":11,"overallStatus":39,"whyStopped":11,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},{"fullName":5,"class":6},"ImmuneOnco Biopharmaceuticals (Shanghai) Inc.","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"IMC-002 + SOC","EXPERIMENTAL",null,[13],"Drug: IMC-002 + SOC",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo + SOC","PLACEBO_COMPARATOR",[18],"Drug: Placebo + SOC",{"label":20,"type":10,"description":11,"interventionNames":21},"IMM0306S + SOC",[22],"Drug: IMM0306S + SOC",[24,30,33],{"type":25,"name":9,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","intravenous injection of 0.8mg\u002Fkg、1.2mg\u002Fkg and1.6mg\u002Fkg",[9],[29],"IMM0306",{"type":25,"name":15,"description":31,"armGroupLabels":32,"otherNames":11},"intravenous or subcutaneous injection of Placebo",[15],{"type":25,"name":20,"description":34,"armGroupLabels":35,"otherNames":11},"subcutaneous injection of 2.0 mg\u002Fkg，4.0 mg\u002Fkg and 6.0mg\u002Fkg",[20],[37],{"facility":38,"status":39,"city":40,"state":11,"zip":11,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Peking University People's Hospital","RECRUITING","Beijing","China",{"type":43,"coordinates":44},"Point",[45,46],116.39723,39.9075,{"lat":46,"lon":45},[49],{"name":38,"role":50,"phone":51,"phoneExt":11,"email":52},"CONTACT","+86 010-88324516","pkuphiao@163.com",{"type":54,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100557230",false,"NCT06535412","A Study of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus","A Multi-center, Randomized, Double-blind, Placebo Control Phase 1b\u002FII Study to Evaluate the Safety and Efficacy of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Has had a diagnosis of SLE for at least 12 weeks prior to the screening Visit.\n* SLEDAI-2000 score ≥8. For screening eligibility only, headache and fever items shall be excluded from SLEDAI-2K scoring. Skin lesions shall meet morphological and distributive characteristics of active cutaneous lupus, with a total active Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) score ≥2.\n* BILAG-2004 organ system scores of at least 1 A or 2 B at screening.\n* Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and\u002For immunosuppressive agent.\n* Other protocol defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Active or unstable neuropsychiatric SLE or lupus nephritis\n* Autoimmune or rheumatic disease other than SLE\n* Significant, uncontrolled medical conditions not related to SLE\n* Active and\u002For severe viral, bacterial or fungal infection\n* History of malignancy within 5 years\n* Other protocol defined exclusion criteria may apply.","ALL","18 Years","65 Years",{"count":65,"type":66},218,"ESTIMATED","INTERVENTIONAL",[69,70],"PHASE1","PHASE2","The purpose of this study is to evaluate the efficacy and safety of IMC-002 and IMM0306S in the treatment of active SLE.",[73],"Systemic Lupus Erythematosus","2026-06-25",{"date":76,"type":77},"2026-06-29","ACTUAL",{"date":79,"type":77},"2024-10-10",{"date":81,"type":66},"2028-12-17",{"name":83,"class":6},"ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.",1]