[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557230":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":11,"centralContacts":11,"locations":36,"responsibleParty":54,"collaborators":11,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":11,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":11,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":11,"overallStatus":39,"whyStopped":11,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},{"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,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Peking University People's Hospital","RECRUITING","Beijing","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50],{"name":38,"role":51,"phone":52,"phoneExt":11,"email":53},"CONTACT","+86 010-88324516","pkuphiao@163.com",{"type":55,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100557230","phase-1-a-study-of-imc-002-for-the-treatment-of-active-systemic-lupus-erythematosus-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":67,"type":68},218,"ESTIMATED","INTERVENTIONAL",[71,72],"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.",[75],"Systemic Lupus Erythematosus","2026-06-25",{"date":78,"type":79},"2026-06-29","ACTUAL",{"date":81,"type":79},"2024-10-10",{"date":83,"type":68},"2028-12-17",{"name":85,"class":6},"ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.",1]