[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606413":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":11,"studyPopulation":11,"armGroups":24,"interventions":41,"overallOfficials":11,"centralContacts":51,"locations":57,"responsibleParty":87,"collaborators":11,"id":89,"slug":11,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":11,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":11,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":11,"overallStatus":107,"whyStopped":11,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Jiangsu Simcere Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Percent change from baseline in Eczema Area and Severity Index (EASI) score at Week 16 (W16).",null,"At Week 16 (W16)",{"allocation":14,"interventionModel":15,"interventionModelDescription":11,"primaryPurpose":16,"observationalModel":11,"timePerspective":11,"maskingInfo":17},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":18,"maskingDescription":11,"whoMasked":19},"QUADRUPLE",[20,21,22,23],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[25,30,33,36],{"label":26,"type":27,"description":11,"interventionNames":28},"cohort 1- Low dose group","EXPERIMENTAL",[29],"Drug: SIM0278 injection",{"label":31,"type":27,"description":11,"interventionNames":32},"cohort 2-Medium dose group",[29],{"label":34,"type":27,"description":11,"interventionNames":35},"cohort 3-High dose group",[29],{"label":37,"type":38,"description":11,"interventionNames":39},"cohort 4- placebo group","PLACEBO_COMPARATOR",[40],"Other: Placebo",[42,46],{"type":43,"name":44,"description":44,"armGroupLabels":45,"otherNames":11},"DRUG","SIM0278 injection",[26,31,34],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":11},"OTHER","Placebo","placebo",[37],[52],{"name":53,"role":54,"phone":55,"phoneExt":11,"email":56},"Yi min Li","CONTACT","+8618021507113","liyimin@simcere.com",[58,74],{"facility":59,"status":11,"city":60,"state":11,"zip":11,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Affiliated Hangzhou First People's Hospital, School of Medicine , West Lake University","Hangzhou","China","CN",{"type":64,"coordinates":65},"Point",[66,67],120.16142,30.29365,{"lat":67,"lon":66},[70],{"name":71,"role":54,"phone":72,"phoneExt":11,"email":73},"Li Ming Wu","13750837205","18957118053@163.com",{"facility":75,"status":11,"city":76,"state":11,"zip":11,"country":61,"countryCode":62,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"The First Hospital of China Medical University","Shenyang",{"type":64,"coordinates":78},[79,80],123.43278,41.79222,{"lat":80,"lon":79},[83],{"name":84,"role":54,"phone":85,"phoneExt":11,"email":86},"Xing hua Gao","13940152467","gaobarry@hotmail.com",{"type":88,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100606413",false,"NCT07175233","A Phase 2 Study to Evaluate the Efficacy, Safety of SIM0278 in Subjects With Moderate to Severe Atopic Dermatitis","A Randomized, Double-blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SIM0278 in Subjects With Moderate to Severe Atopic Dermatitis","Inclusion Criteria:\n\n1. Atopic dermatitis was diagnosed at screening (according to the American Academy of Dermatology consensus criteria for atopic dermatitis, 2014);\n2. Use of a stable dose of emollients at least twice daily at sites of AD involvement starting at least 7 days prior to baseline;Alternatively, if the subject is using a prescribed emollients or moisturizers containing ceramide, urea, filaggrin degradation products, or hyaluronic acid prior to the Screening Visit, they may continue in the study but require a stable dose at least twice daily at the AD affected site starting at least 7 days prior to baseline;\n3. Female and male subjects are willing to use protocol-required contraception from the Screening Visit until at least 90 days after the last dose and do not plan to become pregnant or donate sperm\u002Feggs during this period.\n\nExclusion Criteria:\n\n1. The subject was in an acute exacerbation of AD at baseline (e.g., the subject had a tendency to rapidly develop erythroderma or erythroderma in a short period of time, whichever was judged by the investigator);\n2. Previous drug therapy with IL-2 or IL-2 analogues (including clinical studies);\n3. Use of other immunomodulatory biologics within 3 months prior to baseline or within 5 drug half-lives, whichever is longer, including, but not limited to, anti-IL-23 (e.g., guselkumab), anti-IL-12\u002F23 (e.g., ustekinumab), anti-IL-17 (e.g., secukinumab), or anti-IgE (e.g., omalizumab);\n4. Use of cell depleting agents (e.g. rituximab) within 6 months prior to baseline;\n5. Use of topical drugs for the treatment of AD or that may affect the assessment of the condition of AD within 2 weeks prior to baseline, including but not limited to TCS, TCI, phosphodiesterase-4 (PDE-4) inhibitors, Janus kinase (JAK) inhibitors, aromatic hydrocarbon receptor agonists, or Chinese herbal or herbal treatments, etc.;\n6. ≥ 2 bleaching baths per week within 2 weeks prior to baseline;\n7. Systemic treatment (except glucocorticoid inhalers and nasal sprays) with glucocorticoids or other immunosuppressive\u002Fimmunomodulatory drugs (e.g., cyclosporine, mycophenolate mofetil, azathioprine, methotrexate, or oral JAK inhibitors) within 8 weeks prior to baseline;\n8. Use of systemic Chinese herbal medicine within 4 weeks prior to baseline ;\n9. Phototherapy (narrow-band ultraviolet B (NBUVB), ultraviolet B (UVB), ultraviolet A (UVA), psoralen + ultraviolet A (PUVA)) tanning beds or any other phototherapy within 4 weeks prior to baseline;\n10. Use of any investigational drug\u002Ftherapy within 3 months or 5 drug half-lives (whichever is longer) prior to baseline;","ALL","18 Years","75 Years",{"count":99,"type":100},184,"ESTIMATED","INTERVENTIONAL",[103],"PHASE2","This is a randomized, double-blind, placebo-controlled multicenter clinical study to evaluate the efficacy, safety, and pharmacokinetics of SIM0278 in adult patients (18-75 years) with moderate to severe AD suitable for systemic therapy.\n\nApproximately 184 subjects with moderate to severe AD are planned to be randomized in a 1: 1: 1: 1 ratio to SIM0278 low dose, SIM0278 medium dose, SIM0278 high dose, or placebo. Subjects were stratified at randomization by baseline disease severity (moderate \\[IGA = 3\\] VS severe \\[IGA = 4\\]).\n\nThe study consisted of 4 phases: screening, double-blind induction, open-label maintenance, and safety follow-up.",[106],"Atopic Dermatitis (AD)","NOT_YET_RECRUITING","2025-09-18",{"date":110,"type":111},"2025-09-23","ACTUAL",{"date":113,"type":100},"2025-10-27",{"date":115,"type":100},"2027-08-20",{"name":5,"class":6},2]