[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606413":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":11,"centralContacts":35,"locations":41,"responsibleParty":71,"collaborators":11,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":11,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":11,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":11,"overallStatus":92,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Jiangsu Simcere Pharmaceutical Co., Ltd.","INDUSTRY",[8,14,17,20],{"label":9,"type":10,"description":11,"interventionNames":12},"cohort 1- Low dose group","EXPERIMENTAL",null,[13],"Drug: SIM0278 injection",{"label":15,"type":10,"description":11,"interventionNames":16},"cohort 2-Medium dose group",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"cohort 3-High dose group",[13],{"label":21,"type":22,"description":11,"interventionNames":23},"cohort 4- placebo group","PLACEBO_COMPARATOR",[24],"Other: Placebo",[26,30],{"type":27,"name":28,"description":28,"armGroupLabels":29,"otherNames":11},"DRUG","SIM0278 injection",[9,15,18],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"OTHER","Placebo","placebo",[21],[36],{"name":37,"role":38,"phone":39,"phoneExt":11,"email":40},"Yi min Li","CONTACT","+8618021507113","liyimin@simcere.com",[42,58],{"facility":43,"status":11,"city":44,"state":11,"zip":11,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Affiliated Hangzhou First People's Hospital, School of Medicine , West Lake University","Hangzhou","China","CN",{"type":48,"coordinates":49},"Point",[50,51],120.16142,30.29365,{"lat":51,"lon":50},[54],{"name":55,"role":38,"phone":56,"phoneExt":11,"email":57},"Li Ming Wu","13750837205","18957118053@163.com",{"facility":59,"status":11,"city":60,"state":11,"zip":11,"country":45,"countryCode":46,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"The First Hospital of China Medical University","Shenyang",{"type":48,"coordinates":62},[63,64],123.43278,41.79222,{"lat":64,"lon":63},[67],{"name":68,"role":38,"phone":69,"phoneExt":11,"email":70},"Xing hua Gao","13940152467","gaobarry@hotmail.com",{"type":72,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100606413","phase-2-a-phase-2-study-to-evaluate-the-efficacy-safety-of-sim0278-in-subjects-with-moderate-to-severe-atopic-dermatitis-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":84,"type":85},184,"ESTIMATED","INTERVENTIONAL",[88],"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.",[91],"Atopic Dermatitis (AD)","NOT_YET_RECRUITING","2025-09-18",{"date":95,"type":96},"2025-09-23","ACTUAL",{"date":98,"type":85},"2025-10-27",{"date":100,"type":85},"2027-08-20",{"name":5,"class":6},2]