[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589575":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":25,"interventions":36,"overallOfficials":46,"centralContacts":51,"locations":57,"responsibleParty":69,"collaborators":13,"id":71,"slug":13,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":13,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":13,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":13,"overallStatus":89,"whyStopped":13,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Keymed Biosciences Co.Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of subjects achieving Eczema Area and Severity Index(EASI-75) at week 18","The EASI is a composite index with scores ranging from 0 to 72. Four Atopic Dermatitis(AD) disease characteristics (erythema, edema\u002Fpapulation, excoriation, lichenification) will each be assessed for severity by the investigator on a scale of \"0\" (none) through \"3\" (severe).","Up to week 18",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":20},"QUADRUPLE",[21,22,23,24],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[26,31],{"label":27,"type":28,"description":13,"interventionNames":29},"Stapokibatrt group","EXPERIMENTAL",[30],"Biological: Stapokibatrt",{"label":32,"type":33,"description":13,"interventionNames":34},"Placebo","PLACEBO_COMPARATOR",[35],"Other: Placebo",[37,42],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":13},"BIOLOGICAL","Stapokibatrt","Stapokibatrt 1 or 2 ml,Subcutaneous injection(SC)",[27],{"type":43,"name":32,"description":44,"armGroupLabels":45,"otherNames":13},"OTHER","Placebo of matching volume，Subcutaneous injection(SC)",[32],[47],{"name":48,"affiliation":49,"role":50},"Lin Ma","Beijing Children's Hospital","PRINCIPAL_INVESTIGATOR",[52],{"name":53,"role":54,"phone":55,"phoneExt":13,"email":56},"Qian Jia","CONTACT","028-88610620","qianjia@keymedbio.com",[58],{"facility":59,"status":13,"city":60,"state":13,"zip":13,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":13},"Beijing Children's Hospital Capital Medical University","Beijing","China","CN",{"type":64,"coordinates":65},"Point",[66,67],116.39723,39.9075,{"lat":67,"lon":66},{"type":70,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100589575",false,"NCT06956196","Study of Stapokibatrt in Children Subjects With Atopic Dermatitis","A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Stapokibatrt in Children With Moderate-to-severe Atopic Dermatitis","Inclusion Criteria:\n\n* Age ≥ 2 and ≤ 11 years old.\n* Diagnosis of AD according to the American Academy of Dermatology Consensus (2014) Criteria.\n* With moderate-to-severe AD, and inadequate response to topical medications.\n\nExclusion Criteria:\n\n* Prior treatment with Stapokibart\n* Treatment with dupilumab within 13 weeks prior to the baseline visit, or treatment with anti-IgE(Immunoglobulin E) monoclonal antibody，other biological agents within 5 half-lives prior to the baseline visit .\n* Treatment with immunosuppressants\u002Fimmunomodulatory drugs, ultraviolet therapy, or systemic traditional Chinese medicine for AD within 4 weeks prior to the baseline visit.\n* Treatment with a topical corticosteroids (TCS), topical calcineurin inhibitor (TCI) or topical Phosphodiesterase-4(PDE-4) inhibitor within 1 weeks prior to the baseline visit.\n* History of atopic keratoconjunctivitis invading cornea.\n* Acute attacks of Atopic Dermatitis within 4 weeks prior to the baseline visit.\n* Planned major surgical procedure during the patient's participation in this study.","ALL","2 Years","11 Years",{"count":81,"type":82},240,"ESTIMATED","INTERVENTIONAL",[85],"PHASE3","This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, Pharmacokinetics(PK), PharmacoDynamics(PD) and immunogenicity of Stapokibatrt in children with moderate-to-severe atopic dermatitis.",[88],"Atopic Dermatitis","NOT_YET_RECRUITING","2025-04-30",{"date":92,"type":93},"2025-05-04","ACTUAL",{"date":95,"type":82},"2025-05",{"date":97,"type":82},"2026-08",{"name":5,"class":6},1]