[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589575":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":52,"collaborators":11,"id":54,"slug":11,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":11,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":11,"overallStatus":72,"whyStopped":11,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Keymed Biosciences Co.Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Stapokibatrt group","EXPERIMENTAL",null,[13],"Biological: Stapokibatrt",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Other: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"BIOLOGICAL","Stapokibatrt","Stapokibatrt 1 or 2 ml,Subcutaneous injection(SC)",[9],{"type":26,"name":15,"description":27,"armGroupLabels":28,"otherNames":11},"OTHER","Placebo of matching volume，Subcutaneous injection(SC)",[15],[30],{"name":31,"affiliation":32,"role":33},"Lin Ma","Beijing Children's Hospital","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Qian Jia","CONTACT","028-88610620","qianjia@keymedbio.com",[41],{"facility":42,"status":11,"city":43,"state":11,"zip":11,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":11},"Beijing Children's Hospital Capital Medical University","Beijing","China","CN",{"type":47,"coordinates":48},"Point",[49,50],116.39723,39.9075,{"lat":50,"lon":49},{"type":53,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"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":64,"type":65},240,"ESTIMATED","INTERVENTIONAL",[68],"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.",[71],"Atopic Dermatitis","NOT_YET_RECRUITING","2025-04-30",{"date":75,"type":76},"2025-05-04","ACTUAL",{"date":78,"type":65},"2025-05",{"date":80,"type":65},"2026-08",{"name":5,"class":6},1]