[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530882":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":33,"responsibleParty":113,"collaborators":115,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":120,"sex":126,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":10,"studyType":132,"phases":10,"briefSummary":133,"conditions":134,"keywords":10,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pediatric patients with AD",null,"Pediatric participants (6 months to 17 years) who suffer from severe AD with EASI score \\\u003C 16 for adolescents (age 12-17 years) and \\\u003C 21 for children (6 months to 11 years), eligible for systemic dupilumab treatment according to Italian reimbursement criteria.",[13],"Drug: Dupilumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Dupilumab","This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.",[9],[21],"SAR231893 (REGN668), Dupixent®",[23],{"name":24,"affiliation":5,"role":25},"Clinical Sciences & Operations","STUDY_DIRECTOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Trial Transparency email recommended (Toll free for US & Canada)","CONTACT","800-633-1610","option 6","contact-us@sanofi.com",[34,47,56,65,74,83,89,98,104],{"facility":35,"status":36,"city":37,"state":10,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":10},"Investigational Site Number: 002","RECRUITING","Bologna","40138","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],11.33875,44.49381,{"lat":45,"lon":44},{"facility":48,"status":36,"city":49,"state":10,"zip":50,"country":39,"countryCode":40,"cosmosGeoPoint":51,"geoPoint":55,"contacts":10},"Investigational Site Number: 006","Brescia","25123",{"type":42,"coordinates":52},[53,54],10.21472,45.53558,{"lat":54,"lon":53},{"facility":57,"status":36,"city":58,"state":10,"zip":59,"country":39,"countryCode":40,"cosmosGeoPoint":60,"geoPoint":64,"contacts":10},"Investigational Site Number: 004","Florence","50139",{"type":42,"coordinates":61},[62,63],11.24626,43.77925,{"lat":63,"lon":62},{"facility":66,"status":36,"city":67,"state":10,"zip":68,"country":39,"countryCode":40,"cosmosGeoPoint":69,"geoPoint":73,"contacts":10},"Investigational Site Number: 001","Milan","20122",{"type":42,"coordinates":70},[71,72],12.59836,42.78235,{"lat":72,"lon":71},{"facility":75,"status":36,"city":76,"state":10,"zip":77,"country":39,"countryCode":40,"cosmosGeoPoint":78,"geoPoint":82,"contacts":10},"Investigational Site Number: 010","Naples","80131",{"type":42,"coordinates":79},[80,81],14.26811,40.85216,{"lat":81,"lon":80},{"facility":84,"status":36,"city":76,"state":10,"zip":85,"country":39,"countryCode":40,"cosmosGeoPoint":86,"geoPoint":88,"contacts":10},"Investigational Site Number: 011","80138",{"type":42,"coordinates":87},[80,81],{"lat":81,"lon":80},{"facility":90,"status":36,"city":91,"state":10,"zip":92,"country":39,"countryCode":40,"cosmosGeoPoint":93,"geoPoint":97,"contacts":10},"Investigational Site Number: 005","Roma","00133",{"type":42,"coordinates":94},[95,96],11.10642,44.99364,{"lat":96,"lon":95},{"facility":99,"status":36,"city":91,"state":10,"zip":100,"country":39,"countryCode":40,"cosmosGeoPoint":101,"geoPoint":103,"contacts":10},"Investigational Site Number: 009","00168",{"type":42,"coordinates":102},[95,96],{"lat":96,"lon":95},{"facility":105,"status":36,"city":106,"state":10,"zip":107,"country":39,"countryCode":40,"cosmosGeoPoint":108,"geoPoint":112,"contacts":10},"Investigational Site Number: 014","Verona","37134",{"type":42,"coordinates":109},[110,111],10.9938,45.43854,{"lat":111,"lon":110},{"type":114,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[116],{"name":117,"class":6},"Regeneron Pharmaceuticals","100530882","a-study-to-observe-how-adolescent-patients-with-severe-atopic-dermatitis-despite-less-extensive-skin-lesions-eczema-area-and-severity-index-score--16-respond-to-dupilumab-treatment-100530882",false,"NCT06192563","A Study to Observe How Pediatric Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions Respond to Dupilumab Treatment","A Prospective Observational Study of Pediatric Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions (Eczema Area and Severity Index Score \u003C 16 for Adolescents and \u003C 21 for Children) Receiving Dupilumab","AD-BEASCUITS","Inclusion Criteria:\n\n* Male or female, aged between 6 months and 17 years at the baseline visit.\n* Patients with AD who have been prescribed dupilumab as per clinical practice (according to AIFA reimbursement policy) and who fulfill the following criteria:\n\n  \\-- Adolescents (12 to 17 years old) with EASI \\\u003C 16 and children (6 months to 11 years of age) with EASI \\\u003C 21 and.\n  1. Children's Dermatology Life Quality Index (cDLQI)\\* ≥ 10 and \u002F or\n  2. Itch NRS ≥ 7 and \u002F or\n  3. Localization in visible or sensitive areas (head\u002Fneck\u002Fhands or genitals)\n* Participants\u002F caregivers able to understand and complete study-related questionnaires.\n* Provided signed informed consent or parental\u002Flegally acceptable representative consent and participant assent where applicable.\n\n  * Only for adolescents and children 6-11 years of age.\n\nExclusion Criteria:\n\n* Use of dupilumab within 6 months prior to study entry.\n* Participants currently participating in any interventional clinical trial that modifies patient care.\n* Any condition that, in the opinion of the Investigator, may interfere with participant's ability to participate in the study (e.g., substance abuse).\n\nThe above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.","ALL","6 Months","17 Years",{"count":130,"type":131},230,"ESTIMATED","OBSERVATIONAL","In adolescents treated with dupilumab, clinical trials showed significant improvement of atopic dermatitis (AD) signs and symptoms, with a good safety profile. In these clinical trials, only patients with Eczema Area and Severity Index (EASI) score greater than or equal to (≥) 16 were enrolled, and effectiveness on sensitive\u002Fvisible areas was not specifically evaluated. Further data about the effectiveness of dupilumab in adolescent and children participants with moderate to mild EASI score and severe itching and\u002For localized AD to better understand the potential clinical benefits of dupilumab in these populations.\n\nThe main objective of the study us to assess the real-word effectiveness and safety of dupilumab in pediatric patients (age 6 months-17 years) who suffer from severe AD with EASI score \\\u003C 16 for adolescents (age 12-17 years) and \\\u003C 21 for children (age 6 months-11 years), and who are eligible for systemic therapy according to Italian reimbursement criteria.",[135],"Atopic Dermatitis","2026-08-11",{"date":138,"type":139},"2026-08-13","ACTUAL",{"date":141,"type":139},"2023-11-30",{"date":143,"type":131},"2028-03-31",{"name":5,"class":6},9]