[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100442505":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":34,"responsibleParty":48,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":32,"eligibilityCriteria":60,"healthyVolunteers":57,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":32,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":32,"overallStatus":36,"whyStopped":32,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Northwestern University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dupilumab administration","EXPERIMENTAL","dupilumab administered in weight based dosage for 12 weeks. The drug will be administered once a week during this time through a subcutaneous injection.",[13],"Drug: Dupilumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Dupilumab","12 week dupilumab administration",[9],[21],"Dupixent",[23],{"name":24,"affiliation":25,"role":26},"Amy Paller, MD","Lurie Children's Hospital\u002FNorthwestern University","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Dermatology CTU","CONTACT","312-227-6817",null,"eczemasleepstudy@northwestern.edu",[35],{"facility":25,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":32},"RECRUITING","Chicago","Illinois","60611","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-87.65005,41.85003,{"lat":46,"lon":45},{"type":26,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Amy Paller","Principal Investigator",[52],{"name":53,"class":54},"Regeneron Pharmaceuticals","INDUSTRY","100442505","phase-4-using-dupilumab-to-improve-circadian-function-sleep-and-pruritus-in-children-with-moderatesevere-atopic-dermatitis-100442505",false,"NCT05042258","Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate\u002FSevere Atopic Dermatitis","Inclusion Criteria:\n\n* Participants, 6-17 years old at time of enrollment.\n* Moderate to severe chronic AD inadequately controlled by topical treatment, diagnosed according to Hanifin and Rajka criteria by a pediatric dermatologist or allergist.\n* AD severity will be determined at baseline with Validated Investigator Global Assessment (vIGA) score of moderate (3) or severe (4).\n* Patient assessed or parent-proxy (under 8 years old) PROMIS sleep disturbance T-score ≥60.\n* Willing and able to comply with visits and study-related procedures.\n* On stable regimens (consistent use 14 days before Day 1 of study enrollment) of inhaled corticosteroids, topical steroids, and antihistamines.\n\nExclusion Criteria:\n\n* Poorly controlled asthma (Asthma Control Test ≤19).\n* Self-reported sleep disturbance on 2 or more nights in the past 7 days due to allergic rhinitis.\n* Use of concomitant medication that causes scratching.\n* Major medical condition (such as cancer).\n* Active condition that could affect sleep, such as obstructive sleep apnea, restless leg syndrome, insomnia, narcolepsy, severe sleep disordered breathing, severe depression, COVID-19, or hives (urticaria).\n* Having applied topical steroids within 7 days of first or second PSG (important for biomarkers assessment).\n* Use of systemic immunosuppressant within 30 days of first PSG.\n* Having showered or used moisturizers within 12 hours of first or second PSG.\n* Unable to communicate in English (some PROMIS questionnaires not available in translation).\n* Other contraindication to receiving dupilumab (such as history of allergic reaction to dupilumab or any of its components).\n* Pregnancy.\n* Clinical blindness (circadian disturbing).","ALL","6 Years","17 Years",{"count":65,"type":66},40,"ESTIMATED","INTERVENTIONAL",[69],"PHASE4","Single center, prospective, Open label study of sleep, pruritus and circadian function pre\u002Fpost 12-weeks of dupilumab treatment in children 6-17 years old",[72,73],"Atopic Dermatitis","Sleep Disturbance","2026-04-22",{"date":76,"type":77},"2026-04-27","ACTUAL",{"date":79,"type":77},"2024-08-12",{"date":81,"type":66},"2027-06",{"name":5,"class":6},1]