[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657981":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":34,"studyPopulation":26,"armGroups":35,"interventions":42,"overallOfficials":48,"centralContacts":52,"locations":26,"responsibleParty":58,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":26,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":82,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":26},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":26},[9,13],{"measure":10,"description":11,"timeFrame":12},"Proportion of Participants Maintaining Minimal Disease Activity at Week 16","Proportion of participants who maintain Minimal Disease Activity (MDA) 16 weeks after abrocitinib dose reduction from 200 mg\u002Fday to 100 mg\u002Fday without dose re-escalation. MDA is defined as the concurrent achievement of at least one predefined clinician-reported optimal target (EASI ≤3 or EASI-90) and at least one predefined patient-reported optimal target (peak pruritus NRS ≤1, sleep NRS ≤1, or DLQI 0-1).","16 weeks after dose tapering",{"measure":14,"description":15,"timeFrame":16},"Proportion of Participants Maintaining Minimal Disease Activity at Week 32","Proportion of participants who maintain Minimal Disease Activity (MDA) 32 weeks after abrocitinib dose reduction from 200 mg\u002Fday to 100 mg\u002Fday without dose re-escalation. MDA is defined as the concurrent achievement of at least one predefined clinician-reported optimal target (EASI ≤3 or EASI-90) and at least one predefined patient-reported optimal target (peak pruritus NRS ≤1, sleep NRS ≤1, or DLQI 0-1).","32weeks after dose tapering",[18,22],{"measure":19,"description":20,"timeFrame":21},"Change in Eczema Area and Severity Index","Change in EASI score following abrocitinib dose tapering. EASI ranges from 0 to 72, with higher scores indicating greater disease severity.","Baseline and Weeks 4, 16, and 32",{"measure":23,"description":24,"timeFrame":25},"Maintenance of EASI-50, EASI-75, and EASI-90 Responses","Proportion of participants maintaining at least 50%, 75%, or 90% improvement in EASI relative to the pretreatment baseline assessment.","week 4,16,32",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":26,"timePerspective":26,"maskingInfo":32},"NA","SINGLE_GROUP","All enrolled participants who have achieved sustained Minimal Disease Activity during treatment with abrocitinib 200 mg\u002Fday will undergo dose reduction to abrocitinib 100 mg\u002Fday and will be followed prospectively for 32 weeks.","TREATMENT",{"masking":33,"maskingDescription":26,"whoMasked":26},"NONE","Atopic dermatitis (AD) is a chronic inflammatory skin disease that may require long-term systemic treatment. Abrocitinib is an oral selective Janus kinase 1 inhibitor approved for the treatment of moderate-to-severe AD. While the 200-mg daily dose provides rapid and effective disease control, selected patients achieving sustained optimal response may potentially maintain disease control after dose reduction to 100 mg\u002Fday.\n\nThis prospective, multicenter study will enroll adult patients with moderate-to-severe AD receiving abrocitinib 200 mg once daily who have achieved Minimal Disease Activity (MDA) at two consecutive visits at least one month apart. The second assessment confirming MDA will constitute the study baseline, at which abrocitinib will be reduced from 200 mg\u002Fday to 100 mg\u002Fday.\n\nClinical assessments will be performed at Weeks 4, 16, and 32 after dose tapering. MDA will be defined by the concurrent achievement of at least one predefined optimal clinician-reported outcome and at least one predefined optimal patient-reported outcome. Clinician-reported measures will include Eczema Area and Severity Index (EASI), Hand Eczema Severity Index (HECSI), and assessment of head and neck involvement. Patient-reported outcomes will include itch Numerical Rating Scale (NRS), sleep NRS, Dermatology Life Quality Index (DLQI), and Atopic Dermatitis Control Tool (ADCT).\n\nThe study will evaluate the proportion of patients maintaining MDA after dose tapering, identify potential predictors of successful maintenance of disease control, and assess changes in efficacy, treatment adherence, topical therapy use, and safety. In patients who experience clinically relevant loss of disease control, abrocitinib may be re-escalated to 200 mg\u002Fday according to physician judgment.",[36],{"label":37,"type":38,"description":39,"interventionNames":40},"abrocitinib dose tapering","EXPERIMENTAL","Participants with atopic dermatitis who have achieved sustained Minimal Disease Activity while receiving abrocitinib 200 mg once daily will undergo dose reduction to abrocitinib 100 mg once daily at study baseline. Participants will be followed at Weeks 4, 16, and 32 after dose tapering. In case of clinically relevant loss of disease control, the abrocitinib dose may be re-escalated to 200 mg once daily according to physician judgment.",[41],"Drug: Abrocitinib",[43],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":26},"DRUG","Abrocitinib","Participants who have achieved sustained Minimal Disease Activity while receiving abrocitinib 200 mg once daily will undergo dose reduction to abrocitinib 100 mg once daily at study baseline. Treatment with abrocitinib 100 mg once daily will be continued during follow-up. In case of clinically relevant loss of disease control, the dose may be re-escalated to 200 mg once daily according to physician judgment.",[37],[49],{"name":50,"affiliation":5,"role":51},"Ketty Peris","PRINCIPAL_INVESTIGATOR",[53],{"name":54,"role":55,"phone":56,"phoneExt":26,"email":57},"Ketty Peris, Prof","CONTACT","+390630157258","ketty.peris@policlinicogemelli.it",{"type":59,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100657981","phase-4-abrocitinib-dose-tapering-in-patients-with-atopic-dermatitis-100657981",false,"NCT07848074","Abrocitinib Dose Tapering in Patients With Atopic Dermatitis","Maintenance of Optimal Disease Control During Abrocitinib Dose Tapering in Patients With Atopic Dermatitis","MODA-AD","Inclusion Criteria:\n\nAge ≥18 years. Diagnosis of atopic dermatitis according to Hanifin and Rajka criteria for at least 6 months.\n\nModerate-to-severe atopic dermatitis meeting applicable criteria for systemic treatment.\n\nReceiving abrocitinib 200 mg once daily for at least 3 months. Achievement of Minimal Disease Activity at two consecutive visits at least one month apart; the second visit will constitute the baseline visit for study enrollment and dose tapering.\n\nAbility to provide written informed consent. Ability and willingness to attend scheduled study visits. -\n\nExclusion Criteria:\n\nPresence of another skin disease that may interfere with the diagnosis or clinical assessment of atopic dermatitis.\n\nConcomitant treatment with systemic immunosuppressive or immunomodulatory therapy for another inflammatory or autoimmune condition.\n\nInability to provide informed consent. Inability or unwillingness to attend scheduled follow-up visits.\n\n\\-","ALL","18 Years",{"count":71,"type":72},100,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","This prospective, multicenter study aims to evaluate whether patients with moderate-to-severe atopic dermatitis who achieve optimal disease control during treatment with abrocitinib 200 mg once daily can maintain disease control following dose reduction to 100 mg once daily.\n\nAdult patients who have achieved Minimal Disease Activity (MDA) at two consecutive visits at least one month apart will undergo abrocitinib dose tapering from 200 mg\u002Fday to 100 mg\u002Fday. Patients will be evaluated at Weeks 4, 16, and 32 after dose reduction. The primary objective is to determine the proportion of patients maintaining MDA following dose tapering and to explore clinical factors associated with successful maintenance of disease control.\n\nAdditional outcomes include changes in disease severity, itch, sleep disturbance, quality of life, treatment adherence, involvement of difficult-to-treat anatomical areas, use of topical therapies, and treatment safety and tolerability.",[78],"Atopic Dermatitis",[80,81],"atopic dermatitis","abrocitinib","NOT_YET_RECRUITING","2026-09-23",{"date":85,"type":86},"2026-09-29","ACTUAL",{"date":88,"type":72},"2026-10-01",{"date":90,"type":72},"2027-07-01",{"name":5,"class":6}]