A Phase 4 interventional study of Abrocitinib in Atopic Dermatitis, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Phase 4, Interventional, and Treatment
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.
Adult 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/day to 100 mg/day. 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.
Additional 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.
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/day.
This 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/day to 100 mg/day.
Clinical 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).
The 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/day according to physician judgment.
Age ≥18 years. Diagnosis of atopic dermatitis according to Hanifin and Rajka criteria for at least 6 months.
Moderate-to-severe atopic dermatitis meeting applicable criteria for systemic treatment.
Receiving 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.
Ability to provide written informed consent. Ability and willingness to attend scheduled study visits. -
Exclusion Criteria:
Presence of another skin disease that may interfere with the diagnosis or clinical assessment of atopic dermatitis.
Concomitant treatment with systemic immunosuppressive or immunomodulatory therapy for another inflammatory or autoimmune condition.
Inability to provide informed consent. Inability or unwillingness to attend scheduled follow-up visits.
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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.
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.
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/day to 100 mg/day 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).
Time frame: 16 weeks after dose tapering
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/day to 100 mg/day 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).
Time frame: 32weeks after dose tapering
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.
Time frame: Baseline and Weeks 4, 16, and 32
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.
Time frame: week 4,16,32
No study locations are listed for this record.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS