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Not Yet Recruiting NCT07848074

Abrocitinib Dose Tapering in Patients With Atopic Dermatitis

Conditions: Atopic Dermatitis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 100
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Summary

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.

Eligibility Criteria

Inclusion Criteria: 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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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07848074). StuddyBuddy aggregates publicly available trial information.