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Abrocitinib Dose Tapering in Patients With Atopic Dermatitis

Study acronym: MODA-AD
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07848074
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions
(from sponsor)
Atopic Dermatitis
Related terms Dermatitis, Atopic
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov