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Abrocitinib Dose Tapering in Patients With Atopic Dermatitis
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.
Official title: Maintenance of Optimal Disease Control During Abrocitinib Dose Tapering in Patients With Atopic Dermatitis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-10-01
Completion Date
2027-07-01
Last Updated
2026-09-29
Healthy Volunteers
No
Conditions
Interventions
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.