Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermati… (NCT06899204) | Clinical Trial Compass
RecruitingNot Applicable
Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermatitis Who Had Inadequate Response to Previous Biologic Therapies.
United States150 participantsStarted 2026-01-13
Plain-language summary
This is a prospective, multi-center observational study characterizing clinical and patient reported outcomes of patients receiving abrocitinib for moderate-to-severe atopic dermatitis (M2S AD) who had inadequate response (or intolerance) to ≤2 previous biologic therapies approved for M2S AD in the United States.
The aim of this study is to measure the effectiveness of abrocitinib in a real-world setting in patients with moderate-to-severe atopic dermatitis, with inadequate response or intolerance to ≤2 biologic therapies.
Who can participate
Age range12 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
✕.2.1. Inclusion Criteria
✕. Participants who have chronic AD that has been present for ≥1 year before screening.
✕. Male and female patients aged \>12 years at baseline.
✕. Patients with diagnosis of moderate-to-severe atopic dermatitis confirmed by a certified dermatologist, who are prescribed abrocitinib for use in accordance with the product label (USPI) and independently of the decision to enroll the patient in this study
✕. Patients who have inadequate responses or are intolerant to ≤2 previous biologic therapy approved for M2S AD. (Patients shall have had an inadequate response and/or intolerance to at least one, but no more than 2 biologic therapies approved for moderate-to-severe AD)
✕. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Following receipt of oral and written information about the study, the adolescent (depending on local institutional review board/independent ethics committee requirements) must provide assent, and one or both (according to local regulations) parents or guardians of the child must provide signed informed consent before any study-related activity is carried out.
✕. Patients, who in the opinion of the investigator, are willing and able to comply with regular clinic visits as per standard practice at the site and agree to complete PRO questionnaires and other patient completed questions.
What they're measuring
1
Percentage of patients achieving EASI-75 improvement from baseline at Week 16 after index date
Timeframe: Baseline, week 16
2
Percentage of patients achieving ≥ 4-point improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) collected daily all through the study from baseline at Week 2 by e-diary assessment