Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermatitis Who Had Inadequate Response to Previous Biologic Therapies.
Trial Parameters
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Brief 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.
Eligibility Criteria
This NI study will enroll 150 patients from approximately 15 sites across the US. The study population eligible for enrollment includes adult and adolescent patients aged ≥12 years diagnosed with moderate to severe AD who receive at least one dose of abrocitinib and satisfy the inclusion and exclusion criteria. Patients who had inadequate response or intolerance to previous ≤2 biologic therapies will be included in this study as there is a lack of effectiveness data for abrocitinib in these patients. As this will be an observational study, there will be no sampling and all patients that meet the inclusion and exclusion criteria will be recruited consequently. The study will be open for enrollment for approximately 12 months after the first patient has been enrolled. Regarding the inclusion and exclusion criteria, in the real-world setting recruitment may be slower than expected, thus depending on the observed enrollment rate, the enrollment period and number of sites may be reassessed