Actively Recruiting
Observational Study of Abrocitinib in Moderate-to-Severe Atopic Dermatitis Patients with Inadequate Response to Previous Biologic Therapies
Led by Pfizer · Updated on 2026-04-22
150
Participants Needed
1
Research Sites
32 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the real-world effectiveness of abrocitinib in patients aged 12 years and older with moderate-to-severe atopic dermatitis who have had an inadequate response or intolerance to two or fewer previous biologic therapies approved in the United States. This prospective, multi-center observational study aims to characterize both clinical outcomes and patient-reported experiences while using abrocitinib under typical clinical conditions. Participants are patients currently receiving abrocitinib treatment for moderate-to-severe atopic dermatitis as prescribed by their dermatologist, following the product label. The study will observe these patients without altering their treatment. Data collection includes monitoring outcomes such as skin improvement and itch reduction at various time points, including week 2, 4, 12, and 16 after starting abrocitinib. During the study, patients will complete questionnaires and diaries to report symptoms and quality of life. Researchers will assess measures like EASI-75 improvement, Peak Pruritus Numerical Rating Scale changes, sleep quality, and patient satisfaction. Clinical and demographic data will be collected at baseline, with follow-up assessments through week 16. The study will enroll approximately 150 patients across multiple sites and will last about one year after the first patient is enrolled.
CONDITIONS
Brief Title
Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermatitis Who Had Inadequate Response to Previous Biologic Therapies.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants have had chronic atopic dermatitis for at least 1 year before screening
- Male or female patients aged over 12 years at baseline
- Diagnosis of moderate-to-severe atopic dermatitis confirmed by a certified dermatologist
- Patients prescribed abrocitinib according to product label, independent of study enrollment
- Patients with inadequate response or intolerance to one or two previous biologic therapies approved for moderate-to-severe atopic dermatitis
- Signed informed consent and adolescent assent where required
- Willing and able to comply with clinic visits and complete patient-reported outcome questionnaires
You will not qualify if you...
- Active inflammatory skin diseases other than atopic dermatitis at Day 1, such as psoriasis, seborrheic dermatitis, or lupus
- Previous treatment with abrocitinib or other oral/systemic JAK inhibitors
- Investigator site staff, Pfizer employees involved in the study, and their families
- Patients not confirmed eligible by qualified investigator team before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive abrocitinib treatment for moderate to severe atopic dermatitis and are observed for treatment effectiveness and safety.
Visits at baseline, week 2, week 4, week 12, and week 16
Trial Site Locations
Total: 1 location
1
Pfizer
New York, New York, United States, 10001
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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