Status:
COMPLETED
Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
Lead Sponsor:
Pfizer
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized, double-blind, double-dummy, active-controlled, multi-center study to assess the efficacy and safety of abrocitinib 200 mg (2 x 100 mg tablets) administered orally QD compared wit...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Diagnosis of chronic atopic dermatitis (AD) for at least 6 months
- Moderate to severe AD (BSA at least 10%, IGA at least 3, EASI at least 16, and PP-NRS severity score at least 4)
- Recent history of inadequate response to treatment with medicated topical therapy for AD, or who have required systemic therapies for control of their disease
Exclusion
- Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation
- Have increased risk of developing venous thromboembolism
- Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
- Prior treatment with systemic JAK inhibitors or IL-4 or IL-13 antagonists including dupilumab, lebrikizumab or tralokinumab
- Other active non-AD inflammatory skin diseases or conditions affecting skin
- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
- Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception
Key Trial Info
Start Date :
June 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2021
Estimated Enrollment :
727 Patients enrolled
Trial Details
Trial ID
NCT04345367
Start Date
June 11 2020
End Date
July 13 2021
Last Update
July 8 2022
Active Locations (151)
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1
Total Skin & Beauty Dermatology Center, PC
Birmingham, Alabama, United States, 35205
2
Clinical Research Center Of Alabama
Birmingham, Alabama, United States, 35209
3
Alliance Dermatology & MOHS Center, PC
Phoenix, Arizona, United States, 85032
4
First OC Dermatology
Fountain Valley, California, United States, 92708