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Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

NCT04345367

CompletedPhase 3

Sponsor: Pfizer

Conditions: Atopic Dermatitis

Interventions: Abrocitinib 200 mg, Dupilumab 300 mg

Countries: United States, Australia, Bulgaria, Canada, Chile, Finland, Germany, Hungary

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 with dupilumab 300 mg administered by subcutaneous injection every other week (as per label guidelines) in adult participants on background topical therapy, with moderate to severe AD. The treatment duration is 26 weeks. A total of approximately 600 participants will be enrolled from approximately 220 sites globally. Approximately 600 participants will be randomly assigned to study intervention. There are primary efficacy assessments at Week 2 and Week 4, and a key secondary efficacy assessment at Week 16. Efficacy and safety endpoints will be assessed throughout the entire study. Exploratory endpoints related to hand eczema efficacy will be assessed throughout the study.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Locations (151)

Birmingham, Alabama, United States
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Fountain Valley, California, United States
Long Beach, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Pomona, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
San Francisco, California, United States
Santa Ana, California, United States
Santa Monica, California, United States
Boca Raton, Florida, United States
Largo, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Norcross, Georgia, United States
Normal, Illinois, United States
West Dundee, Illinois, United States
Indianapolis, Indiana, United States
South Bend, Indiana, United States
Overland Park, Kansas, United States
Crowley, Louisiana, United States
Brighton, Massachusetts, United States
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