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

Completed · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT04345367

Run by

Pfizer

People needed

727

Starts

2020-06-11

Expected to finish

2021-07-13

Last updated by the study team

2022-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Research Center Of Alabama — Birmingham, Alabama, United States
• Alliance Dermatology & MOHS Center, PC — Phoenix, Arizona, United States
• First OC Dermatology — Fountain Valley, California, United States
• Ark Clinical Research — Long Beach, California, United States
• Beach Allergy and Asthma Specialty Group, A Medical Corporation — Long Beach, California, United States
• Wallace Medical Group, Inc — Los Angeles, California, United States
• Empire Clinical Research — Pomona, California, United States
• MedDerm Associates — San Diego, California, United States
• University of California San Diego Dermatology — San Diego, California, United States
• University Clinical Trials Inc. — San Diego, California, United States
• Synergy Dermatology — San Francisco, California, United States
• Wolverine Clinical Trials, Llc — Santa Ana, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Skin Care Research, LLC — Boca Raton, Florida, United States
• Olympian Clinical Research — Largo, Florida, United States
• Miami Dermatology & Laser Research, LLC — Miami, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Accel Research Sites - Pure Skin Dermatology & Aesthetics — Orlando, Florida, United States
• Clinical Research Trials of Florida, Inc. — Tampa, Florida, United States
• Olympian Clinical Research — Tampa, Florida, United States
• Integrated Clinical Research — West Palm Beach, Florida, United States
• One Health Research Clinic — Norcross, Georgia, United States
• Sneeze, Wheeze & Itch Associates, LLC — Normal, Illinois, United States
• Dundee Dermatology — West Dundee, Illinois, United States
• Total Skin & Beauty Dermatology Center, PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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