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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Combination Product: Dupilumab 300 mg; Drug: Abrocitinib 200 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04345367

B7451050

2019-004013-13 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 727 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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727 participants in 2 patient groups

Abrocitinib 200 mg plus placebo injection

Experimental group

Description:

Abrocitinib 200 mg daily through Week 26, plus placebo injections every other week through Week 24

Treatment:

Drug: Abrocitinib 200 mg

Dupilumab 300 mg plus placebo tablets

Active Comparator group

Description:

Dupilumab 300 mg every other week (2 injections on Day 1) through Week 24, plus placebo tablets daily through Week 26

Treatment:

Combination Product: Dupilumab 300 mg