Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Abrocitinib 200 mg; Dupilumab 300 mg
Intervention description: Abrocitinib 200 mg administered as two 100 mg tablets to be taken orally once daily for 26 weeks. Placebo injections will be administered every other week for 24 weeks.; Dupilumab 300 mg administered as a single subcutaneous injection every other week for 24 weeks (2 injections on day 1). Placebo tablets will be administered daily.
Intervention MeSH terms: Abrocitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 727.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atopic dermatitis; atopic eczema; eczema; JAK; janus kinase

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 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 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