Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects
Condition: Dermatitis; Dermatitis, Atopic; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases
MeSH terms: Dermatitis, Atopic; Genetic Diseases, Inborn; Skin Diseases, Genetic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Eczematous; Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate
Intervention: PF-04965842 100 mg; PF-04965842 200 mg; Placebo
Intervention description: PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 40 weeks; PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 40 weeks; Placebo, administered as two tablets to be taken orally once daily for 40 weeks
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: 1235.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: atopic dermatitis; atopic eczema; eczema; JAK; janus kinase

Summary:

      B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over
      with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects
      responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken
      orally once daily (QD) will be identified and randomized in a double-blind manner to receive
      200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses
      of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing
      significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue
      treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible
      patients will have the option to enter a long-term extension study after completing the
      initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  12 years of age or older with a minimum body weight of 40 kg

          -  Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate
             to severe disease (>= the following scores: BSA10%, IGA 3, EASI 16, Pruritus NRS 4)

          -  Recent history of inadequate response or inability to tolerate topical AD treatments
             or require systemic treatments for AD control

        Exclusion Criteria:

          -  Unwilling to discontinue current AD medications prior to the study or require
             treatment with prohibited medications during the study

          -  Prior treatment with JAK inhibitors

          -  Other active nonAD inflammatory skin diseases or conditions affecting skin

          -  Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q
             wave interval abnormalities, current or history of certain infections, cancer,
             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