Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: PF-04965842 200 mg; PF-04965842 100 mg; Placebo
Intervention description: PF-04965842 200 mg administered as two tablets to be taken orally once daily for 12 weeks; PF-04965842 100 mg administered as two tablets to be taken orally once daily for 12 weeks; Placebo administered as two tablets to be taken orally once daily for 12 weeks
Intervention MeSH terms: Abrocitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atopic dermatitis; atopic eczema; eczema; JAK; janus kinase

Summary:

      B7451037 is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2a study to
      investigate the mechanism of action of PF-04965842 by correlating efficacy outcomes with
      changes from baseline in key skin and blood biomarkers in adult participants at least 18
      years of age with moderate-to-severe atopic dermatitis. Participants will be screened within
      28 days prior to the first dose of study intervention to confirm eligibility. A total of
      approximately 51 participants will be randomized in a 1:1:1 ratio to receive PF-04965842 200
      mg once daily (QD), PF004965842 100 mg QD, or matching placebo QD for 12 weeks. At the end of
      the 12-week study treatment, qualified participants will have the option to enter the
      long-term extension study B7451015 (NCT03422822). Participants discontinuing early from this
      study will undergo a 4-week off-treatment follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of chronic moderate-to-severe atopic dermatitis (AD) for at least 1
             year

          -  Recent history of inadequate response to medicated topical therapy for AD or required
             systemic therapy to control disease

          -  Moderate-to-severe AD defined as affected BSA at least 10%, IGA at least 3, EASI at
             least 16, Peak Pruritus NRS at least 4

        Exclusion Criteria:

          -  A current or past medical history of conditions associated with thrombocytopenia,
             coagulopathy, or platelet dysfunction

          -  Currently have active forms of other inflammatory skin diseases, i.e. not AD, or have
             evidence of skin conditions (e.g. psoriasis, seborrheic dermatitis, lupus) at the time
             of Day 1 that would interfere with evaluation of AD or response to treatment

          -  Participants who have received prior treatment with any systemic JAK inhibitors

          -  Require treatment with prohibited concomitant medication(s) or have received a
             prohibited concomitant medication within specified time frames prior to the first dose
             of study medication, including topical treatments that could affect AD

          -  Pregnant or breastfeeding women or sexually-active women of childbearing potential who
             are unwilling to use contraception