Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: PF-04965842; PF-04965842; PF-04965842; PF-04965842; Placebo
Intervention description: 10 mg of PF-04965842 QD for 12 weeks; 30 mg of PF-04965842 QD for 12 weeks; 100 mg of PF-04965842 QD for 12 weeks; 200 mg of PF-04965842 QD for 12 weeks; Placebo QD for 12 weeks
Intervention MeSH terms: Abrocitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 269.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Phase 2; randomized; double-blind; placebo; atopic dermatitis; safety; efficacy; JAK; janus kinase; moderate; severe

Summary:

      Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once daily
      (QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the
      efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of
      the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease
      severity in patients with moderate to severe AD as measured by the Investigator's Global
      Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support
      further clinical development of PF 04965842.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between 18 75 years of age, inclusive, at time of informed
             consent.

          -  Must have the following atopic dermatitis criteria:

               1. Have a clinical diagnosis of chronic atopic dermatitis (also known as atopic
                  eczema) for at least 1 year prior to Day 1 and has confirmed atopic dermatitis
                  (Hanifin and Rajka criteria of AD refer to Appendix 2) at the Screening visit.

               2. Have inadequate response to treatment with topical medications given for at least
                  4 weeks, or for whom topical treatments are otherwise medically inadvisable (eg,
                  because of important side effects or safety risks) within 12 months of the first
                  dose of study drug.

               3. Moderate to severe AD (affected BSA >=10 %, IGA >=3, and EASI >=12 at the
                  screening and baseline visits).

        Exclusion Criteria:

          -  History of human immunodeficiency virus (HIV) or positive HIV serology at screening,

          -  Infected with hepatitis B or hepatitis C viruses.

          -  Have evidence of active or latent or inadequately treated infection with Mycobacterium
             tuberculosis (TB)

          -  Have received any of the following treatment regiments specified in the timeframes
             outlined below:

        Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of
        first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks
        of first dose of study drug: Participation in other studies involving investigational
        drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or
        attenuated live vaccine.

        Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy
        (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning
        booth/parlor.

        Within 1 week of first dose of study drug: Topical treatments that could affect atopic
        dermatitis; Herbal medications with unknown properties or known beneficial effects for AD.