Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis

• Drug: PF-04965842
  10 mg of PF-04965842 QD for 12 weeks
• Drug: PF-04965842
  30 mg of PF-04965842 QD for 12 weeks
• Drug: PF-04965842
  100 mg of PF-04965842 QD for 12 weeks
• Drug: PF-04965842
  200 mg of PF-04965842 QD for 12 weeks
• Drug: Placebo
  Placebo QD for 12 weeks

• Experimental: Cohort 1
  10 mg of PF-04965842 QD
  Intervention: Drug: PF-04965842
• Experimental: Cohort 2
  30 mg of PF-04965842 QD
  Intervention: Drug: PF-04965842
• Experimental: Cohort 3
  100 mg of PF-04965842 QD
  Intervention: Drug: PF-04965842
• Experimental: Cohort 4
  200 mg of PF-04965842 QD
  Intervention: Drug: PF-04965842
• Placebo Comparator: Cohort 5
  placebo QD
  Intervention: Drug: Placebo

• Simpson EL, Wollenberg A, Bissonnette R, Silverberg JI, Papacharalambous J, Zhu L, Zhang W, Beebe JS, Vincent M, Peeva E, Bushmakin AG, Cappelleri JC, Chen L, Sikirica V, Xenakis J. Patient-Reported Symptoms and Disease Impacts in Adults With Moderate-to-Severe Atopic Dermatitis: Results From a Phase 2b Study With Abrocitinib. Dermatitis. 2021 Apr 1. doi: 10.1097/DER.0000000000000725. [Epub ahead of print]
• Gooderham MJ, Forman SB, Bissonnette R, Beebe JS, Zhang W, Banfield C, Zhu L, Papacharalambous J, Vincent MS, Peeva E. Efficacy and Safety of Oral Janus Kinase 1 Inhibitor Abrocitinib for Patients With Atopic Dermatitis: A Phase 2 Randomized Clinical Trial. JAMA Dermatol. 2019 Dec 1;155(12):1371-1379. doi: 10.1001/jamadermatol.2019.2855. Erratum in: JAMA Dermatol. 2020 Jan 1;156(1):104.

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.