JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to
      evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to <18 years of
      age with moderate to severe AD.
    

Detailed description: 
      This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to
      evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to <18 years of
      age with moderate to severe AD. Participants will be screened within 28 days prior to the
      first dose of study intervention to confirm study eligibility. Subjects must have
      moderate-severe AD involving at least 10% Body Surface Area (BSA); an Investigator Global
      Assessment (IGA) score of at least 3; an Eczema Area Severity Index (EASI) of at least 16 and
      Peak Pruritus Numerical Rating Score (NRS) of at least 4 on baseline/Day 1. Eligible subjects
      will be randomized at the Baseline/Day 1 visit. Approximately 225 participants will be
      randomized in a 1:1:1 ratio to receive once daily PF 04965842 at 200 mg, 100 mg, or placebo
      for 12 weeks. Randomization will be stratified by baseline disease severity (moderate [IGA =
      3] vs. severe [IGA = 4] AD). The investigational products will be administered QD for 12
      weeks. Background therapy (medicated and non-medicated topical therapy) must be applied BID
      for the duration of the treatment period. The co-primary efficacy endpoints are an IGA score
      of clear (0) or almost clear (1) with a reduction from baseline of greater than 2 points at
      Week 12 AND an at least 75% improvement of the EASI score (EASI-75) at week 12. Safety and
      efficacy assessments will be conducted at the investigator site by a clinical assessor
      blinded to treatment assignment. Scheduled clinic or telephone study visits for all subjects
      will occur at Screening, Baseline/Day 1, Day 8 (by phone), Day 15, Day 29, Day 43 (by phone),
      Day 57, Day 85 (End of treatment/Early termination), Day 113 (End of Study). Participants
      discontinuing early from the study will undergo a 4 week follow up period.

      This study includes an immunogenicity sub study integrated into the last 4 weeks of the main
      study treatment period. At Week 8, up to approximately 90 participants (up to approximately
      30 in each treatment arm) who have completed 8 weeks of treatment with study intervention
      will receive a tetanus, diphtheria and acellular pertussis combination vaccine (Tdap), and
      collection of blood samples for the evaluation of immunogenicity at Weeks 8 and 12.
      Participants of this sub study will complete all other protocol specified procedures in the
      main study.

      At the end of the 12 week study treatment, qualified participants completing the study will
      have the option to enter the long term extension (LTE) study B7451015.
    

Intervention name(s): Placebo; PF-04965842; PF04965842
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo; 100 mg QD; 200 mg QD
Intervention MeSH terms: Abrocitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atopic Dermatitis, JAK1 inhibitor