Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis

Purpose

B7451013 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.

Condition

  • Dermatitis, Atopic

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PF-04965842 100 mg
  • Drug: PF-04965842 100 mg
    PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks
Experimental
PF-04965842 200 mg
  • Drug: PF-04965842 200 mg
    PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks
Placebo Comparator
Placebo
  • Drug: Placebo
    Placebo, administered as two tablets to be taken orally once daily for 12 weeks

More Details

Status
Completed
Sponsor
Pfizer

Study Contact