Trial Search Results

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

B7451012 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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Pfizer

Stanford Investigator(s):

Intervention(s):

  • Drug: PF-04965842 100 mg
  • Drug: PF-04965842 200 mg
  • Drug: Placebo

Phase:

Phase 3

Eligibility


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 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

Ages Eligible for Study

12 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elidia V. Tafoya, MPH
650-724-1982
Recruiting