Summary

for people ages 12 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study To Evaluate The Efficacy And Safety Of Pf-04965842 Monotherapy In Subjects Aged 12 Years And Older, With Moderate To Severe Atopic Dermatitis

Keywords

Dermatitis, Atopic atopic dermatitis atopic eczema eczema JAK janus kinase Dermatitis PF-04965842 100 mg PF-04965842 200 mg

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Rady Children's Hospital - San Diego/University of California, San Diego not yet accepting patients
    San Diego California 92123 United States
  • TCR Medical Corporation accepting new patients
    San Diego California 92123 United States
  • California Dermatology & Clinical Research Institute accepting new patients
    Encinitas California 92024 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
To obtain contact information for a study center near you, click here.
ID
NCT03349060
Phase
Phase 3
Study Type
Interventional
Last Updated
September 5, 2018