Status:
COMPLETED
Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
Lead Sponsor:
Pfizer
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 tw...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2019
Estimated Enrollment :
387 Patients enrolled
Trial Details
Trial ID
NCT03349060
Start Date
December 7 2017
End Date
March 26 2019
Last Update
December 10 2019
Active Locations (88)
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1
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, United States, 35209
2
California Dermatology & Clinical Research Institute
Encinitas, California, United States, 92024
3
Rady Children's Hospital - San Diego/University of California, San Diego
San Diego, California, United States, 92123
4
TCR Medical Corporation
San Diego, California, United States, 92123