Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
Status: | Recruiting |
---|---|
Conditions: | Dermatology, Dermatology, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 3/27/2019 |
Start Date: | June 29, 2018 |
End Date: | August 13, 2019 |
Contact: | Pfizer CT.gov Call Center |
Email: | ClinicalTrials.gov_Inquiries@pfizer.com |
Phone: | 1-800-718-1021 |
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
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.
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.
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
We found this trial at
36
sites
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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