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
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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