Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years
and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment
in Flaring Subjects
Does the drug B7451014 treat atopic dermatitis (eczema) in people age 12 years and
Basic Study Information
Purpose:Location: University of Rochester Medical Center
B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and
with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis.
responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg)
orally once daily (QD) will be identified and randomized in a double-blind manner
200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of
of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing
significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks
treatment and receive 200 mg PF-04965842 together with a marketed topical medicine.
patients will have the option to enter a long-term extension study after completing
initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.
Lead Researcher (Principal Investigator)
Study Contact InformationStudy Coordinator: Alicia Papalia
Phone: (585) 273-4195
Additional Study Details
Trial Not Found
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