Last updated on October 2018

A Phase 3 Randomized Withdrawal, Double-blind, Placebo-controlled, Multi-center Study Investigating The 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


Brief description of study

B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis.

Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo.

Efficacy and safety of 2 doses 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 rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine.

Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.

 

Clinical Study Identifier: TX214964

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