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
研究单位：[1]Pfizer[2]The Second Affiliated Hospital of Army Medical University, PLA Chongqing, Chongqing, China, 400037[3]The First Affiliated Hospital, Sun Yat-sen University Guangzhou, Guangdong, China, 510080[4]Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology Wuhan, Hubei, China, 430030[5]The Second Xiangya Hospital of Central South University Changsha, Hunan, China, 410011
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.
