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
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.
Inclusion Criteria:
Exclusion Criteria:
Vancouver, British Columbia V5Z 4E8, Canada
North York, Ontario M2M 4J5, Canada
Chongqing, Chongqing Municipality 400037, China
Blankenfelde-Mahlow, 15831, Germany
Budapest, 1195, Hungary
Yokohama, Kanagawa 220-6208, Japan
Kamimashiki-gun, Kumamoto 861-3101, Japan
Edogawa-ku, Tokyo 133-0057, Japan
Nakano-ku, Tokyo 165-0026, Japan
Bupyeong-gu, Incheon 21431, South Korea
Jung-gu, Incheon 22332, South Korea