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
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
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.
Responder criteria for randomization at week 12 are defined as a) achieving an IGA of clear (0) or almost clear (1) (on a 5 point scale), b) a reduction from IGA baseline of 2 or more points, and c) reaching an EASI-75 response compared to baseline. Flare requiring rescue treatment is defined as a loss of at least 50% of the EASI response at Week 12 and an IGA score of 2 or higher.
Inclusion Criteria:
Exclusion Criteria:
Birmingham, Alabama 35233, United States
Long Beach, California 90808, United States
Skokie, Illinois 60077, United States
Rosario, Santa Fe Province 2000, Argentina
C.a.b.a., C1027AAP, Argentina
C.a.b.a., C1055AAO, Argentina
C.a.b.a, C1425DKG, Argentina
Porto Alegre, Rio Grande do Sul 90160-093, Brazil
Chongqing, Chongqing Municipality 400037, China
Wuhan, Hubei 430030, China
Tianjin, Tianjin Municipality 300052, China
Hangzhou, Zhejiang 310003, China
Hangzhou, Zhejiang 310009, China
Berlin, 10117, Germany
Modena, 41124, Italy
Rome, 00168, Italy
Gdansk, 80-214, Poland
Warsaw, 02-507, Poland
Brasov, JUD. Brasov 500283, Romania
Cluj-Napoca, JUD. CLUJ 400105, Romania
Saint Petersburg, 194021, Russia
Bratislava, 833 40, Slovakia
Kosice-Saca, 040 15, Slovakia