Dataset from A PHASE 3 RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 AND DUPILUMAB IN COMPARISON WITH PLACEBO IN ADULT SUBJECTS ON BACKGROUND TOPICAL THERAPY, WITH MODERATE TO SEVERE ATOPIC DERMATITIS

B7451029 is a Phase 3 study to investigate PF-04965842 in adult patients who have moderate to
severe atopic dermatitis and use background topical therapy. The efficacy 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. The efficacy of the two dosage strengths of PF-04965842
will be compared with dupilumab in terms of pruritus relief at 2 weeks. The two dosage
strengths of PF-04965842 and dupilumab 300 mg injected subcutaneously once every two weeks
(with a loading dose of 600 mg injected on the first day) will also be evaluated relative to
placebo over 16 weeks. The safety of the investigational products will be evaluated over the
duration of the study. Subjects will use non-medicated emollient at least twice a day and
medicated topical therapy such as corticosteroids, calcineurin inhibitors or PDE4 inhibitors,
as per protocol guidance, to treat active lesions during the study. Subjects who are
randomized to receive one of the two dosage strengths of PF-04965842 will also receive
placebo injectable study drug every two weeks until Week 16 and then will continue on
receiving only the oral study drug for 4 weeks. Subjects who are randomized to receive
dupilumab injections every two weeks will also receive oral placebo to be taken once daily
until Week 16 and will then continue to receive only the oral placebo for 4 weeks. Subjects
who are randomized to the placebo arms, will receive both daily oral placebo and injectable
placebo every two weeks until Week 16, after which they will receive either 100 mg or 200 mg
of PF-04965842 taken orally once daily for 4 weeks, dependent upon which arm they have been
allocated to. Eligible subjects will have an option to enter a long-term extension study
after completing 20 weeks of treatment.