Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

Status:	Recruiting
Conditions:	Skin Cancer, Psoriasis, Skin and Soft Tissue Infections, Infectious Disease, Neurology, Women's Studies, Dermatology, Dermatology, Dermatology
Therapuetic Areas:	Dermatology / Plastic Surgery, Immunology / Infectious Diseases, Neurology, Oncology, Reproductive
Healthy:	No
Age Range:	18 - Any
Updated:	3/27/2019
Start Date:	October 29, 2018
End Date:	February 2, 2020
Contact:	Pfizer CT.gov Call Center
Email:	ClinicalTrials.gov_Inquiries@pfizer.com
Phone:	1-800-718-1021

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.

Inclusion Criteria:

- Male or female subjects aged 18 years or older at the time of informed consent

- Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate
to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS
severity 4)

- Documented recent history (within 6 months before the screening visit) of inadequate
response to treatment with medicated topical therapy for AD for at least 4 weeks, or
who have required systemic therapies for control of their disease.

- Must be willing and able to comply with standardized background topical therapy, as
per protocol guidelines throughout the study

- Female subjects who are of childbearing potential must not be intending to become
pregnant, currently pregnant, or lactating. The following conditions apply:

1. Female subjects of childbearing potential must have a confirmed negative
pregnancy test prior to randomization;

2. Female subjects of childbearing potential must agree to use a highly effective
method of contraception for the duration of the active treatment period and for
at least 28 days after the last dose of investigational product.

- Female subjects of non-childbearing potential must meet at least 1 of the following
criteria:

- Have undergone a documented hysterectomy and/or bilateral oophorectomy;

- Have medically confirmed ovarian failure; or

- Achieved postmenopausal status, defined as follows: cessation of regular menses
for at least 12 consecutive months with no alternative pathological or
physiological cause and have a serum follicle stimulating hormone (FSH) level
confirming the postmenopausal state.

All other female subjects (including female subjects with tubal ligations) are considered
to be of childbearing potential.

-If receiving concomitant medications for any reason other than AD, must be on a stable
regimen prior to Day 1 and through the duration of the study

Exclusion Criteria:

- Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study

- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q
wave interval abnormalities, current or history of certain infections, cancer,
lymphoproliferative disorders and other medical conditions at the discretion of the
investigator

- Unwilling to discontinue current AD medications prior to the study or require
treatment with prohibited medications during the study

- Other active nonAD inflammatory skin diseases or conditions affecting skin

- Prior treatment with JAK inhibitors

- Previous treatment with dupilumab

- Unwilling to discontinue current AD medications prior to the study or require
treatment with prohibited medications during the study

We found this trial at

sites

Florida Academic Centers Research and Education

Coral Gables, Florida 33134

from

Coral Gables, FL