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



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:12 - Any
Updated:3/27/2019
Start Date:June 11, 2018
End Date:July 3, 2020
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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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:

- 12 years of age or older with a minimum body weight of 40 kg

- Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate
to severe disease (>= the following scores: BSA10%, IGA 3, EASI 16, Pruritus NRS 4)

- Recent history of inadequate response or inability to tolerate topical AD treatments
or require systemic treatments for AD control

Exclusion Criteria:

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

- Prior treatment with JAK inhibitors

- Other active nonAD inflammatory skin diseases or conditions affecting skin

- 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

- Pregnant or breastfeeding women, or women of childbearing potential who are unwilling
to use contraception
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Seattle, Washington 98101
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201 Dowman Dr
Atlanta, Georgia 30303
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4650 Sunset Blvd
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601 Elmwood Avenue
Rochester, New York 14642
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Baton Rouge, Louisiana 70808
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10000 Bay Pines Boulevard
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Boca Raton, Florida 33486
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Boston, Massachusetts 02115
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Ciudad de Buenos Aires, Buenos Aires
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
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2010 Jacobssen Drive
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
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