Last updated on June 2019

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


Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT03627767

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Children's Hospital Los Angeles

Los Angeles, CA United States
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Dermatology Specialists, Inc.

Oceanside, CA United States
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San Luis Dermatology and Laser Clinic

San Luis Obispo, CA United States
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Mosaic Dermatology

Santa Monica, CA United States
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Clinical Science Institute

Santa Monica, CA United States
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Bay Pines VAHCS

Bay Pines, FL United States
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Skin Care Research, LLC

Boca Raton, FL United States
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Skin Research Institute

Coral Gables, FL United States
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Park Avenue Dermatology

Orange Park, FL United States
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Emory University

Atlanta, GA United States
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Ds Research

New Albany, IN United States
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Kansas City Dermatology, P.A.

Overland Park, KS United States
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DXP Imaging

Louisville, KY United States
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Quest Diagnostics

Louisville, KY United States
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Skin Sciences, PLLC

Louisville, KY United States
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Qualmedica Research, LLC

Owensboro, KY United States
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Meridian Clinical Research, LLC

Baton Rouge, LA United States
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Tufts Medical Center

Boston, MA United States
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MediSearch Clinical Trials

Saint Joseph, MO United States
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Forest Hills Dermatology Group

Forest Hills, NY United States
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Juva Skin and Laser Center

New York, NY United States
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M3 - Wake Research, Inc.

Raleigh, NC United States
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Lynn Health Science Institute

Oklahoma City, OK United States
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Newton Clinical Research

Oklahoma City, OK United States
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Paddington Testing Company

Philadelphia, PA United States
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Health Concepts

Rapid City, SD United States
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Innovate Research, LLC

Fort Worth, TX United States
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Psoriahue Medicina Interdisciplinaria

Ciudad de Buenos Aires, Argentina
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Buenos Aires Skin

C.a.b.a., Argentina
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Stratica Medical

Edmonton, AB Canada
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DermEdge Research

Mississauga, ON Canada
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JM Research SC

Cuernavaca, Mexico
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Dermedic Jacek Zdybski

Ostrowiec Swietokrzyski, Poland
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ETG Warszawa

Warszawa, Poland
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SBI RR "Skin and Venereal Dispensary"

Rostov-on-Don, Russian Federation
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Vitiligo center

Saint-Petersburg, Russian Federation
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Limited Liability Company "Sanavita"

Saint-Petersburg, Russian Federation
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"Medical Research Institute", LLC

Saint-Petersburg, Russian Federation
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FSBEI HE I.P.Pavlov SPbSMU MOH Russia

Saint-Petersburg, Russian Federation
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BeneDerma s.r.o.

Bratislava, Slovakia
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Hospital Sant Joan de Deu

Esplugues de Llobregat, Spain
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Mayo Clinic

Rochester, MN United States
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Recruitment Status: Open


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