Last updated on June 2019

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


Brief description of study

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.

Clinical Study Identifier: NCT03720470

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Alliance Research Centers

Laguna Hills, CA United States
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MedDerm Associates

San Diego, CA United States
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Clinical Science Institute

Santa Monica, CA United States
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IMMUNOe Research Centers

Centennial, CO United States
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C & R Research Servcies USA, Inc.

Coral Gables, FL United States
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Savin Medical Group LLC

Miami, FL United States
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Advanced Medical Research, PC

Sandy Springs, GA United States
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Great Lakes Clinical Trials

Chicago, IL United States
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DuPage Medical Group

Joliet, IL United States
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Deaconess Clinic Downtown

Evansville, IN United States
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Forefront Dermatology, S.C.

Louisville, KY United States
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Meridian Clinical Research, LLC

Baton Rouge, LA United States
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DermAssociates, LLC

Rockville, MD United States
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TrialSpark - Ronald Shore, MD

Rockville, MD 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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Newton Clinical Research

Oklahoma City, OK United States
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Crisor, LLC

Medford, OR United States
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Valley Immediate Care

Medford, OR United States
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Paddington Testing Co, Inc.

Philadelphia, PA United States
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Health Concepts

Rapid City, SD United States
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Jordan Valley Dermatology Center

West Jordan, UT United States
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DermEffects

London, ON Canada
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BENU Lekarna

Pardubice, Czechia
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CCR Czech, a.s.

Pardubice, Czechia
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Trial Pharma Kft.

Püspökladány, Hungary
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Medmare Bt

Veszprem, Hungary
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Korea University Ansan Hospital

Ansan-si, Korea, Republic of
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MCBK

Grodzisk Mazowiecki, Poland
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Dermedic Jacek Zdybski

Ostrowiec Swietokrzyski, Poland
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Trial Pharma Kft.

Püspökladány, Hungary
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Medication Management, LLC

Greensboro, NC United States
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Sinclair Dermatology

East Melbourne, Australia
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Trial Pharma Kft.

Püspökladány, Hungary
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MeDiNova West London

Wokingham, United Kingdom
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Trial Pharma Kft.

Püspökladány, Hungary
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ASR, LLC

Nampa, ID United States
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Emeritus Research

Camberwell, Australia
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Trial Pharma Kft.

Püspökladány, Hungary
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Medinova Research

Yaxley, United Kingdom
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Trial Pharma Kft.

Püspökladány, Hungary
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Dundee Dermatology

West Dundee, IL United States
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The Skin Centre

Benowa, Australia
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North Eastern Health Specialists

Hectorville, South Australia, Australia
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Trial Pharma Kft.

Püspökladány, Hungary
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Trial Pharma Kft.

Püspökladány, Hungary
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Recruitment Status: Open


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