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

Completed · Phase 3 · Has a placebo group

Conditions studied: Dermatitis, Dermatitis, Atopic, Eczema, Skin Diseases, Skin Diseases, Genetic, Genetic Diseases, Inborn, Skin Diseases, Eczematous, Hypersensitivity, Hypersensitivity, Immediate, Immune System Diseases

In brief

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.

Key facts

Study ID

NCT03627767

Run by

Pfizer

People needed

1235

Starts

2018-06-11

Expected to finish

2020-10-07

Last updated by the study team

2021-09-20

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham, Dermatology at the Whitaker Clinic — Birmingham, Alabama, United States
• Clinical Research Center of Alabama, LLC — Birmingham, Alabama, United States
• Tien Q Nguyen MD Inc dba First OC Dermatology — Fountain Valley, California, United States
• Center for Dermatology Clinical Research, Inc. — Fremont, California, United States
• Beach Allergy and Asthma Specialty Group, A Medical Corporation — Long Beach, California, United States
• Dermatology Specialists, Inc. — Oceanside, California, United States
• University of California San Diego — San Diego, California, United States
• San Luis Dermatology and Laser Clinic — San Luis Obispo, California, United States
• Southern California Dermatology, Inc. — Santa Ana, California, United States
• Mosaic Dermatology — Santa Monica, California, United States
• Bay Pines VAHCS — Bay Pines, Florida, United States
• Skin Care Research, LLC — Boca Raton, Florida, United States
• Skin Research Institute — Coral Gables, Florida, United States
• Baumann Cosmetic and Research Institute — Miami, Florida, United States
• Park Avenue Dermatology — Orange Park, Florida, United States
• USF Asthma, Allergy & Immunology Clinical Research Unit — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Dermatologic Surgery Specialists, PC — Macon, Georgia, United States
• Midwest Allergy Sinus Asthma, SC — Normal, Illinois, United States
• NorthShore University HealthSystem Dermatology Clinical Trials Unit — Skokie, Illinois, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Ds Research — New Albany, Indiana, United States
• The Indiana Clinical Trials Center — Plainfield, Indiana, United States
• Kansas City Dermatology, P.A. — Overland Park, Kansas, United States
• Total Skin and Beauty Dermatology Center, PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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