Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Dermatitis, Atopic

In brief

B7451012 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety 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 of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.

Key facts

Study ID

NCT03349060

Run by

Pfizer

People needed

387

Starts

2017-12-07

Expected to finish

2019-03-26

Last updated by the study team

2019-12-10

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: BSA 10%, 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

• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• Rady Children's Hospital - San Diego/University of California, San Diego — San Diego, California, United States
• TCR Medical Corporation — San Diego, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Florida Academic Centers Research and Education, LLC — Coral Gables, Florida, United States
• Olympian Clinical Research — Largo, Florida, United States
• Forward Clinical Trials, Inc. — Tampa, Florida, United States
• Meridian Clinical Research, LLC — Savannah, Georgia, United States
• NorthShore University HealthSystem Dermatology Clinical Trials Unit — Skokie, Illinois, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Dawes Fretzin Dermatology Group, LLC — Indianapolis, Indiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Henry Ford Medical Center, New Center One — Detroit, Michigan, United States
• Somerset Skin Centre — Troy, Michigan, United States
• MediSearch Clinical Trials — Saint Joseph, Missouri, United States
• Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
• Vital Prospects Clinical Research Institute, P.C. — Tulsa, Oklahoma, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Medical University of South Carolina Investigational Drug Services — Charleston, South Carolina, United States
• MUSC SCTR Research Nexus Clinic and Laboratory — Charleston, South Carolina, United States
• Arlington Research Center, Inc. — Arlington, Texas, United States
• The University of Texas Health Science Center Houston — Houston, Texas, United States
• Texas Dermatology and Laser Specialists — San Antonio, Texas, United States
• Virginia Clinical Research, Inc. — Norfolk, Virginia, United States
• Clinical Research Center of Alabama, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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