Study Evaluating 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

B7451013 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

NCT03575871

Run by

Pfizer

People needed

391

Starts

2018-06-29

Expected to finish

2019-08-13

Last updated by the study team

2020-04-21

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 severity 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

• Advanced Research Center, Inc. - Los Alamitos Site — Los Alamitos, California, United States
• Peninsula Research Associates, Inc. — Rolling Hills Estates, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Asthma and Allergy Associates, PC — Colorado Springs, Colorado, United States
• Colorado Springs Dermatology Clinic, PC — Colorado Springs, Colorado, United States
• Olympian Clinical Research — Clearwater, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Precision Imaging — Jacksonville, Florida, United States
• Solutions Through Advanced Research, Inc. — Jacksonville, Florida, United States
• Clinical Neuroscience Solutions, Inc — Orlando, Florida, United States
• ForCare Clinical Research — Tampa, Florida, United States
• Imaging Center of Idaho — Caldwell, Idaho, United States
• ASR, LLC — Nampa, Idaho, United States
• Meridian Clinical Research — Baton Rouge, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• MediSearch Clinical Trials — Saint Joseph, Missouri, United States
• Sadick Research Group — New York, New York, United States
• PMG Research of Wilmington, LLC — Wilmington, North Carolina, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• The Ohio State University Dermatology East — Gahanna, Ohio, United States
• Tanenbaum Dermatology Center — Memphis, Tennessee, United States
• Clinical Neuroscience Solutions, Inc. — Memphis, Tennessee, United States
• Austin Institute for Clinical Research, Inc. - Central — Austin, Texas, United States
• Center for Clinical Studies, LTD. LLP — Houston, Texas, United States
• Emmaus Research Center, Inc. — Anaheim, California, United States

Full record on ClinicalTrials.gov

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