JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to \<18 years of age with moderate to severe AD.

Key facts

Study ID

NCT03796676

Run by

Pfizer

People needed

287

Starts

2019-02-18

Expected to finish

2020-04-08

Last updated by the study team

2022-04-13

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged between 12 and to 17 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)

You may not qualify if…

• Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation
• 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 non-AD inflammatory skin diseases or conditions affecting skin
• Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, 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

• Madera Family Medical Group — Madera, California, United States
• Allergy & Asthma Associates of Southern California dba Southern California Research — Mission Viejo, California, United States
• UC Davis — Sacramento, California, United States
• Moonshine Research Center, Inc. — Doral, Florida, United States
• Homestead Research Institute — Homestead, Florida, United States
• Olympian Clinical Research — Largo, Florida, United States
• Clinical Trials Solutions — Miami, Florida, United States
• Global Health Clinical Trials Corp — Miami, Florida, United States
• La Salud Research Clinic, Inc. — Miami, Florida, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• South Miami Medical & Research Group, Inc. — Miami, Florida, United States
• Ciocca Dermatology, PA — Miami, Florida, United States
• INTERMED Medical Research Center, Inc — Miami, Florida, United States
• Suncoast Research Associates — Miami, Florida, United States
• AdventHealth Orlando — Orlando, Florida, United States
• AdventHealth Pediatric Dermatology Orlando — Orlando, Florida, United States
• AdventHealth Orlando - Investigational Drug Services — Orlando, Florida, United States
• Outpatient Service Center-AdventHealth Orlando — Orlando, Florida, United States
• Pediatric Outpatient Procedures and Sedation — Orlando, Florida, United States
• NeuroSkeletal Imaging — Orlando, Florida, United States
• Accel Research Sites - Pure Skin Dermatology & Aesthetics — Orlando, Florida, United States
• Accel Research Sites - Nona Pediatric Center — Orlando, Florida, United States
• ForCare Clinical Research — Tampa, Florida, United States
• Columbus Regional Research Institute — Columbus, Georgia, United States
• Clinical Research Center of Alabama, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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