JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis

• Status: Completed
• Trial end date: 2020-04-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Abrocitinib

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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