Overview

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

Status:
Completed
Trial end date:
2019-08-13
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Treatments:
Abrocitinib
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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