Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis

• Status: Completed
• Trial end date: 2020-05-07
• Target enrollment: 0
• Participant gender: All

Summary

This study is being conducted to provide data on efficacy, safety, tolerability and PK of multiple topical formulation concentrations of PF-06700841 topical cream in the treatment of mild to moderate atopic dermatitis (AD). The study is intended to enable selection of the dose and dosing regimen (once daily [QD] vs twice daily [BID] application) for the future clinical development of topical PF-06700841.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: PF-06700841

Criteria

Inclusion Criteria:

• Clinical diagnosis of Atopic Dermatitis for at least 3 months

• Investigator's Global Assessment (IGA) Score of 2 or 3

• Eczema Area Severity Index (EASI) score of 3-21

• Body Surface Area (BSA) of 2-20%

• Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more

Exclusion Criteria:

• Other forms of dermatological diseases (other than atopic dermatitis)

• Fitzpatrick skin type score greater than 5

• Clinically significant abnormal ECG, vital signs, and laboratory values

• Infection with HBV, HCV, herpes zoster or tuberculosis