NCT03349060

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

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04965842 MONOTHERAPY IN SUBJECTS AGED 12 YEARS AND OLDER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 387 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

B7451012 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.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	PF-04965842 100 mg	PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks
DRUG	PF-04965842 200 mg	PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks
DRUG	Placebo	Placebo, administered as two tablets to be taken orally once daily for 12 weeks

Timeline

• Start date: 2017-12-07
• Primary completion: 2019-03-26
• Completion: 2019-03-26
• First posted: 2017-11-21
• Last updated: 2019-12-10
• Results posted: 2019-12-10

Locations

88 sites across 8 countries: United States, Australia, Canada, Czechia, Germany, Hungary, Poland, United Kingdom

Regulatory

• FDA-regulated drug study