At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating PF-04965842 100 mg, PF-04965842 200 mg, and 1 other intervention for Dermatitis, Atopic. Completed, enrolled 391 participants across 115 sites in 13 countries.
Detailed 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.
Study Details
Timeline
Interventions
PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks
PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks
Placebo, administered as two tablets to be taken orally once daily for 12 weeks