CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,235 enrolled
Drug / intervention
PF-04965842 100 mg +2 moredrug
Likely dose
PF-04965842 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03627767
NCT03627767Phase 3Completed
CompareCT.gov

A PHASE 3 RANDOMIZED WITHDRAWAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 IN SUBJECTS AGED 12 YEARS AND OVER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS WITH THE OPTION OF RESCUE TREATMENT IN FLARING SUBJECTS

Pfizer·interventional·Posted Aug 13, 2018·Updated Sep 20, 2021

In Brief

A Phase 3 clinical trial evaluating PF-04965842 100 mg, PF-04965842 200 mg, and 1 other intervention for Dermatitis and 9 related conditions. Completed, enrolled 1,235 participants across 235 sites in 21 countries.

Detailed Summary

B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDermatitis, Dermatitis, Atopic, Eczema, Skin Diseases, Skin Diseases, Genetic, Genetic Diseases, Inborn, Skin Diseases, Eczematous, Hypersensitivity, Hypersensitivity, Immediate, Immune System Diseases
CountriesArgentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, Germany, Israel, Italy, Latvia, Mexico, Netherlands, Poland, Romania, Russia, Serbia, Slovakia, Spain, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 13, 2018
Enrollment StartJun 11, 2018
Primary CompletionSep 2, 2020
Study CompletionOct 7, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.9 years ago

Interventions

PF-04965842 100 mgdrug

PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 40 weeks

PF-04965842 200 mgdrug

PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 40 weeks

Placebodrug

Placebo, administered as two tablets to be taken orally once daily for 40 weeks