CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 740 enrolled
Drug / intervention
Dupilumab +2 moredrug
Likely dose
Not stated in 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/NCT02260986
NCT02260986Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Long-Term Safety of Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis

Regeneron Pharmaceuticals·interventional·Posted Oct 9, 2014·Updated Oct 17, 2017

In Brief

A Phase 3 clinical trial evaluating Dupilumab, Placebo (for Dupilumab), and 1 other intervention for Atopic Dermatitis. Completed, enrolled 740 participants across 148 sites in 14 countries.

Detailed Summary

The primary objective of the study was to demonstrate the efficacy of Dupilumab administered concomitantly with topical corticosteroid (TCS) through Week 16 in adult participants with moderate-to-severe atopic dermatitis (AD) compared to placebo administered concomitantly with TCS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesAustralia, Canada, Czechia, Hungary, Italy, Japan, Netherlands, New Zealand, Poland, Romania, South Korea, Spain, United Kingdom, United States
CollaboratorsSanofi

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 9, 2014
Enrollment StartSep 1, 2014
Primary CompletionAug 1, 2015
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.7 years ago

Interventions

Dupilumabdrug

Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs

Placebo (for Dupilumab)drug

Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs

Topical Corticosteroid (TCS)other

All participants were required to treatment with a (TCS) using a standardized regimen. It was recommended that participants use triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment for medium potency, and hydrocortisone 1% cream for low potency.