NCT02260986

Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 740 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Dupilumab	Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
DRUG	Placebo (for Dupilumab)	Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
OTHER	Topical Corticosteroid (TCS)	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.

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-08-01
• Completion: 2016-10-01
• First posted: 2014-10-09
• Last updated: 2017-10-17
• Results posted: 2017-10-17

Locations

148 sites across 14 countries: United States, Australia, Canada, Czechia, Hungary, Italy, Japan, Netherlands, New Zealand, Poland, Romania, South Korea, Spain, United Kingdom