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

NCT02260986 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 740

Last updated 2017-10-17

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-08-31
Completion
2016-10-31

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Hungary
  • Italy
  • Japan
  • Netherlands
  • New Zealand
  • Poland
  • Romania
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02260986 on ClinicalTrials.gov