Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

NCT02277743 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 671

Last updated 2017-11-21

Study results available
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Summary

This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).

Conditions

  • Dermatitis, Atopic

Interventions

DRUG

Dupilumab

Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms

DRUG

Placebo (for Dupilumab)

Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms

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
2014-10-31
Primary Completion
2015-11-30
Completion
2016-02-29
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Japan
  • Singapore
  • Spain

Study Locations

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Entities

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 NCT02277743 on ClinicalTrials.gov