NCT02277769

Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 708 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2014-11-30
• Primary completion: 2015-10-31
• Completion: 2016-01-31
• First posted: 2014-10-29
• Last updated: 2020-06-02
• Results posted: 2017-10-16

Locations

93 sites across 11 countries: United States, Canada, France, Germany, Hong Kong, Italy, Lithuania, Poland, South Korea, Sweden, United Kingdom