NCT03054428

Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Dupilumab Monotherapy in Patients ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study was to demonstrate the efficacy of dupilumab as a monotherapy in participants ≥12 years to \<18 years of age with moderate-to-severe atopic dermatitis (AD). The secondary objective of the study was to assess the safety of dupilumab as a monotherapy in participants ≥12 years to \<18 years of age with moderate-to-severe AD.

Conditions

• Moderate-to-Severe Atopic Dermatitis
• Dermatitis, Dermatitis Atopic
• Eczema, Skin Diseases, Skin
• Diseases Genetic, Genetic
• Diseases Inborn, Skin
• Disease, Eczematous Skin
• Hypersensitivity, Immediate
• Hypersensitivity, Immune System Diseases
• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	Dupilumab	Subcutaneous injection among the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms.
DRUG	Placebo	Subcutaneous injection among the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms.

Timeline

• Start date: 2017-03-21
• Primary completion: 2018-04-04
• Completion: 2018-06-05
• First posted: 2017-02-15
• Last updated: 2019-07-23
• Results posted: 2019-07-23

Locations

45 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study