NCT03345914

Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Dupilumab Administered Concomitantly With Topical Corticosteroids in Patients, ≥6 Years to <12 Years of Age, With Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 367 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the trial is to demonstrate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) in participants ≥6 years to \<12 years of age with severe atopic dermatitis (AD). The secondary objective is to assess the safety of dupilumab administered concomitantly with TCS in patients ≥6 years to \<12 years of age with severe AD.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	Dupilumab	Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous (SC)
DRUG	Matching Placebo	Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous (SC)
OTHER	Background Treatment: Topical Corticosteroids	All participants are required to initiate treatment with a medium potency TCS using a standardized regimen. It is recommended that participants use triamcinolone acetonide 0.1% cream, fluocinolone acetonide 0.025% cream, or clobetasone butyrate 0.05%.
OTHER	Background Treatment: Moisturizers	All participants should apply moisturizers throughout the study. All types of moisturizers are permitted, but participants may not initiate treatment with prescription moisturizers. Participants may continue using stable doses of such moisturizers if initiated before the screening visit.

Timeline

• Start date: 2017-11-17
• Primary completion: 2019-06-20
• Completion: 2019-09-10
• First posted: 2017-11-17
• Last updated: 2020-08-13
• Results posted: 2020-08-13

Locations

61 sites across 6 countries: United States, Canada, Czechia, Germany, Poland, United Kingdom

Regulatory

• FDA-regulated drug study