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)

NCT03345914 PHASE3 COMPLETED Results posted

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.

Details

Lead sponsor	Regeneron Pharmaceuticals
Phase	PHASE3
Status	COMPLETED
Enrolment	367
Start date	Fri Nov 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Sep 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Dermatitis, Atopic

Interventions

• Dupilumab
• Matching Placebo
• Background Treatment: Topical Corticosteroids
• Background Treatment: Moisturizers

Countries

United Kingdom, Germany, Poland, Canada, United States, Czechia