Last updated on June 2019

Safety Pharmacokinetics and Efficacy of Dupilumab in Patients 6 Months to <6 Years With Severe Atopic Dermatitis (Liberty AD PRESCHOOL)


Brief description of study

This study is a 2-part (parts A and B) phase 2/3 study to evaluate the safety, pharmacokinetics (PK) and efficacy of dupilumab in participants 6 months to less than 6 years of age with severe atopic dermatitis (AD).

Detailed Study Description

  1. Part A (open-label, single-ascending-dose, sequential cohort phase 2 study):
    • Primary objective is to characterize the safety and PK of dupilumab administered as a single dose in pediatric participants, 6 months to less than 6 years of age, with severe AD.
    • Secondary objective is to evaluate the efficacy and immunogenicity of a single dose of dupilumab in participants 6 months to less than 6 years of age with severe AD 2. Part B (randomized, double-blind, parallel-group, placebo-controlled phase 3 study):
    • Primary objective is to demonstrate the efficacy of multiple doses of dupilumab over 16 weeks of treatment when administered concomitantly with topical corticosteroids (TCS) in pediatric participants, 6 months to less than 6 years of age, with severe AD.
    • Secondary objective is to assess the safety and immunogenicity of multiple doses of dupilumab over 16 weeks of treatment when administered concomitantly with TCS in participants 6 months to less than 6 years of age with severe AD

Clinical Study Identifier: NCT03346434

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Regeneron Investigational Site

Newcastle, United Kingdom
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