Last updated on April 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

Birmingham, AL United States
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Los Angeles, CA United States
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Palo Alto, CA United States
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San Diego, CA United States
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Centennial, CO United States
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Coral Gables, FL United States
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Regeneron Investigational Site

Ann Arbor, MI United States
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Regeneron Investigational Site

Minneapolis, MN United States
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Saint Louis, MO United States
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Forest Hills, NY United States
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Regeneron Investigational Site

Charleston, SC United States
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Regeneron Investigational Site

San Antonio, TX United States
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Recruitment Status: Open


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