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

Last Updated: 2022-07-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2021-07-08

Brief Summary

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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 moderate-to-severe atopic dermatitis (AD).

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Detailed Description

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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 moderate-to-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 moderate-to-severe AD.

Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Part A: Single-ascending-dose cohorts staggered by age;

Part B: Parallel Group

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Part A: Open Label;

Part B: Masked, Randomized

Study Groups

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Part A (Open label Dupilumab): Age cohorts 1 & 2

Age cohort 1: ≥2 years old to \<6 years old

Age cohort 2: ≥6 months to \<2 years old

Group Type EXPERIMENTAL