NCT03346434

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

A Phase 2/3 Study Investigating the Pharmacokinetics, Safety, and Efficacy of Dupilumab in Patients Aged ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 6 Months – 5 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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 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

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	Dupilumab	Solution for injection, subcutaneous (SC)
DRUG	Matching placebo	Solution for injection, subcutaneous (SC)

Timeline

• Start date: 2017-11-30
• Primary completion: 2021-07-08
• Completion: 2021-07-08
• First posted: 2017-11-17
• Last updated: 2022-07-28
• Results posted: 2022-07-28

Locations

48 sites across 4 countries: United States, Germany, Poland, United Kingdom

Regulatory

• FDA-regulated drug study