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

Dermatitis, Atopic Clinical Trial

Official title: 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

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

• NCT number: NCT03346434
• Study type: Interventional
• Source: Regeneron Pharmaceuticals
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 30, 2017
• Completion date: July 8, 2021