NCT02612454

Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)

An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Dupilumab in Patients ≥6 Months to <18 Years of Age With Atopic Dermatitis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 880 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to assess the long-term safety of dupilumab in pediatric participants with AD. The secondary objectives of the study are: * To assess the long-term efficacy of dupilumab in pediatric participants with AD * To assess the trough concentrations of functional dupilumab in serum and the immunogenicity in pediatric participants with AD after re-treatment with dupilumab Optional Pre-filled Pen (PFP) Sub-Study in pediatric patients ≥2 to \<12 years of age with AD Co-Primary Objectives are: * To evaluate the pharmacokinetic (PK) of dupilumab PFPs * To evaluate the safety of dupilumab PFPs Secondary Objective is: \- To evaluate the immunogenicity of dupilumab PFPs

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Dupilumab	Weight-tiered dosing administered subcutaneous (SC)

Timeline

• Start date: 2015-10-15
• Primary completion: 2026-10-07
• Completion: 2026-10-07
• First posted: 2015-11-23
• Last updated: 2025-06-26

Locations

84 sites across 7 countries: United States, Canada, Czechia, Germany, Hungary, Poland, United Kingdom

Regulatory

• FDA-regulated drug study