Overview

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

Status:
Enrolling by invitation

Trial end date:
2026-11-03

Target enrollment:

Participant gender:

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

Phase:

Phase 3

Details

Lead Sponsor:

Regeneron Pharmaceuticals

Collaborator:

Sanofi