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

Phase 3 Active not recruiting 880 enrolled Regeneron Pharmaceuticals Sanofi · collab

Non-randomizedParallel-groupOpen-labelTreatment

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

Timeline

Start: 2015-10-15
Primary completion: 2026-10-07
Completion: 2026-10-07

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dupilumab	Monoclonal antibody	2 mg/kg	Subcutaneous
Subject	Dupilumab	Monoclonal antibody	3 mg/kg	Subcutaneous
Subject	Dupilumab	Monoclonal antibody	4 mg/kg	Subcutaneous
Subject	Dupilumab	Monoclonal antibody	6 mg/kg	Subcutaneous
Subject	Dupilumab	Monoclonal antibody	200 mg	Subcutaneous
Subject	Dupilumab	Monoclonal antibody	300 mg	Subcutaneous

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

Summary

Timeline

Publications

Drugs

Indications