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

About the trial

Sponsor

Regeneron Pharmaceuticals (with Sanofi)

Tested

Dupilumab (drug)

Dates

Started 2015-10-15; completion 2026-10-09

Results posted

Not yet

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

From ClinicalTrials.gov, last updated 2026-11-03. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Regeneron Pharmaceuticals, Inc. reported $553,050 in research payments for this study in 2025 (437 payments).

Products named: Dupixent

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.