Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)
연구 개요
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
- 스폰서
- 리드: 리제네론 · 협력: 사노피
- 적응증
- Atopic Dermatitis
- 중재
- Dupilumab
- 목표 등록
- 880명
- 시작일
- 2015-10-15
- 완료(예정)
- 2026-10-07
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