Abstract
The Primary objective is to demonstrate the efficacy of dupilumab treatment compared with
placebo in pediatric patients with active eosinophilic esophagitis (EoE) based on histologic
improvement meeting validated histologic criteria.
The Secondary objectives are:
- To demonstrate the efficacy of dupilumab compared to placebo in pediatric patients with
active EoE after 16 weeks of treatment as assessed by endoscopic visual measurements of
disease activity using the Eosinophilic Esophagitis-Endoscopic Reference Score
(EoE-EREFS) and histologic abnormalities as measured by the EoE Histology Scoring System
(EoE-HSS)
- To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up
to 16 weeks in pediatric patients with active EoE
- To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE
and type 2 inflammation
- To study the effects of dupilumab on the type 2 inflammation gene expression signature
- To evaluate the concentration-time profile of functional dupilumab in serum in this
population
- To assess efficacy of long-term (52 weeks) dupilumab treatment
- To assess safety, tolerability, and immunogenicity of long-term (52 weeks) dupilumab
treatment
- To evaluate the impact of dupilumab treatment on EoE signs and symptoms
