A Randomized Double-Blind Parallel Placebo-Controlled Study of the Efficacy Safety and Tolerability of Dupilumab in Adult Patients with Active Eosinophilic Esophagitis
Brief Description Of Study
This is a multicenter, randomized, double-blind, placebo-controlled, 2-arm, parallel-group, proof-of-concept study. The primary purpose of this study is to evaluate the effect of dupilumab on relieving EoE clinical symptoms and reducing esophageal inflammation in adults. Currently there is no regulatory-approved endpoint for drug registration for this indication. Published clinical trials in EoE treatment with swallowed topical corticosteroids measured clinical responses and histological changes (Alexander 2012, Dellon 2012, Straumann 2010). However, emerging data show that there does not appear to be a correlation between histology changes, such as reduction in eosinophil counts, and clinical symptoms. Collaborative efforts by the international Eosinophilic Esophagitis Activity Index (EEsAI) study group with the Food and Drug Administration (FDA) are ongoing in developing and validating clinically meaningful endpoints, such as patient-reported outcome (PRO), for evaluating efficacy for approval of treatment for EoE (Fiorentino 2012). Therefore, efficacy in this study will be assessed based on clinical signs and symptoms using the EoE-specific PROs currently in development, as well as on anatomical and histological findings from esophagogastroscopy with biopsies.