CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
Dupilumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02379052
NCT02379052Phase 2Completed

A Randomized, Double-Blind, Parallel, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Dupilumab in Adult Patients With Active Eosinophilic Esophagitis

Regeneron Pharmaceuticals·interventional·Posted Mar 4, 2015·Updated Feb 28, 2020

In Brief

A Phase 2 clinical trial evaluating Dupilumab and Placebo for Eosinophilic Esophagitis. Completed, enrolled 47 participants across 14 sites.

Detailed Summary

The primary objective of the study is to assess the clinical efficacy of repeat subcutaneous (SC) doses of dupilumab, compared with placebo, to relieve symptoms in adult participants with active, moderate to severe Eosinophilic Esophagitis (EoE). The secondary objectives of the study are: * To assess the safety, tolerability, and immunogenicity of SC doses of dupilumab in adult participants with active, moderate to severe EoE * To assess the effect of dupilumab on esophageal eosinophilic infiltration * To evaluate the pharmacokinetics (PK) of dupilumab in adult participants with EoE

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsSanofi

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 4, 2015
Enrollment StartMay 12, 2015
Primary CompletionFeb 17, 2017
Study CompletionJul 10, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.3 years ago

Interventions

Dupilumabdrug

Placebodrug