NCT02379052

Study of Dupilumab in Adult Participants With Active Eosinophilic Esophagitis (EoE)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
DRUG	Dupilumab
DRUG	Placebo

Timeline

• Start date: 2015-05-12
• Primary completion: 2017-02-17
• Completion: 2017-07-10
• First posted: 2015-03-04
• Last updated: 2020-02-28
• Results posted: 2020-02-28

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study