drugset / Trial / NCT00538434

Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years

NCT00538434

Phase 2/3 Completed 227 enrolled Ception Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This trial will study three doses of reslizumab versus placebo in children with eosinophilic esophagitis (EE). The objectives of the trial will be to study the effectiveness of reslizumab in improving the clinical signs and symptoms and reducing esophageal eosinophils as well as assessing the safety profile compared to placebo.

Timeline

Start
2008-03
Primary completion
2009-10
Completion
2009-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Reslizumab Monoclonal antibody 1 mg/kg Intravenous
Subject Reslizumab Monoclonal antibody 2 mg/kg Intravenous
Subject Reslizumab Monoclonal antibody 3 mg/kg Intravenous