NCT00635089

Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis

An Open-Label Safety and Efficacy Study of Reslizumab (CTx55700) for the Treatment of Pediatric Subjects With Eosinophilic Esophagitis Who Completed Study Res-5-0002

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Ception Therapeutics · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label study where all subjects will receive active drug, reslizumab. Subjects are able to enter this trial only through completion of study Res-05-0002 (NCT00538434). The goal of the study is to show longer term safety and efficacy in pediatric subjects who have eosinophilic esophagitis.

Detailed description

Subjects will enter this open-label extension study after completing the placebo-controlled, double-blind study Res-5-0002 (NCT00538434). The end of study visit for Res-05-0002 will serve as the screening visit for this trial. All subjects will receive reslizumab and be followed by their principal investigators in an unblinded fashion. Visits and administration of reslizumab will be monthly.

Conditions

• Eosinophilic Esophagitis

Interventions

Type	Name	Description
DRUG	reslizumab

Timeline

• Start date: 2008-07-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2008-03-13
• Last updated: 2017-03-23
• Results posted: 2017-03-23

Locations

36 sites across 2 countries: United States, Canada