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

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ception Therapeutics
• Collaborator: Cephalon
• Treatments: Reslizumab

Criteria

Inclusion Criteria:

• Informed consent

• Received at least two doses of study drug in Study Res-05-0002 (NCT00538434)

• Did not withdraw from Study Res-05-0002 due to drug related adverse event

• Completed End of Treatment Visit for Study Res-05-0002

Exclusion Criteria:

• Pregnant or nursing females

• Concurrent Immunodeficiency

• Current use of immunosuppressive drugs

• Did not tolerate study drug in Study Res-05-0002