A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

Summary

The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study. The GED-0301-CD-003 trial was not initiated; see detailed description.

Timeline

Start

2016-07-25

Primary completion

2018-01-04

Completion

2018-01-04

Outcome

Outcome not reported

Stopped: “Study terminated by Sponsor following a recommendation from external DMC based on lack of emerging benefit; there were no new emergent safety findings”

Drugs

Indications