A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
Status:
Terminated
Trial end date:
2018-01-04
Target enrollment:
Participant gender:
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.