Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease
Status:
Terminated
Trial end date:
2018-01-05
Target enrollment:
Participant gender:
Summary
The purpose of study is to test the effects of an experimental medication GED-0301
(mongersen) in patients who have active Crohn's disease. The study will test GED-0301
compared to placebo for 52 weeks. The study treatment is blinded which means that patients
and the study doctor will not know which treatment has been assigned. Patients in this study
will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids,
immunosupressants and antibiotics for the treatment of Crohn's disease.
After 12 weeks in the study until the end of the study, patients who do not have an
improvement in their Crohns disease symptoms will have the option to enter a long term active
treatment study. Participants who discontinued the study anytime or completed the study at
Week 52 were then observed for an additional 4 weeks.