An Efficacy and Safety Study of Mongersen (GED-0301) in Subjects With Active Ulcerative Colitis
Status:
Completed
Trial end date:
2017-08-08
Target enrollment:
Participant gender:
Summary
This is a phase 2, open-label, multicenter study to explore the efficacy and safety of oral
GED- 0301 in subjects with active UC, defined as a modified Mayo score (MMS) ≥ 4 and ≤ 9 and
a Mayo endoscopic subscore≥ 2.
Approximately 40 subjects will be enrolled using an Interactive Voice Response System (IVRS)
or an Interactive Web Response System (IWRS) to receive open-label, oral GED-0301 160 mg for
duration of 52 week treatment. Enrollment of subjects with previous exposure to TNF-α
blockers will be limited to approximately 15 subjects. The number of subjects with extensive
colitis is targeted to comprise approximately 50% of the entire study population.