Project
Mongersen GED-0301
Completed · 2016 until 2018
Dora Barbara, Knellwolf Christina, Krieger-Grübel Claudia, Sulz Michael
Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Completed
Start Date
2016
End Date
2018
Financing
Industry
Study Design
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate
the efficacy and safety of 3 treatment regimens of oral GED-0301 versus placebo in subjects
with active CD (defined by a CDAI score ≥ 220 and ≤ 450 and a total SES-CD ≥ 6 at screening,
or the ileum segmental SES-CD ≥ 4 at screening). Approximately 1064 subjects will be
randomized in a 1:1:1:1 ratio (266 subjects per GED-0301 arm [total 798] and 266 subjects in the placebo arm) to receive 1 of 3 double-blind, oral GED-0301 treatment regimens, or identically
appearing placebo once daily (QD) for 52 weeks.
Brief description/objective
A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the
efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s
disease.