Crohn's Disease Clinical Trial
Official title:
A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
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.
This is a long-term active treatment study in patients with Crohn's disease (CD). Subjects
who met the early escape criteria in Study GED-0301-CD-002, or subjects who completed Study
GED-0301-002 or GED-0301-003, may be eligible for this study. Primary objective is to assess
long-term safety of GED 0301. Additional efficacy and patient reported outcomes will be
explored.
There are 5 possible treatment groups for GED-0301-CD-002 Subjects (Groups 1-5). There are 3
possible treatment groups for GED-0301-CD-003 subjects (Groups 1-3). Treatment is assigned
based on clinical improvement achieved or not achieved from the core GED-0301 study.
1. continuous GED-0301 160 mg once daily for 12 weeks, followed by alternating placebo once
daily for 4 weeks with GED-0301 160 mg once daily for 4 weeks, through Week 208;
2. alternating GED-0301 160 mg once daily for 4 weeks with placebo once daily for 4 weeks,
through Week 208;
3. alternating placebo once daily for 4 weeks with GED-0301 160 mg once daily for 4 weeks,
through Week 208;
4. continuous GED-0301 40 mg once daily through Week 208;
5. alternating placebo once daily for 4 weeks, followed by GED-0301 40 mg once daily for 4
weeks, through Week 208.
The GED-0301-CD-003 trial was not initiated; the GED-0301 program was terminated; no safety
findings were noted.
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