This study is design to explore the effect of GED-0301 on clinical and endoscopic outcome and to evaluate its safety in subjects with active Crohn's disease.
A Randomized, Double-blind, Multicenter Study to Explore the Effect of GED-0301 on Endoscopic and Clinical Outcomes in Subjects With Active Crohn's Disease.
Approximately 51 subjects will be randomized in a 1:1:1 ratio to receive 1 of 3 treatment regimens in a 12-week Induction Phase:
GED-0301 160 mg Once Daily (QD) for 12 weeks GED-0301 160 mg Once Daily (QD) for 8 weeks followed by 4 weeks of placebo GED-0301 160 mg Once Daily (QD) for 4 weeks followed by 8 weeks of placebo Treatment assignment at baseline will be stratified via an Interactive Voice Response System (IVRS)/or an Interactive Web Response System (IWRS) based on previous exposure to TNF-α blockers (yes/no) and disease location (disease restricted to the terminal ileum and/or up to the mid transverse colon only, or disease involving at least 1 ulcerated segment distal to mid transverse colon). The number of subjects with previous exposure to TNF-α blockers is targeted to be approximately 40%. The number of subjects with disease involving distal to mid transverse colon is targeted to comprise approximately 50% of the study population.
The study will consist of 5 phases:
Screening Phase - up to 4 weeks Induction Phase - 12 weeks Eligible subjects will enter the Induction Phase at the Baseline Visit (Week 0/Induction Visit 1). Subjects will be assigned randomly to receive IP as described above.
At Induction Week 12, subjects (responders) who achieve clinical remission, defined as a CDAI score < 150, or clinical response, defined as a decrease from baseline of ≥ 100 points in Crohn's Disease Activity Index (CDAI) score, at any of the following Induction Visits (Weeks 4, 8 and/or Week 12) will enter the Observation Phase. The Observation Phase will have a duration of up to 52 weeks. Subjects who are unable to achieve clinical remission or clinical response (no responders) at the following Induction Visits (Weeks 4, 8 and Week 12), will be discontinued from the study. Subjects who enter the Observation Phase and were receiving corticosteroids at baseline will start tapering corticosteroids at the end of the Induction Phase (Induction Week 12).
Observation Phase - up to 52 weeks Subjects who enter the Observation Phase will be evaluated by CDAI score every 4 weeks. Subjects will not receive investigational product (IP) during the Observation Phase. Subjects who experience a partial loss of response or are unable to taper corticosteroids during the Observation Phase will enter the Extension Phase. Partial loss of response is defined as 2 consecutive visits with both a CDAI score ≥ 150 and an increase of CDAI score ≥ 50 points from the CDAI score at the visit when the subject was first a responder during the Induction Phase. Partial loss of response must be confirmed 2 to 4 weeks post initial identification of partial loss of response. Subjects who do not experience a partial loss of response until Observation Week 52 will have an end-of-study visit.
Extension Phase -24 weeks Subjects who enter the Extension Phase will receive GED-0301 40 mg QD on a 4-week, alternating dosing schedule (4 weeks of treatment with GED-0301, followed by 4 weeks without GED-0301 treatment) for 24 weeks.
Follow-up Phase - 4 weeks
Subjects who complete the Extension Week 24 Visit will have 2 options:
Subjects who prematurely discontinue from the study, for any reason, will enter the Follow-up Phase, the 4-week period after the last study visit.
Crohn Disease Crohn's Disease Active Crohn's Disease GED-0301 Endoscopic Double-Blind IBD Mongersen
Open to people ages 18 years and up
Must have failed or experienced intolerance to at least one of the following:
aminosalicylates, budesonide, systemic corticosteroids, immunosuppressants (ie, 6 mercaptopurine [6-MP], azathioprine [AZA], or methotraxate [MTX]) or tumor necrosis factor-α tumor necrosis factor-α (TNF-α) blockers (eg, infliximab, adalimumab or certolizumab) .
Option 2: Any two of the following effective methods: male or female condom PLUS one of the following additional barrier methods:
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