chronic bowel inflammation inflammatory bowel disease
Conditions
Interventions
Subjects will receive double-blind treatment with oral GED-0301 160 mg or
placebo QD for 12 weeks as follows:
* GED-0301 (1 x 160 mg gastro-resistant, delayed release, pH-dependent tablet)
and 4 pla
* GED-0301 (4 x 40 mg gastro-resistant, delayed release, pH-dependent tablets)
and 1 placebo tablet (identical in appearance to GED-0301 160 mg tablet)
* Placebo (4 placebo tablets identical in appearance to GED-0301 40 mg tablet
and 1 placebo tablet identical in appearance to GED-0301 160 mg tablet).
Crohn's disease
Inflammatory bowel disease
Mongersen
Sponsors
Celgene Corporation
Eligibility
Age
12 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Diagnosis of CD with a duration of at least 3 months prior to the Screening Visit * Presence of ileitis, ileocolitis, or colitis, as determined by ileocolonoscopy at screening * Active disease, defined as a CDAI score * 220 and * 450 at screening * Must have a 7-day average daily liquid or soft stool frequency * 3.5 or abdominal pain * 1.5 at screening * Must have a total SES-CD * 6 at screening, or the ileum segmental SES-CD * 4 at screening * Must have failed or experienced intolerance to at least one of the following: budesonide; systemic corticosteroids; immunosuppressants (ie, AZA, 6-MP, or MTX); or biologics for the treatment of CD (ie, infliximab, adalimumab, certolizumab, or vedolizumab)
Exclusion criteria
Exclusion criteria: 1. diagnosis of UC, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis, diverticular disease-associated colitis, or colitis due to immunodeficiency. 2. local manifestations of CD such as abscesses, short bowel syndrome, or other disease complications for which surgery might be indicated or which could confound the evaluation of efficacy. 3. strictures with prestenotic dilatation, requiring procedural intervention, or with obstructive symptoms. In addition, subjects with colonic strictures that are not passable with an age-appropriate colonoscope, or strictures in the ileum or ileocecal valve that are fibrotic in nature, will be excluded. 4. intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the Screening Visit. 5. ileostomy or a colostomy. 6. prior treatment with mycophenolic acid, tacrolimus, sirolimus, cyclosporine, thalidomide or apheresis (eg, Adacolumn®) within 8 weeks prior to the Screening Visit. 7. intravenous (IV) corticosteroids within 2 weeks prior to the Screening Visit. 8. changed or discontinued the dose of oral aminosalicylates within 2 weeks prior to the Screening Visit. 9. changed or discontinued the dose of oral corticosteroids (prednisone * 20 mg/day or equivalent, budesonide * 9 mg/day) within 3 weeks prior to the Screening Visit. 10. Adolescents with delayed growth or pubertal development who are on corticosteroids at baseline and who should not continue treatment with the same dose of corticosteroids until Week 12 visit. 11. immunosuppressants (eg, AZA, 6-MP, or MTX) within 12 weeks prior to the Screening Visit and has changed or discontinued the dose of immunosuppressants within 8 weeks prior to the Screening Visit. 12. topical GI treatments, such as, 5-aminosalicylic acid (5-ASA) or corticosteroid enemas or suppositories within 2 weeks prior to the Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects achieving clinical remission, defined as a CDAI score | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects who have a clinical response, defined as a decrease from baseline in CDAI score * 100 points, at Week 12 The proportion of subjects with endoscopic response-25 (ER-25), defined as a reduction of at least 25% from baseline in SES-CD, at Week 12 The proportion of subjects who have a clinical response, defined as a decrease from baseline in CDAI * 100 points, at Week 4 The proportion of subjects achieving clinical remission, defined as a CDAI score | — |
Countries
Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Korea (the Republic of), Latvia, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan (Province of China), Turkey, Ukraine, United Kingdom, United States of America
Outcome results
None listed