Active Crohn's disease MedDRA version: 20.0 Level: LLT Classification code 10021315 Term: Ileitis terminal System Organ Class: 100000016693
Conditions
Sponsors
Celgene Corporation
Eligibility
Sex/Gender
All
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 stool frequency = 3.5 or abdominal pain = 1.5 at screening. Must have a total SES-CD = 6 at screening, or the ileum segmental SESCD = 4 at screening Must have failed or experienced intolerance to at least one of the following: budesonide; systemic corticosteroids; immunosuppressants (ie, azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]); or biologics for the treatment of CD (ie, infliximab, adalimumab, certolizumab or vedolizumab) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1010 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria
Exclusion criteria: Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease associated colitis Local manifestations of CD such as abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy Strictures with prestenotic dilatation, requiring procedural intervention, or with obstructive symptoms. In addition, colonic strictures that are not passable with an adult colonoscope, or strictures in the ileum or ileocecal valve that are fibrotic in nature, will be excluded. Any intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the Screening Visit Prior treatment with mycophenolic acid, tacrolimus, sirolimus, cyclosporine, thalidomide or apheresis (eg, Adacolumn®) within 8 weeks prior to the Screening Visit Use of intravenous (IV) corticosteroids within 2 weeks prior to the Screening Visit Use of topical GI treatments such as 5-aminosalicylic acid (5-ASA) or corticosteroid enemas or suppositories within 2 weeks prior to the Screening Visit Use of bile acid sequestrants, (eg, cholestyramine) within 3 weeks prior to the Screening Visit Prior treatment with biologics for the treatment of CD (approved or investigational), other than infliximab, adalimumab, certolizumab or vedolizumab Prior treatment with more than 3 biologics for the treatment of CD (ie, infliximab, adalimumab, certolizumab or vedolizumab). Treatment with a biologic within 8 weeks prior to the Screening Visit, or 5 elimination half lives, whichever is longer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of GED-0301 compared with placebo on clinical activity at 12 Weeks, in subjects with active Crohn’s disease (CD).;Secondary Objective: To evaluate the efficacy of GED-0301 compared with placebo on endoscopic outcomes, as measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD) in subjects with active CD; To evaluate the long term efficacy of GED-0301 compared with placebo on clinical activity in subjects with active CD To evaluate the efficacy of GED-0301 compared with placebo on corticosteroid-free clinical remission in subjects with active CD; To evaluate the long-term efficacy of GED-0301 compared with placebo on clinical activity and endoscopic outcomes in subjects with active CD; To evaluate the safety and tolerability of GED-0301 in subjects with active CD.;Primary end point(s): Efficacy as clinical remision: the proportion of subjects achieving clinical remission defined as a (CDAI) score < 150 at Week 12;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of subjects achieving: - clinical remission, defined as a CDAI score < 150, at Week 52. - endoscopic response-50 (ER-50), defined as a reduction of at least 50% in SES-CD compared with baseline, at Week 52. Proportion of subjects with clinical response: - defined as a decrease from baseline in CDAI = 100 points, at Week 12. - defined as a decrease from baseline in CDAI = 100 points, at Week 4. Proportion of subjects: - achieving clinical remission, defined as a CDAI score < 150, at Week 4. - who achieve corticosteroid-free clinical remission (CDAI <150) at Week 52 among subjects receiving oral corticosteroids for CD at baseline. - achieving sustained clinical remission, defined as a CDAI score < 150,at both Week 12 and Week 52. - with endoscopic response-25 (ER-25), defined as a reduction of at least 25% in the SES-CD compared with baseline, at Week 12. - endoscopic remission, defined as SES-CD = 2, at Week 52. Type, frequency, severity, seriousness, and relationship of AEs to IP. Number of subjects who discontinue investigational product (IP) due to any AE. Clinically significant changes in vital signs, ECG and/or laboratory findings.;Timepoint(s) of evaluation of this end point: as given above | — |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Latvia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinicalTrialDisclosure
Celgene Corporation
Outcome results
None listed