A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn?s disease
- Conditions
- Active Crohn's diseaseMedDRA version: 18.1Level: LLTClassification code 10021315Term: Ileitis terminalSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2015-001925-18-ES
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1064
Diagnosis of CD with a duration of at least 3 months prior to the Screening Visit
Diagnosis of ileitis, ileocolitis or colitis, as determined by endoscopic, radiographic or any other imaging modality (eg, magnetic resonance imaging [MRI], computed tomography [CT] scan)
Active disease, defined as a CDAI score ? 220 and ? 450 at screening
Subject must have a 7-day average stool frequency ? 3.5 or abdominal pain ? 1.5 at screening
Subject 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: aminosalicylates; budesonide; systemic corticosteroids; immunosuppressants (ie, azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]); or biologics for the treatment of CD
Are the trial subjects under 18? no
Number of subjects for this age range:
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
Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis
Subject has local manifestations of CD such as strictures, abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy
Subject had any intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the Screening Visit
Subject had 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 treatment such as 5-aminosalicylic acid (5-ASA) or corticosteroid enemas or suppositories within 2 weeks prior to the Screening Visit
Use of cholestyramine within 3 weeks prior to the Screening Visit
Prior treatment with more than 3 biologics for the treatment of CD
Treatment with a biologic within 8 weeks prior to the Screening Visit
Prior treatment with natalizumab
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of GED-0301 compared with placebo on clinical activity, as measured by the Crohn?s Disease Activity Index (CDAI) 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;<br>To evaluate the efficacy of GED-0301 compared with placebo on corticosteroid-free clinical remission in subjects with active CD;<br>To evaluate the long-term efficacy of GED-0301 compared with placebo on clinical activity and endoscopic outcomes in subjects with active CD;<br>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 Crohn?s Disease Activity Index (CDAI) score < 150 at Week 4;Timepoint(s) of evaluation of this end point: Week 4
- Secondary Outcome Measures
Name Time Method