A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1064

Inclusion Criteria

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

Exclusion Criteria

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.
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.
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 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 more than 3 biologics for the treatment of CD (ie, infliximab, adalimimumab, certolizumab or vedolizumab).
Treatment with a biologic within 8 weeks prior to the Screening Visit, or 5 elimination half lives, whichever is longer.
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 at Week 12 as measured by the Crohn’s Disease Activity Index (CDAI) in subjects with active Crohn’s disease (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 12;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 in subjects with active CD;<br>To evaluate the safety and tolerability of GED-0301 in subjects with active CD.;Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome Measures

Name	Time	Method

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