A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 798

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)

Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 658
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate efficacy of GED-0301 at Week 12, administered as either a single 160 mg tablet or as four 40 mg tablets, compared with placebo on clinical activity in subjects with active CD;<br> Secondary Objective: • evaluate efficacy of GED-0301 compared with placebo on endoscopic outcomes<br> • evaluate efficacy of GED-0301 at Week 4 and Week 12 compared with placebo on clinical activity <br> • evaluate efficacy of GED-0301 compared with placebo on clinical activity in adolescent subjects (aged 12 to 17 years, inclusive) <br> • evaluate systemic exposure of GED-0301 using PK sampling<br> • evaluate safety and tolerability of GED-0301 <br> ;Primary end point(s): Proportion of subjects achieving clinical remission, defined as a CDAI score < 150 ;Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome Measures

Name	Time	Method

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