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

Phase 1

• Conditions: Active Crohn's disease; MedDRA version: 20.0Level: LLTClassification code 10021315Term: Ileitis terminalSystem Organ Class: 100000016693; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-001925-18-SK
• Lead Sponsor: Celgene Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-30
• Last Update Posted: 13 November 2017

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
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 SES-CD = 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:
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
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified