Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Intervention: GED-0301; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 701.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Crohn's Disease; GED-0301; Mongersen; IBD; Safety; Efficacy

Summary:

      The purpose of study is to test the effects of an experimental medication GED-0301
      (mongersen) in patients who have active Crohn's disease. The study will test GED-0301
      compared to placebo for 52 weeks. The study treatment is blinded which means that patients
      and the study doctor will not know which treatment has been assigned. Patients in this study
      will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids,
      immunosupressants and antibiotics for the treatment of Crohn's disease.

      After 12 weeks in the study until the end of the study, patients who do not have an
      improvement in their Crohns disease symptoms will have the option to enter a long term active
      treatment study. Participants who discontinued the study anytime or completed the study at
      Week 52 were then observed for an additional 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must satisfy the following criteria to be enrolled in the study:

          -  Male or female ≥ 18 years

          -  Active Crohn's disease (CD) disease as determined by the Crohn's Disease Activity
             Index (CDAI) score and the Simple Endoscopic Score for Crohn's Disease (SES-CD)

          -  Must meet a determined average minimum number of daily stools or rating of abdominal
             pain over a 7 day period

          -  Subject must have failed or experienced intolerance to at least one of the following:
             budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine,
             6-mercaptopurine, or methotrexate); or biologics for the treatment of CD.

        Exclusion Criteria:

        The presence of any of the following will exclude a subject from enrollment:

          -  Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis,
             microscopic colitis, radiation colitis or diverticular disease-associated colitis

          -  Local manifestations of Crohn's Disease (CD) such as symptomatic/severe strictures,
             abscesses, short bowel syndrome; or other disease complications for which surgery
             might be indicated or could confound the evaluation of efficacy

          -  Intestinal resection within 6 months or any intra-abdominal surgery within 3 months
             prior to the Screening Visit

          -  Ileostomy or a colostomy

          -  Subject has a history of any clinically significant medical condition that, in the
             investigator's opinion, would prevent the subject from participating in the study.