Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease

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.