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

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

- Male or female ≥ 12 years

- Subject is able to swallow the IP tablets

- 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 7day 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 (ie,
infliximab, adalimumab, certolizumab, or vedolizumab).

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, or colitis due to
immunodeficiency

- Local manifestations of Crohn's Disease (CD) such as abscesses, short bowel syndrome;
or other disease complications for which surgery might be indicated or could confound
the evaluation of efficacy

- Subject has 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

- 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

- 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 the Week 12 visit.