A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease

Inclusion Criteria:

- Age 18 to 80

- Diagnosis of moderately to severely active Crohn's disease

- Crohn's Disease involvement of the ileum and/or colon

- Demonstrated, over the previous 5 year period, an inadequate response to, loss of
response to, or intolerance of at least one conventional therapy as defined by the
protocol

- May be receiving a therapeutic dose of conventional therapies for IBD as defined by
the protocol

Exclusion Criteria

- Evidence of abdominal abscess at the initial screening visit

- Extensive colonic resection, subtotal or total colectomy

- History of >3 small bowel resections or diagnosis of short bowel syndrome

- Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine

- Have received non permitted therapies within either 30 or 60 days, depending on the
medication, as stated in the protocol

- Chronic hepatitis B or C infection; HIV infection

- Active or latent tuberculosis