Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease

The drug being tested in this study is called vedolizumab SC. Vedolizumab SC is being tested
to treat people who have moderate to severely active CD. This study will look at clinical
remission, as well as enhanced clinical response and corticosteroid-free remission in
participants with CD who receive vedolizumab SC maintenance therapy after having achieved a
clinical response to vedolizumab IV induction therapy.

The study will enroll approximately 824 participants. All participants will enter a 6 week
Induction Phase where they will be administered open-label vedolizumab IV 300 mg via IV
infusion at Week 0 (Day 1) and Week 2 (Day 15), and will then be assessed for a clinical
response at Week 6. Participants who achieve a clinical response at Week 6 will be randomly
assigned to one of the two treatment groups:

- Vedolizumab SC 108 mg Maintenance Arm

- Placebo SC Maintenance Arm

Participants who do not achieve a clinical response will not be randomized into the
Maintenance Period, and instead will receive a third infusion of vedolizumab IV 300 mg at
Week 6.

This multi-center trial will be conducted worldwide. The overall time to participate in this
study is up to 71 weeks. Participants will make multiple visits to the clinic, plus a final
visit 18 weeks after last dose of study drug for a follow-up assessment. Participants will
also participate in a long-term safety follow-up, by phone, at 6 months after the last dose
of study drug.

Inclusion Criteria:

1. Diagnosis of CD established at least 3 months prior to screening by clinical and
endoscopic evidence corroborated by a histopathology report.

2. Moderately to severely active CD as determined by a CDAI score of 220 to 450 and 1 of
the following:

- C-reactive protein (CRP) level greater than (>) 2.87 milligram per liter (mg/L)
OR

- Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic
ulcerations (each >0.5 centimeter [cm] in diameter) or 10 aphthous ulcerations
(involving a minimum of 10 contiguous cm of intestine) consistent with CD OR

- Fecal calprotectin >250 microgram per gram (mcg/g) stool during the screening
period in conjunction with computed tomography enterography (CTE), magnetic
resonance enterography (MRE), contrast-enhanced small bowel radiography, or
wireless capsule endoscopy revealing CD ulcerations (aphthae not sufficient), .

3. CD involvement of the ileum and/or colon, at a minimum.

4. Inadequate response with, loss of response to, or intolerance to corticosteroids,
immunomodulators, or Tumor necrosis factor-alpha (TNF-α) antagonists.

Exclusion Criteria:

1. Evidence of abdominal abscess at Screening.

2. Extensive colonic resection, subtotal or total colectomy.

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

4. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.

5. Prior exposure to investigational or approved non-biologic therapies (example,
cyclosporine, tacrolimus, thalidomide, or tofacitinib) for the treatment of underlying
disease within 30 days or 5 half-lives of screening (whichever is longer).

6. Prior exposure to any investigational or approved biologic or biosimilar agent within
60 days or 5 half-lives of screening (whichever is longer).

7. Prior exposure to vedolizumab

8. Surgical intervention for CD required at any time during the study.

9. History or evidence of adenomatous colonic polyps that have not been removed, or of
colonic mucosal dysplasia.

10. Suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis,
ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or
microscopic colitis.

11. Active infections

12. Chronic hepatitis B virus (HBV) or C (HCV) infection, tuberculosis (TB) (active or
latent), or congenital or acquired immunodeficiency. HBV immune participants (ie,
being hepatitis B surface antigen [HBsAg] negative and hepatitis B antibody positive)
may, however, be included.

13. History of any major neurological disorders, including stroke, multiple sclerosis,
brain tumor, or neurodegenerative disease.