Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's Disease

Inclusion Criteria

• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
• Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
• Has a diagnosis of moderately to severely active Crohn's disease (CD) at least 3 months prior to enrollment, with a Crohn's Disease Activity Index (CDAI) score of 220-450 during the Screening Period, a simple endoscopic score for Crohn's Disease (SES-CD) score of ≥7 and presence of at least one mucosal ulceration documented by recorded ileocolonoscopy at Screening assessed by the central reader.
• Has CD with involvement of the ileum and/or colon that can be assessed by ileocolonoscopy.
• Is male or female and aged 18 to 80 years, inclusive.
• A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
• A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
• Has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below:
• Immunomodulators:

i. Has signs and symptoms of persistently active disease despite a history of at least one 12-week regimen of oral azathioprine (≥1.5 mg/kg) or 6-mercaptopurine (≥0.75 mg/kg), OR ii. Has a history of intolerance (including but not limited to nausea/vomiting, abdominal pain, pancreatitis, liver function test abnormalities, lymphopenia, thiopurine S-methyltransferase non wild type [where wild type is defined as thiopurine S-methyltransferase (TPMT)*1/*1], infection) to at least 1 immunomodulator.

• Tumor necrosis factor- alpha (TNF-α) antagonists:

i. Has signs and symptoms of persistently active disease despite a history of at least 1 induction with:

• Infliximab: 4-week regimen of 5 mg/kg, 2 doses at 2 weeks apart, OR
• Adalimumab: 2-week regimen of 160 mg on Day 1 and 80 mg on Day 15, OR
• Certolizumab: 4-week regimen of 400 mg initially at Weeks 0, 2, 4 OR ii. Has recurrence of symptoms during maintenance dosing following prior clinical benefit (discontinuation despite clinical benefit does not qualify), OR iii. Has a history of intolerance of infliximab, adalimumab, or certolizumab, including but not limited to, infusion-related reaction, demyelination, congestive heart failure, or infection.
• Corticosteroids i. Signs and symptoms of persistently active disease despite a history of at least one 4-week induction regimen that included a dose equivalent to prednisone 30 mg daily orally for 2 weeks or intravenous(ly) (IV) for 1 week, OR ii. Signs and symptoms of persistently active disease despite treatment with budesonide 9 mg daily or 6 mg daily for maintenance, OR iii. At least one failed attempt to taper corticosteroids to below a dose equivalent to prednisone 10 mg daily orally, OR iv. History of intolerance to corticosteroids (including, but not limited to, Cushing's syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, and infection).
• May be receiving a stable therapeutic dose of conventional therapies for CD (excluding other biologic agents 60 days before enrollment).
• Has a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factors must be up-to-date on colorectal cancer surveillance (may be performed during Screening).

Exclusion Criteria

• Has received a diagnosis of ulcerative colitis or indeterminate colitis.
• Has clinical evidence of abdominal abscess.
• Has a history of >3 small bowel resections or diagnosis of short bowel syndrome.
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