A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease

Exclusion Criteria25

• The participant has evidence of abdominal abscess at the initial screening visit.
• The participant has had extensive colonic resection, subtotal or total colectomy.
• The participant has a history of \>3 small bowel resections or diagnosis of short bowel syndrome.
• The participant has received tube feeding, defined formula diets, or parenteral alimentation within 21 days before administration of the first dose of study drug.
• The participant has had ileostomy, colostomy, known fixed symptomatic stenosis of the intestine, or evidence of fixed stenosis, or small bowel stenosis with prestenotic dilation.
• Within 30 days before randomization, the participant has received any of the following for the treatment of underlying disease:
• Nonbiologic therapies (eg, cyclosporine, thalidomide) other than those specifically listed in the Permitted Medications and Treatments section.
• An approved or investigational nonbiologic therapy in an investigational protocol.
• The participant has received traditional Chinese medication (TCMs) within 30 days before randomization.
• The participant has had previous exposure to approved or investigational anti-integrins including, but not limited to natalizumab, efalizumab, etrolizumab, or abrilumab (AMG-181), or mucosal vascular addressin cell adhesion molecule 1 (MAdCAM-1) antagonists, or rituximab.
• The participant has had previous exposure to vedolizumab.
• The participant has used topical (rectal) treatment with 5-aminosalicylic acid (5-ASA), corticosteroid enemas/suppositories or traditional Chinese medications for CD treatment within 2 weeks of the administration of the first dose of study drug.
• The participant requires currently or is anticipated to require surgical intervention for CD during the study.
• The participant has a history or evidence of adenomatous colonic polyps that have not been removed.
• The participant has a history or evidence of colonic mucosal dysplasia including low or high-grade dysplasia, as well as indeterminate for dysplasia.
• The participant has evidence of active infection during the screening period.
• The participant has evidence of treatment for Clostridioides difficile (C difficile) infection or other intestinal pathogen within, 28 days before first dose of study drug.
• The participant has chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection.
• The participant has active or latent tuberculosis (TB).
• The participant has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation).
• The participants has received any live vaccinations within 30 days before screening.
• The participant has a clinically significant active infection (eg, pneumonia, pyelonephritis, or coronavirus disease 2019 \[COVID-19\]) within 30 days before screening or during screening, or has an ongoing chronic infection or any ongoing COVID-19-related symptom(s), if previously diagnosed as having COVID-19.
• The participant has had any surgical procedure requiring general anesthesia within 30 days before enrollment or is planning to undergo major surgery during the study period.
• The participant has any history of malignancy, except for the following: (a) adequately-treated nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been adequately treated and has not recurred for at least 1 year before randomization; and (c) history of cervical carcinoma in situ that has been adequately treated and has not recurred for at least 3 years before randomization. Participants with remote history of malignancy (eg, \>10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received and must be discussed with the sponsor on a case-by-case basis before randomization.
• The participant has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.