Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis

Inclusion Criteria:

1. Has a diagnosis of ulcerative colitis (UC) established at least 3 months prior toScreening by clinical and endoscopic evidence corroborated by a histopathologyreport. Cases of UC established at least 6 months before randomization for which ahistopathology report is not available will be considered based on the weight ofevidence supporting the diagnosis and excluding other potential diagnoses and mustbe discussed with the sponsor on a case-by case basis before randomization.

2. Has moderately to severely active UC as determined by a complete Mayo score of 6-12with an endoscopic subscore ≥2 within 10 days prior to the first dose of IP. Theendoscopy can be performed during the Screening Phase (Day -10 to Day -5 to allowfor central reading prior to first dose at Week 0).

3. Has evidence of UC extending proximal to the rectum (≥15 cm of involved colon).

4. Participants with extensive colitis or pancolitis of >8 years duration or left-sidedcolitis >12 years duration must have documented evidence that a surveillancecolonoscopy was performed within 12 months of the initial Screening Visit (may beperformed during screening).

5. Participants with a family history of colorectal cancer, personal history ofincreased colorectal cancer risk, age >50 years, or other known risk factors must beup-to-date on colorectal cancer surveillance (may be performed during screening).

6. Has demonstrated an inadequate response to, loss of response to, or intolerance ofat least 1 of the following agents: corticosteroids, immunomodulators, or tumornecrosis factor alpha (TNF-α) antagonists.

Exclusion Criteria:

1. Has evidence of abdominal abscess or toxic megacolon at the initial Screening Visit.

2. Has had extensive colonic resection, subtotal or total colectomy.

3. Has an existing ileostomy, colostomy, or known fixed symptomatic stenosis of theintestine. A history of ileostomy or colostomy that has been reversed may beacceptable.

4. Has had any previous exposure to approved or investigational anti-integrins (forexample, natalizumab, efalizumab, etrolizumab, or AMG-181) or mucosal address incell adhesion molecule-1 (MAdCAM-1) antagonist, or rituximab.

5. Has used a topical (rectal) treatment with 5-acetyl salicylic acid (5-ASA) orcorticosteroid enemas/suppositories or traditional Chinese medications for treatmentof UC within 2 weeks of the administration of the first dose of IP.

6. Currently requires or is anticipated to require surgical intervention for UC duringthe study.

7. Has a history or evidence of adenomatous colonic polyps that have not been removedor has a history or evidence of colonic mucosal dysplasia including low orhigh-grade dysplasia, as well as indeterminate for dysplasia.

8. Has a suspected or confirmed diagnosis of Crohn's enterocolitis, indeterminatecolitis, ischemic colitis, radiation colitis, diverticular disease associated withcolitis, or microscopic colitis.

9. Has evidence of or has had treatment for C. difficile infection or other intestinalpathogen within 28 days prior to randomization.

10. Has chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV)infection.

11. Has active or latent TB.

12. Has any identified congenital or acquired immunodeficiency (for example, commonvariable immunodeficiency, human immunodeficiency virus [HIV] infection, organtransplantation).

13. Has any history of malignancy, except for the following: (a) adequately treatednon-metastatic basal cell skin cancer; (b) squamous cell skin cancer that has beenadequately treated and that has not recurred for at least 1 year prior torandomization; and (c) history of cervical carcinoma in situ that has beenadequately treated and that has not recurred for at least 3 years prior torandomization. Subjects with remote history of malignancy (for example, >10 yearssince completion of curative therapy without recurrence) will be considered based onthe nature of the malignancy and the therapy received and must be discussed with thesponsor on a case-by-case basis prior to randomization.

14. Has a history of any major neurological disorders, including stroke, multiplesclerosis, brain tumor, or neurodegenerative disease.

15. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptomchecklist at Screening or prior to the administration of the first dose of IP atWeek 0.