Study of Vedolizumab Following Multiple Intravenous Doses in Patients With Ulcerative Colitis

Inclusion Criteria

Each patient must meet all of the following inclusion criteria to be enrolled in the study. - Males or non-pregnant, non-lactating females voluntarily able to give informed consent - All patients must agree to use 2 effective forms of contraception from screening to the end of the study - Negative surveillance colonoscopy within the last 6 months if indicated by standard clinical practice guidelines - Confirmed and active ulcerative colitis (UC) - Partial Mayo Score 1 - 7 - Disease involvement extending proximal to the rectum - May be receiving a therapeutic dose of conventional therapies for UC as defined by the protocol

Exclusion Criteria

Patients meeting any of the following exclusion criteria are not to be enrolled in the study. - Patients who require ulcerative colitis (UC) surgical intervention or for whom surgical intervention is anticipated during the study - Patients who fail to meet laboratory values as specified in the protocol or have a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during the screening period - Low-grade dysplasia, high-grade dysplasia, dysplasia-associated lesion or mass, or colorectal cancer - Treatment with cyclosporine, FK506 (tacrolimus) or infliximab within 60 days prior to study - Patients receiving any of the following within 14-days prior to the study: antibiotics for treatment of irritable bowel syndrome, heparin or warfarin, narcotics, tube feeding, defined formula diets or parenteral alimentation - Colostomy, fistulae or known fixed symptomatic stenosis of the intestine - Immunologic or ischemic intestinal condition - Toxic megacolon - Chronic hepatitis B or C or human immunodeficiency virus (HIV) infection - Any vaccinations within 30 days prior to study drug administration - History of imaging abnormalities, multiple sclerosis (MS), brain tumor or neurodegenerative disease - Significantly impaired liver or renal function - Current or recent history of alcohol dependence - Current use of illicit drugs - Active or recent serious infections or serious underlying disease as specified in protocol - Active psychiatric problems that might interfere with compliance to study - Previous exposure to MLN0002 - Participated in an investigational study within 30 days prior to study drug administration or received treatment with an investigational monoclonal antibody within the last 6 months