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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objectives of this study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of vedolizumab in patients with ulcerative colitis (UC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Treatments: Vedolizumab

Criteria

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