Study of Vedolizumab Following Multiple Intravenous Doses in Patients With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Vedolizumab; Placebo
Intervention description: Vedolizumab for intravenous infusion; Placebo intravenous infusion
Intervention MeSH terms: Vedolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

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).
    

Eligibility 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