Clinical trial NCT01177228 (phase 2, status: completed)
Conditions: ulcerative colitis
ICD codes: K51.80, K51.813, K51.814, K51.90, K51.913, K51.914, K51.811
Drugs: vedolizumab, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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