Overview

Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis

Status:
Completed

Trial end date:
2012-03-01

Target enrollment:
0

Participant gender:
All

Summary

The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.

Phase:

Phase 3

Accepts Healthy Volunteers?

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:

1. Diagnosis of moderately to severely active ulcerative colitis

2. Demonstrated, over the previous 5 year period, an inadequate response to, loss of
response to, or intolerance at least 1 of the following agents:

1. Immunomodulators

2. Tumor necrosis factor-alpha (TNFα) antagonists

3. Corticosteroids

3. May be receiving a therapeutic dose of conventional therapies for inflammatory bowel
disease (IBD) as defined by the protocol

Exclusion Criteria:

1. Evidence of abdominal abscess at the initial screening visit

2. Extensive colonic resection, subtotal or total colectomy

3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine

4. Have received non permitted IBD therapies within either 30 or 60 days, depending on
the medication, as stated in the protocol

5. Chronic hepatitis B or C infection

6. Active or latent tuberculosis