Trial Information

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

This multicenter, phase 3, randomized, blinded, placebo-controlled study in patients with moderately to severely active ulcerative colitis comprises two phases:

The Induction Phase, designed to establish the efficacy and safety of vedolizumab (MLN0002) for the induction of clinical response and remission
The Maintenance Phase, designed to establish the efficacy and safety of vedolizumab (MLN0002) for the maintenance of clinical response and remission

Official Title
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis

Inclusion Criteria:
Each patient must meet all of the following inclusion criteria to be enrolled in the study:

Age 18 to 80
Diagnosis of moderately to severely active ulcerative colitis
Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one conventional therapy as defined by the protocol
May be receiving a therapeutic dose of conventional therapies for IBD as defined by the protocol

Exclusion Criteria:

Evidence of abdominal abscess at the initial screening visit
Extensive colonic resection, subtotal or total colectomy
Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
Have received non permitted IBD therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
Chronic hepatitis B or C infection
Active or latent tuberculosis

For a listing of recruitment sites in your area contact: Millennium Medical and Drug Information Center:
1-877-674-3784 or complete the email form below.

Syracuse Gastroenterological Associates
Located in:
Syracuse, NY 13210
Phone: 315-234-6677
Email: medical@mlnm.com

If you would like to learn more about participating in this study, please send an email message using the form below.

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