NCT01177228

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

A Phase 2, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN0002 Following Multiple Intravenous Doses in Patients With Ulcerative Colitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

At the end of the study, eligible participants could enroll and receive treatment and follow-up in Study C13004 (NCT00619489). Participants who did not proceed into Study C13004 were followed by telephone contact at 6-month intervals for 2 years after the last administration of study treatment to collect reports of adverse events, including colectomy, severe infections \[including progressive multifocal leukoencephalopathy (PML)\], and dysplasia/cancer.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Vedolizumab	Vedolizumab for intravenous infusion
DRUG	Placebo	Placebo intravenous infusion

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-06-01
• Completion: 2008-09-01
• First posted: 2010-08-06
• Last updated: 2014-07-18
• Results posted: 2014-07-18