Last updated on April 2019

Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis

Brief description of study

The purpose of this study is to assess the effect of vedolizumab intravenous IV as induction and maintenance treatment in Chinese participants with moderately to severely active ulcerative colitis (UC).

Detailed Study Description

The drug being tested in this study is called Vedolizumab. Vedolizumab will be administered as an intravenous (IV) infusion. This study will investigate the efficacy and safety of vedolizumab IV as induction and maintenance therapy in participants with moderately to severely active ulcerative colitis (UC).

The study will enroll approximately 302 moderately to severely active patients with ulcerative colitis.

The Induction Phase contained 2 cohorts of participants: Cohort 1 participants will be randomized 1:2 in a double-blinded manner to receive:

  • Vedolizumab IV 300 mg
  • Placebo IV

Cohort 2 participants will be treated with open-label vedolizumab. The second cohort was enrolled to ensure that the sample size of Induction Phase responders randomized into the Maintenance Study provided sufficient power for the Maintenance Study primary efficacy analysis.

Participants will receive induction therapy of Vedolizumab 300 mg or matching placebo, intravenous (IV) infusion at Weeks 0, 2, and 6. At Week 10, participants will be assessed for clinical response based on complete clinic Mayo score. Results of Week 10 clinical response will determine the treatment pathway in maintenance phase.

In the Maintenance Phase, participants who received vedolizumab in the induction phase and achieved clinical response at Week 10 will be randomized 1:1 in a double-blinded manner to receive vedolizumab IV 300 mg or placebo starting from Week 14 (i.e., Weeks 14, 22, 30, 38, 46, and 54).

This multi-center trial will be conducted in China. The overall time to participate in this study is 60 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone, 6 months after last dose of study drug for a long term follow-up safety survey.

Clinical Study Identifier: NCT03221036

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Yinchuan, China
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