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Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's Disease.

Crohn's Disease Clinical Trial

Official title:
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Chinese Subjects With Moderately to Severely Active Crohn's Disease

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of vedolizumab intravenous (IV) infusion as induction treatment in Chinese participants with moderately to severely active Crohn's disease (CD) at Week 10.

Clinical Trial Description

The drug being tested in this study is called vedolizumab. Vedolizumab will be administered as an intravenous (IV) infusion in Chinese participants. This study will investigate the efficacy and safety of vedolizumab IV as induction and maintenance therapy in participants with moderately to severely active Crohn's Disease (CD). The study will enroll approximately 300 moderately to severely active Chinese patients with CD. Induction Phase: participants will be randomized 2:1 to receive: - Vedolizumab IV 300 mg - Placebo IV Participants will receive vedolizumab 300 mg or matching placebo, intravenous (IV) infusion at Weeks 0, 2, and 6 in the induction phase. At Week 10, participants will be assessed for clinical response. Results of Week 10 clinical response will determine the treatment pathway in the maintenance phase. Maintenance Phase: participants who achieved clinical response at Week 10 will continue to receive the same treatment as they received in Induction Phase; every 8 weeks (Q8W) starting at Week 14. Participants who received vedolizumab IV or placebo in the Induction Phase and did not achieve clinical response at Week 10 will receive vedolizumab every 4 weeks (Q4W) starting at Week 14. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03234907
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 3
Start date August 3, 2017
Completion date August 14, 2020
View Details
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