NCT03234907

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Vedolizumab IV	Vedolizumab IV infusion
DRUG	Placebo	Vedolizumab placebo-matching

Timeline

• Start date: 2017-08-03
• Primary completion: 2020-08-14
• Completion: 2020-08-14
• First posted: 2017-07-31
• Last updated: 2023-03-01
• Results posted: 2022-09-21

Locations

29 sites across 1 country: China

Regulatory

• FDA-regulated drug study