NCT02425111

Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's Disease

An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate endoscopic remission at Week 26 as assessed by ileocolonoscopy.

Detailed description

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have Crohn's disease. This study will look at mucosal healing in people who take vedolizumab. The study will enroll approximately 100 patients and will be conducted in 2 Parts. Part A will consist of a 26-week treatment period and all participants will receive vedolizumab 300 mg intravenously (IV) on Day 1 and at Weeks 2, 6, 14 and 22. Part B will consist of a 26-week extension treatment period and all participants will receive vedolizumab 300 mg IV at Weeks 30, 38, and 46. This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 70 weeks for Parts A, B and 18-Week Follow-up combined. Participants will make multiple visits to the clinic. All participants included in the study will also have a 6 month safety follow-up telephone call following his/her last dose of study drug.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Vedolizumab	Vedolizumab intravenous injection

Timeline

• Start date: 2015-03-30
• Primary completion: 2017-06-02
• Completion: 2018-02-21
• First posted: 2015-04-23
• Last updated: 2018-09-14
• Results posted: 2018-09-14

Locations

79 sites across 8 countries: United States, Belgium, Canada, Czechia, France, Hungary, Italy, Poland