Crohn's Disease Clinical Trial
Official title:
An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV
The purpose of this study is to evaluate endoscopic remission at Week 26 as assessed by ileocolonoscopy.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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