Crohn's Disease Clinical Trial
Official title:
A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease (ENTERPRISE)
The purpose of this study is to evaluate the percentage of participants with perianal fistula healing at Week 30 in 2 different dose regimens of vedolizumab intravenous (IV) 300 milligram (mg) in participants with fistulizing Crohn's disease (CD).
The drug being tested in this study is called vedolizumab IV. Vedolizumab IV is being tested
to treat people who have fistulizing CD. This study will look at fistula healing in people
who take vedolizumab IV.
The study is planned to enroll approximately 100 patients. Participants will be randomly
assigned (by chance, like flipping a coin) to one of the two treatment groups—which will
remain undisclosed to the patient and study doctor during the study (unless there is an
urgent medical need):
- Group 1: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 14 and 22, and a placebo infusion
at Week 10 (dummy inactive infusion - this is a solution that looks like the study drug
but has no active ingredient).
- Group 2: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 10, 14 and 22.
This multi-center trial will be conducted worldwide. The overall time to participate in this
study from screening to 18 weeks after the last dose is 44 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 follow-up assessment.
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