Inflammatory Bowel Disease Clinical Trial
Official title:
A Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Vedolizumab IV for the Treatment of Primary Sclerosing Cholangitis, With Underlying Inflammatory Bowel Disease
The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) in non-end-stage primary sclerosing cholangitis (PSC) participants with underlying inflammatory bowel disease (IBD).
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to
treat people who have non-end-stage primary sclerosing cholangitis (PSC) with underlying
inflammatory bowel disease (IBD). This study will look at changes in fibrosis staging in
people who take vedolizumab.
The study will enroll approximately 258 patients. Participants will be randomly assigned (by
chance, like flipping a coin) to one of the three treatment groups in ratio 1:1:1—which will
remain undisclosed to the patient and study doctor during the study (unless there is an
urgent medical need):
- Vedolizumab 300 mg once every 4 weeks (Q4W)
- Vedolizumab 300 mg once every 8 weeks (Q8W)
- Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has
no active ingredient
All participants will be administered vedolizumab or placebo via intravenous infusion
This multi-center trial will be conducted worldwide. The overall time to participate in this
study is up to 124 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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