Last updated on December 2019

Phase 4 Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis


Brief description of study

The purpose of this study is to assess the efficacy and safety of vedolizumab intravenous (IV) in participants with a proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis (UC) who have developed chronic or recurrent pouchitis, or require continuous antibiotic treatment.

Detailed Study Description

Vedolizumab is being tested to treat people who have chronic pouchitis. This study will look at the healing of inflammation of ileal pouch in people who take vedolizumab as compared to those receiving a matching placebo. The study will enroll approximately 110 patients. Participants will be randomly assigned to one of the two treatment groupswhich will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

  • Vedolizumab 300 mg IV
  • Placebo

All participants will receive an intravenous infusion at Weeks 0, 2, 6, 14, 22, and 30 along with concomitant antibiotic treatment with ciprofloxacin 500 mg twice daily through Week 4.

This multicenter trial will be conducted in North America and Europe. The overall time to participate in treatment and efficacy assessment of this study is 34 weeks. Participants will make multiple visits to the clinic, plus a final visit 18 weeks after the last dose of study drug for a safety follow-up assessment (up to Week 48). Participants will also participate in a long-term follow-up, by phone after the last dose of study drug up to Week 56.

Clinical Study Identifier: NCT02790138

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University of Minnesota

Minneapolis, MN United States
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Mayo Clinic

Rochester, MN United States
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University of North Carolina GI

Chapel Hill, NC United States
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Cleveland Clinic Foundation

Cleveland, OH United States
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UZ Leuven

Leuven, Belgium
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Hopital Saint-Eloi

Montpellier cedex 5, France
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CHU Lyon - Hopital Lyon Sud

Pierre Benite cedex, France
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CHU Saint Etienne - Hopital Nord

Saint-Priest en Jarez, France
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Hopital de Brabois

Vandoeuvre les Nancy, France
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Hospital Doctor Negrin

Las Palmas de Gran Canaria, Spain
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St. Mark's Hospital

Harrow, United Kingdom
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Royal London Hospital

London, United Kingdom
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CHRU Nancy Hopital de Brabois

Vandoeuvre les Nancy, France
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