Last updated on October 2018

A Six Week Efficacy Safety and Tolerability Study of V565 in Crohn's Disease

Brief description of study

The purpose of this study is to evaluate the efficacy and safety of V565 in participants with active Crohn's Disease.

Detailed Study Description

This study will be a multiple-site, double-blind, placebo-controlled, parallel-group study in approximately 126 subjects with a confirmed diagnosis of CD for at least three months and have CD involving the ileum and/or colon. Following a screening period of up to 28 days, subjects will be randomly allocated into one of two treatment arms: either V565 or placebo using a 2:1 active:placebo ratio for a treatment period of 6 weeks.

Subjects will be treated with study drug as an add-on to any permitted stable medications already being taken for CD.

Clinical Study Identifier: NCT02976129

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Sarkis Clinical Trials

Gainesville, FL United States
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Galiz Research, LLC

Miami Springs, FL United States
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Via Christi Research

Wichita, KS United States
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Clinical Trials of America

Mount Airy, NC United States
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Global Medical Research

DeSoto, TX United States
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CI City Hospital #1

Zaporizhzhia, Ukraine
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St Thomas' Hospital

London, United Kingdom
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West Central Gastroenterology

Clearwater, FL United States
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Northwestern University

Evanston, IL United States
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Leipzig, Germany
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ETZ Elisabeth

Tilburg, Netherlands
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Praxis fuer Magen

Heidelberg, Germany
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DRC Gyogyszervizsgalo

Balatonfüred, Hungary
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Recruitment Status: Open

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