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



Status:Recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:10/11/2018
Start Date:December 2016
Contact:VHsquared Information
Email:info@vhsquared.com
Phone:+44 (0)1223 837650

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Phase 2 Study to Investigate the Efficacy, Safety, and Tolerability of Six Weeks Treatment With V565 in Subjects With Active Crohn's Disease

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

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.

Inclusion Criteria:

- History of Crohn's Disease of at least 3 months duration prior to screening

- CDAI score of ≥220 to ≤450 during screening

- CRP ≥5 mg/L (or, if CRP is normal, FCP ≥250 µg/g) at screening

- Permitted CD medication regimen expected to remain stable during the period of the
study

Exclusion Criteria:

- Previous lack of response or current contra-indication to an anti-TNFα agent

- Certain complications of Crohn's Disease that would make it hard to assess response to
study drug

- Known history or suspicion of IBD other than Crohn's disease

- History of TB or latent TB infection that has not been treated

- Any significant illness or condition which would preclude effective participation in
the study

- GI infection as demonstrated by presence of enteric pathogens

- Pregnant or lactating women

- Abdominal surgery in the previous 6 months

- Unsuitable for inclusion in the study in the opinion of the investigator or sponsor
for any reason that may compromise the subject's safety or confound data
interpretation
We found this trial at
14
sites
Gainesville, Florida 32607
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2147 Northeast Coachman Road
Clearwater, Florida 33765
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Clearwater, FL
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1100 N. St. Francis
Wichita, Kansas 67214
316-291-4774
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Wichita, KS
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Anaheim, California 92805
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Anaheim, CA
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3001 Executive Drive
Clearwater, Florida 33762
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Clearwater, FL
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DeSoto, Texas 75115
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DeSoto, TX
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Evanston, Illinois 60208
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Evanston, IL
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11 Feschnigstraße
Klagenfurt, 9020
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Klagenfurt,
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Miami, Florida 33175
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Miami, FL
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Miami Springs, Florida 33166
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Miami Springs, FL
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Mount Airy, North Carolina 27030
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Mount Airy, NC
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San Diego, California 92115
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San Diego, CA
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901 Southwest Garfield Avenue
Topeka, Kansas 66606
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Topeka, KS
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Tucson, Arizona 85710
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Tucson, AZ
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