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

Clinical Trial ID: NCT02976129

Description

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.


Criteria

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

  • Start Date

    2016-12-31

  • Last Updated

    2018-10-08

  • Sponsor

    VHsquared Ltd.

  • Condition Name

    Crohn's Disease

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