Last updated on October 2018

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Crohn's Disease
  • Age: Between 18 - 80 Years
  • Gender: Male or Female

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 g/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-TNF 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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