A Six Week Efficacy, Safety and Tolerability Study of V565 in 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