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

Date de début de l'étude : 1 décembre 2016

Inclusion Criteria: * History of Crohn's Disease of at least 3 months duration prior to screening * Crohn's Disease Activity Index (CDAI) score of ≥220 to ≤450 during screening * C-reactive protein (CRP) ≥5 mg/L (or, if CRP is normal, faecal calprotectin (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-tumour necrosis factor α (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 inflammatory bowel disease other than Crohn's disease * History of tuberculosis (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