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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VHsquared Ltd.

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