Phase 2 Study to Investigate the Efficacy, Safety, and Tolerability of Six Weeks Treatment With V565 in Subjects With Active Crohn's Disease
Phase 2 Study to Investigate the Efficacy, Safety, and Tolerability of Six Weeks Treatment With V565 in Subjects With Active Crohn's Disease
The purpose of this study is to evaluate the efficacy and safety of V565 in participants with active Crohn's Disease (CD).
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:
Exclusion Criteria:
Lørenskog, 1478, Norway