Phase IIIb study of treat to target versus routine care maintenance strategies in Crohn’s disease patients treated with ustekinemab.
The study includes a 5-week screening period, a 8-week induction period, and a maintenance period up to week 48. Non-responder at week 8 leave the study. Responders are randomized to either the routine care arm or the treat to target arm where their treatment intervals can be shortened to 8-weekly or 4-weekly dosing.
Main inclusion criteria
– Active moderate to severe Crohn’s disease defined by CDAI between 220-450.
– Have received treatment with conventional therapy or one previous biologic agent approved for the treatment of Crohn’s disease
Main exclusion criteria
– Crohn’s disease complications such as strictures, stenoses, fistulizing disease or abdominal/perianal abscesses
– Previous exposure to IL-23 or IL-12