Multicentric, KSSG as participating partner
This is a multicenter, Phase III, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderate to severely active CD. The study design will comprise 1) a Screening Phase (up to 28 days) to determine patients’ eligibility for the study, 2) an Induction Phase (14 weeks), followed by 3) a Maintenance Phase (60 weeks) in patients demonstrating a CDAI-70 response at the end of the Induction Phase, and 4) a Safety Follow-Up Phase (12 weeks) after administration of the last dose of study drug in the Maintenance Phase for those patients who are not participating in Part 1 of open-label extension Study GA29145 to receive etrolizumab treatment. At the completion of the Safety Follow-Up Phase, patients will be asked to enter an extended PML-monitoring phase (open-label extension Study GA29145, Part 2) for 92 weeks. An independent Data Monitoring Committee (iDMC) will monitor safety and study conduct on an ongoing basis.