BA phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of etrolizumab as an induction and maintenance treatment for patients with moderately to severely active Crohn's disease

-
Sponsor: Genentech, Inc.

Location(s): United States

Description

This is a phase 3 study for patients with moderate to severely active Crohn's disease to evaluate the safety and effectiveness of etrolizumab, a beta7 anti-integrin that acts on the lining of the gut to block white blood cell trafficking. The study lasts up to 72 weeks and involves a screening visit, baseline enrollment visit, and follow-up drug administration visits every 4 weeks. Patients are also required to have a colonoscopy done at screening, week 14, and week 72 to assess disease activity and response to study medication. Patients who enroll in the study will be randomly assigned to etrolizumab or placebo (inactive medication). All patients have a 20% chance of receiving placebo. After completing the Bergamot study, patients have the option to roll over into the open-label portion of the study known as Juniper, and receive active study medication for up to 6 years or until the medication is approved by the FDA.