Phase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors
Phase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors
This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with infliximab in treating participants with moderate to severe ulcerative colitis (UC) who are naive to tumor necrosis factor (TNF) inhibitors. Participants will be randomized in a 1:1 ratio to receive either etrolizumab 105 milligrams (mg) by subcutaneous (SC) injection once every 4 weeks (Q4W) + placebo (intravenous [IV] infusion at Weeks 0, 2, and 6, then once every 8 weeks [Q8W]) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6, then Q8W) + placebo (SC Q4W). Time on treatment is 54 weeks.
Inclusion Criteria:
Exclusion Criteria:
Edmonton, Alberta T6G 2X8, Canada
Greenfield Park, Quebec J4V 2H1, Canada
Kladno, 272 59, Czechia
Ústí nad Labem, 401 13, Czechia
Freiburg im Breisgau, 79106, Germany
Budapest, H-1077, Hungary
Miskolc, 3526, Hungary
Tel Litwinsky, 52621, Israel
Milan, Lombardy 20162, Italy
Milan, Lombardy, Italy
San Giovanni Rotondo, Lombardy 71013, Italy
NL -nijmegen, 6525 GA, Netherlands
Lørenskog, 1478, Norway