A 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
A 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
This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderately to severely active Crohn's Disease (CD). The target population includes participants with CD who are refractory or intolerant to corticosteroids (CS) and/or immunosuppressant (IS) therapy and who have either not received prior anti-tumor necrosis factor (anti-TNF) therapy (TNF-naive) or who have had prior exposure to anti-TNF therapies and demonstrated inadequate responses or intolerance to anti-TNFs.
The study period will consist of a Screening Phase (up to 35 days) plus (+) a 14-week Induction Phase + a 52-week Maintenance Phase + a 12-week Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving a decrease from baseline of at least 70 points in the Crohn's Disease Activity Index (CDAI) score (CDAI-70 response) without the use of rescue therapy will continue to the Maintenance Phase.
Inclusion Criteria:
Exclusion Criteria:
San Francisco, California 94158, United States
Chicago, Illinois 60611, United States
Jackson, Mississippi 39216, United States
New York, New York 10021, United States
Dallas, Texas 75390-9151, United States
Parkville, Victoria 3050, Australia
Rio de Janeiro, Rio de Janeiro 21941-590, Brazil
Passo Fundo, Rio Grande do Sul 99010-080, Brazil
Botucatu, São Paulo 18618-970, Brazil
Edmonton, Alberta T6G 2X8, Canada
Halifax, Nova Scotia B3H 1V7, Canada
Ottawa, Ontario K1H 1A2, Canada
Ostrava - Poruba, 708 52, Czechia
Milan, Lombardy 20162, Italy
Vilnius, LT-08661, Lithuania
Sittard-Geleen, 6162 BG, Netherlands
Torun, 87-100, Poland
Moskva, Adygeya Republic 127015, Russia
Novosibirsk, Altaj 630007, Russia
Saint Petersburg, Sankt-Peterburg 191015, Russia
Saint Petersburg, 194044, Russia
Majadahonda, Madrid 28222, Spain
Bern, 3012, Switzerland
Istanbul, 34722, Turkey (Türkiye)
Kozyataği, 34742, Turkey (Türkiye)
Kharkiv, Kharkiv Governorate 61204, Ukraine
Kyiv, KIEV Governorate 1023, Ukraine
Kyiv, KIEV Governorate 2091, Ukraine
Kremenchuk, Poltava Governorate 39617, Ukraine
Odesa, 65059, Ukraine