Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Crohn's Disease
Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Crohn's Disease
The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced.
Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Washington D.C., District of Columbia 20007, United States
Boston, Massachusetts 02114, United States
New York, New York 10016, United States
Milwaukee, Wisconsin 53215, United States
Clayton, New South Wales 3168, Australia
North York, M6A 3B4, Canada
Mladá Boleslav, 293 01, Czechia
Prague, 190 00, Czechia
Frankfurt am Main, 60594, Germany
Athens, 11527, Greece
Athens, 12462, Greece
Ioannina, 45332, Greece
Pátrai, 26500, Greece
Thessaloniki, 54642, Greece
Shatin, Hong Kong
Békéscsaba, 5600, Hungary
Budapest, 1097, Hungary
Budapest, 1125, Hungary
Debrecen, 4032, Hungary
Mosonmagyaróvár, 9200, Hungary
Pune, 411001, India
Ageo-shi, 362-0075, Japan
Jonan-ku, 814-0180, Japan
Kitakyushu-shi, 802-0077, Japan
Kurume-shi, 830-0011, Japan
Kurume-shi, 839-0809, Japan
Mitaka-shi, 181-8611, Japan
Nagakute-shi, 480-1195, Japan
Shinjuku-ku, 169-0073, Japan
Takasaki-shi, 3700829, Japan
Toyota-shi, 470-1219, Japan
Bialystok, 15-276, Poland
Bydgoszcz, 85-168, Poland
Lodz, 90-153, Poland
Poznan, 60-848, Poland
Torun, 87-100, Poland
Warsaw, 02-507, Poland
Bucharest, 010825, Romania
Chelyabinsk, 454076, Russia
Irkutsk, 669079, Russia
Moscow, 127015, Russia
Moscow, 129110, Russia
Nizhny Novgorod, 603126, Russia
Novosibirsk, 630087, Russia
Novosibirsk, 630091, Russia
Saint Petersburg, 191015, Russia
Seoul, 06351, South Korea
Chernivtsi, 58000, Ukraine
Dnipropetrovsk, 49000, Ukraine
Ivano-Frankivsk, 76018, Ukraine
Kharkiv, 61037, Ukraine
Kharkiv, 63101, Ukraine
Kropyvnytskyi, 25006, Ukraine
Kyiv, 1103, Ukraine
Odesa, 65025, Ukraine
Ternopil, 46002, Ukraine
Vinnytsia, 21005, Ukraine
Vinnytsia, 21018, Ukraine
Zaporizhzhya, 69600, Ukraine
Norwich, Norfolk NR4 7UY, United Kingdom
Glasgow, G51 4TF, United Kingdom