Combined Phase 2b/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 Ulcerative Colitis
Combined Phase 2b/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 Ulcerative Colitis
The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced.
Participants who complete the study, or met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899: NCT02914535).
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Boston, Massachusetts 02114, United States
Hamilton, Ontario L8S 4K1, Canada
Mladá Boleslav, 293 01, Czechia
Prague, 190 00, Czechia
Athens, 11527, Greece
Shatin, Hong Kong
Békéscsaba, 5600, Hungary
Budapest, 1097, Hungary
Budapest, 1125, Hungary
Debrecen, 4032, Hungary
Mosonmagyaróvár, 9200, Hungary
Milan, 20121, Italy
Hachioji-shi, 192-0032, 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
Lørenskog, N-1478, Norway
Bialystok, 15-276, Poland
Poznan, 60-848, Poland
Torun, 87-100, Poland
Warsaw, 02-507, Poland
Bucharest, 020125, Romania
Chelyabinsk, 454076, Russia
Irkutsk, 669079, Russia
Moscow, 115446, Russia
Moscow, 127015, Russia
Moscow, 129110, Russia
Nizhny Novgorod, 603126, Russia
Novosibirsk, 630084, Russia
Novosibirsk, 630087, Russia
Saint Petersburg, 191015, Russia
Tyumen, 625026, Russia
Seoul, 06351, South Korea
Cherkasy, 18000, Ukraine
Chernivtsi, 58000, Ukraine
Chernivtsi, 58000, Ukraine
Dnipropetrovsk, 49000, Ukraine
Ivano-Frankivsk, 76000-490, Ukraine
Kharkiv, 61037, Ukraine
Kharkiv, 61039, Ukraine
Kharkiv, 63101, Ukraine
Kropyvnytskyi, 25006, Ukraine
Kyiv, 1103, Ukraine
Odesa, 65010, Ukraine
Odesa, 65025, Ukraine
Ternopil, 46002, Ukraine
Vinnytsia, 21005, Ukraine
Vinnytsia, 21018, Ukraine
Zaporizhzhya, 69600, Ukraine
Glasgow, G51 4TF, United Kingdom