An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).
Inclusion Criteria:
Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies listed below or other qualified region-specific studies and meet the following additional criteria:
Exclusion Criteria:
Dothan, Alabama 36305, United States
Atlanta, Georgia 30342, United States
Gurnee, Illinois 60031, United States
Chevy Chase, Maryland 20815, United States
Creve Coeur, Missouri 63141, United States
Cincinnati, Ohio 45219, United States
Lemoyne, Pennsylvania 17043, United States
Arlington, Texas 76012, United States
New Braunfels, Texas 78130, United States
San Marcos, Texas 78666, United States
Tyler, Texas 75701, United States
North Mackey, Queensland 4740, Australia
Buderim, 4556, Australia
Vienna, 1090, Austria
Grodno, 230023, Belarus
Sofia, 1606, Bulgaria
Ostrava-Poruba, 708 52, Czechia
Tbilisi, 0159, Georgia
Berlin, 10117, Germany
Bonn-Duisdorf, 53123, Germany
Gyula, Bekes County 5600, Hungary
Gyula, Bekes County 5700, Hungary
Florence, Tuscany 50134, Italy
Roma, 00168, Italy
Kashiwa-shi, Chiba 277-0871, Japan
Nagareyama-shi, Chiba 270-0116, Japan
Kasuga-shi, Fukuoka 816-0863, Japan
Kitakyushu-shi, Fukuoka 807-1266, Japan
Onga-gun, Fukuoka 807-0051, Japan
Ota-shi, Gunma 373-8585, Japan
Fukuyama-shi, Hiroshima 720-0822, Japan
Asahikawa-shi, Hokkaido 070-8610, Japan
Higashiibaraki-gun, Ibaraki 311-3193, Japan
Toride-shi, Ibaraki 302-0014, Japan
Takainatsu-shi, Kagawa-ken 760-8557, Japan
Yokohama, Kanagawa 234-0054, Japan
Yokkaichi- Shi, Mie-ken 510-0891, Japan
Yokkaichi-shi, Mie-ken 510-8561, Japan
Nagaoka-shi, Niigata 940-2085, Japan
Hirakata-shi, Osaka 573-1191, Japan
Chuo-ku, Tokyo 104-8560, Japan
Itabashi-ku, Tokyo 173-8606, Japan
Kodaira-shi, Tokyo 187-8510, Japan
Minato-ku, Tokyo 108-8642, Japan
Shinjuku-ku, Tokyo 169-0073, Japan
Riga, LV-1002, Latvia
Monterrey, Nuevo León 64660, Mexico
Veracruz, 91900, Mexico
Jelenia Góra, 58-500, Poland
Sosonowiec, 41-209, Poland
Vila Nova de Gaia, Porto District 4434-502, Portugal
Novosibirsk, 630084, Russia
Penza, 440026, Russia
Saint Petersburg, 191015, Russia
Saint Petersburg, 191015, Russia
Saint Petersburg, 197022, Russia
Saint Petersburg, 197706, Russia
Samara, 443001, Russia
Stavropol, 355017, Russia
Stavropol, 355032, Russia
Banská Bystrica, 97517, Slovakia
Suwon, Gyeonggi-do 16247, South Korea
Suwon, Gyeonggi-do 16247, South Korea
Suwon, Gyeonggi-do 16247, South Korea
Bangkoknoi, Bangkok 10700, Thailand
Dnipro, 49005, Ukraine
Ivano-Frankivsk, 76000, Ukraine
Kharkiv, 61018, Ukraine
Kharkiv, 61037, Ukraine
Kharkiv, 61124, Ukraine
Kyiv, 02091, Ukraine
Lviv, 79059, Ukraine
Odesa, 65025, Ukraine
Uzhagorod, 88018, Ukraine
Vinnytsia, 21009, Ukraine
Vinnytsia, 21018, Ukraine
Vinnytsia, 21029, Ukraine