A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis
A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis
The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.
This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally.
Inclusion Criteria:
- Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.
Exclusion Criteria:
Los Angeles, California 90067-2001, United States
Topeka, Kansas 66606, United States
Boston, Massachusetts 02114, United States
Ann Arbor, Michigan 48109, United States
North Massapequa, New York 11758, United States
Rochester, New York 14642, United States
Tulsa, Oklahoma 74136-7823, United States
Hershey, Pennsylvania 17033-2360, United States
Wyomissing, Pennsylvania 19610, United States
Greenville, South Carolina 29607, United States
Garland, Texas 75044, United States
San Antonio, Texas 78212, United States
Roanoke, Virginia 24014-1372, United States
Ciudad Autonoma Buenos Aires, Buenos Aires 1431, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1115, Argentina
Córdoba, 5016, Argentina
Anderlecht, Brussels Capital 1070, Belgium
Yvoir, Namur 5530, Belgium
Goiânia, Goiás 74535-170, Brazil
Ribeirão Preto, São Paulo 14049-900, Brazil
Sofiya, Sofia 1527, Bulgaria
Montreal, Quebec H1T 2M4, Canada
Montreal, Quebec H3G 1A4, Canada
Victoria, Araucania 4720843, Chile
Guangzhou, Guangdong 510655, China
Wuhan, Hubei 430048, China
Huaian, Jiangsu 223399, China
Shanghai, Shanghai Municipality 200065, China
Shanghai, Shanghai Municipality 200127, China
Xi’an, Shanxi 710038, China
Hangzhou, Zhejiang 310009, China
Hangzhou, Zhejiang 310018, China
Bogota DC, Cundinamarca 111221, Colombia
Copenhagen NV, Capital Region 2400, Denmark
Menoufiya, Monufia Governorate 35111, Egypt
Alexandria, 21131, Egypt
Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54511, France
Saint Priest EN Jarez, Pays de la Loire Region 42270, France
Neuilly-sur-Seine, Île-de-France Region 92200, France
Kassel, Hesse 34117, Germany
Minden, North Rhine-Westphalia 32423, Germany
Kiel, Schleswig-Holstein 24105, Germany
Athens, 10676, Greece
Rome, Roma 00161, Italy
Hirosaki-shi, Aomori 036-8545, Japan
Abiko-shi, Chiba 270-1168, Japan
Kashiwa-shi, Chiba 277-0871, Japan
Sakura-shi, Chiba 285-8741, Japan
Kurume-shi, Fukuoka 830-0011, Japan
Ogaki-shi, Gifu 503-8502, Japan
Takasaki-shi, Gunma 370-0829, Japan
Fukuyama-shi, Hiroshima 720-8520, Japan
Asahikawa-shi, Hokkaido 078-8510, Japan
Nishinomiya-shi, Hyōgo 663-8501, Japan
Kamakura-shi, Kanagawa 247-0056, Japan
Kawasaki-shi, Kanagawa 216-8511, Japan
Sagamihara-shi, Kanagawa 252-0375, Japan
Yokkaichi-shi, Mie-ken 510-0016, Japan
Takatsuki-shi, Osaka 569-8686, Japan
Saitama-shi, Saitama 336-0963, Japan
Sunto-gun, Shizuoka 411-8611, Japan
Bunkyo-ku, Tokyo 113-8519, Japan
Chuo-ku, Tokyo 104-8560, Japan
Hachioji-shi, Tokyo 192-0032, Japan
Minato-ku, Tokyo 108-8642, Japan
Mitaka-shi, Tokyo 181-8611, Japan
Shinagawa-ku, Tokyo 141-8625, Japan
Shinjuku-ku, Tokyo 160-8582, Japan
Shunan-shi, Yamaguchi 745-8522, Japan
Kaunas, 50161, Lithuania
Del. Benito Juárez, 03810, Mexico
Tauranga South, Bay of Plenty 3112, New Zealand
Otago, Otago 9016, New Zealand
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-079, Poland
Warsaw, Masovian Voivodeship 00-728, Poland
Warsaw, Masovian Voivodeship 02-507, Poland
Warsaw, Masovian Voivodeship 02-781, Poland
Guimarães, Braga District 4839-008, Portugal
Portimão, Faro District 8500-338, Portugal
Santa Maria DA Feira, Porto District 4520-211, Portugal
Lisbon, 1169-050, Portugal
Anzorey, Kabardino-Balkarskaya Respublika 361350, Russia
Nal'chik, Kabardino-Balkarskaya Respublika 360001, Russia
Saint Petersburg, Leningradskaya Oblast' 198218, Russia
Perm, Permskiy Kray 614109, Russia
Moscow, 123423, Russia
Banská Bystrica, Banská Bystrica Region 975 17, Slovakia
CAPE TOWN Milnerton, Western Cape 7441, South Africa
Busan, Busan Gwang Yeogsi 49241, South Korea
Daejeon, Daejeon Gwang Yeogsi 34943, South Korea
Suwon, Gyeonggido 16247, South Korea
Ferrol, A Coruna 15405, Spain
Taipei City, Taipei 100, Taiwan
Battalgazi/malatya, 44280, Turkey (Türkiye)
Istanbul, 34098, Turkey (Türkiye)
Istanbul, 34899, Turkey (Türkiye)
Kherson, 73000, Ukraine
Kyiv, 02091, Ukraine
Edinburgh, Edinburgh, City of EH4 2XU, United Kingdom
London, Greater London E1 2ES, United Kingdom
London, Greater London SE5 9RS, United Kingdom
London, Greater London SW17 0QT, United Kingdom
Southampton, Hampshire SO16 6YD, United Kingdom