A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).
Study M14-675 consists of 2 parts, Part 1 and Part 2. Part 1 is a randomized, double-blind, placebo-controlled 8-week induction period. Part 2 is an open-label, 8-week extended treatment period for participants who did not achieve clinical response at Week 8 in Part 1.
Eligible participants are randomized in a 2:1 ratio to one of the two treatment groups (upadacitinib 45 mg or matching placebo) for 8 weeks. The randomization is stratified by biologic inadequate responder (bio-IR) status (bio-IR vs non-bio-IR), corticosteroid use (yes or no), and Adapted Mayo score (≤ 7 or > 7) at Baseline. Within bio-IR, the randomization is further stratified by number of prior biologic treatments (≤ 1 or > 1). Within non-bio-IR, the randomization is further stratified by previous biologic use (yes or no).
Participants who achieve clinical response defined by Adapted Mayo Score at Week 8 or Week 16 and do not meet any study discontinuation criteria are eligible to enroll into Study M14-234 Substudy 3 (NCT02819635; 52-week maintenance study) or Study M14-533 Cohort 1 (NCT03006068; long-term follow-up study).
Inclusion Criteria:
- Male or female participants ≥ 16 and ≤ 75 years of age at Baseline Note: Adolescent participants at the age of 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authorities.
Note: Adolescent participants at the age of 16 or 17 years old must weigh ≥ 40 kilograms and meet the definition of Tanner Stage 5 at the Screening Visit.
Note: Participants who have had inadequate response, loss of response to conventional therapy but have not failed biologic therapy (Non-bio-IR) and have received a prior biologic for up to 1 year may be enrolled, however they must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease), and must meet criteria for inadequate response, loss of response, or intolerance as defined above.
Exclusion Criteria:
Tempe, Arizona 85284-2604, United States
Los Angeles, California 90067-2001, United States
Jackson, Mississippi 39216, United States
Albuquerque, New Mexico 87131-0001, United States
Lake Success, New York 11042, United States
North Massapequa, New York 11758, United States
Charlotte, North Carolina 28207, United States
Winston-Salem, North Carolina 27157-0001, United States
Greenville, South Carolina 29615-3593, United States
Dallas, Texas 75246, United States
Houston, Texas 77030-3411, United States
San Antonio, Texas 78212, United States
Milwaukee, Wisconsin 53215, United States
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires 1128, Argentina
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires 1280, Argentina
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires 1426, Argentina
Macquarie University, New South Wales 2109, Australia
Banja Luka, Republika Srpska 78000, Bosnia and Herzegovina
Banja Luka, Republika Srpska 78000, Bosnia and Herzegovina
Ribeirão Preto, São Paulo 14051-140, Brazil
Calgary, Alberta T2N 4Z6, Canada
Guangzhou, Guangdong 510120, China
Wuhan, Hubei 430022, China
Shanghai, Shanghai Municipality 200025, China
Hangzhou, Zhejiang 310009, China
Wuhan, 430030, China
Bogota DC, Cundinamarca 111221, Colombia
Montería, Departamento de Córdoba 230002, Colombia
Herne, North Rhine-Westphalia 44623, Germany
Athens, 10676, Greece
Rome, Roma 00168, Italy
Toyota-shi, Aichi-ken 470-1219, Japan
Hirosaki-shi, Aomori 036-8545, Japan
Abiko-shi, Chiba 270-1168, Japan
Kashiwa-shi, Chiba 277-0871, Japan
Sakura-shi, Chiba 285-8741, Japan
Urayasu-shi, Chiba 279-0021, Japan
Kurume-shi, Fukuoka 830-0011, Japan
Ogaki-shi, Gifu 503-8502, Japan
Fukuyama-shi, Hiroshima 720-8520, Japan
Midorigaokahiga-shi, Hokkaido 078-8510, Japan
Obihiro-shi, Hokkaido 080-0024, Japan
Nishinomiya-shi, Hyōgo 663-8501, Japan
Kawasaki-shi, Kanagawa 216-8511, Japan
Yokkaichi-shi, Mie-ken 510-0016, Japan
Omura-shi, Nagasaki 856-8562, Japan
Yamatotakada-shi, Nara 635-0022, Japan
Kurashiki-shi, Okayama-ken 710-0142, Japan
Toyonaka-shi, Osaka 560-0055, Japan
Kawagoe-shi, Saitama 350-8550, Japan
Saitama-shi, Saitama 336-0963, Japan
Higashi-ohmi-shi, Shiga 527-8505, Japan
Izumo-shi, Shimane 693-0021, 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
Itabashi-ku, Tokyo 173-8606, Japan
Shinjuku-ku, Tokyo 162-8655, Japan
Shinjuku-ku, Tokyo 162-8666, Japan
Shunan-shi, Yamaguchi 745-8522, Japan
Takatsuki-shi, 569-0086, Japan
Kaunas, 50161, Lithuania
Kuala Lumpur, Selangor 56000, Malaysia
Guadalajara, Jalisco 44650, Mexico
Lorenskog, Akershus 1478, Norway
Guimarães, Braga District 4835-044, Portugal
Santa Maria DA Feira, Porto District 4520-211, Portugal
Ponte de Lima, Viana do Castelo District 4990-041, Portugal
Lisbon, 1649-035, Portugal
San Juan, 00935, Puerto Rico
Saint Petersburg, Leningradskaya Oblast' 191015, Russia
Perm, Permskiy Kray 614109, Russia
Stavropol, Stavropol Kray 355012, Russia
Banská Bystrica, 975 17, Slovakia
Johannesburg, Gauteng 2193, South Africa
CAPE TOWN Milnerton, Western Cape 7441, South Africa
Seongnam-si, Gyeonggi-do, 13496, South Korea
Santiago de Compostela, A Coruna 15706, Spain
Taipei City, Taipei 100, Taiwan
Ankara GAZI, 06500, Turkey (Türkiye)
Istanbul, 34098, Turkey (Türkiye)
Kharkiv, Kharkiv Oblast 61204, Ukraine