A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in adults with moderately and severely active Crohn's disease (CD).
This study includes two parts:
In Part 1, participants will be randomized in a 2:1 ratio to upadacitinib 45 mg once daily (QD) or matching placebo for 12 weeks. The randomization will be stratified by baseline corticosteroid use (yes or no), endoscopic disease severity (Simplified Endoscopic Score for Crohn's disease [SES-CD] < 15 and ≥ 15), and number of prior biologics with prior inadequate response or intolerance (0, 1, > 1).
Participants who do not achieve clinical response at Week 12 will be able to enroll in Part 2 to receive a double-blind extended treatment with upadacitinib until Week 24. Clinical response is defined as a ≥ 30% decrease in average daily very soft or liquid stool frequency (SF) and/or ≥ 30% decrease in average daily abdominal pain (AP) score (both not worse than Baseline).
Participants who achieve clinical response at Week 12 may be eligible to enter the 52-week, double-blind, maintenance portion of Study M14-430 (NCT03345823).
Inclusion Criteria:
Confirmed diagnosis of CD for at least 3 months prior to Baseline.
Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.
Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.
Demonstrated an inadequate response or intolerance to one or more conventional and/or biologic therapies (oral locally acting steroids, intravenous or oral corticosteroids, immunosuppressants or biologic therapies for CD), in the opinion of the investigator.
If female, participant must meet the contraception recommendations.
Exclusion Criteria:
Los Angeles, California 90067-2001, United States
Baltimore, Maryland 21287-0010, United States
Chevy Chase, Maryland 20815, United States
Ann Arbor, Michigan 48109, United States
Farmington Hills, Michigan 48334-3230, United States
Jackson, Mississippi 39216, United States
Lake Success, New York 11042, United States
Raleigh, North Carolina 27612, 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
Ciudad Autonoma Buenos Aires, Ciuadad Autonoma de Buenos Aires 1199, Argentina
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires 1115, Argentina
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires 1431, Argentina
Banja Luka, Republika Srpska 78000, Bosnia and Herzegovina
Goiânia, Goiás 74535-170, Brazil
Ribeirão Preto, São Paulo 14051-140, Brazil
Montreal, Quebec H4A 3J1, Canada
Wuhan, Hubei 430022, China
Shanghai, Shanghai Municipality 200065, China
Hangzhou, Zhejiang 310009, China
Hangzhou, Zhejiang 310018, China
Hilleroed, Capital Region 3600, Denmark
Alexandria, 21131, Egypt
Alexandria, 21131, Egypt
Alexandria, 21131, Egypt
Menoufiya, 35111, Egypt
Kiel, Schleswig-Holstein 24105, Germany
Encs, Borsod-Abauj Zemplen county 3860, Hungary
Budapest, Pest County 1036, Hungary
Rome, Roma 00168, Italy
Nagakute-shi, Aichi-ken 480-1195, Japan
Hirosaki-shi, Aomori 036-8545, Japan
Sakura-shi, Chiba 285-8741, Japan
Kurume-shi, Fukuoka 830-0011, 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
Yokkaichi-shi, Mie-ken 510-0016, Japan
Yamatotakada-shi, Nara 635-0022, Japan
Kurashiki-shi, Okayama-ken 710-0142, Japan
Suita-shi, Osaka 565-0871, 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
Hachioji-shi, Tokyo 192-0032, Japan
Minato-ku, Tokyo 105-8471, Japan
Mitaka-shi, Tokyo 181-8611, Japan
Shinjuku-ku, Tokyo 162-8666, Japan
Kaunas, 50161, Lithuania
Kelantan, Kelantan 16150, Malaysia
Kuala Lumpur, Selangor 56000, Malaysia
Durango, Durango 34000, Mexico
Guadalajara, Jalisco 44650, Mexico
Guimarães, Braga District 4835-044, Portugal
Lisbon, Porto District 1349-019, Portugal
Ponte de Lima, Viana do Castelo District 4990-041, Portugal
San Juan, 00935, Puerto Rico
Perm, Permskiy Kray 614109, Russia
Stavropol, Stavropol Kray 355012, Russia
Banská Bystrica, 975 17, Slovakia
Seoul, Seoul Teugbyeolsi 03722, South Korea
Battalgazi/malatya, 44280, Turkey (Türkiye)
Istanbul, 34899, Turkey (Türkiye)
Kyiv, Kyivska Oblast 01030, Ukraine
Lviv, 79000, Ukraine
Vinnytsia, 21028, Ukraine
Warrington, Cheshire West And Chester WA5 1QG, United Kingdom
Warrington, Cheshire West And Chester WA5 1QG, United Kingdom
Newcastle upon Tyne, NE7 7DN, United Kingdom