A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Launched by ABBVIE · Jun 28, 2016
Trial Information
Current as of June 21, 2025
Completed
Keywords
ClinConnect Summary
Substudy 1 was a Phase 2b dose-ranging study designed to evaluate the efficacy and safety of different oral doses of upadacitinib compared to placebo as 8-week induction therapy in participants with moderately to severely active UC. Approximately 250 participants were planned to be randomized 1:1:1:1:1 to the placebo group and 4 upadacitinib doses (7.5, 15, 30, and 45 mg). Randomization was stratified by previous biologic therapy use (yes/no), Baseline corticosteroid use (yes/no), and Baseline Adapted Mayo score (≤ 7 or \> 7). The study duration included a Screening Period of up to 5 weeks ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Note: Adolescent participants who are 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authority. If approval has not been granted, only participants ≥18 years old will be enrolled. Adolescents must weigh ≥ 40 kilograms and meet the definition of Tanner Stage 5 at Screening Visit.
- • Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.
- • Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic sub score of 2 to 3 (confirmed by central reader).
- • Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following treatments including: oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies in the opinion of the investigator.
- • 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 to aminosalicylates, corticosteroids, and/or immunosuppressants as defined above.
- • If female, participant must meet the criteria for Contraception Recommendations
- • Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit prior to study drug dosing.
- Exclusion Criteria:
- • Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC)
- • Current diagnosis of fulminant colitis and/or toxic megacolon
- • Participant with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy
- • Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline
- • Participant on azathioprine or 6-mercaptopurine within 10 days of Baseline
- • Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
- • Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
- • Screening laboratory and other analyses show any abnormal results meeting the exclusion criteria
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
Mobile, Alabama, United States
Mobile, Alabama, United States
Chandler, Arizona, United States
Mesa, Arizona, United States
Sun City, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Covina, California, United States
Huntington Beach, California, United States
La Jolla, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Mission Hills, California, United States
Murrieta, California, United States
Oxnard, California, United States
Rialto, California, United States
San Diego, California, United States
San Diego, California, United States
San Francisco, California, United States
Colorado Springs, Colorado, United States
Lone Tree, Colorado, United States
Wheat Ridge, Colorado, United States
Danbury, Connecticut, United States
Hamden, Connecticut, United States
Clearwater, Florida, United States
Doral, Florida, United States
Doral, Florida, United States
Hialeah, Florida, United States
Inverness, Florida, United States
Jacksonville, Florida, United States
Kissimmee, Florida, United States
Maitland, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Macon, Georgia, United States
Riverdale, Georgia, United States
Suwanee, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Evanston, Illinois, United States
Hoffman Estates, Illinois, United States
Urbana, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Topeka, Kansas, United States
Crestview Hills, Kentucky, United States
Houma, Louisiana, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Columbia, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Ann Arbor, Michigan, United States
Chesterfield, Michigan, United States
Southfield, Michigan, United States
Troy, Michigan, United States
Wyoming, Michigan, United States
Rochester, Minnesota, United States
Saint Paul, Minnesota, United States
Jackson, Mississippi, United States
Jackson, Mississippi, United States
Saint Louis, Missouri, United States
Las Vegas, Nevada, United States
Lebanon, New Hampshire, United States
Egg Harbor Township, New Jersey, United States
Morristown, New Jersey, United States
New Brunswick, New Jersey, United States
Albuquerque, New Mexico, United States
Bronx, New York, United States
Bronx, New York, United States
Brooklyn, New York, United States
Great Neck, New York, United States
New York, New York, United States
North Massapequa, New York, United States
Poughkeepsie, New York, United States
Rochester, New York, United States
Staten Island, New York, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
Winston Salem, North Carolina, United States
Winston Salem, North Carolina, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Englewood, Ohio, United States
Mentor, Ohio, United States
Mentor, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Sayre, Pennsylvania, United States
State College, Pennsylvania, United States
Charleston, South Carolina, United States
Greenville, South Carolina, United States
Germantown, Tennessee, United States
Johnson City, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Baytown, Texas, United States
Cedar Park, Texas, United States
Cedar Park, Texas, United States
Dallas, Texas, United States
Garland, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Lubbock, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Temple, Texas, United States
Tyler, Texas, United States
Victoria, Texas, United States
Bountiful, Utah, United States
Ogden, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Franklin, Virginia, United States
Leesburg, Virginia, United States
Bellevue, Washington, United States
Seattle, Washington, United States
Seattle, Washington, United States
Vancouver, Washington, United States
Grafton, Wisconsin, United States
Milwaukee, Wisconsin, United States
Milwaukee, Wisconsin, United States
San Isidro, Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina
San Miguel De Tucuman, Tucuman, Argentina
Cordoba, , Argentina
Macquarie University, New South Wales, Australia
South Brisbane, Queensland, Australia
Southport, Queensland, Australia
Clayton, Victoria, Australia
Fitzroy Melbourne, Victoria, Australia
Murdoch, Western Australia, Australia
Linz, Oberoesterreich, Austria
Vienna, Wien, Austria
Vienna, Wien, Austria
Salzburg, , Austria
витебск, , Belarus
Leuven, Vlaams Brabant, Belgium
Gent, , Belgium
Roeselare, , Belgium
Banja Luka, Republika Srpska, Bosnia And Herzegovina
Banja Luka, Republika Srpska, Bosnia And Herzegovina
Tuzla, Tuzlanski, Bosnia And Herzegovina
Mostar, , Bosnia And Herzegovina
Sarajevo, , Bosnia And Herzegovina
Goiânia, Goias, Brazil
Curitiba, Parana, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Botucatu, Sao Paulo, Brazil
Ribeirão Preto, Sao Paulo, Brazil
Santo André, Sao Paulo, Brazil
Sao Jose Do Rio Preto, Sao Paulo, Brazil
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Kelowna, British Columbia, Canada
Victoria, British Columbia, Canada
Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
Sudbury, Ontario, Canada
Vaughan, Ontario, Canada
Greenfield Park, Quebec, Canada
Levis, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montréal, Quebec, Canada
Sherbrooke, Quebec, Canada
Santiago, Region Metropolitana De Santiago, Chile
Santiago, Region Metropolitana Santiago, Chile
Viña Del Mar, Valparaíso, Chile
Concepción, , Chile
Providencia, , Chile
Santiago, , Chile
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Shiyan, Hubei, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Nanchang, Jiangxi, China
Changchun, Jilin, China
Shanghai, Shanghai, China
Shanghai, Shanghai, China
Shanghai, Shanghai, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Changsha, , China
Chengdu, , China
Shenyang, , China
Tianjin, , China
Monteria, Cordoba, Colombia
Bogota Dc, Cundinamarca, Colombia
Medellin, , Colombia
Zagreb, Grad Zagreb, Croatia
Zagreb, Grad Zagreb, Croatia
Zagreb, Grad Zagreb, Croatia
Zagreb, Grad Zagreb, Croatia
Osijek, Osjecko Baranjska Zupanija, Croatia
Rijeka, Primorsko Goranska Zupanija, Croatia
Split, Splitsko Dalmatinska Zupanija, Croatia
Zadar, , Croatia
Hradec Kralove, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Pardubice, , Czechia
Praha, , Czechia
Praha, , Czechia
Praha, , Czechia
Kesklinna Linnaosa, Harjumaa, Estonia
Mustamäe Linnaosa, Harjumaa, Estonia
Tartu Linn, Tartumaa, Estonia
Tallinn, , Estonia
Tampere, Pirkanmaa, Finland
Helsinki, , Finland
Jyvaskyla, , Finland
Mikkeli, , Finland
Turku, , Finland
Nice, Alpes Maritimes, France
Pierre Benite Cedex, Auvergne Rhone Alpes, France
Marseille, Bouches Du Rhone, France
Lille, Hauts De France, France
Montpellier Cedex 5, Herault, France
Amiens Cedex 1, Somme, France
La Roche Sur Yon, , France
Saint Etienne Cedex 1, , France
Mannheim, Baden Wuerttemberg, Germany
Tubingen, Baden Wuerttemberg, Germany
Munster, Niedersachsen, Germany
Herne, Nordrhein Westfalen, Germany
Saarbrücken, Saarland, Germany
Kiel, Schleswig Holstein, Germany
Berlin, , Germany
Frankfurt Am Main, , Germany
Muenster, , Germany
Wiesbaden, , Germany
Athens, Attiki, Greece
Athens, Attiki, Greece
Heraklion, Kriti, Greece
Athens, , Greece
Ioannina, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Szombathely, Vas, Hungary
Bekescsaba, , Hungary
Budapest, , Hungary
Kecskemet, , Hungary
Sopron, , Hungary
Szekesfehervar, , Hungary
Beaumont, Dublin, Ireland
Dublin 8, Dublin, Ireland
Elm Park, Dublin, Ireland
Cork, , Ireland
Galway, , Ireland
Be'er Sheva, Hadarom, Israel
Haifa, , Israel
Jerusalem, , Israel
Jerusalem, , Israel
Rome, Lazio, Italy
Rho, Milano, Italy
Rozzano, Milano, Italy
Rome, Roma, Italy
Rome, Roma, Italy
Negrar, Verona, Italy
Bologna, , Italy
Milano, , Italy
Milan, , Italy
Palermo, , Italy
Nagakute Shi, Aichi, Japan
Nagoya Shi, Aichi, Japan
Nagoyashi, Aichi, Japan
Toyohashi Shi, Aichi, Japan
Toyota Shi, Aichi, Japan
Hirosaki Shi, Aomori, Japan
Abiko Shi, Chiba, Japan
Kashiwa Shi, Chiba, Japan
Sakura Shi, Chiba, Japan
Urayasu Shi, Chiba, Japan
Fukui Shi, Fukui, Japan
Chikushino Shi, Fukuoka, Japan
Fukuoka Shi, Fukuoka, Japan
Fukuoka Shi, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Kurume Shi, Fukuoka, Japan
Ogaki Shi, Gifu, Japan
Fukuyama Shi, Hiroshima, Japan
Hiroshima Shi, Hiroshima, Japan
Asahikawa Shi, Hokkaido, Japan
Obihiro Shi, Hokkaido, Japan
Sapporo Shi, Hokkaido, Japan
Sapporo Shi, Hokkaido, Japan
Sapporo Shi, Hokkaido, Japan
Sapporo Shi, Hokkaido, Japan
Kobe Shi, Hyogo, Japan
Nishinomiya Shi, Hyogo, Japan
Higashi Ibaraki Gun, Ibaraki, Japan
Kanazawa Shi, Ishikawa, Japan
Morioka Shi, Iwate, Japan
Kagoshima Shi, Kagoshima, Japan
Kagoshima Shi, Kagoshima, Japan
Kagoshima Shi, Kagoshima, Japan
Kawasaki Shi, Kanagawa, Japan
Yokohama Shi, Kanagawa, Japan
Yokohama Shi, Kanagawa, Japan
Kyoto Shi, Kyoto, Japan
Kyoto Shi, Kyoto, Japan
Tsu Shi, Mie, Japan
Yokkaichi Shi, Mie, Japan
Sendai Shi, Miyagi, Japan
Omura Shi, Nagasaki, Japan
Yamatotakada Shi, Nara, Japan
Niigata Shi, Niigata, Japan
Niigata Shi, Niigata, Japan
Oita Shi, Oita, Japan
Kurashiki Shi, Okayama, Japan
Okayama Shi, Okayama, Japan
Osaka Shi, Osaka, Japan
Osaka Shi, Osaka, Japan
Osaka Shi, Osaka, Japan
Osaka Shi, Osaka, Japan
Osaka Shi, Osaka, Japan
Toyonaka Shi, Osaka, Japan
Saga Shi, Saga, Japan
Kawagoe Shi, Saitama, Japan
Saitama Shi, Saitama, Japan
Higashi Ohmi Shi, Shiga, Japan
Izumo Shi, Shimane, Japan
Hamamatsu Shi, Shizuoka, Japan
Sunto Gun, Shizuoka, Japan
Bunkyo Ku, Tokyo, Japan
Chuo Ku, Tokyo, Japan
Hachioji Shi, Tokyo, Japan
Itabashi Ku, Tokyo, Japan
Minato Ku, Tokyo, Japan
Mitaka Shi, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Yamagata Shi, Yamagata, Japan
Shunan Shi, Yamaguchi, Japan
Kofu Shi, Yamanashi, Japan
Takatsuki Shi, , Japan
Guri, Gyeonggido, Korea, Republic Of
Seongnam Si, Gyeonggido, Korea, Republic Of
Suwon, Gyeonggido, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Busan, , Korea, Republic Of
Busan, , Korea, Republic Of
Daegu, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Riga, , Latvia
Riga, , Latvia
Kaunas, , Lithuania
Klaipeda, , Lithuania
Klaipeda, , Lithuania
Vilnius, , Lithuania
Alor Setar, Kedah, Malaysia
Kuala Lumpur, Selangor, Malaysia
Ampang, , Malaysia
Kuala Lumpur, , Malaysia
Leon, Guanajuato, Mexico
Guadalajara, Jalisco, Mexico
Monterrey, Nuevo Leon, Mexico
Nijmegen, Gelderland, Netherlands
Rotterdam, Zuid Holland, Netherlands
Amsterdam, , Netherlands
Leiden, , Netherlands
Utrecht, , Netherlands
Nordbyhagen, Akershus, Norway
Tromsø, Troms, Norway
Torun, Kujawsko Pomorskie, Poland
Warszawa, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Sopot, Pomorskie, Poland
Guimaraes, Braga, Portugal
Santa Maria Da Feira, Porto, Portugal
Ponte De Lima, Viana Do Castelo, Portugal
Almada, , Portugal
Braga, , Portugal
Lisboa, , Portugal
Lisboa, , Portugal
Porto, , Portugal
San Juan, , Puerto Rico
Kaliningrad, Kaliningradskaya Oblast, Russian Federation
St. Petersburg, Leningradskaya Oblast, Russian Federation
Perm, Permskiy Kray, Russian Federation
Samara, Samarskaya Oblast, Russian Federation
Pyatigorsk, Stavropol Skiy Kray, Russian Federation
Kazan, Tatarstan, Respublika, Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Petrozavodsk, , Russian Federation
Pushkin, , Russian Federation
Stavropol, , Russian Federation
Belgrade, Beograd, Serbia
Belgrade, Beograd, Serbia
Belgrade, Beograd, Serbia
Belgrade, Beograd, Serbia
Nis, Nisavski Okrug, Serbia
Kragujevac, Sumadijski Okrug, Serbia
Novi Sad, Vojvodina, Serbia
Leskovac, , Serbia
Singapore, , Singapore
Singapore, , Singapore
Singapore, , Singapore
Banska Bystrica, , Slovakia
Bratislava, , Slovakia
Ilava, , Slovakia
Kosice, , Slovakia
Nove Zamky, , Slovakia
Presov, , Slovakia
Boksburg North, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Cape Town Milnerton, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Santiago De Compostela, A Coruna, Spain
Santander, Cantabria, Spain
Las Palmas De Gran Canaria, Las Palmas, Spain
A Coruna, , Spain
Barcelona, , Spain
Cordoba, , Spain
Madrid, , Spain
Madrid, , Spain
Salamanca, , Spain
Valencia, , Spain
Gothenburg, Vastra Gotalands Lan, Sweden
Basel, Basel Stadt, Switzerland
St. Gallen, Sankt Gallen, Switzerland
Zürich, Zuerich, Switzerland
Bern, , Switzerland
Kaohsiung, , Taiwan
Taichung City, , Taiwan
Taichung, , Taiwan
Tainan, , Taiwan
Taipei City, , Taiwan
Taipei City, , Taiwan
Melikgazi, Kayseri, Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Mersin, , Turkey
Yenimahalle, , Turkey
Vinnytsya, Vinnytska Oblast, Ukraine
Dnipro, , Ukraine
Kharkiv, , Ukraine
Kropyvnytskyi, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Vinnytsia, , Ukraine
Exeter, Devon, United Kingdom
Basingstoke, Essex, United Kingdom
London, London, City Of, United Kingdom
Glasgow, Scotland, United Kingdom
Bath, , United Kingdom
Birmingham, , United Kingdom
Huddersfield, , United Kingdom
Tooting, , United Kingdom
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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