Search / Trial NCT03653026

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis
Launched by ABBVIE · Aug 28, 2018

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Trial Information

Current as of June 21, 2025

Completed

Keywords

Upadacitinib Abt 494 Ulcerative Colitis

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

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.
• Diagnosis of Ulcerative Colitis (UC) 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 UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3.
• Demonstrated an inadequate response, loss of response, or intolerance to at lease one of the following treatments including, oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies.
• 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.
• 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.
• If female, participant must meet the contraception recommendation criteria.
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 who received azathioprine or 6-mercaptopurine (6-MP) 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 prespecified abnormal hematologic results.

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.

Locations

Mobile, Alabama, United States

Sun City, Arizona, United States

Tempe, 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

Mission Hills, California, United States

Murrieta, California, United States

Oxnard, California, United States

Rialto, California, United States

San Diego, California, United States

Colorado Springs, Colorado, United States

Wheat Ridge, Colorado, United States

Danbury, Connecticut, United States

Hamden, Connecticut, United States

Clearwater, Florida, United States

Doral, Florida, United States

Hialeah, Florida, United States

Inverness, Florida, United States

Jacksonville, Florida, United States

Maitland, Florida, United States

Miami, Florida, United States

New Port Richey, Florida, United States

Orlando, Florida, United States

Tampa, Florida, United States

Macon, Georgia, United States

Riverdale, Georgia, United States

Suwanee, Georgia, United States

Chicago, Illinois, United States

Effingham, 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

Shreveport, Louisiana, United States

Columbia, Maryland, United States

Ann Arbor, Michigan, United States

Chesterfield, Michigan, United States

Southfield, Michigan, United States

Troy, Michigan, United States

Rochester, Minnesota, United States

Jackson, Mississippi, United States

Las Vegas, Nevada, 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

Brooklyn, New York, United States

Lake Success, 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

Winston Salem, North Carolina, United States

Fargo, North Dakota, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Dayton, Ohio, United States

Englewood, Ohio, United States

Mentor, Ohio, United States

Oklahoma City, Oklahoma, United States

Tulsa, Oklahoma, United States

Sayre, 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

Arlington, Texas, United States

Baytown, Texas, United States

Cedar Park, Texas, United States

Dallas, Texas, United States

Garland, Texas, United States

Houston, Texas, United States

Lubbock, Texas, United States

San Antonio, Texas, United States

Temple, Texas, United States

Tyler, Texas, United States

Victoria, Texas, United States

Ogden, Utah, United States

Franklin, Virginia, United States

Bellevue, Washington, United States

Seattle, Washington, United States

Vancouver, Washington, United States

Milwaukee, Wisconsin, United States

San Isidro, Buenos Aires, Argentina

Ciudad Autonoma De Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina

Cordoba, , Argentina

Macquarie University, New South Wales, Australia

South Brisbane, Queensland, Australia

Southport, Queensland, Australia

Fitzroy, Victoria, Australia

Melbourne, Victoria, Australia

Murdoch, Western Australia, Australia

Vienna, Wien, Austria

Salzburg, , Austria

Leuven, Vlaams Brabant, Belgium

Gent, , Belgium

Banja Luka, Republika Srpska, Bosnia And Herzegovina

Tuzla, Tuzlanski, Bosnia And Herzegovina

Mostar, , Bosnia And Herzegovina

Sarajevo, , Bosnia And Herzegovina

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

Victoria, British Columbia, Canada

Vaughan, Ontario, Canada

Montreal, Quebec, Canada

Sherbrooke, Quebec, Canada

Santiago, Region Metropolitana De Santiago, Chile

Concepción, , Chile

Providencia, , Chile

Santiago, , Chile

Guangzhou, Guangdong, China

Shiyan, Hubei, China

Wuhan, Hubei, China

Nanchang, Jiangxi, China

Changchun, Jilin, China

Shanghai, Shanghai, China

Hangzhou, Zhejiang, China

Chengdu, , China

Tianjin, , China

Wuhan, , China

Monteria, Cordoba, Colombia

Bogota Dc, Cundinamarca, Colombia

Medellin, , Colombia

Zagreb, Grad Zagreb, Croatia

Rijeka, Primorsko Goranska Zupanija, Croatia

Split, , Croatia

Hradec Kralove, , Czechia

Olomouc, , Czechia

Ostrava, , Czechia

Pardubice, , Czechia

Praha, , Czechia

Tallinn, Harjumaa, Estonia

Tallinn, , Estonia

Tartu, , Estonia

Tampere, Pirkanmaa, Finland

Jyvaskyla, , Finland

Mikkeli, , Finland

Turku, , Finland

Nice Cedex 3, Alpes Maritimes, France

Pierre Benite Cedex, Rhone, France

Mannheim, Baden Wuerttemberg, Germany

Tübingen, Baden Wuerttemberg, Germany

Herne, Nordrhein Westfalen, Germany

Saarbrücken, Saarland, Germany

Berlin, , Germany

Frankfurt Am Main, , Germany

Kiel, , Germany

Muenster, , Germany

Athens, Attiki, Greece

Heraklion, Kriti, Greece

Athens, , Greece

Thessaloniki, , Greece

Bekescsaba, , Hungary

Budapest, , Hungary

Sopron, , Hungary

Szekesfehervar, , Hungary

Dublin, , Ireland

Galway, , Ireland

Haifa, , Israel

Jerusalem, , Israel

Bologna, Emilia Romagna, Italy

Rho, Milano, Italy

Rozzano, Milano, Italy

Rome, Roma, Italy

Negrar, Verona, Italy

Milan, , Italy

Palermo, , Italy

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

Kurume Shi, Fukuoka, Japan

Ogaki Shi, Gifu, Japan

Fukuyama Shi, Hiroshima, Japan

Hiroshima Shi, Hiroshima, Japan

Midorigaokahiga Shi, Hokkaido, Japan

Obihiro Shi, Hokkaido, Japan

Sapporo Shi, Hokkaido, Japan

Kobe Shi, Hyogo, Japan

Nishinomiya Shi, Hyogo, Japan

Kanazawa Shi, Ishikawa, Japan

Morioka Shi, Iwate, Japan

Kagoshima Shi, Kagoshima, Japan

Kawasaki Shi, Kanagawa, Japan

Yokohama Shi, Kanagawa, 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

Oita Shi, Oita, Japan

Kurashiki Shi, Okayama, Japan

Okayama Shi, Okayama, 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

Shinjuku Ku, Tokyo, Japan

Yamagata Shi, Yamagata, Japan

Shunan Shi, Yamaguchi, Japan

Takatsuki Shi, , Japan

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Busan, , Korea, Republic Of

Daegu, , Korea, Republic Of

Seongnam Si, Gyeonggi Do, , Korea, Republic Of

Seoul, , Korea, Republic Of

Riga, , Latvia

Kaunas, , Lithuania

Klaipeda, , Lithuania

Vilnius, , Lithuania

Kuala Lumpur, Selangor, Malaysia

Kuala Lumpur, , Malaysia

Leon, Guanajuato, Mexico

Guadalajara, Jalisco, Mexico

Monterrey, Nuevo Leon, Mexico

Rotterdam, , Netherlands

Lorenskog, Akershus, Norway

Tromsø, Troms, Norway

Torun, Kujawsko Pomorskie, Poland

Warsaw, 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

Lisbon, , 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

Stavropol, Stavropol Skiy Kray, Russian Federation

Kazan, Tatarstan, Respublika, Russian Federation

Moscow, , Russian Federation

Petrozavodsk, , Russian Federation

Pushkin, , Russian Federation

Pyatigorsk, , Russian Federation

Belgrade, Beograd, Serbia

Nis, Nisavski Okrug, Serbia

Kragujevac, Sumadijski Okrug, Serbia

Novi Sad, Vojvodina, Serbia

Leskovac, , Serbia

Singapore, , Singapore

Bratislava, Bratislavsky Kraj, Slovakia

Banska Bystrica, , Slovakia

Kosice, , Slovakia

Nove Zamky, , Slovakia

Presov, , Slovakia

Boksburg North, Gauteng, South Africa

Johannesburg, Gauteng, South Africa

Cape Town Milnerton, 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

Salamanca, , Spain

Valencia, , Spain

St. Gallen, Sankt Gallen, Switzerland

Basel, , Switzerland

Bern, , Switzerland

Zurich, , Switzerland

Taichung City, Taichung, Taiwan

Taipei City, Taipei, Taiwan

Kaohsiung, , Taiwan

Taipei City, , Taiwan

Melikgazi, Kayseri, Turkey

Ankara Gazi, , Turkey

Istanbul, , Turkey

Mersin, , Turkey

Kharkiv, Kharkivska Oblast, Ukraine

Kyiv, Kyivska Oblast, Ukraine

Kropyvnytskyi, , Ukraine

Kyiv, , Ukraine

Vinnytsia, , Ukraine

Basingstoke, , United Kingdom

Glasgow, , United Kingdom

Huddersfield, , United Kingdom

London, , United Kingdom

Whitechapel, , United Kingdom

Patients applied

0 patients applied

Trial Officials

ABBVIE INC.

Study Director

AbbVie

Timeline

First submit

August 28, 2018

Trial launched

December 06, 2018

Trial updated

February 17, 2022

Estimated completion

Not reported

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A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis
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