AzTrials
AzTrials

Ulcerative Colitis (UC)Phase 3U-AccomplishNCT03653026

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

A Phase 3 study testing Upadacitinib in people with Ulcerative Colitis (UC), run by AbbVie at 379 sites in 44 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 16 to 75 years
Conditions the study is for
Ulcerative Colitis (UC)
What is being tested?
Upadacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
522 participants
Where
379 sitesin 44 countries
Study dates
6 Dec 2018to 14 Jan 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

379 sites in 44 countries.

379 sites in 44 countries

United States114 sites

  • University of New Mexico Department of Internal Medicine /ID# 214397

    Albuquerque, New Mexico, 87131-0001

  • University of Michigan Health Systems /ID# 206918

    Ann Arbor, Michigan, 48109

  • Huron Gastroenterology Assoc /ID# 205109

    Ann Arbor, Michigan, 48197

  • TX Clinical Research Institute /ID# 206718

    Arlington, Texas, 76012

  • Digestive Health Partners, P.A /ID# 206842

    Asheville, North Carolina, 28801

  • Inquest Clinical Research /ID# 206132

    Baytown, Texas, 77521

  • Washington Gastroenterology Associates /ID# 206177

    Bellevue, Washington, 98004

  • NY Scientific /ID# 206080

    Brooklyn, New York, 11235

  • Texas Digestive Disease Consultants /ID# 209805

    Cedar Park, Texas, 78613-5028

  • Texas Digestive Disease Consultants /ID# 209948

    Cedar Park, Texas, 78613-5028

  • Pharmacorp Clinical Trials /ID# 206074

    Charleston, South Carolina, 29412

  • Atrium Health Carolinas Medical Center /ID# 206085

    Charlotte, North Carolina, 28203

  • Charlotte Gastroenterology and Hepatology, PLLC /ID# 206138

    Charlotte, North Carolina, 28207

  • Clin Res Inst of Michigan, LLC /ID# 207078

    Chesterfield, Michigan, 48047

  • Next Innovative Clinical Research - Chicago /ID# 217324

    Chicago, Illinois, 60605-2168

  • The University of Chicago Medical Center /ID# 206172

    Chicago, Illinois, 60637-1443

  • University of Cincinnati /ID# 205633

    Cincinnati, Ohio, 45267-0585

  • Gastro Florida /ID# 206174

    Clearwater, Florida, 33756

  • Delta Waves, Inc. /ID# 206170

    Colorado Springs, Colorado, 80918

  • Gastro Center of Maryland /ID# 206883

    Columbia, Maryland, 21045

  • The Ohio State University /ID# 205637

    Columbus, Ohio, 43210

  • Optimed Research, Ltd. /ID# 205638

    Columbus, Ohio, 43235

  • Citrus Valley Gastroenterology /ID# 205627

    Covina, California, 91722-3797

  • Tri-State Gastroenterology /ID# 206124

    Crestview Hills, Kentucky, 41017

  • Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 207484

    Dallas, Texas, 75246

  • Western Connecticut Medical Group /ID# 208290

    Danbury, Connecticut, 06810-6000

  • Hometown Urgent Care and Resea /ID# 205630

    Dayton, Ohio, 45424

  • Universal Axon Clinical Research /ID# 213462

    Doral, Florida, 33166

  • Carle Foundation Hospital /ID# 207397

    Effingham, Illinois, 62401

  • AGA Clinical Research Associates, LLC /ID# 206880

    Egg Harbor, New Jersey, 08234

  • Dayton Gastroenterology, Inc. /ID# 205639

    Englewood, Ohio, 45415

  • MediSphere Medical Research Center /ID# 206073

    Evansville, Indiana, 47714-8011

  • Duplicate_Plains Clinical Research Center, LLC /ID# 205111

    Fargo, North Dakota, 58104

  • Ctr for Gastrointestinal Healt /ID# 208475

    Franklin, Virginia, 23851

  • DHAT Research Institute /ID# 206716

    Garland, Texas, 75044-2208

  • Gastro One /ID# 206178

    Germantown, Tennessee, 38138

  • Gastroenterology Associates, P.A. of Greenville /ID# 206098

    Greenville, South Carolina, 29615-3593

  • Gastroenterology Center of CT /ID# 208291

    Hamden, Connecticut, 06518

  • Palmetto Research, LLC /ID# 208293

    Hialeah, Florida, 33016

  • Houma Digestive Health Special /ID# 206176

    Houma, Louisiana, 70360

  • Vilo Research Group Inc /ID# 212625

    Houston, Texas, 77017-2337

  • Baylor College of Medicine - Baylor Medical Center /ID# 206717

    Houston, Texas, 77030-3411

  • Centex Studies, Inc. - Houston /ID# 206168

    Houston, Texas, 77058

  • GI Specialists of Houston /ID# 206090

    Houston, Texas, 77070-4347

  • Care Access Research /ID# 217003

    Huntington Beach, California, 92648-5994

  • Indianapolis Gastroenterology /ID# 206381

    Indianapolis, Indiana, 46237

  • Nature Coast Clinical Research - Inverness /ID# 206087

    Inverness, Florida, 34452-4717

  • University of Iowa Hospitals and Clinics /ID# 206167

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center /ID# 213116

    Jackson, Mississippi, 39216-4500

  • Southern Therapy and Advanced Research (STAR) LLC /ID# 206069

    Jackson, Mississippi, 39216

  • Encore Borland-Groover Clinical Research /Id# 208128

    Jacksonville, Florida, 32256

  • East Tennessee Research Institute /ID# 206169

    Johnson City, Tennessee, 37604

  • Moore UC San Diego Cancer Center /ID# 204919

    La Jolla, California, 92093

  • NYU Langone Long Island Clinical Research Associates /ID# 206079

    Lake Success, New York, 11042

  • Las Vegas Medical Research /ID# 206814

    Las Vegas, Nevada, 89113

  • United Medical Doctors /ID# 207867

    Los Alamitos, California, 90720-3309

  • TLC Clinical Research Inc /ID# 216831

    Los Angeles, California, 90048

  • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 205314

    Los Angeles, California, 90067-2001

  • Caprock Gastro Research /ID# 215115

    Lubbock, Texas, 79424-3017

  • Gastroenterology Associates of Central Georgia, LLC /ID# 216940

    Macon, Georgia, 31201

  • Cfagi Llc /Id# 207995

    Maitland, Florida, 32751-6108

  • Great Lakes Gastroenterology Research LLC /ID# 205631

    Mentor, Ohio, 44060-6211

  • University of Miami /ID# 215445

    Miami, Florida, 33136

  • Coral Research Clinic /ID# 208292

    Miami, Florida, 33186-4643

  • Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 206917

    Milwaukee, Wisconsin, 53215

  • Froedtert Memorial Lutheran Hospital /ID# 206945

    Milwaukee, Wisconsin, 53226-3522

  • Facey Medical Foundation /ID# 205301

    Mission Hills, California, 91345

  • East View Medical Research, LLC /ID# 216933

    Mobile, Alabama, 36606

  • CB Flock Research Corporation /ID# 206094

    Mobile, Alabama, 36608

  • Atlantic Digestive Health Inst /ID# 208748

    Morristown, New Jersey, 07960

  • United Medical Doctors - Murrieta /ID# 205313

    Murrieta, California, 92563

  • Quality Medical Research /ID# 206088

    Nashville, Tennessee, 37211

  • Vanderbilt University Medical Center /ID# 210405

    Nashville, Tennessee, 37232-0011

  • Rutgers Robert Wood Johnson /ID# 207382

    New Brunswick, New Jersey, 08901

  • Advanced Research Institute, Inc /ID# 206077

    New Port Richey, Florida, 34653

  • DiGiovanna Institute for Medical Education & Research /ID# 206885

    North Massapequa, New York, 11758

  • Advanced Research Institute /ID# 206133

    Ogden, Utah, 84403

  • Hightower Clinical /ID# 216336

    Oklahoma City, Oklahoma, 73102

  • Digestive Disease Specialists /ID# 206076

    Oklahoma City, Oklahoma, 73112

  • Endoscopic Research, Inc. /ID# 207360

    Orlando, Florida, 32803

  • Omega Research Consultants /ID# 206066

    Orlando, Florida, 32810

  • InSite Digestive Health Care - Oxnard /ID# 205628

    Oxnard, California, 93030

  • Premier Medical Group - GI Division /ID# 206097

    Poughkeepsie, New York, 12601

  • Inland Empire Clinical Trials, LLC /ID# 216164

    Rialto, California, 92377

  • Infinite Clinical Trials /ID# 215343

    Riverdale, Georgia, 30274

  • Mayo Clinic /ID# 205645

    Rochester, Minnesota, 55905-0001

  • Gastro Group of Rochester /ID# 206881

    Rochester, New York, 14618-5703

  • Clinical Associates in Research Therapeutics of America, LLC /ID# 206710

    San Antonio, Texas, 78212

  • Southern Star Research Institute, LLC /ID# 205379

    San Antonio, Texas, 78229-5390

  • San Diego Clinical Trials /ID# 212122

    San Diego, California, 92120

  • Medical Assoc Research Grp /ID# 205626

    San Diego, California, 92123

  • Guthrie Medical Group, PC /ID# 206078

    Sayre, Pennsylvania, 18840

  • Virginia Mason - Seattle Orthapedics /ID# 206070

    Seattle, Washington, 98101

  • Louisana Research Center, LLC /ID# 206064

    Shreveport, Louisiana, 71105-6800

  • Revival Research Institute, LLC /ID# 207282

    Southfield, Michigan, 48034-1659

  • Richmond University Medical Center /ID# 213185

    Staten Island, New York, 10310-1664

  • Arizona Arthritis & Rheumatology Research, PLLC /ID# 211030

    Sun City, Arizona, 85306

  • Atlanta Gastroenterology Spec /ID# 206173

    Suwanee, Georgia, 30024

  • Clinical Research Trials of Florida, Inc. /ID# 206068

    Tampa, Florida, 33607

  • University of South Florida /ID# 214495

    Tampa, Florida, 33612

  • AdventHealth Tampa /ID# 207363

    Tampa, Florida, 33613-4680

  • Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211887

    Tempe, Arizona, 85284-2604

  • Baylor Scott & White Center for Diagnostic Medicine /ID# 206096

    Temple, Texas, 76508

  • Advantage Clinical Trials /ID# 206082

    The Bronx, New York, 10468

  • Cotton-O'Neil Clinical Res Ctr /ID# 206175

    Topeka, Kansas, 66606

  • Center for Digestive Health /ID# 207080

    Troy, Michigan, 48098-6363

  • University of Arizona /ID# 208856

    Tucson, Arizona, 85724

  • Options Health Research, LLC /ID# 206707

    Tulsa, Oklahoma, 74104

  • Healthcare Research Consultant /ID# 206706

    Tulsa, Oklahoma, 74135

  • Duplicate_Tyler Research Institue /ID# 206075

    Tyler, Texas, 75701

  • The Vancouver Clinic, INC. PS /ID# 204973

    Vancouver, Washington, 98664

  • Gastro Health & Nutrition - Victoria /ID# 205378

    Victoria, Texas, 77904

  • Western States Clinical Res /ID# 206091

    Wheat Ridge, Colorado, 80033-2896

  • Wake Forest Baptist Medical Center /ID# 206067

    Winston-Salem, North Carolina, 27157-0001

Other trials in United States

Japan62 sites

  • Tokatsu Tsujinaka Hospital /ID# 214963

    Abiko-shi, Chiba, 270-1168

  • Tokyo Medical And Dental University, Medical Hospital /ID# 206453

    Bunkyo-ku, Tokyo, 113-8519

  • Fukuoka University Chikushi Hospital /ID# 214405

    Chikushino-shi, Fukuoka, 818-8502

  • St.Luke's International Hospital /ID# 208076

    Chuo-ku, Tokyo, 104-8560

  • Fukui Prefectural Hospital /ID# 210449

    Fukui-shi, Fukui, 910-8526

  • Saiseikai Fukuoka Genaral Hospital /ID# 209482

    Fukuoka, Fukuoka, 810-0001

  • NHO Fukuyama Medical Center /ID# 206295

    Fukuyama-shi, Hiroshima, 720-8520

  • Tokai University Hachioji Hospital /ID# 208903

    Hachioji-shi, Tokyo, 192-0032

  • Hamamatsu University Hospital /ID# 206459

    Hamamatsu, Shizuoka, 431-3192

  • National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210710

    Higashi-ohmi-shi, Shiga, 527-8505

  • Hirosaki National Hospital /ID# 206387

    Hirosaki-shi, Aomori, 036-8545

  • Hiroshima University Hospital /ID# 206464

    Hiroshima, Hiroshima, 734-8551

  • Shimane University School of Medicine /ID# 208905

    Izumo-shi, Shimane, 693-0021

  • Idzuro Imamura Hospital /ID# 207639

    Kagoshima, Kagoshima-ken, 892-0824

  • Sameshima Hospital /ID# 207935

    Kagoshima, Kagoshima-ken, 892-0846

  • Kanazawa University Hospital /ID# 206316

    Kanazawa, Ishikawa-ken, 920-8641

  • Tsujinaka Hospital Kashiwanoha /ID# 209573

    Kashiwa-shi, Chiba, 277-0871

  • Saitama Medical Center /ID# 206393

    Kawagoe-shi, Saitama, 350-8550

  • St. Marianna University School of Medicine Hospital /ID# 209451

    Kawasaki-shi, Kanagawa, 216-8511

  • Aoyama Clinic /ID# 206452

    Kobe, Hyōgo, 650-0015

  • Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 206646

    Kurashiki-shi, Okayama-ken, 710-0142

  • Kurume University Hospital /ID# 206385

    Kurume-shi, Fukuoka, 830-0011

  • Kyoto University Hospital /ID# 211809

    Kyoto, Kyoto, 606-8507

  • Asahikawa Medical University Hospital /ID# 206404

    Midorigaokahiga-shi, Hokkaido, 078-8510

  • Iwate Medical University Uchimaru Medical Center /ID# 207051

    Morioka, Iwate, 020-8505

  • Nagoya University Hospital /ID# 206355

    Nagoya, Aichi-ken, 4668560

  • Nagoya City University Hospital /ID# 206058

    Nagoya, Aichi-ken, 467-8602

  • Saiseikai Niigata Hospital /ID# 209921

    Niigata, Niigata, 950-1104

  • Niigata University Medical & Dental Hospital /ID# 218049

    Niigata, Niigata, 951-8520

  • Hyogo College of Medicine Hospital /ID# 206455

    Nishinomiya-shi, Hyōgo, 663-8501

  • Obihiro kosei Hospital /ID# 210424

    Obihiro-shi, Hokkaido, 080-0024

  • Ogaki Municipal Hospital /ID# 208227

    Ogaki-shi, Gifu, 503-8502

  • Ishida Clinic of IBD and Gastroenterology /ID# 210119

    Ōita, Oita Prefecture, 870-0823

  • Okayama University Hospital /ID# 217925

    Okayama, Okayama-ken, 700-8558

  • NHO Nagasaki Medical Center /ID# 210822

    Omura-shi, Nagasaki, 856-8562

  • Kinshukai Infusion Clinic /ID# 207865

    Osaka, Osaka, 530-0011

  • Kitano Hospital /ID# 210397

    Osaka, Osaka, 530-8480

  • Japanese Red Cross Osaka Hospital /ID# 209478

    Osaka, Osaka, 543-8555

  • Osaka City University Hospital /ID# 206457

    Osaka, Osaka, 545-8586

  • Saga University Hospital /ID# 209270

    Saga, Saga-ken, 849-8501

  • Tokitokai Tokito clinic /ID# 206313

    Saitama-shi, Saitama, 336-0963

  • Toho University Medical Center Sakura Hospital /ID# 207705

    Sakura-shi, Chiba, 285-8741

  • Sapporo Tokushukai Hospital /ID# 209448

    Sapporo, Hokkaido, 004-0041

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 206059

    Sapporo, Hokkaido, 060-0033

  • Sapporo Medical University Hospital /ID# 206314

    Sapporo, Hokkaido, 060-8543

  • Sapporo Higashi Tokushukai Hospital /ID# 208494

    Sapporo, Hokkaido, 065-0033

  • National Hospital Organization Sendai Medical Center /ID# 209528

    Sendai, Miyagi, 983-8520

  • Center Hospital of the National Center for Global Health and Medicine /ID# 209532

    Shinjuku-ku, Tokyo, 162-8655

  • Tokyo Women's Medical University Hospital /ID# 206460

    Shinjuku-ku, Tokyo, 162-8666

  • Tokuyama Central Hospital /ID# 216994

    Shunan-shi, Yamaguchi, 745-8522

  • NHO Shizuoka Medical Center /ID# 208785

    Sunto-gun, Shizuoka, 411-8611

  • Teikyo University Hospital /ID# 209866

    tabashi City, Tokyo, 173-8606

  • Shoyukai Fujita Gastroenterological Hospital /ID# 216493

    Takatsuki-shi, 569-0086

  • Toyohashi Municipal Hospital /ID# 207625

    Toyohashi, Aichi-ken, 441-8570

  • Toyonaka Municipal Hospital /ID# 217082

    Toyonaka-shi, Osaka, 560-0055

  • Ieda Hospital /ID# 207479

    Toyota-shi, Aichi-ken, 470-1219

  • Mie University Hospital /ID# 206803

    Tsu, Mie-ken, 514-8507

  • Juntendo University Urayasu Hospital /ID# 208784

    Urayasu-shi, Chiba, 279-0021

  • Yamagata University Hospital /ID# 206465

    Yamagata, Yamagata, 990-9585

  • Kenseikai Dongo Hospital /ID# 208101

    Yamatotakada-shi, Nara, 635-0022

  • Yokkaichi Hazu Medical Center /ID# 214348

    Yokkaichi-shi, Mie-ken, 510-0016

  • Showa University Fujigaoka Hospital /ID# 208224

    Yokohama, Kanagawa, 227-8501

Other trials in Japan

China11 sites

  • The First Hospital of Jilin University /ID# 210088

    Changchun, Jilin, 130021

  • West China Hospital, Sichuan University /ID# 205332

    Chengdu, 610041

  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 205267

    Guangzhou, Guangdong, 510120

  • The Sixth Affiliated Hosp Sun /ID# 205268

    Guangzhou, Guangdong, 510655

  • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 205271

    Hangzhou, Zhejiang, 310009

  • The First Affiliated Hospital of Nanchang University /ID# 212186

    Nanchang, Jiangxi, 330006

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 205333

    Shanghai, Shanghai Municipality, 200025

  • Affiliated Taihe Hospital of Hubei University of Medicine /ID# 216406

    Shiyan, Hubei, 442700

  • Duplicate_Tianjin Med Univ General Hosp /ID# 205246

    Tianjin, 300052

  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 205266

    Wuhan, Hubei, 430022

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 205265

    Wuhan, 430030

Other trials in China

Russia10 sites

  • Immanuel Kant Baltic Federal University /ID# 208264

    Kaliningrad, Kaliningrad Oblast, 236016

  • Kazan State Medical University /ID# 208256

    Kazan', Tatarstan, Respublika, 420012

  • Olla-Med Clinic /ID# 215335

    Moscow, 105554

  • Perm Clinical Center of the Federal Medical and Biological Agency /ID# 211653

    Perm, Permskiy Kray, 614109

  • Republican hospital named after V.A. Baranov /ID# 206507

    Petrozavodsk, 185019

  • Euromedservice /ID# 208265

    Pushkin, 196603

  • LLC Novaya Clinica /ID# 208260

    Pyatigorsk, 357532

  • NW State Medical Univ na Mechn /ID# 208258

    Saint Petersburg, Leningradskaya Oblast', 191015

  • Medical Company Hepatolog /ID# 208261

    Samara, Samara Oblast, 443063

  • Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 211652

    Stavropol, Stavropol Kray, 355012

Other trials in Russia

Spain10 sites

  • Hospital Universitario A Coruna - CHUAC /ID# 206907

    A Coruña, 15006

  • Hospital Clinic de Barcelona /ID# 206906

    Barcelona, 08036

  • Hospital Universitario Reina Sofia /ID# 204412

    Córdoba, 14004

  • Hospital Universitario Dr. Negrin /ID# 206905

    Las Palmas de Gran Canaria, Las Palmas, 35010

  • Hospital Universitario Ramon y Cajal /ID# 204410

    Madrid, 28034

  • Hospital Universitario La Paz /ID# 214540

    Madrid, 28046

  • Hospital Clinico Universitario de Salamanca /ID# 205013

    Salamanca, 37007

  • Hospital Unversitario Marques de Valdecilla /ID# 216622

    Santander, Cantabria, 39008

  • Hospital Clínico Universitario de Santiago-CHUS /ID# 204411

    Santiago de Compostela, A Coruna, 15706

  • Hospital Universitario y Politecnico La Fe /ID# 206904

    Valencia, 46026

Other trials in Spain

Germany8 sites

  • Duplicate_Praxis am Bayrischen Platz /ID# 206733

    Berlin, 10825

  • Agaplesion Markus Krankenhaus /ID# 206731

    Frankfurt am Main, 60431

  • Gastroenterologische Gemeinschaftspraxis Herne /ID# 214576

    Herne, North Rhine-Westphalia, 44623

  • Duplicate_Univ Hosp Schleswig-Holstein /ID# 206791

    Kiel, 24105

  • Universitatsklinikum Mannheim /ID# 206811

    Mannheim, Baden-Wurttemberg, 68167

  • Medizinisches Versorgungszentrum Portal 10 /ID# 207137

    Münster, 48155

  • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215813

    Saarbrücken, Saarland, 66111

  • Duplicate_Universitaetsklinikum Tuebingen /ID# 206737

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Portugal8 sites

  • Hospital Garcia de Orta, EPE /ID# 206143

    Almada, 2805-267

  • CCA Braga - Hospital de Braga /ID# 206144

    Braga, 4710-243

  • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 205554

    Guimarães, Braga District, 4835-044

  • Hospital Santo Antonio dos Cap /ID# 206145

    Lisbon, 1150-069

  • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 206117

    Lisbon, 1649-035

  • Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 205556

    Ponte de Lima, Viana do Castelo District, 4990-041

  • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 206142

    Porto, 4200-319

  • Centro Hospitalar de Entre Douro e Vouga /ID# 205563

    Santa Maria DA Feira, Porto District, 4520-211

Other trials in Portugal

Serbia8 sites

  • Clinical Hosp Center Zvezdara /ID# 205258

    Belgrade, Beograd, 11000

  • Military Medical Academy /ID# 205257

    Belgrade, Beograd, 11000

  • University Clinical Center Serbia /ID# 205256

    Belgrade, Beograd, 11000

  • Clin Hosp Ctr Bezanijska Kosa /ID# 206413

    Belgrade, Beograd, 11080

  • University Clinical Center Kragujevac /ID# 206410

    Kragujevac, Sumadijski Okrug, 34000

  • General Hospital Leskovac /ID# 217881

    Leskovac, 16000

  • University Clinical Center of Nis /ID# 206411

    Niš, Nisavski Okrug, 18000

  • Clinical Center Vojvodina /ID# 205259

    Novi Sad, Vojvodina, 21000

Other trials in Serbia

South Africa8 sites

  • MD Search /ID# 208084

    Boksburg North, Gauteng, 1460

  • Kingsbury Hospital /ID# 205281

    Cape Town, Western Cape, 7708

  • Private Practice Dr MN Rajabally /ID# 205273

    Cape Town, Western Cape, 7800

  • Mediclinic Milnerton /ID# 207979

    CAPE TOWN Milnerton, Western Cape, 7441

  • Clinresco Centers /ID# 208083

    Johannesburg, Gauteng, 1619

  • Lenasia Clinical Trial Centre /ID# 214359

    Johannesburg, Gauteng, 1820

  • Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 208082

    Johannesburg, Gauteng, 2193

  • Wits Clinical Research Site /ID# 208949

    Johannesburg, Gauteng, 2193

Other trials in South Africa

Canada7 sites

  • University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 205755

    Calgary, Alberta, T2N 4Z6

  • Allen Whey Khye Lim Professional Corporation /ID# 211167

    Edmonton, Alberta, T5R 1W2

  • Covenant Health /ID# 205500

    Edmonton, Alberta, T6K 4B2

  • Crchum /Id# 207387

    Montreal, Quebec, H2X 0A9

  • CIUSSS de l'Estrie - CHUS /ID# 205499

    Sherbrooke, Quebec, J1G 2E8

  • Duplicate_Toronto Digestive Disease Asso /ID# 205498

    Vaughan, Ontario, L4L 4Y7

  • Percuro Clinical Research, Ltd /ID# 205501

    Victoria, British Columbia, V8V 3M9

Other trials in Canada

Czechia7 sites

  • Hepato-Gastroenterologie HK, s.r.o. /ID# 205672

    Hradec Králové, 500 12

  • CTCenter MaVe s.r.o. /ID# 205671

    Olomouc, 779 00

  • Artroscan s.r.o. /ID# 205668

    Ostrava, 722 00

  • Nemocnice Pardubickeho kraje, a.s. /ID# 213540

    Pardubice, 530 03

  • Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 216223

    Prague, 118 33

  • Axon Clinical, s.r.o. /ID# 205670

    Prague, 140 00

  • ISCARE a.s. /ID# 209240

    Prague, 190 00

Other trials in Czechia

Italy7 sites

  • A.O.U. Policlinico S.Orsola-Malpighi /ID# 206351

    Bologna, Emilia-Romagna, 40138

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 206349

    Milan, 20122

  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 206354

    Negrar, Verona, 37024

  • A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 206350

    Palermo, 90146

  • ASST Rhodense/Presidio Ospedaliero di Rho /ID# 216611

    Rho, Milano, 20017

  • Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 206347

    Rome, Roma, 00168

  • Istituto Clinico Humanitas /ID# 206346

    Rozzano, Milano, 20089

Other trials in Italy

Australia6 sites

  • St Vincent's Hospital Melbourne /ID# 205758

    Fitzroy, Victoria, 3065

  • Macquarie University Hospital /ID# 211955

    Macquarie University, New South Wales, 2109

  • Monash Medical Centre /ID# 206486

    Melbourne, Victoria, 3168

  • Fiona Stanley Hospital /ID# 211642

    Murdoch, Western Australia, 6150

  • Duplicate_Mater Misericordiae /ID# 212687

    South Brisbane, Queensland, 4101

  • Griffith University /ID# 211956

    Southport, Queensland, 4222

Other trials in Australia

Brazil6 sites

  • Upeclin Fmb - Unesp /Id# 206986

    Botucatu, São Paulo, 18618-686

  • Hospital Nossa Senhora das Graças /ID# 206981

    Curitiba, Paraná, 80810-040

  • Hospital de Clinicas de Porto Alegre /ID# 206985

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 206504

    Ribeirão Preto, São Paulo, 14051-140

  • Faculdade de Medicina do ABC /ID# 206984

    Santo André, São Paulo, 09060-870

  • Kaiser Clinica e Hospital Dia /ID# 206982

    São José do Rio Preto, São Paulo, 15015-110

Other trials in Brazil

Poland6 sites

  • Endoskopia Sp. z o.o. /ID# 212964

    Sopot, Pomeranian Voivodeship, 81-756

  • Gastromed /Id# 216108

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Centrum Zdrowia MDM /ID# 205874

    Warsaw, Masovian Voivodeship, 00-635

  • Centrum Medyczne Reuma Park w Warszawie /ID# 212913

    Warsaw, Masovian Voivodeship, 02-691

  • NZOZ Vivamed /ID# 216697

    Warsaw, Masovian Voivodeship, 03-580

  • Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215070

    Warsaw, Masovian Voivodeship, 04-730

Other trials in Poland

South Korea6 sites

  • Dong-A University Hospital /ID# 206955

    Busan, 49201

  • Pusan National University Hospital /ID# 206956

    Busan, 49241

  • Yeungnam University Medical Center /ID# 206959

    Daegu, 42415

  • Duplicate_CHA Bundang Medical Center /ID# 207432

    Seongnam-si, Gyeonggi-do, 13496

  • Kangbuk Samsung Hospital /ID# 206960

    Seoul, Seoul Teugbyeolsi, 03181

  • Yonsei University Health System, Severance hospital /ID# 206958

    Seoul, 03722

Other trials in South Korea

Argentina5 sites

  • Mautalen Salud e Investigacion /ID# 206033

    Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1128

  • Hospital Britanico de Buenos Aires /ID# 209497

    Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1280

  • Gedyt /ID# 210017

    Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1426

  • Hospital Privado Univesitario /ID# 206030

    Córdoba, 5016

  • Cardio Alem /ID# 211282

    San Isidro, Buenos Aires, 1642

Other trials in Argentina

Bosnia and Herzegovina5 sites

  • University Clinical Centre of the Republic of Srpska /ID# 208053

    Banja Luka, Republika Srpska, 78000

  • University Clinical Centre of the Republic of Srpska /ID# 208055

    Banja Luka, Republika Srpska, 78000

  • University Clinical Hospital Mostar /ID# 208054

    Mostar, 88000

  • Clinical Center University of Sarajevo /ID# 208058

    Sarajevo, 71000

  • University Clinical Center Tuzla /ID# 208057

    Tuzla, Tuzlanski, 75000

Other trials in Bosnia and Herzegovina

Chile5 sites

  • Hospital Guillermo Grant Benavente de Concepción /ID# 212426

    Concepción, 4070038

  • CTR Estudios Clinicos /ID# 208036

    Providencia, 7500571

  • Research Group /ID# 208037

    Santiago, Santiago Metropolitan, 2540364

  • M y F Estudios Clínicos Ltda. /ID# 208035

    Santiago, Santiago Metropolitan, 7750495

  • Hospital Clinico Universidad De Los Andes /ID# 207426

    Santiago, 7501504

Other trials in Chile

Slovakia5 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 205147

    Banská Bystrica, 975 17

  • Medak s.r.o. /ID# 205191

    Bratislava, Bratislava Region, 851 01

  • B+B MED, s.r.o. /ID# 205213

    Košice, 040 01

  • Fakultna nemocnica s poliklini /ID# 211372

    Nové Zámky, 940 34

  • GASTRO I., s.r.o. /ID# 205148

    Prešov, 080 01

Other trials in Slovakia

Turkey (Türkiye)5 sites

  • Gazi University Med. Faculty /ID# 208040

    Ankara GAZI, 06500

  • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 207507

    Istanbul, 34098

  • Umraniye Training and Res Hosp /ID# 208206

    Istanbul, 34764

  • Erciyes University Medical Fac /ID# 207506

    Melikgazi, Kayseri, 38030

  • Mersin University Medical /ID# 208039

    Mersin, 33343

Other trials in Turkey (Türkiye)

Ukraine5 sites

  • Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical /ID# 206939

    Kharkiv, Kharkiv Oblast, 61204

  • PE PMC Acinus, Medical and Diagnostic Center /ID# 217218

    Kropyvnytskyi, 25006

  • Kyiv Regional Hospital /ID# 217373

    Kyiv, Kyivska Oblast, 04073

  • Medical centre of CONSILIUM MEDICAL LLC /ID# 217447

    Kyiv, 04050

  • Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 216300

    Vinnytsia, 21018

Other trials in Ukraine

United Kingdom5 sites

  • Basingstoke & North Hampshire /ID# 207985

    Basingstoke, RG24 9NA

  • Queen Elizabeth University Hos /ID# 205154

    Glasgow, G514TF

  • Huddersfield Royal Infirmary /ID# 217660

    Huddersfield, HD3 3EA

  • St. George's Healthcare NHS /ID# 208375

    London, SW17 0QT

  • Barts and the London NHS Trust /ID# 205153

    Whitechapel, E1 1 BB

Other trials in United Kingdom

Croatia4 sites

  • Klinicki bolnicki centar Rijeka /ID# 208650

    Rijeka, Primorje-Gorski Kotar County, 51000

  • Klinicki bolnicki centar Split /ID# 217027

    Split, 21000

  • Klinicka bolnica Dubrava Zagreb /ID# 208460

    Zagreb, City of Zagreb, 10000

  • Poliklinika Solmed /ID# 211568

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Estonia4 sites

  • East Tallinn Central Hospital /ID# 207564

    Tallinn, Harju, 10138

  • West Tallinn Central Hospital /ID# 207356

    Tallinn, 10617

  • North Estonia Medical Centre /ID# 207357

    Tallinn, 13419

  • Tartu University Hospital /ID# 212282

    Tartu, 51014

Other trials in Estonia

Finland4 sites

  • Keski-Suomen Sairaala Nova /ID# 206159

    Jyväskylä, 40620

  • Laakarikeskus Ikioma /ID# 205814

    Mikkeli, 50100

  • Tampere University Hospital /ID# 206161

    Tampere, Pirkanmaa, 33520

  • Tyks /Id# 205813

    Turku, 20521

Other trials in Finland

Greece4 sites

  • General Hospital of Athens Laiko /ID# 208671

    Athens, Attica, 11527

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 206332

    Athens, 10676

  • University General Hospital of Heraklion PA.G.N.I /ID# 207061

    Heraklion, Crete, 711 10

  • Duplicate_General Hospital of Thessaloniki Hippokrateio /ID# 208822

    Thessaloniki, 54642

Other trials in Greece

Hungary4 sites

  • Bekes Megyei Kozponti Korhaz /ID# 205885

    Békéscsaba, 5600

  • Semmelweis Egyetem /ID# 205883

    Budapest, 1085

  • Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 207992

    Sopron, 9400

  • Mentahaz Maganorvosi Kozpont /ID# 205882

    Székesfehérvár, 8000

Other trials in Hungary

Lithuania4 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 209052

    Kaunas, 50161

  • Klaipeda Seamens Hospital /ID# 208791

    Klaipėda, 92288

  • Klaipeda University Hospital /ID# 208790

    Klaipėda, 92288

  • Vilnius University Hospital /ID# 209051

    Vilnius, LT-08661

Other trials in Lithuania

Switzerland4 sites

  • Universitaetsspital Basel /ID# 211381

    Basel, 4031

  • Inselspital, Universitaetsklinik /ID# 211312

    Bern, 3010

  • Kantonsspital St. Gallen /ID# 211310

    Sankt Gallen, Canton of St. Gallen, 9007

  • Universitaetsspital Zuerich /ID# 211308

    Zurich, 8091

Other trials in Switzerland

Taiwan4 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 207848

    Kaohsiung City, 80708

  • China Medical University Hosp /ID# 207845

    Taichung, Taichung, 40447

  • Taipei Veterans General Hosp /ID# 207849

    Taipei, 11217

  • National Taiwan University Hospital /ID# 207847

    Taipei City, Taipei, 100

Other trials in Taiwan

Austria3 sites

  • LKH Salzburg and Paracelsus /ID# 208788

    Salzburg, 5020

  • Klinik Landstrasse /ID# 205764

    Vienna, State of Vienna, 1030

  • Medical University of Vienna /ID# 205763

    Vienna, State of Vienna, 1090

Other trials in Austria

Colombia3 sites

  • Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 208886

    Bogota DC, Cundinamarca, 111221

  • Hospital Universitario San Vic /ID# 208888

    Medellín, 50010

  • Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 208887

    Montería, Departamento de Córdoba, 230002

Other trials in Colombia

Mexico3 sites

  • Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 208068

    Guadalajara, Jalisco, 44650

  • Morales Vargas Centro de Investigacion S.C. /ID# 211326

    León, Guanajuato, 37000

  • Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 208067

    Monterrey, Nuevo León, 64610

Other trials in Mexico

Singapore3 sites

  • National University Hospital /ID# 209099

    Singapore, 119074

  • Gleneagles Medical Centre /ID# 206954

    Singapore, 258499

  • Tan Tock Seng Hospital /ID# 207663

    Singapore, 308433

Other trials in Singapore

Belgium2 sites

  • AZ Maria Middelares /ID# 210928

    Ghent, 9000

  • Universitair Ziekenhuis Leuven /ID# 205988

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

France2 sites

  • Chu de Nice-Hopital L'Archet Ii /Id# 209118

    Nice, Alpes-Maritimes, 06202

  • Centre Hospitalier Lyon Sud /ID# 209121

    Pierre-Bénite, Rhone, 69495

Other trials in France

Ireland2 sites

  • Beaumont Hospital /ID# 206509

    Dublin, D09 XR63

  • University Hospital Galway /ID# 218035

    Galway, H91 YR71

Other trials in Ireland

Israel2 sites

  • Rambam Health Care Campus /ID# 206362

    Haifa, 3109601

  • Shaare Zedek Medical Center /ID# 206365

    Jerusalem, 91031

Other trials in Israel

Latvia2 sites

  • Riga East Clinical Univ Hosp /ID# 206828

    Riga, 1038

  • P. Stradins Clinical Univ Hosp /ID# 206827

    Riga, LV-1002

Other trials in Latvia

Malaysia2 sites

  • Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 207662

    Kuala Lumpur, Selangor, 56000

  • Duplicate_Uni Malaya MC /ID# 208936

    Kuala Lumpur, 59100

Other trials in Malaysia

Norway2 sites

  • Akershus Universitetssykehus_MAIN /ID# 205293

    Lorenskog, Akershus, 1478

  • Universitetssykehuset Nord-Norge /ID# 205691

    Tromsø, Troms, 9019

Other trials in Norway

Netherlands1 site

  • Erasmus Medisch Centrum /ID# 205280

    Rotterdam, 3015 GD

Other trials in Netherlands

Puerto Rico1 site

  • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 209626

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: 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).

Read the detailed description

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).

Being tested
Placebo, Upadacitinib
Keywords
Upadacitinib, ABT-494, Ulcerative Colitis
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Tablet for oral administration

  • UpadacitinibDrug

    Also called ABT-494, RINVOQ®

    Tablet for oral administration

Study groups in NCT03653026
Study groupRoleWhat they receive
Upadacitinib 45 mgExperimentalParticipants received 45 mg upadacitinib once daily (QD) for 8 weeks. Participants who did not achieve clinical response per Adapted Mayo score at Week 8 received upadacitinib 45 mg once daily for 8 additional weeks in the open-label extension period.
Receives: Drug: Upadacitinib
PlaceboPlacebo comparatorParticipants received placebo matching to upadacitinib once daily for 8 weeks. Participants who did not achieve clinical response per Adapted Mayo score at Week 8 received upadacitinib 45 mg once daily for 8 weeks in the open-label extension period.
Receives: Drug: Placebo; Drug: Upadacitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8

    The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:

    1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
    2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
    3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).

    The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.

    Clinical remission is defined as an Adapted Mayo score ≤ 2, with SFS ≤ 1 and not higher than Baseline, RBS of 0, and endoscopic subscore ≤ 1.

    Measured: Week 8

Secondary outcomes (11)

  1. Percentage of Participants With Endoscopic Improvement at Week 8

    Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).

    Measured: Week 8

  2. Percentage of Participants With Endoscopic Remission at Week 8

    Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).

    Measured: Week 8

  3. Percentage of Participants Who Achieved Clinical Response Per Adapted Mayo Score at Week 8

    The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:

    1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
    2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
    3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).

    The overall Adapted Mayo score ranges from 0 to 9 with higher scores representing more severe disease.

    Clinical response per the Adapted Mayo Score is defined as a decrease in Adapted Mayo score ≥ 2 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.

    Measured: Week 8

  4. Percentage of Participants Who Achieved Clinical Response Per Partial Adapted Mayo Score at Week 2

    The Partial Adapted Mayo Score is a composite score of UC disease activity based on the following 2 subscores:

    1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
    2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).

    The overall Partial Adapted Mayo score ranges from 0 to 6 with higher scores representing more severe disease.

    Clinical response per Partial Adapted Mayo Score is defined as a decrease in Partial Adapted Mayo score ≥ 1 point and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.

    Measured: Week 2

  5. Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 8

    Histologic endoscopic mucosal improvement is defined as an endoscopic subscore of 0 or 1 and a Geboes score ≤ 3.1.

    The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).

    The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.

    Measured: Week 8

  6. Percentage of Participants Who Reported No Bowel Urgency at Week 8

    Bowel urgency was assessed by participants in a subject diary completed once a day.

    Measured: Week 8

  7. Percentage of Participants Who Reported No Abdominal Pain at Week 8

    Abdominal pain was assessed by participants in a subject diary completed once a day.

    Measured: Week 8

  8. Percentage of Participants Who Achieved Histologic Improvement at Week 8

    Histologic improvement is defined as a decrease from Baseline in Geboes score. The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.

    Measured: Week 8

  9. Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 8

    The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with ulcerative colitis. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.

    Measured: Baseline (Week 0) to Week 8

  10. Percentage of Participants Who Achieved Mucosal Healing at Week 8

    Mucosal healing is defined as an endoscopic score of 0 and Geboes score < 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).

    The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.

    Measured: Week 8

  11. Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 8

    The FACIT fatigue questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. Each question is answered on a 5-point Likert scale: 0 (not at all); 1 (a little bit); 2 (somewhat); 3 (quite a bit); and 4 (very much). The total score ranges from 0 to 52, where higher scores represent less fatigue, and a positive change from Baseline indicates improvement.

    Measured: Baseline (Week 0) to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2018
  2. Study start6 Dec 2018
  3. Primary completion14 Jan 2021
  4. Study completion14 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
522 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03653026
Sponsor's protocol ID
M14-675
Other IDs
2016-000642-62, 2016
Acronym
U-Accomplish
Status last verified
Feb 2022
First submitted
28 Aug 2018
Last updated
2 Mar 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

  • Wei SC, Nakase H, Ye BD, Chao K, Wu HY, Eccleston J, Yao X, Palac H, Mohamed MF, Ponce-Bobadilla AV, Suravaram S, Barrachina EM, Hisamatsu T, Gao X. Efficacy, Safety, and Pharmacokinetics of Upadacitinib Among Patients in East Asia With Moderately to Severely Active Ulcerative Colitis: A Post Hoc Subanalysis of Randomized Phase 3 Studies. J Gastroenterol Hepatol. 2026 Aug 19. doi: 10.1111/jgh.70634. Online ahead of print.

    PubMed 42613995

  • Vermeire S, Colombel JF, Danese S, Panaccione R, Peyrin-Biroulet L, Beck K, Chaparro M, Gisbert JP, Dubcenco E, Klaff J, Naling G, Ford S, Remple V, Joshi N, Suravaram S, Duncan B, Wang Y, Wick-Urban B, Loftus EV. Benefit-risk profile of upadacitinib: exploratory post hoc analysis of phase 2b/3 studies in patients with moderately to severely active ulcerative colitis or Crohn's disease. J Crohns Colitis. 2026 Jan 9;20(1):jjaf198. doi: 10.1093/ecco-jcc/jjaf198.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Upadacitinib in people with Ulcerative Colitis (UC), run by AbbVie at 379 sites in 44 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 379 sites in United States, Japan, China, Russia, Spain and 39 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03653026, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.

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