AzTrials
AzTrials

Ulcerative Colitis (UC)Phase 2/3NCT02819635

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)

A Phase 2/3 study testing Upadacitinib in people with Ulcerative Colitis (UC), run by AbbVie at 496 sites in 46 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

This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. 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
1,302 participants
Where
496 sitesin 46 countries
Study dates
26 Sep 2016to 13 Dec 2021
Phase
Phase 2/3
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

  • 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.

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 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

Trial locations and contacts

496 sites in 46 countries.

496 sites in 46 countries

United States149 sites

  • Duplicate_University of New Mexico Department of Internal Medicine /ID# 214396

    Albuquerque, New Mexico, 87131

  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 151140

    Ann Arbor, Michigan, 48109

  • Huron Gastroenterology Assoc /ID# 152710

    Ann Arbor, Michigan, 48197

  • TX Clinical Research Institute /ID# 151526

    Arlington, Texas, 76012

  • Digestive Health Partners, P.A /ID# 167237

    Asheville, North Carolina, 28801

  • University of Maryland Med Ctr /ID# 150449

    Baltimore, Maryland, 21201

  • Inquest Clinical Research /ID# 164635

    Baytown, Texas, 77521-2415

  • Washington Gastroenterology /ID# 163629

    Bellevue, Washington, 98004

  • Birmingham Gastroenterology Associates P.C /ID# 151276

    Birmingham, Alabama, 35209

  • Massachusetts General Hospital /ID# 165676

    Boston, Massachusetts, 02114

  • HP Clinical Research /ID# 163939

    Bountiful, Utah, 84010

  • NY Scientific /ID# 152707

    Brooklyn, New York, 11235

  • Texas Digestive Disease Consultants /ID# 209947

    Cedar Park, Texas, 78613-5028

  • Texas Digestive Disease Consultants /ID# 209804

    Cedar Park, Texas, 78613

  • Delsol Research Management, Ll /Id# 170131

    Chandler, Arizona, 85224

  • Pharmacorp Clinical Trials /ID# 153354

    Charleston, South Carolina, 29412

  • Atrium Health Carolinas Medical Center /ID# 156971

    Charlotte, North Carolina, 28203

  • Charlotte Gastroenterology and Hepatology, PLLC /ID# 150545

    Charlotte, North Carolina, 28207

  • Clin Res Inst of Michigan, LLC /ID# 153027

    Chesterfield, Michigan, 48047

  • Next Innovative Clinical Research - Chicago /ID# 216060

    Chicago, Illinois, 60605-2168

  • The University of Chicago DCAM /ID# 150547

    Chicago, Illinois, 60637

  • Consultants for Clinical Research /ID# 151679

    Cincinnati, Ohio, 45219

  • University of Cincinnati /ID# 164582

    Cincinnati, Ohio, 45267-0585

  • Gastro Florida /ID# 155245

    Clearwater, Florida, 33756

  • Delta Waves, Inc. /ID# 151721

    Colorado Springs, Colorado, 80918

  • Gastro Center of Maryland /ID# 200022

    Columbia, Maryland, 21045

  • The Ohio State University /ID# 169416

    Columbus, Ohio, 43210

  • Optimed Research, Ltd. /ID# 169696

    Columbus, Ohio, 43235

  • Citrus Valley Gastroenterology /ID# 151914

    Covina, California, 91722-3797

  • Tri-State Gastroenterology /ID# 169811

    Crestview Hills, Kentucky, 41017

  • Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 200770

    Dallas, Texas, 75246

  • Western Connecticut Medical Group /ID# 169210

    Danbury, Connecticut, 06810

  • Hometown Urgent Care and Resea /ID# 200065

    Dayton, Ohio, 45424

  • Moonshine Research Center, Inc /ID# 152533

    Doral, Florida, 33166

  • Universal Axon Clinical Research /ID# 213461

    Doral, Florida, 33166

  • AGA Clinical Research Associates, LLC /ID# 153040

    Egg Harbor, New Jersey, 08234

  • Dayton Gastroenterology, Inc. /ID# 167631

    Englewood, Ohio, 45415

  • NorthShore University HealthSystem /ID# 150555

    Evanston, Illinois, 60201

  • MediSphere Medical Research Center /ID# 152064

    Evansville, Indiana, 47714-8011

  • Plains Clinical Research Center, LLC /ID# 170290

    Fargo, North Dakota, 58104-5925

  • Ctr for Gastrointestinal Healt /ID# 153360

    Franklin, Virginia, 23851

  • DHAT Research Institute /ID# 151218

    Garland, Texas, 75044-2208

  • Gastro One /ID# 151144

    Germantown, Tennessee, 38138

  • Aurora Medical Center - Grafto /ID# 151717

    Grafton, Wisconsin, 53024

  • NYU Langone Long Island Clinical Research Association /ID# 155272

    Great Neck, New York, 11021

  • Atlantic Gastroenterology Clinical Research /ID# 151899

    Greenville, North Carolina, 27834

  • Gastroenterology Associates, P.A. of Greenville /ID# 150541

    Greenville, South Carolina, 29615-3593

  • Medical Research Center of CT /ID# 150482

    Hamden, Connecticut, 06518

  • Palmetto Research, LLC /ID# 151716

    Hialeah, Florida, 33016

  • Northwest Health Care Associates /ID# 151590

    Hoffman Estates, Illinois, 60169

  • Houma Digestive Health Special /ID# 151844

    Houma, Louisiana, 70360

  • Vilo Research Group Inc /ID# 212624

    Houston, Texas, 77017-2337

  • CliniCore International, LLC /ID# 152062

    Houston, Texas, 77027-6812

  • Baylor College of Medicine - Baylor Medical Center /ID# 150486

    Houston, Texas, 77030-3411

  • Centex Studies, Inc. - Houston /ID# 201216

    Houston, Texas, 77058

  • GI Specialists of Houston /ID# 202327

    Houston, Texas, 77070-4347

  • Newport Huntington Medical Group /ID# 217005

    Huntington Beach, California, 92648-5994

  • Indianapolis Gastroenterology /ID# 162901

    Indianapolis, Indiana, 46237

  • Nature Coast Clinical Research - Inverness /ID# 154064

    Inverness, Florida, 34452-4717

  • University of Iowa Hospitals and Clinics /ID# 157058

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center /ID# 213139

    Jackson, Mississippi, 39216-4500

  • Southern Therapy and Advanced Research (STAR) LLC /ID# 170712

    Jackson, Mississippi, 39216

  • Encore Borland-Groover Clinical Research /Id# 170912

    Jacksonville, Florida, 32256

  • East Tennessee Research Institute /ID# 203610

    Johnson City, Tennessee, 37604

  • SIH Research Mumtaz, Inc /ID# 163319

    Kissimmee, Florida, 34741-4161

  • UC San Diego Health System /ID# 155185

    La Jolla, California, 92093

  • Las Vegas Medical Research /ID# 153044

    Las Vegas, Nevada, 89113

  • Dartmouth-Hitchcock Medical Center /ID# 150549

    Lebanon, New Hampshire, 03756

  • Emeritas Research Group, LLC /ID# 150258

    Leesburg, Virginia, 20176

  • South Denver Gastroenterology /ID# 151223

    Lone Tree, Colorado, 80124

  • United Medical Doctors /ID# 207464

    Los Alamitos, California, 90720-3309

  • TLC Clinical Research Inc /ID# 216829

    Los Angeles, California, 90048

  • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 157080

    Los Angeles, California, 90067-2001

  • Caprock Gastro Research, LLC /ID# 214754

    Lubbock, Texas, 79424-3017

  • Gastroenterology Associates of Central Georgia, LLC /ID# 165782

    Macon, Georgia, 31201

  • Cfagi Llc /Id# 202017

    Maitland, Florida, 32751-6108

  • Great Lakes Medical Research, LLC /ID# 201772

    Mentor, Ohio, 44060-6211

  • Ohio Clinical Research Partner /ID# 154068

    Mentor, Ohio, 44060

  • Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211885

    Mesa, Arizona, 85206

  • University of Miami /ID# 215441

    Miami, Florida, 33136

  • Advanced Pharma /ID# 151719

    Miami, Florida, 33147

  • New Horizon Research Center /ID# 152474

    Miami, Florida, 33165-3372

  • Crystal Pharmacology Research /ID# 151841

    Miami, Florida, 33165

  • Coral Research Clinic /ID# 150444

    Miami, Florida, 33186-4643

  • Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 151838

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin /ID# 151843

    Milwaukee, Wisconsin, 53226-3522

  • Facey Medical Foundation /ID# 203133

    Mission Hills, California, 91345

  • East View Medical Research, LLC /ID# 171183

    Mobile, Alabama, 36606

  • CB Flock Research Corporation /ID# 165980

    Mobile, Alabama, 36608

  • Atlantic Digestive Health Inst /ID# 150447

    Morristown, New Jersey, 07960

  • United Medical Doctors - Murrieta /ID# 151211

    Murrieta, California, 92563

  • Quality Medical Research /ID# 203426

    Nashville, Tennessee, 37211

  • Vanderbilt University Medical Center /ID# 153355

    Nashville, Tennessee, 37232-0011

  • Rutgers Robert Wood Johnson /ID# 155248

    New Brunswick, New Jersey, 08901

  • Nola Research Works, LLC /ID# 153356

    New Orleans, Louisiana, 70115

  • Advanced Research Institute, Inc /ID# 163098

    New Port Richey, Florida, 34653

  • Columbia Univ Medical Center /ID# 163410

    New York, New York, 10032-3725

  • DiGiovanna Institute for Medical Education & Research /ID# 201533

    North Massapequa, New York, 11758

  • Advanced Research Institute /ID# 162624

    Ogden, Utah, 84403

  • Hightower Clinical /ID# 216337

    Oklahoma City, Oklahoma, 73102

  • Digestive Disease Specialists /ID# 201056

    Oklahoma City, Oklahoma, 73112

  • Endoscopic Research, Inc. /ID# 151720

    Orlando, Florida, 32803

  • Omega Research Maitland, LLC /ID# 200269

    Orlando, Florida, 32808

  • InSite Digestive Health Care - Oxnard /ID# 163414

    Oxnard, California, 93030

  • Northwest Gastroenterology Clinic /ID# 152527

    Portland, Oregon, 97210

  • Premier Medical Group - GI Division /ID# 153357

    Poughkeepsie, New York, 12601

  • Inland Empire Clinical Trials, LLC /ID# 216038

    Rialto, California, 92377

  • Infinite Clinical Trials /ID# 215340

    Riverdale, Georgia, 30274

  • Mayo Clinic - Rochester /ID# 151677

    Rochester, Minnesota, 55905-0001

  • Gastoenterology Group of Rochester /ID# 151079

    Rochester, New York, 14618-5703

  • Minnesota Gastroenterology PA /ID# 151678

    Saint Paul, Minnesota, 55114

  • Utah Gastroenternology - St. Mark's Office /ID# 163101

    Salt Lake City, Utah, 84124

  • Clinical Associates in Research Therapeutics of America, LLC /ID# 201260

    San Antonio, Texas, 78212

  • Southern Star Research Institute, LLC /ID# 169396

    San Antonio, Texas, 78229-5390

  • San Diego Clinical Trials /ID# 212120

    San Diego, California, 92120

  • Medical Assoc Research Grp /ID# 169148

    San Diego, California, 92123

  • Univ of California San Francis /ID# 164581

    San Francisco, California, 94158

  • Guthrie Medical Group, PC /ID# 150481

    Sayre, Pennsylvania, 18840

  • Virginia Mason Medical Center /ID# 153026

    Seattle, Washington, 98101

  • The Polyclinic /ID# 164369

    Seattle, Washington, 98122-4201

  • Louisana Research Center, LLC /ID# 150446

    Shreveport, Louisiana, 71105-6800

  • Revival Research Institute, LLC /ID# 207280

    Southfield, Michigan, 48034-1659

  • Washington University-School of Medicine /ID# 150485

    St Louis, Missouri, 63110

  • Penn State Health Colonnade /ID# 150259

    State College, Pennsylvania, 16803-2309

  • Richmond University Medical Center /ID# 201859

    Staten Island, New York, 10310-1664

  • Carl R. Meisner Medical Clinic /ID# 171061

    Sugar Land, Texas, 77478

  • Arizona Arthritis & Rheumatology Research, PLLC /ID# 169822

    Sun City, Arizona, 85306

  • Atlanta Gastroenterology Spec /ID# 150548

    Suwanee, Georgia, 30024

  • Clinical Research Trials of Florida, Inc. /ID# 201790

    Tampa, Florida, 33607

  • University of South Florida /ID# 214493

    Tampa, Florida, 33612

  • AdventHealth Tampa /ID# 200272

    Tampa, Florida, 33613-4680

  • Baylor Scott & White Center for Diagnostic Medicine /ID# 204499

    Temple, Texas, 76508

  • Montefiore Medical Center - Moses Campus /ID# 150543

    The Bronx, New York, 10467

  • Advantage Clinical Trials /ID# 163938

    The Bronx, New York, 10468

  • Cotton-O'Neil Clinical Res Ctr /ID# 167182

    Topeka, Kansas, 66606

  • Center for Digestive Health /ID# 161984

    Troy, Michigan, 48098-6363

  • Adobe Clinical Research LLC /ID# 155250

    Tucson, Arizona, 85712

  • University of Arizona /ID# 150553

    Tucson, Arizona, 85724

  • Options Health Research, LLC /ID# 150554

    Tulsa, Oklahoma, 74104

  • Healthcare Research Consultant /ID# 163100

    Tulsa, Oklahoma, 74135

  • Tyler Research Institute, LLC /ID# 169146

    Tyler, Texas, 75701-4464

  • Carle Foundation Hospital /ID# 151137

    Urbana, Illinois, 61801

  • The Vancouver Clinic, INC. PS /ID# 162333

    Vancouver, Washington, 98664

  • Gastro Health & Nutrition - Victoria /ID# 167761

    Victoria, Texas, 77904

  • Velocity Clinical Research - Salt Lake City /ID# 163181

    West Jordan, Utah, 84088

  • Western States Clinical Res /ID# 158076

    Wheat Ridge, Colorado, 80033-2896

  • Clinical Trials of America /ID# 153448

    Winston-Salem, North Carolina, 27103

  • Wake Forest Baptist Medical Center /ID# 150448

    Winston-Salem, North Carolina, 27157-0001

  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 157484

    Wyoming, Michigan, 49519

Other trials in United States

Japan73 sites

  • Tokatsu Tsujinaka Hospital /ID# 214962

    Abiko-shi, Chiba, 270-1168

  • Asahikawa Medical University Hospital /ID# 170289

    Asahikawa-shi, Hokkaido, 078-8510

  • Tokyo Medical And Dental University Hospital /ID# 152016

    Bunkyo-ku, Tokyo, 113-8519

  • Fukuoka University Chikushi Hospital /ID# 152628

    Chikushino-shi, Fukuoka, 818-8502

  • St.Luke's International Hospital /ID# 208074

    Chuo-ku, Tokyo, 104-8560

  • Fukui Prefectural Hospital /ID# 210448

    Fukui-shi, Fukui, 910-8526

  • Saiseikai Fukuoka Genaral Hospital /ID# 209479

    Fukuoka, Fukuoka, 810-0001

  • Kyushu University Hospital /ID# 152526

    Fukuoka, Fukuoka, 812-8582

  • NHO Fukuyama Medical Center /ID# 206293

    Fukuyama-shi, Hiroshima, 720-8520

  • Tokai University Hachioji Hospital /ID# 152587

    Hachioji-shi, Tokyo, 192-0032

  • Hamamatsu University Hospital /ID# 205708

    Hamamatsu, Shizuoka, 431-3192

  • National Hospital Organization Mito Medical Center /ID# 152631

    Higashi Ibaraki-gun, Ibaraki, 311-3193

  • National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210709

    Higashi-ohmi-shi, Shiga, 527-8505

  • Hirosaki National Hospital /ID# 152763

    Hirosaki-shi, Aomori, 036-8545

  • Hiroshima University Hospital /ID# 151951

    Hiroshima, Hiroshima, 734-8551

  • Shimane University Hospital /ID# 208899

    Izumo-shi, Shimane, 693-8501

  • Imamura General Hospital /ID# 227134

    Kagoshima, Kagoshima-ken, 890-0064

  • Idzuro Imamura Hospital /ID# 206024

    Kagoshima, Kagoshima-ken, 892-0824

  • Sameshima Hospital /ID# 206672

    Kagoshima, Kagoshima-ken, 892-0846

  • Kanazawa University Hospital /ID# 205099

    Kanazawa, Ishikawa-ken, 920-8641

  • Tsujinaka Hospital Kashiwanoha /ID# 209130

    Kashiwa-shi, Chiba, 277-0871

  • Saitama Medical Center /ID# 152031

    Kawagoe-shi, Saitama, 350-8550

  • St. Marianna University School of Medicine Hospital /ID# 208654

    Kawasaki-shi, Kanagawa, 216-8511

  • Kitakyushu Municipal Med Ctr /ID# 152588

    Kitakyushu, Fukuoka, 8020077

  • Aoyama Clinic /ID# 152049

    Kobe, Hyōgo, 650-0015

  • Yamanashi Prefectural Central Hospital /ID# 151908

    Kofu, Yamanashi, 400-8506

  • Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 157821

    Kurashiki-shi, Okayama-ken, 710-0142

  • Kurume University Hospital /ID# 151976

    Kurume-shi, Fukuoka, 830-0011

  • Japanese Red Cross Kyoto Daiichi Hosital /ID# 152359

    Kyoto, Kyoto, 605-0981

  • Kyoto University Hospital /ID# 211758

    Kyoto, Kyoto, 606-8507

  • Kitasato University Kitasato Institute Hospital /ID# 152686

    Minato-ku, Tokyo, 108-8642

  • Kyorin University Hospital /ID# 153194

    Mitaka-shi, Tokyo, 181-8611

  • Iwate Medical University Uchimaru Medical Center /ID# 203411

    Morioka, Iwate, 020-8505

  • Aichi Medical University Hospital /ID# 151993

    Nagakute-shi, Aichi-ken, 480-1195

  • Nagoya University Hospital /ID# 152709

    Nagoya, Aichi-ken, 4668560

  • Nagoya City University Hospital /ID# 151950

    Nagoya, Aichi-ken, 467-8602

  • Saiseikai Niigata Hospital /ID# 209916

    Niigata, Niigata, 950-1104

  • Niigata University Medical & Dental Hospital /ID# 218048

    Niigata, Niigata, 951-8520

  • Hyogo College of Medicine College Hospital /Id# 152434

    Nishinomiya-shi, Hyōgo, 663-8501

  • Obihiro kosei Hospital /ID# 210412

    Obihiro-shi, Hokkaido, 080-0024

  • Ogaki Municipal Hospital /ID# 208225

    Ogaki-shi, Gifu, 503-8502

  • Ishida Clinic of IBD and Gastroenterology /ID# 210117

    Ōita, Oita Prefecture, 870-0823

  • Okayama University Hospital /ID# 217923

    Okayama, Okayama-ken, 700-8558

  • NHO Nagasaki Medical Center /ID# 209531

    Omura-shi, Nagasaki, 856-8562

  • Kinshukai Infusion Clinic /ID# 207864

    Osaka, Osaka, 530-0011

  • Kitano Hospital /ID# 210395

    Osaka, Osaka, 530-8480

  • Osaka City General Hospital /ID# 152704

    Osaka, Osaka, 534-0021

  • Japanese Red Cross Osaka Hospital /ID# 209476

    Osaka, Osaka, 543-8555

  • Osaka City University Hospital /ID# 152682

    Osaka, Osaka, 545-8586

  • Saga University Hospital /ID# 209268

    Saga, Saga-ken, 849-8501

  • Tokitokai Tokito clinic /ID# 152677

    Saitama-shi, Saitama, 336-0963

  • Toho University Sakura Medical Center /ID# 151936

    Sakura-shi, Chiba, 285-8741

  • Sapporo Tokushukai Hospital /ID# 209397

    Sapporo, Hokkaido, 004-0041

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 151506

    Sapporo, Hokkaido, 060-0033

  • Sapporo Medical University Hospital /ID# 206492

    Sapporo, Hokkaido, 060-8543

  • Sapporo Higashi Tokushukai Hospital /ID# 208487

    Sapporo, Hokkaido, 065-0033

  • National Hospital Organization Sendai Medical Center /ID# 209527

    Sendai, Miyagi, 983-8520

  • Center Hospital of the National Center for Global Health and Medicine /ID# 209267

    Shinjuku-ku, Tokyo, 162-8655

  • Tokyo Women's Medical University Hospital /ID# 205977

    Shinjuku-ku, Tokyo, 162-8666

  • Tokuyama Central Hospital /ID# 216993

    Shunan-shi, Yamaguchi, 745-8522

  • NHO Shizuoka Medical Center /ID# 163572

    Sunto-gun, Shizuoka, 411-8611

  • Teikyo University Hospital /ID# 208897

    tabashi City, Tokyo, 173-8606

  • Shoyukai Fujita Gastroenterological Hospital /ID# 216492

    Takatsuki-shi, 569-0086

  • Toyohashi Municipal Hospital /ID# 171457

    Toyohashi, Aichi-ken, 441-8570

  • Toyonaka Municipal Hospital /ID# 217079

    Toyonaka-shi, Osaka, 560-0055

  • Ieda Hospital /ID# 157781

    Toyota-shi, Aichi-ken, 470-1219

  • Mie University Hospital /ID# 205362

    Tsu, Mie-ken, 514-8507

  • Juntendo University Urayasu Hospital /ID# 208781

    Urayasu-shi, Chiba, 279-0021

  • Yamagata University Hospital /ID# 171454

    Yamagata, Yamagata, 990-9585

  • Kenseikai Dongo Hospital /ID# 208100

    Yamatotakada-shi, Nara, 635-0022

  • Yokkaichi Hazu Medical Center /ID# 214347

    Yokkaichi-shi, Mie-ken, 510-0016

  • Showa University Fujigaoka Hospital /ID# 208222

    Yokohama, Kanagawa, 227-8501

  • Yokohama City University Medical Center /ID# 169899

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

Canada16 sites

  • University of Calgary /ID# 151821

    Calgary, Alberta, T2N 4Z6

  • Allen Whey Khye Lim Professional Corporation /ID# 211168

    Edmonton, Alberta, T5R 1W2

  • University of Alberta - Zeidler Ledcor Centre /ID# 151100

    Edmonton, Alberta, T6G 2X8

  • Covenant Health /ID# 158930

    Edmonton, Alberta, T6K 4B2

  • Medicor Research Inc /ID# 151101

    Greater Sudbury, Ontario, P3A 1W8

  • CISSS de la Monteregie /ID# 159215

    Greenfield Park, Quebec, J4V 2H1

  • Hamilton Health Sciences - McMaster University Medical Centre /ID# 150365

    Hamilton, Ontario, L8S 4K1

  • Okanagan Clinical Trials /ID# 153178

    Kelowna, British Columbia, V1Y 1Z9

  • CISSS de Chaudière-Appalaches, Hôpital Hotel-Dieu de Lévis /ID# 150361

    Lévis, Quebec, G6V 3Z1

  • Recherche GCP Research /ID# 151822

    Montreal, Quebec, H1M 1B1

  • Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 167169

    Montreal, Quebec, H2X 0A9

  • Montreal General Hospital - McGill University Health Centre /ID# 170012

    Montreal, Quebec, H3G 1A4

  • Ottawa Hospital Research Institute /ID# 151820

    Ottawa, Ontario, K1H 8L6

  • CIUSSS de l'Estrie - CHUS /ID# 150366

    Sherbrooke, Quebec, J1G 2E8

  • Toronto Digestive Disease Asso /ID# 150363

    Vaughan, Ontario, L4L 4Y7

  • Percuro Clinical Research, Ltd /ID# 150367

    Victoria, British Columbia, V8V 3M9

Other trials in Canada

China16 sites

  • The First Hospital of Jilin University /ID# 209986

    Changchun, Jilin, 130021

  • Xiangya Hospital Central South University /ID# 167229

    Changsha, 410008

  • West China Hospital, Sichuan University /ID# 167040

    Chengdu, 610041

  • The First Affiliated Hospital, Sun Yat-sen University /ID# 150455

    Guangzhou, Guangdong, 510080

  • The Sixth Affiliated Hosp Sun /ID# 150456

    Guangzhou, Guangdong, 510655

  • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 165807

    Hangzhou, Zhejiang, 310009

  • Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 150454

    Hangzhou, Zhejiang, 310018

  • The First Affiliated Hospital of Nanchang University /ID# 211750

    Nanchang, Jiangxi, 330006

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 150461

    Shanghai, Shanghai Municipality, 200065

  • Shanghai Tenth People's Hospital /ID# 150460

    Shanghai, Shanghai Municipality, 200072

  • Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 165815

    Shanghai, Shanghai Municipality, 200127

  • Shengjing Hospital of China Medical University /ID# 166920

    Shenyang, 110022

  • Affiliated Taihe Hospital of Hubei University of Medicine /ID# 216405

    Shiyan, Hubei, 442700

  • Tianjin Medical University General Hospital /ID# 170604

    Tianjin, 300052

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167088

    Wuhan, Hubei, 430022

  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167078

    Wuhan, Hubei, 430022

Other trials in China

Russia11 sites

  • Immanuel Kant Baltic Federal University /ID# 200719

    Kaliningrad, Kaliningrad Oblast, 236016

  • Kazan State Medical University /ID# 166042

    Kazan', Tatarstan, Respublika, 420012

  • Olla-Med Clinic /ID# 215332

    Moscow, 105554

  • City Clinical Hospital #24 /ID# 150395

    Moscow, 127015

  • Perm Clinical Center of the Federal Medical and Biological Agency /ID# 150386

    Perm, Permskiy Kray, 614109

  • Republican hospital named after V.A. Baranov /ID# 206506

    Petrozavodsk, 185019

  • Euromedservice /ID# 203800

    Pushkin, 196603

  • LLC Novaya Klinika /ID# 208107

    Pyatigorsk, Stavropol Kray, 357500

  • NW State Medical Univ na Mechn /ID# 169322

    Saint Petersburg, Leningradskaya Oblast', 191015

  • Medical Company Hepatolog /ID# 200197

    Samara, Samara Oblast, 443063

  • Duplicate_Stavropol State Medical Univ /ID# 150387

    Stavropol, 355017

Other trials in Russia

Germany10 sites

  • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 150766

    Berlin, 10825

  • Agaplesion Markus Krankenhaus /ID# 161982

    Frankfurt am Main, 60431

  • Gastroenterologische Gemeinschaftspraxis Herne /ID# 214574

    Herne, North Rhine-Westphalia, 44623

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 161981

    Kiel, Schleswig-Holstein, 24105

  • Universitatsklinikum Mannheim /ID# 150173

    Mannheim, Baden-Wurttemberg, 68167

  • Universitatsklinikum Munster /ID# 150158

    Munster, Lower Saxony, 48149

  • Medizinisches Versorgungszentrum Portal 10 /ID# 207135

    Münster, 48155

  • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215811

    Saarbrücken, Saarland, 66111

  • Universitaetsklinimum Tuebingen /ID# 150767

    Tübingen, Baden-Wurttemberg, 72076

  • Praxis medicum /ID# 150166

    Wiesbaden, 65189

Other trials in Germany

Italy10 sites

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 150337

    Bologna, 40138

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 150334

    Milan, 20122

  • ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 150602

    Milan, 20121

  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 201725

    Negrar, Verona, 37024

  • A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 150253

    Palermo, 90146

  • ASST Rhodense/Presidio Ospedaliero di Rho /ID# 216610

    Rho, Milano, 20017

  • Azienda Ospedaliera San Camillo Forlanini /ID# 151360

    Rome, Lazio, 00152

  • Fondazione PTV Policlinico Tor Vergata /ID# 150338

    Rome, Roma, 00133

  • Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 150333

    Rome, Roma, 00168

  • Istituto Clinico Humanitas /ID# 151361

    Rozzano, Milano, 20089

Other trials in Italy

South Korea10 sites

  • Dong-A University Hospital /ID# 159480

    Busan, 49201

  • Pusan National University Hospital /ID# 159481

    Busan, 49241

  • Yeungnam University Medical Center /ID# 150345

    Daegu, 42415

  • Hayang University GuriHospital /ID# 150344

    Guri-si, Gyeonggido, 11923

  • CHA University Bundang Medical Center /ID# 159479

    Seongnam-si, Gyeonggido, 13496

  • Kangbuk Samsung Hospital /ID# 150348

    Seoul, Seoul Teugbyeolsi, 03181

  • Yonsei University Health System Severance Hospital /ID# 159478

    Seoul, Seoul Teugbyeolsi, 03722

  • Asan Medical Center /ID# 150900

    Seoul, 05505

  • Samsung Medical Center /ID# 150346

    Seoul, 06351

  • The Catholic University of Korea, ST. Vincent's Hospital /ID# 150347

    Suwon, Gyeonggido, 16247

Other trials in South Korea

Spain10 sites

  • Hospital Universitario A Coruna - CHUAC /ID# 203911

    A Coruña, 15006

  • Hospital Clinic de Barcelona /ID# 150612

    Barcelona, 08036

  • Hospital Universitario Reina Sofia /ID# 151066

    Córdoba, 14004

  • Hospital Universitario Dr. Negrin /ID# 203937

    Las Palmas de Gran Canaria, Las Palmas, 35019

  • Hospital Universitario Ramon y Cajal /ID# 151067

    Madrid, 28034

  • Hospital Universitario La Paz /ID# 214539

    Madrid, 28046

  • Hospital Universitario de Salamanca /ID# 150509

    Salamanca, 37711

  • Hospital Unversitario Marques de Valdecilla /ID# 216620

    Santander, Cantabria, 39008

  • Hospital Clínico Universitario de Santiago-CHUS /ID# 151065

    Santiago de Compostela, A Coruna, 15706

  • Hospital Universitario y Politecnico La Fe /ID# 150611

    Valencia, 46026

Other trials in Spain

Ukraine10 sites

  • Municipal Enterprise "I.I. Mechnikov Dnipropetrovsk Regional Clinical Hospital" /ID# 207723

    Dnipro, 49005

  • CNCE of Kharkiv Regional Council Regional Clinical Hospital /ID# 206940

    Kharkiv, 61058

  • PE PMC Acinus, Medical and Diagnostic Center /ID# 217216

    Kropyvnytskyi, 25006

  • Kyiv Municipal Clinical Hospital #18 /ID# 150372

    Kyiv, 01030

  • Medical Center CONSILIUM MEDICAL /ID# 217446

    Kyiv, 04050

  • CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 217372

    Kyiv, 04073

  • Lviv Regional Clinical Hospital /ID# 150375

    Lviv, 79010

  • Municipal Non-Commercial Enterprise Odesa Regional Clinical Hospital of the Od /ID# 151275

    Odesa, 65025

  • Medical Center of the "Health /ID# 151274

    Vinnytsia, Vinnytsia Oblast, 21009

  • CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 216297

    Vinnytsia, 21028

Other trials in Ukraine

Croatia8 sites

  • Duplicate_Klinicki bolnicki centar Osijek /ID# 150216

    Osijek, County of Osijek-Baranja, 31000

  • Klinicki bolnicki centar Rijeka /ID# 150708

    Rijeka, Primorje-Gorski Kotar County, 51000

  • Klinicki bolnicki centar Split /ID# 213988

    Split, Split-Dalmatia County, 21000

  • Zadar General Hospital /ID# 150221

    Zadar, 23000

  • Clinical Hospital Dubrava /ID# 150213

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 150225

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 150709

    Zagreb, City of Zagreb, 10000

  • Poliklinika Solmed /ID# 211483

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

France8 sites

  • CHU Amiens-Picardie Site Sud /ID# 163456

    Amiens, Somme, 80054

  • CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 154452

    La Roche-sur-Yon, 85000

  • CHRU Lille - Hopital Claude Huriez /ID# 152607

    Lille, Hauts-de-France, 59037

  • CHU Hopital Nord /ID# 163508

    Marseille, Bouches-du-Rhone, 13915

  • CHU Montpellier - Hôpital Saint Eloi /ID# 200006

    Montpellier, Herault, 34295

  • Chu de Nice-Hopital L'Archet Ii /Id# 152606

    Nice, Alpes-Maritimes, 06200

  • HCL - Hôpital Lyon Sud /ID# 152539

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • CHU de Saint-Etienne, Hopital Nord /ID# 154453

    Saint-Etienne, 42270

Other trials in France

Portugal8 sites

  • Hospital Garcia de Orta, EPE /ID# 151613

    Almada, 2805-267

  • CCA Braga - Hospital de Braga /ID# 151608

    Braga, 4710-243

  • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 151607

    Guimarães, Braga District, 4835-044

  • Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 151611

    Lisbon, 1169-050

  • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 151606

    Lisbon, 1649-035

  • Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 151609

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

  • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 151610

    Porto, 4200-319

  • Centro Hospitalar de Entre Douro e Vouga /ID# 152335

    Santa Maria DA Feira, Porto District, 4520-211

Other trials in Portugal

Serbia8 sites

  • Clinical Hosp Center Zvezdara /ID# 150427

    Belgrade, Beograd, 11000

  • Military Medical Academy /ID# 150429

    Belgrade, Beograd, 11000

  • University Clinical Center Serbia /ID# 150428

    Belgrade, Beograd, 11000

  • Clin Hosp Ctr Bezanijska Kosa /ID# 150426

    Belgrade, Beograd, 11080

  • University Clinical Center Kragujevac /ID# 150430

    Kragujevac, Sumadijski Okrug, 34000

  • General Hospital Leskovac /ID# 217880

    Leskovac, 16000

  • University Clinical Center of Nis /ID# 151903

    Niš, Nisavski Okrug, 18000

  • Clinical Center Vojvodina /ID# 150764

    Novi Sad, Vojvodina, 21000

Other trials in Serbia

South Africa8 sites

  • MD Search /ID# 167293

    Boksburg North, Gauteng, 1460

  • Kingsbury Hospital /ID# 150497

    Cape Town, Western Cape, 7708

  • Private Practice Dr MN Rajabally /ID# 155144

    Cape Town, Western Cape, 7800

  • Spoke Research Inc /ID# 162202

    CAPE TOWN Milnerton, Western Cape, 7441

  • Clinresco Centers /ID# 163622

    Johannesburg, Gauteng, 1619

  • Lenasia Clinical Trial Centre /ID# 214344

    Johannesburg, Gauteng, 1820

  • Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 150785

    Johannesburg, Gauteng, 2193

  • Wits Clinical Research Site /ID# 150496

    Johannesburg, Gauteng, 2193

Other trials in South Africa

United Kingdom8 sites

  • Hampshire Hospitals NHS Foundation Trust /ID# 150380

    Basingstoke, Essex, RG24 9NA

  • Royal United Hospitals Bath /ID# 151532

    Bath, BA1 3NG

  • University Hospitals Birmingham NHS Foundation Trust /ID# 150382

    Birmingham, B15 2TH

  • Royal Devon and Exeter NHS Trust Hospital /ID# 150379

    Exeter, Devon, EX2 5DW

  • NHS Greater Glasgow and Clyde /ID# 163787

    Glasgow, Scotland, G12 0XH

  • Calderdale and Huddersfield NHS Foundation Trust /ID# 217658

    Huddersfield, HX3 0PW

  • Barts Health NHS Trust /ID# 150384

    London, London, City of, E1 2ES

  • St George's University Hospitals NHS Foundation Trust /ID# 208374

    Tooting, SW17 0QT

Other trials in United Kingdom

Brazil7 sites

  • Upeclin Fmb - Unesp /Id# 152485

    Botucatu, São Paulo, 18618-686

  • Hospital Nossa Senhora das Graças /ID# 152480

    Curitiba, Paraná, 80810-040

  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 153742

    Goiânia, Goiás, 74535-170

  • Hospital de Clinicas de Porto Alegre /ID# 153743

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 152484

    Ribeirão Preto, São Paulo, 14051-140

  • Faculdade de Medicina do ABC /ID# 152481

    Santo André, São Paulo, 09060-870

  • Kaiser Clinica e Hospital Dia /ID# 152483

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

Other trials in Brazil

Czechia7 sites

  • Hepato-Gastroenterologie HK, s.r.o. /ID# 150912

    Hradec Králové, 500 12

  • CTCenter MaVe s.r.o. /ID# 150904

    Olomouc, 779 00

  • ARTROSCAN s.r.o. /ID# 150401

    Ostrava, 722 00

  • Nemocnice Pardubickeho kraje, a.s. /ID# 213539

    Pardubice, 530 03

  • Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 216221

    Prague, 118 33

  • Axon Clinical, s.r.o. /ID# 152479

    Prague, 140 00

  • ISCARE a.s. /ID# 209278

    Prague, 190 00

Other trials in Czechia

Greece7 sites

  • General Hospital of Athens Laiko /ID# 208669

    Athens, Attica, 11527

  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202100

    Athens, Attica, 11527

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 150309

    Athens, 10676

  • University General Hospital of Heraklion PA.G.N.I /ID# 150250

    Heraklion, Crete, 71500

  • University General Hospital of Ioannina /ID# 164248

    Ioannina, 45500

  • Theageneio Anticancer Hospital /ID# 163896

    Thessaloniki, 54639

  • General Hospital of Thessaloniki Hippokrateio /ID# 209521

    Thessaloniki, 54642

Other trials in Greece

Poland7 sites

  • Endoskopia Sp. z o.o. /ID# 150765

    Sopot, Pomeranian Voivodeship, 81-756

  • Gastromed /Id# 216197

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Centrum Zdrowia MDM /ID# 150351

    Warsaw, Masovian Voivodeship, 00-635

  • Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 150580

    Warsaw, Masovian Voivodeship, 02-507

  • Centrum Medyczne Reuma Park /ID# 150349

    Warsaw, Masovian Voivodeship, 02-665

  • NZOZ Vivamed /ID# 216742

    Warsaw, Masovian Voivodeship, 03-580

  • Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215732

    Warsaw, Masovian Voivodeship, 04-730

Other trials in Poland

Argentina6 sites

  • Gedyt /ID# 210015

    Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1115

  • Mautalen Salud e Investigacion /ID# 171173

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

  • Hospital Britanico de Buenos Aires /ID# 209495

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

  • Hospital Privado Univesitario /ID# 164185

    Córdoba, 5016

  • Cardio Alem /ID# 211280

    San Isidro, Buenos Aires, 1642

  • Sanatorio 9 de Julio /ID# 150189

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Australia6 sites

  • Monash Medical Centre /ID# 150206

    Clayton, Victoria, 3168

  • St Vincent's Hospital Melbourne /ID# 152472

    Fitzroy Melbourne, Victoria, 3065

  • Macquarie University Hospital /ID# 211951

    Macquarie University, New South Wales, 2109

  • Fiona Stanley Hospital /ID# 211640

    Murdoch, Western Australia, 6150

  • Mater Misericordiae Limited /ID# 212685

    South Brisbane, Queensland, 4101

  • Griffith University /ID# 211952

    Southport, Queensland, 4222

Other trials in Australia

Chile6 sites

  • Hospital Guillermo Grant Benavente de Concepción /ID# 212424

    Concepción, 4070038

  • CTR Estudios Clinicos /ID# 200110

    Providencia, 7500571

  • M y F Estudios Clínicos /ID# 200107

    Santiago, Region Metropolitana Santiago, 7750495

  • Research Group /ID# 203176

    Santiago, Santiago Metropolitan, 2540364

  • Hospital Clinico Universidad De Los Andes /ID# 207422

    Santiago, 7501504

  • Centro de Investigaciones Clínicas Viña del Mar /ID# 150212

    Viña del Mar, Valparaiso, 2540488

Other trials in Chile

Hungary6 sites

  • Bekes Megyei Kozponti Korhaz /ID# 151572

    Békéscsaba, 5600

  • Semmelweis Egyetem /ID# 150312

    Budapest, 1085

  • Meditres Kft. /ID# 151521

    Kecskemét, 6000

  • Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 151523

    Sopron, 9400

  • Mentahaz Maganorvosi Kozpont /ID# 205884

    Székesfehérvár, 8000

  • Markusovszky Egyetemi Oktatokorhaz /ID# 150313

    Szombathely, Vas County, 9700

Other trials in Hungary

Slovakia6 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 150868

    Banská Bystrica, 975 17

  • Medak s.r.o. /ID# 150480

    Bratislava, 851 01

  • Slovak Research Center Team Me /ID# 150257

    Ilava, 019 01

  • B+B MED, s.r.o. /ID# 150471

    Košice, 040 01

  • Fakultna nemocnica s poliklinikou Nove Zamky /ID# 211370

    Nové Zámky, 940 34

  • GASTRO I., s.r.o. /ID# 150472

    Prešov, 080 01

Other trials in Slovakia

Taiwan6 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 150575

    Kaohsiung City, 807

  • Chung Shan Medical University Hospital /ID# 150573

    Taichung, 40201

  • China Medical University Hospital /ID# 150571

    Taichung, 40447

  • National Cheng Kung University Hospital /ID# 151749

    Tainan, 704

  • National Taiwan University Hospital /ID# 150574

    Taipei, 100

  • Taipei Veterans General Hosp /ID# 151748

    Taipei, 11217

Other trials in Taiwan

Turkey (Türkiye)6 sites

  • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 150125

    Istanbul, 34098

  • Umraniye Training and Res Hosp /ID# 162659

    Istanbul, 34764

  • Marmara University Medical Fac /ID# 213969

    Istanbul, 34899

  • Erciyes University Medical Fac /ID# 150129

    Melikgazi, Kayseri, 38030

  • Mersin University Medical /ID# 157849

    Mersin, 33343

  • Gazi Universitesi Tip Fakultes /ID# 150127

    Yenimahalle, 06560

Other trials in Turkey (Türkiye)

Bosnia and Herzegovina5 sites

  • University Clinical Centre of the Republic of Srpska /ID# 150209

    Banja Luka, Republika Srpska, 78000

  • University Clinical Centre of the Republic of Srpska /ID# 150706

    Banja Luka, Republika Srpska, 78000

  • University Clinical Hospital Mostar /ID# 150705

    Mostar, 88000

  • Clinical Center University of Sarajevo /ID# 150208

    Sarajevo, 71000

  • University Clinical Center Tuzla /ID# 150211

    Tuzla, Tuzlanski, 75000

Other trials in Bosnia and Herzegovina

Finland5 sites

  • Duplicate_Helsinki Univ Central Hospital /ID# 150407

    Helsinki, 00290

  • Keski-Suomen Sairaala Nova /ID# 155666

    Jyväskylä, 40620

  • Laakarikeskus Ikioma /ID# 150121

    Mikkeli, 50100

  • Tampere University Hospital /ID# 150114

    Tampere, Pirkanmaa, 33520

  • Turku University Hospital /ID# 168301

    Turku, 20520

Other trials in Finland

Ireland5 sites

  • Beaumont Hospital /ID# 150321

    Beaumont, Dublin, D09 XR63

  • Mercy University Hospital /ID# 151529

    Cork, T12 WE28

  • St James Hospital /ID# 150320

    Dublin, Dublin, D08 NHY1

  • St Vincent's University Hospital /ID# 150318

    Elm Park, Dublin, D04 T6F4

  • University Hospital Galway /ID# 150319

    Galway, H91 YR71

Other trials in Ireland

Netherlands5 sites

  • Academisch Medisch Centrum /ID# 150647

    Amsterdam, 1105 AZ

  • Leids Universitair Medisch Centrum /ID# 152624

    Leiden, 2333 ZA

  • Radboud Universitair Medisch Centrum /ID# 151700

    Nijmegen, Gelderland, 6525 GA

  • Erasmus Medisch Centrum /ID# 150308

    Rotterdam, South Holland, 3015 GD

  • Universitair Medisch Centrum Utrecht /ID# 152775

    Utrecht, 3584 CX

Other trials in Netherlands

Austria4 sites

  • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 150305

    Linz, Upper Austria, 4010

  • Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 150306

    Salzburg, 5020

  • Klinik Landstrasse /ID# 162866

    Vienna, State of Vienna, 1030

  • Medizinische Universitaet Wien /ID# 150614

    Vienna, State of Vienna, 1090

Other trials in Austria

Estonia4 sites

  • East Tallinn Central Hospital /ID# 150417

    Kesklinn, Harju, 10138

  • North Estonia Medical Centre /ID# 160870

    Mustamäe, Harju, 13419

  • West Tallinn Central Hospital /ID# 150419

    Tallinn, 10617

  • Tartu University Hospital /ID# 150418

    Tartu, Tartu, 50406

Other trials in Estonia

Israel4 sites

  • Soroka University Medical Center /ID# 156561

    Beersheba, Southern District, 8443901

  • Rambam Health Care Campus /ID# 150325

    Haifa, 3109601

  • Shaare Zedek Medical Center /ID# 161677

    Jerusalem, 91031

  • Hadassah Medical Center-Hebrew University /ID# 165118

    Jerusalem, 91120

Other trials in Israel

Lithuania4 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 150357

    Kaunas, 50161

  • Klaipeda Seamens Hospital /ID# 154319

    Klaipėda, 92288

  • Klaipeda University Hospital /ID# 158862

    Klaipėda, 92288

  • Vilnius University Hospital /ID# 154318

    Vilnius, LT-08661

Other trials in Lithuania

Malaysia4 sites

  • Hospital Sultanah Bahiyah /ID# 151687

    Alor Star, Kedah, 05460

  • Hospital Ampang /ID# 151298

    Ampang, 68000

  • Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 151689

    Kuala Lumpur, Selangor, 56000

  • Uni Malaya MC /ID# 150359

    Kuala Lumpur, 59100

Other trials in Malaysia

Switzerland4 sites

  • Universitätsspital Basel /ID# 161731

    Basel, Canton of Basel-City, 4031

  • Inselspital, Universitätsspital Bern /ID# 152590

    Bern, 3010

  • Kantonsspital St. Gallen /ID# 152599

    Sankt Gallen, Canton of St. Gallen, 9007

  • Universitätsspital Zürich /ID# 152591

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Belgium3 sites

  • AZ Maria Middelares /ID# 150331

    Ghent, 9000

  • Universitair Ziekenhuis Leuven /ID# 150332

    Leuven, Vlaams-Brabant, 3000

  • AZ-Delta /ID# 150330

    Roeselare, 8800

Other trials in Belgium

Colombia3 sites

  • Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 151564

    Bogota DC, Cundinamarca, 111221

  • Hospital Universitario de San /ID# 155387

    Medellín

  • Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 207042

    Montería, Departamento de Córdoba, 230002

Other trials in Colombia

Mexico3 sites

  • Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 150710

    Guadalajara, Jalisco, 44650

  • Morales Vargas Centro de Investigacion S.C. /ID# 211325

    León, Guanajuato, 37000

  • Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 150256

    Monterrey, Nuevo León, 64610

Other trials in Mexico

Singapore3 sites

  • National University Hospital /ID# 150453

    Singapore, 119074

  • Gleneagles Medical Centre /ID# 206018

    Singapore, 258499

  • Tan Tock Seng Hospital /ID# 150443

    Singapore, 308433

Other trials in Singapore

Latvia2 sites

  • Pauls Stradins Clinical University Hospital /ID# 151409

    Riga, 1002

  • Riga East Clinical University Hospital /ID# 150354

    Riga, LV-1079

Other trials in Latvia

Norway2 sites

  • Akershus universitetssykehus /ID# 150317

    Nordbyhagen, Akershus, 1474

  • Universitetssykehuset Nord-Norge /ID# 152835

    Tromsø, Troms, 9019

Other trials in Norway

Belarus1 site

  • Vitebsk Regional Advanced Clin /ID# 169612

    Vitebsk, 210001

Other trials in Belarus

Puerto Rico1 site

  • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 150358

    San Juan, 00935

Other trials in Puerto Rico

Sweden1 site

  • Sahlgrenska University Hospital /ID# 151496

    Gothenburg, Västra Götaland County, 413 45

Other trials in Sweden

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.

Read the detailed description

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 and an 8-week double-blind (DB) Induction Period. After all randomized participants completed the 8-week induction, a dose-selection analysis of efficacy and safety (selected laboratory parameters) of upadacitinib versus placebo was performed. Based on this dose-selection analysis, one induction dose (upadacitinib 45 mg) was identified for further evaluation in two Phase 3 induction studies, M14-234 Substudy 2 and M14-675 (NCT03653026). During the analysis period, 132 additional participants were randomized into Groups 3 and 4 of Substudy 1 (upadacitinib 30 mg and 45 mg dose groups; approximately 66 participants per dose group). The objectives of enrolling these additional participants were to avoid interrupting the study activities during the analysis period and to support a sufficient number of participants with clinical response to be re-randomized into the maintenance portion in Substudy 3. Substudy 1 main participants are defined as those first 250 randomized 250, and additional participants are defined as those who were randomized after the main participants.

Substudy 2 was a two-part Phase 3 dose-confirming study designed to evaluate the efficacy and safety of oral administration of upadacitinib 45 mg compared to placebo as induction therapy for up to 16 weeks in participants with moderately to severely active UC. Substudy 2 included a Screening Period of up to 5 weeks, Part 1, and Part 2. Part 1 was a randomized, DB, placebo-controlled 8-week induction period. Part 2 was an open-label, 8-week extended treatment period for clinical non-responders from Part 1 of Substudy 2. Part 1 was planned to enroll 462 subjects; actual enrollment was 474 subjects. Eligible participants were randomized in a 2:1 ratio to one of the two treatment groups (DB upadacitinib 45 mg or matching placebo) for 8 weeks. The randomization was stratified by bio-IR status (Biologic inadequate responders [bio-IR] vs Non-biologic-inadequate responders [non-bio-IR], corticosteroid use (yes or no), and Adapted Mayo score (≤ 7 or > 7) at Baseline. Within bio-IR, the randomization was further stratified by number of prior biologic treatments (≤ 1 or > 1). Within non-bio-IR, the randomization was further stratified by previous biologic use (yes or no). Part 2 was an open label, 8-week Extended Treatment Period for those who did not achieve clinical response per Adapted Mayo score at Week 8 in Part 1. All participants received upadacitinib 45 mg.

Substudy 3 was a Phase 3 maintenance study designed to evaluate the efficacy and safety of upadacitinib 15 and 30 mg once daily (QD) compared to placebo in achieving clinical remission per Adapted Mayo score in participants with moderately to severely active UC who achieved clinical response per Adapted Mayo score following induction therapy from Substudy 1, Substudy 2, or Study M14-675. A total of 1,046 subjects who achieved clinical response per Adapted Mayo score after completion of induction treatment or Extended Treatment Period in Study M14-234 Substudy 1, Substudy 2, or Study M14-675 entered Substudy 3, and 1,044 were treated with a blinded treatment assignment for up to 52 weeks. Substudy 3 included 4 cohorts. Cohort 1: 847 participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, and received upadacitinib 15, 30, or 45 mg QD. The treatment groups in Cohort 1 were Group 1: upadacitinib 15 mg QD; Group 2: upadacitinib 30 mg QD; and Group 3: placebo QD. Those who achieved clinical response and received upadacitinib 15 mg QD in Substudy 1 were re-randomized 1:1 to only receive upadacitinib 15 mg QD or placebo QD (treatment Group 1 or 3). Cohort 2: 104 participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3. Cohort 3: 75 participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 were re-randomized 1:1 and received blinded upadacitinib 30 mg QD or upadacitinib 15 mg QD in Substudy 3. Cohort 4: 20 participants who received double-blinded treatment of upadacitinib 7.5 mg QD for 8 weeks during Substudy 1 and achieved clinical response at Week 8 continued to receive blinded treatment of upadacitinib 7.5 mg QD in Substudy 3.

Being tested
Placebo, Upadacitinib
Keywords
Upadacitinib (ABT-494), Moderately to Severely Active UC, RINVOQ
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

    Film-coated tablet for oral administration

  • UpadacitinibDrug

    Also called ABT-494, RINVOQ

    Film-coated tablet for oral administration

Study groups in NCT02819635
Study groupRoleWhat they receive
SS1: PlaceboPlacebo comparatorDuring the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Receives: Drug: Placebo
SS1: Upadacitinib 7.5 mgExperimentalDuring the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Receives: Drug: Upadacitinib
SS1: Upadacitinib 15 mgExperimentalDuring the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
Receives: Drug: Upadacitinib
SS1: Upadacitinib 30 mgExperimentalDuring the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
Receives: Drug: Upadacitinib
SS1: Upadacitinib 45 mgExperimentalDuring the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
Receives: Drug: Upadacitinib
SS2: Placebo/Upadacitinib 45 mgExperimentalDuring the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
Receives: Drug: Placebo; Drug: Upadacitinib
SS2: Upadacitinib 45 mg/Upadacitinib 45 mgExperimentalDuring the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
Receives: Drug: Upadacitinib
SS3: M14-675 clinical respondersExperimentalParticipants in Study M14-675 (NCT03653026) who achieved clinical response defined by Adapted Mayo Score at Week 8 or Week 16 in that study and did not meet any study discontinuation criteria were eligible to enroll into Substudy 3. Participants were re-randomized and treated with a blinded treatment assignment (15 mg upadacitinib film-coated tablets once daily by mouth [QD], or 30 mg upadacitinib film-coated tablets QD, or placebo for upadacitinib film-coated tablets QD) for up to 52 weeks.
Receives: Drug: Placebo; Drug: Upadacitinib

What is being measured

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

  1. Substudy 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.

    For Substudy 1, clinical remission is defined as SFS ≤ 1, RBS of 0, and endoscopic subscore ≤ 1.

    Measured: At Week 8

  2. Substudy 2: 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.

    For Substudy 2, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In Substudy 2, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.

    Measured: At Week 8

  3. Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 52

    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.

    For Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.

    Measured: At Week 52

Secondary outcomes (30)

  1. Substudy 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: At Week 8

  2. Substudy 1: Percentage Of Participants Achieving Clinical Remission Per Full Mayo Score at Week 8

    The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.

    Measured: At Week 8

  3. Substudy 1: Percentage Of Participants Achieving 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, spontaneous bleeding, ulceration).

    The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).

    Measured: At Week 8

  4. Substudy 1: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2

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

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

    Measured: At Week 2

  5. Substudy 1: Change in Full Mayo Score From Baseline to Week 8

    The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.

    Measured: Baseline (Week 0), Week 8

  6. Substudy 1: 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: At Week 8

  7. Substudy 1: Percentage Of Participants Who Achieved Histologic Improvement at Week 8

    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.

    Histologic improvement was defined as decrease from baseline in Geboes score.

    Measured: At Week 8

  8. Substudy 2: 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: At Week 8

  9. Substudy 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: At Week 8

  10. Substudy 2: Percentage Of Participants Achieving 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, spontaneous bleeding, ulceration).

    The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).

    Measured: At Week 8

  11. Substudy 2: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2

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

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

    Measured: At Week 2

  12. Substudy 2: 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: At Week 8

  13. Substudy 2: Percentage Of Participants Who Report No Bowel Urgency at Week 8

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

    Measured: At Week 8

  14. Substudy 2: 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: At Week 8

  15. Substudy 2: Percentage Of Participants Who Achieved Histologic Improvement at Week 8

    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. Histologic improvement was defined as decrease from baseline in Geboes score.

    Measured: At Week 8

  16. Substudy 2: 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), Week 8

  17. Substudy 2: Percentage Of Participants With 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: At Week 8

  18. Substudy 2: 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), Week 8

  19. Substudy 3: Percentage Of Participants With Endoscopic Improvement at Week 52

    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: At Week 52

  20. Substudy 3: Percentage of Participants With Clinical Remission Per Adapted Mayo Score at Week 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment

    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.

    For Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.

    Measured: At Week 52

  21. Substudy 3: Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Wk 52 and Were Corticosteroid Free for ≥ 90 Days Immediately Preceding Wk 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment

    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.

    For Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.

    Measured: At Week 52

  22. Substudy 3: Percentage of Participants With Endoscopic Improvement at Wk 52 Among Those Who Achieved Endoscopic Improvement at the End of the Induction Treatment

    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: At Week 52

  23. Substudy 3: Percentage Of Participants With Endoscopic Remission At Week 52

    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: At Week 52

  24. Substudy 3: Percentage Of Participants Who Maintained Clinical Response Per Adapted Mayo Score at Wk 52 Among Those Who Achieved Clinical Response at the End of the Induction Treatment

    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 response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).

    Measured: At Week 52

  25. Substudy 3: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 52

    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: At Week 52

  26. Substudy 3: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 52

    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), Week 52

  27. Substudy 3: Percentage Of Participants With Mucosal Healing at Week 52

    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: At Week 52

  28. Substudy 3: Percentage Of Participants Who Reported No Bowel Urgency at Week 52

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

    Measured: At Week 52

  29. Substudy 3: Percentage Of Participants Who Reported No Abdominal Pain at Week 52

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

    Measured: At Week 52

  30. Substudy 3: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 52

    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), Week 52

Timeline

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

  1. First posted30 Jun 2016 (estimated)
  2. Study start26 Sep 2016
  3. Primary completion13 Dec 2021
  4. Study completion13 Dec 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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02819635
Sponsor's protocol ID
M14-234
Other IDs
2016-000641-31, 2016
Status last verified
Jun 2022
First submitted
28 Jun 2016
Last updated
30 Jun 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

  • Burmester GR, Deodhar A, Irvine AD, Panaccione R, Winthrop KL, Vleugels RA, Levy G, Suravaram S, Palac H, Wegrzyn L, Ford S, Meerwein S, Guttman-Yassky E. Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease. Adv Ther. 2025 Oct;42(10):5215-5237. doi: 10.1007/s12325-025-03328-y. Epub 2025 Aug 28.

    PubMed 40875187

  • Panes J, Dubinsky MC, Ishiguro Y, Shukla N, Dubcenco E, Remple V, Sharma D, Panaccione R. Achievement of long-term treatment goals in upadacitinib-treated patients with moderately to severely active ulcerative colitis: a post hoc analysis of phase 3 trial data. J Crohns Colitis. 2025 Jul 3;19(7):jjaf095. doi: 10.1093/ecco-jcc/jjaf095.

    PubMed 40488552

  • Panaccione R, Danese S, Zhou W, Klaff J, Ilo D, Yao X, Levy G, Higgins PDR, Loftus EV Jr, Chen S, Gonzalez YS, Leonard C, Hebuterne X, Lindsay JO, Cao Q, Nakase H, Colombel JF, Vermeire S. Efficacy and safety of upadacitinib for 16-week extended induction and 52-week maintenance therapy in patients with moderately to severely active ulcerative colitis. Aliment Pharmacol Ther. 2024 Feb;59(3):393-408. doi: 10.1111/apt.17816. Epub 2023 Nov 27.

    PubMed 38010661

  • Raine T, Ishiguro Y, Rubin DT, Finney-Hayward T, Vladea R, Liu J, Phillips C, Cheng E, Targownik L, Loftus EV Jr. Impact of Baseline Corticosteroid Use on the Efficacy and Safety of Upadacitinib in Patients with Ulcerative Colitis: A Post Hoc Analysis of the Phase 3 Clinical Trial Programme. J Crohns Colitis. 2024 May 31;18(5):695-707. doi: 10.1093/ecco-jcc/jjad190.

    PubMed 37942921

  • Vermeire S, Danese S, Zhou W, Ilo D, Klaff J, Levy G, Yao X, Chen S, Sanchez Gonzalez Y, Hebuterne X, Lindsay JO, Higgins PDR, Cao Q, Nakase H, Colombel JF, Loftus EV Jr, Panaccione R. Efficacy and safety of upadacitinib maintenance therapy for moderately to severely active ulcerative colitis in patients responding to 8 week induction therapy (U-ACHIEVE Maintenance): overall results from the randomised, placebo-controlled, double-blind, phase 3 maintenance study. Lancet Gastroenterol Hepatol. 2023 Nov;8(11):976-989. doi: 10.1016/S2468-1253(23)00208-X. Epub 2023 Sep 9.

    PubMed 37683686

  • Parkes G, Ungaro RC, Danese S, Abreu MT, Arenson E, Zhou W, Ilo D, Laroux FS, Deng H, Sanchez Gonzalez Y, Peyrin-Biroulet L. Correlation of mucosal healing endpoints with long-term clinical and patient-reported outcomes in ulcerative colitis. J Gastroenterol. 2023 Oct;58(10):990-1002. doi: 10.1007/s00535-023-02013-7. Epub 2023 Jul 25.

    PubMed 37490069

  • Loftus EV Jr, Ananthakrishnan AN, Lee WJ, Gonzalez YS, Fitzgerald KA, Wallace K, Zhou W, Litcher-Kelly L, Ollis SB, Su S, Danese S. Content Validity and Psychometric Evaluation of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) in Patients with Crohn's Disease and Ulcerative Colitis. Pharmacoecon Open. 2023 Sep;7(5):823-840. doi: 10.1007/s41669-023-00419-w. Epub 2023 Jun 9.

    PubMed 37296268

  • Danese S, Tran J, D'Haens G, Rubin DT, Aoyama N, Zhou W, Ilo D, Yao X, Sanchez Gonzalez Y, Panaccione R. Upadacitinib Induction and Maintenance Therapy Improves Abdominal Pain, Bowel Urgency, and Fatigue in Patients With Ulcerative Colitis: A Post Hoc Analysis of Phase 3 Data. Inflamm Bowel Dis. 2023 Nov 2;29(11):1723-1729. doi: 10.1093/ibd/izad016.

    PubMed 36790041

  • Panes J, Loftus EV, Higgins PDR, Lindsay JO, Zhou W, Yao X, Ilo D, Phillips C, Tran J, Sanchez Gonzalez Y, Vermeire S. Induction and Maintenance Treatment With Upadacitinib Improves Health-Related Quality of Life in Patients With Moderately to Severely Active Ulcerative Colitis: Phase 3 Study Results. Inflamm Bowel Dis. 2023 Sep 1;29(9):1421-1430. doi: 10.1093/ibd/izac260.

    PubMed 36645051

  • Ponce-Bobadilla AV, Stodtmann S, Eckert D, Zhou W, Liu W, Mohamed MF. Upadacitinib Population Pharmacokinetics and Exposure-Response Relationships in Ulcerative Colitis Patients. Clin Pharmacokinet. 2023 Jan;62(1):101-112. doi: 10.1007/s40262-022-01191-6. Epub 2022 Dec 26.

    PubMed 36571701

  • Loftus EV Jr, Colombel JF, Takeuchi K, Gao X, Panaccione R, Danese S, Dubinsky M, Schreiber S, Ilo D, Finney-Hayward T, Zhou W, Phillips C, Gonzalez YS, Shu L, Yao X, Zhou Q, Vermeire S. Upadacitinib Therapy Reduces Ulcerative Colitis Symptoms as Early as Day 1 of Induction Treatment. Clin Gastroenterol Hepatol. 2023 Aug;21(9):2347-2358.e6. doi: 10.1016/j.cgh.2022.11.029. Epub 2022 Dec 1.

    PubMed 36464141

  • Danese S, Vermeire S, Zhou W, Pangan AL, Siffledeen J, Greenbloom S, Hebuterne X, D'Haens G, Nakase H, Panes J, Higgins PDR, Juillerat P, Lindsay JO, Loftus EV Jr, Sandborn WJ, Reinisch W, Chen MH, Sanchez Gonzalez Y, Huang B, Xie W, Liu J, Weinreich MA, Panaccione R. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022 Jun 4;399(10341):2113-2128. doi: 10.1016/S0140-6736(22)00581-5. Epub 2022 May 26.

    PubMed 35644166

  • Sandborn WJ, Ghosh S, Panes J, Schreiber S, D'Haens G, Tanida S, Siffledeen J, Enejosa J, Zhou W, Othman AA, Huang B, Higgins PDR. Efficacy of Upadacitinib in a Randomized Trial of Patients With Active Ulcerative Colitis. Gastroenterology. 2020 Jun;158(8):2139-2149.e14. doi: 10.1053/j.gastro.2020.02.030. Epub 2020 Feb 22.

    PubMed 32092309

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Upadacitinib in people with Ulcerative Colitis (UC), run by AbbVie at 496 sites in 46 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 7 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 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 496 sites in United States, Japan, Canada, China, Russia and 41 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 30 Jun 2022). 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?

Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8 (time frame: At Week 8). The study lists 3 primary outcomes in all. 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 NCT02819635, which also lists 14 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 30 Jun 2022.

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