AzTrials
AzTrials

Crohn's DiseasePhase 3U-ENDURENCT03345823

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433

A Phase 3 study testing Upadacitinib in people with Crohn's Disease, run by AbbVie at 466 sites in 49 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease
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
747 participants
Where
466 sitesin 49 countries
Study dates
21 Mar 2018to Sep 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For Substudy 1:
  • Participant who achieve clinical response in Study M14-431 or Study M14-433.
  • Participant completes study procedures in the parent study. The final endoscopy for Studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.
  • For Substudy 2:
  • Participant completes Substudy 1. The Week 52 endoscopy may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.
  • Participant who achieved clinical response at the time described in the protocol and completes study procedures in the parent study/ substudy.

Who cannot join

  • For Substudies 1 and 2:
  • Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
  • Participant who has a known hypersensitivity to upadacitinib or its excipients, or had an adverse event during Studies M14-431 and M14-433 or Substudy 1 or 2 of Study M14-430 that in the investigator's judgment makes the participant unsuitable for this study.
  • Participant at the final visit of M14-431 or M14-433 with any active or chronic recurring infections based on the investigator's assessment that makes the participant an unsuitable candidate for the study. Participants with serious infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is resolved, based on the investigator's assessment.
  • Participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Studies M14-431, M14-433 or Substudy 1 of Study M14-430 (Week 52).

Trial locations and contacts

466 sites in 49 countries.

466 sites in 49 countries

United States123 sites

  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 164654

    Ann Arbor, Michigan, 48109

  • TX Clinical Research Institute /ID# 164719

    Arlington, Texas, 76012

  • Duplicate_Johns Hopkins University School of Medicine /ID# 211939

    Baltimore, Maryland, 21287-0010

  • Inquest Clinical Research /ID# 164676

    Baytown, Texas, 77521-2415

  • Texas Digestive Disease Consultants, PLLC dba GI Alliance /ID# 164728

    Bellevue, Washington, 98004

  • Treasure Valley Medical Research /ID# 215030

    Boise, Idaho, 83706

  • HP Clinical Research /ID# 164631

    Bountiful, Utah, 84010

  • NY Scientific /ID# 164630

    Brooklyn, New York, 11235

  • Duplicate_Lahey Hospital and Medical Center /ID# 214724

    Burlington, Massachusetts, 01805

  • GI Alliance /ID# 209803

    Cedar Park, Texas, 78613

  • Delsol Research Management, Ll /Id# 170164

    Chandler, Arizona, 85224

  • Pharmacorp Clinical Trials /ID# 165008

    Charleston, South Carolina, 29412

  • Atrium Health Carolinas Medical Center /ID# 164632

    Charlotte, North Carolina, 28203

  • Duplicate_PMG Research of Charlotte /ID# 171178

    Charlotte, North Carolina, 28209

  • Clin Res Inst of Michigan, LLC /ID# 170163

    Chesterfield, Michigan, 48047

  • Metropolitan Gastroenterology Group - Chevy Chase /ID# 164647

    Chevy Chase, Maryland, 20815

  • Duplicate_Rush University Medical Center /ID# 165470

    Chicago, Illinois, 60612

  • Duplicate_University of Chicago Medicine /ID# 165509

    Chicago, Illinois, 60637-1426

  • Gastro Health Research /ID# 164668

    Cincinnati, Ohio, 45219

  • Duplicate_Duplicate_University Of Cincinnati Medical Center /ID# 164729

    Cincinnati, Ohio, 45267-0585

  • Cleveland Clinic Main Campus /ID# 209230

    Cleveland, Ohio, 44195

  • Peak Gastroenterology Associates, PC /ID# 170166

    Colorado Springs, Colorado, 80907

  • Delta Waves, Inc. /ID# 164656

    Colorado Springs, Colorado, 80918

  • Gastro Center of Maryland /ID# 171180

    Columbia, Maryland, 21045

  • Ohio State University/ Gastroe /ID# 170159

    Columbus, Ohio, 43210

  • Optimed Research, Ltd. /ID# 205625

    Columbus, Ohio, 43235

  • Advanced Research - Coral Springs /ID# 218019

    Coral Springs, Florida, 33067-3173

  • Gastro One /ID# 164730

    Cordova, Tennessee, 38018

  • Southern California Res. Ctr. /ID# 169653

    Coronado, California, 92118-1408

  • Citrus Valley Gastroenterology /ID# 166230

    Covina, California, 91722-3797

  • Tri-State Gastroenterology /ID# 165469

    Crestview Hills, Kentucky, 41017

  • Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 170161

    Dallas, Texas, 75246

  • Hometown Urgent Care and Resea /ID# 201289

    Dayton, Ohio, 45424

  • DuPage Medical Group /ID# 205320

    Downers Grove, Illinois, 60515-5509

  • Cooper Gastroenterology at Fire Road /ID# 164641

    Egg Harbor, New Jersey, 08234

  • Dayton Gastroenterology, Inc. /ID# 167623

    Englewood, Ohio, 45415

  • MediSphere Medical Research Center /ID# 166233

    Evansville, Indiana, 47714-8011

  • Plains Clinical Research Center, LLC /ID# 170169

    Fargo, North Dakota, 58104-5925

  • Digestive Health Associates (DHA) - Farmington Hills /ID# 206101

    Farmington Hills, Michigan, 48334-3230

  • Gastroenterology Associates, P.A. of Greenville /ID# 164643

    Greenville, South Carolina, 29607

  • Gastroenterology Center of Connecticut /ID# 164614

    Hamden, Connecticut, 06518

  • Houma Digestive Health Special /ID# 164727

    Houma, Louisiana, 70360

  • Baylor College of Medicine /ID# 164609

    Houston, Texas, 77030

  • Centex Studies, Inc. - Houston /ID# 201212

    Houston, Texas, 77058

  • GI Specialists of Houston /ID# 202340

    Houston, Texas, 77070-4347

  • Indianapolis Gastroenterology /ID# 164649

    Indianapolis, Indiana, 46237

  • University of Iowa Hospitals and Clinics /ID# 165405

    Iowa City, Iowa, 52242

  • Hoag Memorial Hosp Presbyterian /ID# 222538

    Irvine, California, 92618

  • Southern Therapy and Advanced Research (STAR) LLC /ID# 165295

    Jackson, Mississippi, 39216

  • Encore Borland-Groover Clinical Research /Id# 203500

    Jacksonville, Florida, 32256

  • United Health Services Hospitals, Inc /ID# 217483

    Johnson City, New York, 13790-2107

  • Duplicate_East Tennessee Research Institute /ID# 203614

    Johnson City, Tennessee, 37604

  • UC San Diego Health System /ID# 164763

    La Jolla, California, 92037

  • NYU Langone Long Island Clinical Research Associates /ID# 164627

    Lake Success, New York, 11042

  • Las Vegas Medical Research /ID# 168551

    Las Vegas, Nevada, 89113

  • United Medical Doctors /ID# 207458

    Los Alamitos, California, 90720-3309

  • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164640

    Los Angeles, California, 90067-2001

  • Duplicate_University of Louisville /ID# 165391

    Louisville, Kentucky, 40202

  • University of Louisville Hospital /ID# 168520

    Louisville, Kentucky, 40202

  • Caprock Gastro Research - Lubbock - 80th Street /ID# 215436

    Lubbock, Texas, 79424

  • Gastroenterology Associates of Central Georgia, LLC /ID# 165492

    Macon, Georgia, 31201

  • Ctr for Advanced Gastroenterol /ID# 165306

    Maitland, Florida, 32751-6108

  • Great Lakes Gastroenterology Research, LLC /ID# 202006

    Mentor, Ohio, 44060-6211

  • Crystal Pharmacology Research /ID# 166118

    Miami, Florida, 33165

  • Coral Research Clinic /ID# 164604

    Miami, Florida, 33186-4643

  • Froedtert Memorial Lutheran Hospital /ID# 202285

    Milwaukee, Wisconsin, 53226-3522

  • Facey Medical Foundation /ID# 203138

    Mission Hills, California, 91345

  • East View Medical Research, LLC /ID# 171132

    Mobile, Alabama, 36606

  • CB Flock Research Corporation /ID# 166239

    Mobile, Alabama, 36608

  • United Medical Doctors - Murrieta /ID# 164602

    Murrieta, California, 92563

  • Quality Medical Research /ID# 205264

    Nashville, Tennessee, 37211

  • Vanderbilt University Medical Center /ID# 164607

    Nashville, Tennessee, 37232-0011

  • Aquiant Research /ID# 205505

    New Albany, Indiana, 47150-4053

  • Rutgers Robert Wood Johnson /ID# 166110

    New Brunswick, New Jersey, 08901

  • Nola Research Works, LLC /ID# 164612

    New Orleans, Louisiana, 70115

  • Advanced Research Institute, Inc /ID# 164601

    New Port Richey, Florida, 34653

  • The Mount Sinai Hospital /ID# 170256

    New York, New York, 10029

  • Columbia Univ Medical Center /ID# 164692

    New York, New York, 10032-3725

  • Advanced Research Institute /ID# 164689

    Ogden, Utah, 84405

  • Digestive Disease Specialists /ID# 201063

    Oklahoma City, Oklahoma, 73112

  • Quality Clinical Research Inc. /ID# 170162

    Omaha, Nebraska, 68114-3723

  • CHI Health Research Center /ID# 168513

    Omaha, Nebraska, 68124

  • Endoscopic Research, Inc. /ID# 206139

    Orlando, Florida, 32803

  • Omega Research Group /ID# 203482

    Orlando, Florida, 32808

  • University of Pennsylvania /ID# 168406

    Philadelphia, Pennsylvania, 19104-5502

  • Duplicate_Thomas Jefferson University /ID# 168003

    Philadelphia, Pennsylvania, 19107-4414

  • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164752

    Raleigh, North Carolina, 27612

  • Rapid City Medical Center - GI Research /ID# 201733

    Rapid City, South Dakota, 57701

  • Mayo Clinic - Rochester /ID# 164691

    Rochester, Minnesota, 55905-0001

  • Gastoenterology Group of Rochester /ID# 166235

    Rochester, New York, 14618-5703

  • Gastroenterology Consultants, P.C /ID# 218218

    Roswell, Georgia, 30076-4913

  • Duplicate_Care Access Research /ID# 164685

    Salt Lake City, Utah, 84124-1377

  • Clinical Associates in Research Therapeutics of America, LLC /ID# 164675

    San Antonio, Texas, 78212

  • Southern Star Research Institute, LLC /ID# 169756

    San Antonio, Texas, 78229-5390

  • Medical Assoc Research Grp /ID# 169704

    San Diego, California, 92123

  • UCSF Medical Center - Mount Zion /ID# 202372

    San Francisco, California, 94115

  • Univ of California San Francis /ID# 164653

    San Francisco, California, 94158

  • Care Access Research /ID# 167765

    San Pablo, California, 94806

  • Duplicate_HonorHealth Research Institute - Shea /ID# 164725

    Scottsdale, Arizona, 85258

  • Virginia Mason Hospital & Medical Center /ID# 164862

    Seattle, Washington, 98101

  • University of Washington /ID# 164646

    Seattle, Washington, 98109

  • Louisiana Research Center, LLC /ID# 164694

    Shreveport, Louisiana, 71105-6800

  • Richmond University Medical Center /ID# 201858

    Staten Island, New York, 10310-1664

  • Carl R. Meisner Medical Clinic /ID# 171057

    Sugar Land, Texas, 77478

  • Duplicate_Arizona Arthritis & Rheumatology Research, PLLC /ID# 164702

    Sun City, Arizona, 85306

  • Atlanta Gastroenterology Spec /ID# 164698

    Suwanee, Georgia, 30024

  • Duplicate_Clinical Research of West Florida, Inc /ID# 205828

    Tampa, Florida, 33606-1246

  • Duplicate_Clinical Research of West Florida, Inc /ID# 208119

    Tampa, Florida, 33606-1246

  • Clinical Research Trials of Florida, Inc. /ID# 203486

    Tampa, Florida, 33607

  • Duplicate_AdventHealth Tampa /ID# 171181

    Tampa, Florida, 33613-4680

  • Montefiore Medical Center - Moses Campus /ID# 166242

    The Bronx, New York, 10467

  • Advantage Clinical Trials /ID# 168582

    The Bronx, New York, 10468

  • Center for Digestive Health /ID# 164726

    Troy, Michigan, 48098-6363

  • Options Health Research, LLC /ID# 164704

    Tulsa, Oklahoma, 74104

  • Healthcare Research Consultant /ID# 166244

    Tulsa, Oklahoma, 74135

  • Tyler Research Institute, LLC /ID# 168679

    Tyler, Texas, 75701

  • The Vancouver Clinic, INC. PS /ID# 164874

    Vancouver, Washington, 98664

  • Gastro Health & Nutrition - Victoria /ID# 167810

    Victoria, Texas, 77904

  • Allegiance Research Specialists /ID# 165298

    Wauwatosa, Wisconsin, 53226

  • Texas Digestive Disease Consultants /ID# 209954

    Webster, Texas, 77598

  • Duplicate_Velocity Clinical Research - Salt Lake City /ID# 166113

    West Jordan, Utah, 84088

  • Western States Clinical Res /ID# 164625

    Wheat Ridge, Colorado, 80033-2896

  • Duplicate_Atrium Health Wake Forest Baptist Medical Center /ID# 164755

    Winston-Salem, North Carolina, 27157-0001

Other trials in United States

Japan50 sites

  • Duplicate_Asahikawa Medical University Hospital /ID# 167148

    Asahikawa-shi, Hokkaido, 078-8510

  • Institute of Science Tokyo Hospital /ID# 165982

    Bunkyo-ku, Tokyo, 113-8519

  • Fukuoka University Chikushi Hospital /ID# 214402

    Chikushino-shi, Fukuoka, 818-8502

  • Duplicate_NHO Fukuyama Medical Center /ID# 167155

    Fukuyama-shi, Hiroshima, 720-8520

  • Tokai University Hachioji Hospital /ID# 165984

    Hachioji-shi, Tokyo, 192-0032

  • Duplicate_Hamamatsu University Hospital /ID# 224402

    Hamamatsu, Shizuoka, 431-3192

  • National Hospital Organization Hirosaki General Medical Center /ID# 165976

    Hirosaki-shi, Aomori, 036-8545

  • Hiroshima University Hospital /ID# 165998

    Hiroshima, Hiroshima, 734-8551

  • Imamura General Hospital /ID# 227135

    Kagoshima, Kagoshima-ken, 890-0064

  • Idzuro Imamura Hospital /ID# 206655

    Kagoshima, Kagoshima-ken, 892-0824

  • Sameshima Hospital /ID# 206677

    Kagoshima, Kagoshima-ken, 892-0846

  • Kanazawa University Hospital /ID# 169212

    Kanazawa, Ishikawa-ken, 920-8641

  • Nara Medical University Hospital /ID# 169213

    Kashihara-shi, Nara, 634-8522

  • Aoyama Clinic /ID# 165993

    Kobe, Hyōgo, 650-0015

  • Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 165994

    Kurashiki-shi, Okayama-ken, 710-0142

  • Kurume University Hospital /ID# 165996

    Kurume-shi, Fukuoka, 830-0011

  • Japanese Red Cross Kyoto Daiichi Hosital /ID# 165990

    Kyoto, Kyoto, 605-0981

  • Duplicate_Kyoto University Hospital /ID# 169887

    Kyoto, Kyoto, 606-8507

  • Duplicate_The Jikei University Hospital /ID# 167154

    Minato-ku, Tokyo, 105-8471

  • Kyorin University Hospital /ID# 165983

    Mitaka-shi, Tokyo, 181-8611

  • Iwate Medical University Uchimaru Medical Center /ID# 202465

    Morioka, Iwate, 020-8505

  • Aichi Medical University Hospital /ID# 165989

    Nagakute, Aichi-ken, 480-1195

  • Nagoya University Hospital /ID# 165987

    Nagoya, Aichi-ken, 466-8560

  • Nagoya City University Hospital /ID# 165988

    Nagoya, Aichi-ken, 467-8602

  • Duplicate_Niigata University Medical & Dental Hospital /ID# 170042

    Niigata, Niigata, 951-8520

  • Duplicate_Hyogo Medical University Hospital /ID# 165991

    Nishinomiya-shi, Hyōgo, 663-8501

  • Ishida Clinic of IBD and Gastroenterology /ID# 167149

    Ōita, Oita Prefecture, 870-0823

  • Duplicate_Okayama University Hospital /ID# 167354

    Okayama, Okayama-ken, 700-8558

  • Kinshukai Infusion Clinic /ID# 218873

    Osaka, Osaka, 530-0011

  • Osaka Metropolitan University Hospital /ID# 165999

    Osaka, Osaka, 545-8586

  • Duplicate_Shiga University of Medical Science Hospital /ID# 167157

    Ōtsu, Shiga, 520-2192

  • Tokitokai Tokito clinic /ID# 165977

    Saitama-shi, Saitama, 336-0963

  • Toho University Sakura Medical Center /ID# 165978

    Sakura-shi, Chiba, 285-8741

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165975

    Sapporo, Hokkaido, 060-0033

  • Duplicate_Sapporo Medical University Hospital /ID# 167152

    Sapporo, Hokkaido, 060-8543

  • Sapporo IBD Clinic /ID# 223559

    Sapporo, Hokkaido, 064-0919

  • Tohoku University Hospital /ID# 167150

    Sendai, Miyagi, 9808574

  • Duplicate_Tokyo Women's Medical University Hospital /ID# 205979

    Shinjuku-ku, Tokyo, 162-8666

  • Duplicate_Osaka University Hospital /ID# 169661

    Suita-shi, Osaka, 565-0871

  • Duplicate_NHO Shizuoka Medical Center /ID# 167153

    Sunto-gun, Shizuoka, 411-8611

  • National Hospital Organization Takasaki General Medical Center /ID# 167151

    Takasaki-shi, Gunma, 370-0829

  • Osaka Medical and Pharmaceutical University Hospital /ID# 206323

    Takatsuki-shi, Osaka, 569-8686

  • Toyama Prefectural Central Hospital /ID# 217836

    Toyama, Toyama, 930-8550

  • Toyohashi Municipal Hospital /ID# 200176

    Toyohashi, Aichi-ken, 441-8570

  • Japanese Red Cross Wakayama Medical Center /ID# 200641

    Wakayama, Wakayama, 640-8558

  • Wakayama Medical University Hospital /ID# 169480

    Wakayama, Wakayama, 641-8510

  • Yamagata University Hospital /ID# 200158

    Yamagata, Yamagata, 990-9585

  • Kenseikai Dongo Hospital /ID# 208105

    Yamatotakada-shi, Nara, 635-0022

  • Yokkaichi Hazu Medical Center /ID# 167201

    Yokkaichi-shi, Mie-ken, 510-0016

  • Duplicate_Yokohama City University Medical Center /ID# 167156

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

Canada17 sites

  • University of Calgary /ID# 166990

    Calgary, Alberta, T2N 4Z6

  • Allen Whey Khye Lim Professional Corporation /ID# 168047

    Edmonton, Alberta, T5R 1W2

  • University of Alberta Hospital /ID# 166987

    Edmonton, Alberta, T6G 2B7

  • Covenant Health /ID# 166996

    Edmonton, Alberta, T6K 4B2

  • Medicor Research Inc /ID# 166997

    Greater Sudbury, Ontario, P3A 1W8

  • QEII - Health Sciences Centre /ID# 169308

    Halifax, Nova Scotia, B3H 2Y9

  • Hotel Dieu de Levis /ID# 166985

    Lévis, Quebec, G6V 3Z1

  • London Health Sciences Center- University Hospital /ID# 221039

    London, Ontario, N6A 5W9

  • Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 170122

    Montreal, Quebec, H2X 0A9

  • Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 170011

    Montreal, Quebec, H4A 3J1

  • Fraser Clinical Trials Inc /ID# 166984

    New Westminster, British Columbia, V3L 3W4

  • Scott Shulman Medicine Professional Corporation /ID# 169065

    North Bay, Ontario, P1B 2H3

  • Taunton surgical centre /ID# 168045

    Oshawa, Ontario, L1H 7K4

  • Ottawa Hospital Research Institute /ID# 212412

    Ottawa, Ontario, K1H 8L6

  • CIUSSS de l'Estrie - CHUS /ID# 170936

    Sherbrooke, Quebec, J1G 2E8

  • Giri Gi Research Institute - Vancouver /ID# 166994

    Vancouver, British Columbia, V5Z 2K5

  • Toronto Digestive Disease Associates /ID# 166988

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

France16 sites

  • Duplicate_CHU Amiens-Picardie Site Sud /ID# 171023

    Amiens, Somme, 80054

  • CHRU Tours - Hopital Trousseau /ID# 169783

    Chambray-lès-Tours, 37170

  • Hopital Beaujon /ID# 171007

    Clichy, Île-de-France Region, 92110

  • Duplicate_CHU Henri Mondor /ID# 169782

    Créteil, 94000

  • Duplicate_CHU Grenoble - Hopital Michallon /ID# 222403

    La Tronche, Isere, 38700

  • CHRU Lille - Hopital Claude Huriez /ID# 206653

    Lille, Nord, 59037

  • Duplicate_Hopital Saint Eloi /ID# 170039

    Montpellier, Herault, 34295

  • Clinique Jules Verne /ID# 222240

    Nantes, 44300

  • Chu de Nice-Hopital Larchet Ii /Id# 171004

    Nice, Alpes-Maritimes, 06202

  • Polyclinique Grand Sud /ID# 170037

    Nîmes, 30932

  • Duplicate_CHU Bordeaux - Hopital Haut Leveque /ID# 207812

    Pessac, Gironde, 33604

  • HCL - Hopital Lyon Sud /ID# 171030

    Pierre-Bénite, Rhone, 69495

  • Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 171027

    St-Priest-en-Jarez, Pays de la Loire Region, 42270

  • CHU Toulouse - Hopital Rangueil /ID# 169784

    Toulouse, Haute-Garonne, 31400

  • CH Valenciennes /ID# 222399

    Valenciennes, Nord, 59300

  • Duplicate_CHRU Nancy - Hopitaux de Brabois /ID# 170970

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500

Other trials in France

China15 sites

  • Beijing Friendship Hospital /ID# 204175

    Beijing, Beijing Municipality, 100032

  • The First Hospital of Jilin University /ID# 206865

    Changchun, Jilin, 130021

  • The Second Xiangya Hospital Of Central South University /ID# 204057

    Changsha, Hunan, 410011

  • The First Affiliated Hospital, Sun Yat-sen University /ID# 205227

    Guangzhou, Guangdong, 510080

  • Nanfang Hospital of Southern Medical University /ID# 204056

    Guangzhou, Guangdong, 510515

  • The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 204054

    Guangzhou, Guangdong, 510655

  • The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 204058

    Hangzhou, Zhejiang, 310009

  • Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204050

    Hangzhou, Zhejiang, 310018

  • The First Affiliated Hospital of Nanchang University /ID# 204052

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital /ID# 204899

    Nanjing, Jiangsu, 210008

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204055

    Shanghai, Shanghai Municipality, 200065

  • Duplicate_Tianjin Med Univ General Hosp /ID# 206979

    Tianjin, 300052

  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204065

    Wuhan, Hubei, 430022

  • Tongji Hospital Tongji Medical College of HUST /ID# 204051

    Wuhan, Hubei, 430030

  • Zhongshan Hospital Xiamen University /ID# 204986

    Xiamen, Fujian, 361004

Other trials in China

Italy15 sites

  • Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 168155

    Bologna, Emilia-Romagna, 40138

  • Ospedale Cannizzaro /ID# 168161

    Catania, 95126

  • Azienda Ospedaliero-Universitaria Renato Dulbecco /ID# 201986

    Catanzaro, 88100

  • Policlinico San Martino/Univer /ID# 168162

    Genova, 16132

  • ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168149

    Milan, Milano, 20122

  • ASST Grande Ospedale Metropolitano Niguarda /ID# 170906

    Milan, Milano, 20162

  • Azienda Ospedaliero-Universitaria di Modena /ID# 200009

    Modena, 41124

  • Duplicate_IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168154

    Negrar, Verona, 37024

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 168157

    Palermo, 90146

  • Duplicate_Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202419

    Pisa, 56125

  • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 168151

    Roma, 00128

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 168156

    Rome, Roma, 00133

  • Duplicate_Azienda Ospedaliera San Camillo Forlanini /ID# 168152

    Rome, Roma, 00152

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 168150

    Rome, Roma, 00168

  • IRCCS Istituto Clinico Humanitas /ID# 168153

    Rozzano, Lombardy, 20089

Other trials in Italy

Spain14 sites

  • Duplicate_Hospital Universitario A Coruna - CHUAC /ID# 203909

    A Coruña, 15006

  • Hospital Universitario Vall de Hebron /ID# 202721

    Barcelona, 08035

  • Hospital Clinic de Barcelona /ID# 202726

    Barcelona, 08036

  • Hospital Universitario de Girona Doctor Josep Trueta /ID# 202644

    Girona, 17007

  • Hospital Juan Ramon Jimenez /ID# 202727

    Huelva, 21005

  • Hospital Universitario Dr. Negrin /ID# 202723

    Las Palmas de Gran Canaria, Las Palmas, 35019

  • Hospital Universitario La Paz /ID# 202725

    Madrid, 28046

  • Hospital Universitari Son Espases /ID# 201969

    Palma de Mallorca, Balearic Islands, 07120

  • Hospital Universitario de Navarra /ID# 202354

    Pamplona, Navarre, 31008

  • Hospital Universitario de Salamanca /ID# 206359

    Salamanca, 37711

  • Hospital Universitario Marques de Valdecilla /ID# 202495

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen Macarena /ID# 202722

    Seville, 41009

  • Hospital Clinico Universitario de Valencia /ID# 209658

    Valencia, 46010

  • Hospital Universitario y Politecnico La Fe /ID# 202720

    Valencia, 46026

Other trials in Spain

United Kingdom14 sites

  • Duplicate_Royal United Hospitals Bath /ID# 169062

    Bath, Bath And North East Somerset, BA1 3NG

  • Ulster Hospital - South Eastern Health & Social Care Trust /ID# 205324

    Belfast, BT16 1RH

  • University Hospitals Birmingham NHS Foundation Trust /ID# 169058

    Birmingham, B15 2TH

  • The Dudley Group NHS Foundation Trust /ID# 169057

    Dudley, DY1 2HQ

  • London North West University Healthcare NHS Trust /ID# 169056

    Harrow, HA1 3UJ

  • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 218830

    London, Greater London, E1 2ES

  • Kings College Hospital NHS Foundation Trust /ID# 169060

    London, Greater London, SE5 9RS

  • St George University Hospitals NHS Foundation Trust /ID# 205550

    London, Greater London, SW17 0QT

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169063

    Newcastle upon Tyne, NE3 3HD

  • Mersey and West Lancashire NHS teaching hospitals trust /ID# 209087

    Prescot, Warrington, L35 5DR

  • Duplicate_Stockport NHS foundation trust /ID# 208717

    Stockport, SK2 7JE

  • Taunton and Somerset NHS Foundation Trust /ID# 209666

    Taunton, Somerset, TA1 5DA

  • Warrington and Halton Hospitals NHS Foundation Trust /ID# 171396

    Warrington, Cheshire West And Chester, WA5 1QG

  • The Royal Wolverhampton NHS Trust /ID# 171395

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Germany12 sites

  • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 169271

    Berlin, 12203

  • Gastroenterologie am Mexikoplatz /ID# 203574

    Berlin, 14163

  • Universitaetsklinikum Erlangen /ID# 203550

    Erlangen, Bavaria, 91054

  • Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203569

    Essen, 45239

  • Duplicate_Agaplesion Markus Krankenhaus /ID# 168753

    Frankfurt am Main, Hesse, 60431

  • Universitaetsklinikum Frankfurt /ID# 203567

    Frankfurt am Main, Hesse, 60590

  • Universitaetsklinikum Halle (Saale) /ID# 207453

    Halle, 06120

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168755

    Kiel, Schleswig-Holstein, 24105

  • Universitatsklinikum Mannheim /ID# 168754

    Mannheim, Baden-Wurttemberg, 68167

  • Medizinisches Versorgungszentrum Portal 10 /ID# 200212

    Münster, 48155

  • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206739

    Saarbrücken, Saarland, 66111

  • Universitaetsklinikum Ulm /ID# 203554

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Russia12 sites

  • Immanuel Kant Baltic Federal University /ID# 203810

    Kaliningrad, Kaliningrad Oblast, 236016

  • Kazan State Medical University /ID# 169589

    Kazan', Tatarstan, Respublika, 420012

  • Olla-Med Clinic /ID# 208723

    Moscow, 105554

  • P.A. Bayandin Murmansk Regiona /ID# 169590

    Murmansk, 183047

  • LLC Medical Center /ID# 209234

    Novosibirsk, Novosibirsk Oblast, 630099

  • Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202989

    Perm, Permskiy Kray, 614109

  • Republican hospital named after V.A. Baranov /ID# 206497

    Petrozavodsk, Murmansk Oblast, 185019

  • Euromedservice /ID# 206608

    Pushkin, 196603

  • LLC Novaya Klinika /ID# 206613

    Pyatigorsk, Stavropol Kray, 357500

  • X7 Clinical Research Center /ID# 216348

    Saint Petersburg, 194156

  • City Clinical Hospital No. 31 /ID# 208871

    Saint Petersburg, 197110

  • Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202996

    Stavropol, Stavropol Kray, 355012

Other trials in Russia

Hungary11 sites

  • Obudai Egeszsegugyi Centrum /ID# 201886

    Budapest, 1036

  • Duplicate_Semmelweis Egyetem /ID# 210166

    Budapest, 1085

  • Magyar Honvedseg Egeszsegugyi Kozpont /ID# 200888

    Budapest, 1134

  • Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 216420

    Debrecen, Hajdú-Bihar, 4032

  • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 200887

    Debrecen, 4031

  • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205549

    Encs, Borsod-Abauj Zemplen county, 3860

  • Gyongyosi Bugat Pal Korhaz /ID# 201885

    Gyöngyös, Heves County, 3200

  • Kistarcsai Flor Ferenc Korhaz /ID# 206153

    Kistarcsa, Pest County, 2143

  • Pecsi Tudomanyegyetem Klinikai Kozpont Mohacsi Korhaz /ID# 209440

    Mohács, Baranya, 7700

  • Mentahaz Maganorvosi Kozpont /ID# 201888

    Székesfehérvár, 8000

  • Komarom-Esztergom Varmegyei Szent Borbala Korhaz (Clinexpert Tatabanya Kft.) /ID# 209896

    Tatabánya, Komárom-Esztergom, 2800

Other trials in Hungary

South Korea10 sites

  • Inje University Haeundae Hospital /ID# 202631

    Busan, Busan Gwang Yeogsi, 48108

  • Dong-A University Medical Center /ID# 167568

    Busan, Busan Gwang Yeogsi, 49201

  • Duplicate_Pusan National University Hospital /ID# 167565

    Busan, Busan Gwang Yeogsi, 49241

  • Kyungpook National University Hospital /ID# 207020

    Daegu, Daegu Gwang Yeogsi, 41944

  • Chungang University Hospital /ID# 207021

    Dongjak-gu, Seoul Teugbyeolsi, 06973

  • Duplicate_Hanyang University Gurihospital /ID# 167563

    Guri-si, Gyeonggido, 11923

  • Duplicate_CHA University Bundang Medical Center /ID# 167569

    Seongnam-si, Gyeonggido, 13496

  • Kangbuk Samsung Hospital /ID# 167562

    Seoul, Seoul Teugbyeolsi, 03181

  • Samsung Medical Center /ID# 167564

    Seoul, Seoul Teugbyeolsi, 06351

  • Yonsei University Health System Severance Hospital /ID# 167567

    Seoul, 03722

Other trials in South Korea

Turkey (Türkiye)10 sites

  • Ankara Univ Medical Faculty /ID# 206408

    Ankara, 06590

  • Inonu Universitesi Turgut Ozal /ID# 201266

    Battalgazi/malatya, 44280

  • Mustafa Kemal University Medic /ID# 171328

    Hatay, 31001

  • Duplicate_Istanbul University Istanbul Medical Faculty /ID# 171365

    Istanbul, 34093

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171326

    Istanbul, 34899

  • Acibadem Kozyatagi Hospital /ID# 209404

    Kadıköy, Istanbul, 34742

  • Duplicate_Erciyes University Medical Fac /ID# 171325

    Melikgazi, Kayseri, 38030

  • Mersin University Medical /ID# 171330

    Mersin, 33343

  • Sisli Etfal Train & Res Hosp /ID# 171327

    Şişli, Istanbul, 34371

  • Gazi Universitesi Tip Fakultes /ID# 217445

    Yenimahalle, Ankara, 06560

Other trials in Turkey (Türkiye)

Brazil7 sites

  • Upeclin Fmb - Unesp /Id# 166860

    Botucatu, São Paulo, 18618-686

  • Hospital Nossa Senhora das Graças /ID# 166856

    Curitiba, Paraná, 80810-040

  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166853

    Goiânia, Goiás, 74535-170

  • Hospital de Clinicas de Porto Alegre /ID# 166855

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 166859

    Ribeirão Preto, São Paulo, 14049-900

  • Faculdade de Medicina do ABC /ID# 166854

    Santo André, La Spezia, 09060-870

  • Kaiser Clinica e Hospital Dia /ID# 166858

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

Other trials in Brazil

Egypt7 sites

  • Alexandria University /ID# 171008

    Alexandria, Alexandria Governorate, 21131

  • Alexandria University /ID# 171017

    Alexandria, Alexandria Governorate, 21131

  • Duplicate_Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 209561

    Alexandria, 21131

  • National Hepatology and Tropical Medicine Research Institute /ID# 170991

    Cairo, 11559

  • Ain Shams University Faculty of Medicine /ID# 209566

    Cairo, 11566

  • Air Force Specialized Hospital /ID# 170993

    Cairo

  • National Liver Institute /ID# 170987

    Menoufiya, Monufia Governorate, 35111

Other trials in Egypt

Israel7 sites

  • Barzilai Medical Center /ID# 223374

    Ashkelon, Southern District, 7830604

  • Soroka University Medical Center /ID# 169911

    Beersheba, Southern District, 8443901

  • Hadassah Medical Center-Hebrew University /ID# 169926

    Jerusalem, Jerusalem, 91120

  • Rabin Medical Center. /ID# 202634

    Petah Tikva, 4941492

  • Duplicate_Kaplan Medical Center /ID# 170275

    Rehovot, Central District, 7661041

  • Tel Aviv Sourasky Medical Center /ID# 206450

    Tel Aviv, Tel Aviv, 6423906

  • Yitzhak Shamir Medical Center /ID# 206449

    Tsrifin, Central District, 70300

Other trials in Israel

Argentina6 sites

  • Cemic /Id# 169183

    Ciudad Autonoma Buenos Aires, Buenos Aires, 1431

  • Hospital Italiano de Buenos Aires /ID# 215542

    Ciudad Autonoma Buenos Aires, Buenos Aires F.D., 1199

  • Gedyt /ID# 210018

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1115

  • Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 169229

    Córdoba, 5016

  • Hospital Provincial del Centenario /ID# 171251

    Rosario, Santa Fe Province, 2000

  • Cardio Alem /ID# 211283

    San Isidro, Buenos Aires, 1642

Other trials in Argentina

Australia6 sites

  • Royal Adelaide Hospital /ID# 171508

    Adelaide, South Australia, 5000

  • Box Hill Hospital /ID# 203735

    Box Hill, Victoria, 3128

  • Concord Repatriation General Hospital /ID# 171506

    Concord, New South Wales, 2139

  • Fiona Stanley Hospital /ID# 171507

    Murdoch, Western Australia, 6150

  • Coral Sea Clinical Research institute /ID# 212989

    North Mackay, Queensland, 4740

  • Mater Misericordiae Limited /ID# 204910

    South Brisbane, Queensland, 4101

Other trials in Australia

Croatia6 sites

  • Klinicki Bolnicki Centar KBC Split /ID# 171205

    Split, Split-Dalmatia County, 21000

  • Zadar General Hospital /ID# 205533

    Zadar, 23000

  • Clinical Hospital Dubrava /ID# 171165

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Sestre milosrdnice /ID# 171194

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 171168

    Zagreb, City of Zagreb, 10000

  • Poliklinika Solmed /ID# 211517

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Greece6 sites

  • General Hospital of Athens Ippokratio /ID# 167032

    Athens, Attica, 11527

  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202102

    Athens, Attica, 11527

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 167033

    Athens, 10676

  • University General Hospital of Heraklion PA.G.N.I /ID# 167031

    Heraklion, Crete, 71500

  • Tzaneio general hospital of Piraeus /ID# 206435

    Piraeus, Attica, 18536

  • General Hospital of Thessaloniki Hippokrateio /ID# 208823

    Thessaloniki, 54642

Other trials in Greece

Serbia6 sites

  • Clinical Hosp Center Zvezdara /ID# 168216

    Belgrade, Beograd, 11000

  • Military Medical Academy /ID# 168785

    Belgrade, Beograd, 11000

  • University Clinical Center Serbia /ID# 168217

    Belgrade, Beograd, 11000

  • Clin Hosp Ctr Bezanijska Kosa /ID# 168787

    Belgrade, Beograd, 11080

  • Duplicate_University Clinical Center Kragujevac /ID# 205856

    Kragujevac, Sumadijski Okrug, 34000

  • Duplicate_Clinical Center Vojvodina /ID# 168196

    Novi Sad, Vojvodina, 21000

Other trials in Serbia

South Africa6 sites

  • Farmovs (Pty) Ltd /Id# 207534

    Bloemfontein, Free State, 9301

  • Allergy & Immunology (AIU) /ID# 171427

    Cape Town, Western Cape, 7700

  • Dr JP Wright /ID# 170882

    Cape Town, Western Cape, 7708

  • Private Practice Dr MN Rajabally /ID# 169851

    Cape Town, Western Cape, 7800

  • Lenasia Clinical Trial Centre /ID# 205143

    Johannesburg, Gauteng, 1820

  • Wits Clinical Research /ID# 170850

    Johannesburg, Gauteng, 1864

Other trials in South Africa

Sweden6 sites

  • Alingsas lasarett /ID# 170814

    Alingsås, Västra Götaland County, 441 33

  • Sodra Alvsborgs sjukhus /ID# 203078

    Borås, Västra Götaland County, 501 82

  • Duplicate_Sahlgrenska University Hospital /ID# 169032

    Gothenburg, Västra Götaland County, 413 46

  • Duplicate_Sahlgrenska University Hospital /ID# 169170

    Gothenburg, Västra Götaland County, 413 46

  • Hallands Hospital Halmstad /ID# 170815

    Halmstad, Halland County, 302 33

  • Karolinska University Hospital Solna /ID# 224489

    Solna, Stockholm County, 171 64

Other trials in Sweden

Ukraine6 sites

  • Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 167918

    Kharkiv, 61037

  • Kyiv City Clinical Hospital No.18 /ID# 207890

    Kyiv, 01030

  • Medical Centre of "Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV" /ID# 203739

    Kyiv, 01030

  • MNE KRC Kyiv Regional Clinical Hospital /ID# 202456

    Kyiv, 04106

  • Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 167917

    Lviv, Lviv Oblast, 79000

  • MNE Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 222111

    Vinnytsia, Vinnytsia Oblast, 21018

Other trials in Ukraine

Belgium5 sites

  • Cliniques Universitaires UCL Saint-Luc /ID# 200293

    Brussels, Brussels Capital, 1200

  • Duplicate_AZ Sint-Lucas /ID# 200296

    Ghent, Oost-Vlaanderen, 9000

  • Universitair Ziekenhuis Leuven /ID# 200031

    Leuven, Vlaams-Brabant, 3000

  • CHU de Liege /ID# 200294

    Liège, 4000

  • Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 200295

    Yvoir, Namur, 5530

Other trials in Belgium

Chile5 sites

  • Hospital Guillermo Grant Benavente de Concepción /ID# 212421

    Concepción, Biobio, 4070038

  • CEC SpA /ID# 169872

    Ñuñoa, 7750495

  • CTR Estudios Clinicos /ID# 203940

    Providencia, Region Metropolitana Santiago, 7500571

  • Research Group /ID# 203178

    Santiago, Santiago Metropolitan, 2540364

  • Hospital Clinico Universidad De Los Andes /ID# 207463

    Santiago, 7501504

Other trials in Chile

Netherlands5 sites

  • Amsterdam UMC, Location VUmc /ID# 166930

    Amsterdam, North Holland, 1081 HV

  • Olvg /Id# 166932

    Amsterdam, North Holland, 1091 AC

  • Medisch Spectrum Twente /ID# 170299

    Enschede, Overijssel, 7512 KZ

  • Zuyderland Medisch Centrum /ID# 169699

    Heerlen, Limburg, 6419 PC

  • Radboud Universitair Medisch Centrum /ID# 166931

    Nijmegen, Gelderland, 6525 GA

Other trials in Netherlands

Poland5 sites

  • Malopolskie Centrum Kliniczne /ID# 202169

    Krakow, Lesser Poland Voivodeship, 30-149

  • Centrum Zdrowia MDM /ID# 200493

    Warsaw, Masovian Voivodeship, 00-189

  • Duplicate_WIP Warsaw IBD Point Profesor Kierkus /ID# 224302

    Warsaw, Masovian Voivodeship, 00-728

  • Centrum Medyczne Reuma Park /ID# 200489

    Warsaw, Masovian Voivodeship, 02-665

  • Vistamed /ID# 208571

    Wroclaw, Lower Silesian Voivodeship, 53-149

Other trials in Poland

Portugal5 sites

  • Duplicate_Hospital Garcia de Orta, EPE /ID# 170209

    Almada, Setúbal District, 2805-267

  • Duplicate_Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170204

    Guimarães, Braga District, 4835-044

  • Hospital Egas Moniz /ID# 170232

    Lisbon, Porto District, 1349-019

  • Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 200608

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

  • Unidade Local de Saude Sao Joao, EPE /ID# 170211

    Porto, 4200-319

Other trials in Portugal

Bosnia and Herzegovina4 sites

  • Duplicate_University Clinical Centre of the Republic of Srpska /ID# 200743

    Banja Luka, Republika Srpska, 78000

  • Clinical Center University of Sarajevo /ID# 201346

    Sarajevo, 71000

  • Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217843

    Sarajevo, 71000

  • University Clinical Center Tuzla /ID# 210323

    Tuzla, Tuzlanski, 75000

Other trials in Bosnia and Herzegovina

Czechia4 sites

  • Nemocnice Ceske Budejovice a.s. /ID# 224390

    České Budějovice, 370 01

  • Hepato-Gastroenterologie HK, s.r.o. /ID# 171564

    Hradec Králové, 500 12

  • ARTROSCAN s.r.o. /ID# 171575

    Ostrava, 722 00

  • ResTrial s.r.o. /ID# 208651

    Prague, 143 00

Other trials in Czechia

Denmark4 sites

  • Herlev Hospital /ID# 200785

    Herlev, Capital Region, 2730

  • Nordsjaellands Hospital /ID# 200788

    Hilleroed, Capital Region, 3600

  • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 200787

    Hvidovre, Capital Region, 2650

  • Duplicate_Sjaellands Universitets Hospital /ID# 200786

    Roskilde, Region Sjælland, 4000

Other trials in Denmark

Taiwan4 sites

  • China Medical University Hospital /ID# 169803

    Taichung, 40447

  • Taichung Veterans General Hospital /ID# 169802

    Taichung, 40705

  • National Taiwan University Hospital /ID# 169805

    Taipei City, Taipei, 100

  • Linkou Chang Gung Memorial Hospital /ID# 169804

    Taoyuan City, 333

Other trials in Taiwan

Austria3 sites

  • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 214468

    Salzburg, 5020

  • Klinik Landstrasse /ID# 203438

    Vienna, State of Vienna, 1030

  • Medizinische Universitaet Wien /ID# 169459

    Vienna, State of Vienna, 1090

Other trials in Austria

Bulgaria3 sites

  • Duplicate_UMHAT Kaspela EOOD /ID# 167615

    Plovdiv, 4001

  • Duplicate_Second MHAT Sofia /ID# 167616

    Sofia, 1202

  • MHAT Trakia /ID# 201677

    Stara Zagora, 6004

Other trials in Bulgaria

Latvia3 sites

  • VCA Polyclinic Aura /ID# 169499

    Riga, 1035

  • Pauls Stradins Clinical University Hospital /ID# 169494

    Riga, LV-1002

  • Duplicate_Digestive Disease Center Gastro /ID# 169518

    Riga, LV-1079

Other trials in Latvia

Malaysia3 sites

  • Duplicate_Hospital Sultanah Bahiyah /ID# 201317

    Alor Star, Kedah, 05460

  • Universiti Sains Malaysia /ID# 200101

    Kelantan, Kelantan, 16150

  • Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170780

    Kuala Lumpur, Selangor, 56000

Other trials in Malaysia

Mexico3 sites

  • Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207681

    Durango, Durango, 34000

  • Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 206843

    Guadalajara, Jalisco, 44650

  • Morales Vargas Centro de Investigacion S.C. /ID# 203496

    León, Guanajuato, 37000

Other trials in Mexico

Romania3 sites

  • Fundeni Clinical Institute /ID# 167831

    Bucharest, Bucharest, 022328

  • Duplicate_Clinica GASTRO MED SRL /ID# 206363

    Cluj-Napoca, Cluj, 400380

  • Cabinet Particular Policlinic Algomed /ID# 167832

    Timișoara, 300002

Other trials in Romania

Singapore3 sites

  • Duplicate_KL Ling Gastroenterology and Liver Clinic /ID# 205739

    Singapore, Central Singapore, 228510

  • Gleneagles Medical Centre /ID# 206019

    Singapore, 258499

  • Tan Tock Seng Hospital /ID# 203158

    Singapore, 308433

Other trials in Singapore

Colombia2 sites

  • Duplicate_Hospital Pablo Tobon Uribe /ID# 202403

    Medellín, Antioquia, 50034

  • Hospital San Vicente de Paul /ID# 200020

    Medellín, Antioquia, 50034

Other trials in Colombia

Estonia2 sites

  • West Tallinn Central Hospital /ID# 202787

    Tallinn, Harju, 10617

  • Tartu University Hospital /ID# 203141

    Tartu, 50406

Other trials in Estonia

Hong Kong2 sites

  • Queen Mary Hospital /ID# 171214

    Hong Kong, 999077

  • Tuen Mun Hospital /ID# 171213

    Hong Kong

Other trials in Hong Kong

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207030

    Kaunas, 50161

  • Vilnius University Hospital Santaros Klinikos /ID# 203269

    Vilnius, 08661

Other trials in Lithuania

Puerto Rico2 sites

  • Mindful Medical Research /ID# 203356

    San Juan, 00918-3756

  • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166769

    San Juan, 00935

Other trials in Puerto Rico

Slovakia2 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169960

    Banská Bystrica, Banská Bystrica Region, 975 17

  • KM Management, spol. s.r.o. /ID# 170202

    Nitra, Nitra Region, 949 01

Other trials in Slovakia

Switzerland2 sites

  • Inselspital, Universitaetsspital Bern /ID# 170994

    Bern, 3010

  • Duplicate_Universitatsspital Zurich /ID# 171000

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Ireland1 site

  • Mercy University Hospital /ID# 206512

    Cork, T12 WE28

Other trials in Ireland

Slovenia1 site

  • Univ Medical Ctr Ljubljana /ID# 211041

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.

Conditions
Crohn's Disease
Being tested
Upadacitinib, Placebo for Upadacitinib
Keywords
Upadacitinib, ABT-494, Extension Study, Efficacy, Safety, Crohn's Disease, Maintenance Study
Medical subject headings
Crohn Disease

What participants receive

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

  • UpadacitinibDrug

    Also called ABT-494, RINVOQ

    Oral; Tablet

  • Placebo for UpadacitinibDrug

    Oral; Tablet

Study groups in NCT03345823
Study groupRoleWhat they receive
Substudy 1: Cohort 1 Upadacitinib Dose AExperimentalThis is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive upadacitinib dose A for 52 weeks.
Receives: Drug: Upadacitinib
Substudy 1: Cohort 1 Upadacitinib Dose BExperimentalThis is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive upadacitinib dose B for 52 weeks.
Receives: Drug: Upadacitinib
Substudy 1: Cohort 1 PlaceboExperimentalThis is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive placebo for 52 weeks.
Receives: Drug: Placebo for Upadacitinib
Substudy 1: Cohort 2 PlaceboExperimentalThis is a maintenance group which includes participants who received double-blind placebo in studies M14-431 and M14-433 and achieved clinical response will continue to receive blinded placebo for 52 Weeks.
Receives: Drug: Placebo for Upadacitinib
Substudy 1: Cohort 3 Upadacitinib Dose BExperimentalThis is a maintenance group which includes participants who achieved clinical response to upadacitinib from the extended treatment period of studies M14-431 and M14-433 and will receive upadacitinib Dose B for 52 Weeks.
Receives: Drug: Upadacitinib
Substudy 2: Cohort 4 Upadacitinib Dose BExperimentalThis is a long-term extension group which includes participants who achieved clinical response in the open-label extended treatment period of study M14-431 and will receive upadacitinib dose B for 240 weeks.
Receives: Drug: Upadacitinib
Substudy 2: Cohort 5 Upadacitinib Dose AExperimentalThis is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose A for 240 weeks.
Receives: Drug: Upadacitinib
Substudy 2: Cohort 5 Upadacitinib Dose BExperimentalThis is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose B for 240 weeks.
Receives: Drug: Upadacitinib
Substudy 2: Cohort 5 PlaceboExperimentalThis is a long-term extension group which includes participants who complete Substudy 1 and will receive placebo for 240 weeks.
Receives: Drug: Placebo for Upadacitinib

What is being measured

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

  1. Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI)

    Clinical remission per CDAI is defined as CDAI <150.

    Measured: Week 52

  2. Sub-Study 1: Percentage of Participants with Endoscopic Response

    Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline.

    Measured: Week 52

  3. Number of Participants with Adverse Events

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section.

    Measured: Through Week 240

Secondary outcomes (11)

  1. Sub-Study 1: Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs)

    Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

    Measured: Week 52

  2. Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100)

    Decrease of at least 100 points in CDAI from Baseline.

    Measured: Week 52

  3. Sub-Study 1: Percentage of Participants with Endoscopic Remission

    Endoscopic remission is defined per Simplified Endoscopic Score for Crohn's Disease (SES-CD).

    Measured: Week 52

  4. Sub-Study 1: Percentage of Participants without Corticosteroid use for Crohn's Disease Among All Participants

    This is assessed in participants not taking corticosteroids at least 90 days prior to Week 52 and achieved clinical remission per CDAI. Clinical remission is defined as CDAI <150.

    Measured: Week 52

  5. Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI and Endoscopic Remission

    Clinical remission per CDAI is defined as CDAI <150. Endoscopic remission is defined per SES-CD.

    Measured: Week 52

  6. Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI

    Clinical remission per CDAI is defined as CDAI <150 (as measured by the percentage of participants with clinical remission at Week 52 among those with clinical remission at Week 0).

    Measured: Through Week 52

  7. Sub-Study 1: Percentage of Participants who Discontinue Corticosteroid Use for Crohn's Disease at Least 90 Days Prior to Week 52 and Achieve Clinical Remission, in Participants Taking Corticosteroids at Baseline.

    This is assessed in participants taking corticosteroids at Baseline. Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

    Measured: Week 52

  8. Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)

    The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.

    Measured: Baseline (Week 0) to Week 52

  9. Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

    The FACIT-F questionnaire was developed to assess fatigue.

    Measured: Baseline (Week 0) to Week 52

  10. Sub-Study 1: Percentage of Participants with Hospitalizations due to Crohn's Disease (CD)

    This is assessed by reviewing participant's hospitalization data.

    Measured: Up to Week 52

  11. Sub-Study 1: Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline

    EIMs are defined as manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.

    Measured: 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 posted17 Nov 2017
  2. Study start21 Mar 2018
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

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
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
747 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03345823
Sponsor's protocol ID
M14-430
Other IDs
2023-504951-29, 2023-504951-29-00, 2023
Acronym
U-ENDURE
Status last verified
Apr 2026
First submitted
15 Nov 2017
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Publications

  • Panaccione R, Panes J, Peyrin-Biroulet L, Colombel JF, Lindsay JO, Baert F, Atreya R, Vermeire S, Fujii T, Dubcenco E, Klaff J, Duncan B, Suravaram S, Fish I, Lacerda AP, Vladea R, Ford S, Shah S, Anyanwu SI, Rubin DT. Long-Term Safety of Upadacitinib in Patients With Inflammatory Bowel Disease: Integrated Analysis of Phase 2/3 Studies. Clin Gastroenterol Hepatol. 2026 Feb 27:S1542-3565(26)00145-X. doi: 10.1016/j.cgh.2026.02.018. Online ahead of print.

    PubMed 41763462

  • 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.

    PubMed 41264726

  • Dubinsky MC, D'Haens G, Dewit O, Juillerat P, Panaccione R, Fujii T, Dubcenco E, Lacerda AP, Anyanwu SI, Ford S, Cunneen C, Fish I, Joshi N, Garrison A, Loftus EV. Efficacy and Safety with Upadacitinib by Baseline Corticosteroid Use in Patients with Moderately to Severely Active Crohn's Disease. Inflamm Bowel Dis. 2026 Mar 1;32(3):498-511. doi: 10.1093/ibd/izaf250.

    PubMed 41189093

  • 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

  • Panaccione R, Regueiro M, Lee SD, Atreya R, Pedersen G, Broide E, Rodriguez C, van Bodegraven AA, Dubcenco E, Lacerda AP, Feng T, Geng Z, Wang T, van Haaren S, Anyanwu SI, Panes J. Upadacitinib Maintenance Therapy in Crohn's Disease: Final Results From the Randomized Phase 3 U-ENDURE Study. Clin Gastroenterol Hepatol. 2026 Mar;24(3):772-783. doi: 10.1016/j.cgh.2025.07.028. Epub 2025 Jul 28.

    PubMed 40738276

  • Loftus EV Jr, D'Haens G, Louis E, Regueiro M, Jairath V, Magro F, Nakase H, Dubcenco E, Lacerda AP, Ford S, Feng T, Duncan B, Fish I, Cunneen C, Anyanwu SI, Aponte F, Griffith J, Blumenstein I. Efficacy and safety of upadacitinib maintenance therapy in patients with moderately to severely active Crohn's disease: 2-year results from the U-ENDURE Long-Term Extension study. J Crohns Colitis. 2025 Sep 7;19(8):jjaf138. doi: 10.1093/ecco-jcc/jjaf138.

    PubMed 40704669

  • Colombel JF, Lacerda AP, Irving PM, Panaccione R, Reinisch W, Rieder F, Steinlauf A, Schwartz D, Feng T, Dubcenco E, Anyanwu SI, Laroux FS, Cunneen C, Powell N. Efficacy and Safety of Upadacitinib for Perianal Fistulizing Crohn's Disease: A Post Hoc Analysis of 3 Phase 3 Trials. Clin Gastroenterol Hepatol. 2025 May;23(6):1019-1029. doi: 10.1016/j.cgh.2024.08.032. Epub 2024 Sep 24.

    PubMed 39326583

  • Panes J, Louis E, Bossuyt P, Joshi N, Lee WJ, Lacerda AP, Kligys K, Xuan S, Shukla N, Loftus EV Jr. Induction of Endoscopic Response, Remission, and Ulcer-Free Endoscopy With Upadacitinib Is Associated With Improved Clinical Outcomes and Quality of Life in Patients With Crohn's Disease. Inflamm Bowel Dis. 2025 Feb 6;31(2):394-403. doi: 10.1093/ibd/izae200.

    PubMed 39231444

  • Bhatnagar S, Schlachter L, Eckert D, Stodtmann S, Liu W, Lacerda AP, Mohamed MF. Pharmacokinetics and Exposure-Response Analyses to Support Dose Selection of Upadacitinib in Crohn's Disease. Clin Pharmacol Ther. 2024 Nov;116(5):1240-1251. doi: 10.1002/cpt.3359. Epub 2024 Jul 9.

    PubMed 38982567

  • Ghosh S, Feagan BG, Parra RS, Lopes S, Steinlauf A, Kakuta Y, Joshi N, Lee WJ, Lacerda AP, Zhou Q, Xuan S, Kligys K, Shukla N, Louis E. Impact of Upadacitinib Induction and Maintenance Therapy on Health-related Quality of Life, Fatigue, and Work Productivity in Patients with Moderately-to-severely Active Crohn's Disease. J Crohns Colitis. 2024 Nov 4;18(11):1804-1818. doi: 10.1093/ecco-jcc/jjae083.

    PubMed 38835235

  • Peyrin-Biroulet L, Panaccione R, Louis E, Atreya R, Rubin DT, Lindsay JO, Siffledeen J, Lukin DJ, Wright J, Watanabe K, Ford S, Remple VP, Lacerda AP, Dubcenco E, Garrison A, Zhou Q, Berg S, Anyanwu SI, Schreiber S. Upadacitinib Achieves Clinical and Endoscopic Outcomes in Crohn's Disease Regardless of Prior Biologic Exposure. Clin Gastroenterol Hepatol. 2024 Oct;22(10):2096-2106. doi: 10.1016/j.cgh.2024.02.026. Epub 2024 Mar 15.

    PubMed 38492904

  • Colombel JF, Hisamatsu T, Atreya R, Bresso F, Thin L, Panaccione R, Parra RS, Ford S, Remple VP, Lacerda AP, Anyanwu SI, Mallick M, Garrison A, Regueiro M. Upadacitinib Reduces Crohn's Disease Symptoms Within the First Week of Induction Therapy. Clin Gastroenterol Hepatol. 2024 Aug;22(8):1668-1677. doi: 10.1016/j.cgh.2024.02.027. Epub 2024 Mar 15.

    PubMed 38492903

  • Loftus EV Jr, Panes J, Lacerda AP, Peyrin-Biroulet L, D'Haens G, Panaccione R, Reinisch W, Louis E, Chen M, Nakase H, Begun J, Boland BS, Phillips C, Mohamed MF, Liu J, Geng Z, Feng T, Dubcenco E, Colombel JF. Upadacitinib Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2023 May 25;388(21):1966-1980. doi: 10.1056/NEJMoa2212728.

    PubMed 37224198

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Upadacitinib in people with Crohn's Disease, run by AbbVie at 466 sites in 49 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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 466 sites in United States, Japan, Canada, France, China and 44 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) (time frame: Week 52). 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 NCT03345823, which also lists 13 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 9 Apr 2026.

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