AzTrials
AzTrials

Crohn's DiseasePhase 3U-EXCELNCT03345849

A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

A Phase 3 study testing Upadacitinib in people with Crohn's Disease, run by AbbVie at 432 sites in 49 countries.

Completed

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

Official record
Search all trials

Trial summary

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in adults with moderately and severely active Crohn's disease (CD). 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
526 participants
Where
432 sitesin 49 countries
Study dates
7 Dec 2017to 13 Jan 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

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

Who may be able to join

  • Confirmed diagnosis of CD for at least 3 months prior to Baseline.
  • Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.
  • Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.
  • Demonstrated an inadequate response or intolerance to one or more conventional and/or biologic therapies (oral locally acting steroids, intravenous or oral corticosteroids, immunosuppressants or biologic therapies for CD), in the opinion of the investigator.
  • Note: Participants who have had inadequate response or intolerance to conventional therapy who have received prior biologic may be enrolled; however, participants must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease).
  • If female, participant must meet the contraception recommendations.

Who cannot join

  • Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
  • Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX).
  • Participant with the following ongoing known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, > 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum, or any other manifestation that might require surgery while enrolled in the study.
  • Participant with ostomy or ileoanal pouch.
  • Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome.
  • Screening laboratory and other analyses show abnormal results.

Trial locations and contacts

432 sites in 49 countries.

432 sites in 49 countries

United States119 sites

  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 164943

    Ann Arbor, Michigan, 48109

  • TX Clinical Research Institute /ID# 164896

    Arlington, Texas, 76012

  • Johns Hopkins University School of Medicine /ID# 211941

    Baltimore, Maryland, 21287-0010

  • Inquest Clinical Research /ID# 164785

    Baytown, Texas, 77521-2415

  • Washington Gastroenterology /ID# 164824

    Bellevue, Washington, 98004

  • Treasure Valley Medical Research /ID# 215032

    Boise, Idaho, 83706

  • HP Clinical Research /ID# 164933

    Bountiful, Utah, 84010

  • NY Scientific /ID# 164931

    Brooklyn, New York, 11235

  • Lahey Hospital and Medical Center /ID# 214726

    Burlington, Massachusetts, 01805

  • Texas Digestive Disease Consultants /ID# 209953

    Cedar Park, Texas, 78613-5028

  • Texas Digestive Disease Consultants /ID# 209801

    Cedar Park, Texas, 78613

  • Delsol Research Management, Ll /Id# 170145

    Chandler, Arizona, 85224

  • Pharmacorp Clinical Trials /ID# 164916

    Charleston, South Carolina, 29412

  • Atrium Health Carolinas Medical Center /ID# 164932

    Charlotte, North Carolina, 28203

  • PMG Research of Charlotte /ID# 171160

    Charlotte, North Carolina, 28209

  • MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164935

    Chevy Chase, Maryland, 20815

  • Rush University Medical Center /ID# 165497

    Chicago, Illinois, 60612

  • University of Chicago Medicine /ID# 165503

    Chicago, Illinois, 60637-1426

  • Gastro Health Research /ID# 164791

    Cincinnati, Ohio, 45219

  • University of Cincinnati /ID# 164825

    Cincinnati, Ohio, 45267-0585

  • Clinical Research of West Florida, Inc /ID# 205827

    Clearwater, Florida, 33765

  • Clinical Research of West Florida, Inc /ID# 208118

    Clearwater, Florida, 33765

  • Cleveland Clinic Main Campus /ID# 209231

    Cleveland, Ohio, 44195

  • Peak Gastroenterology Associates, PC /ID# 170143

    Colorado Springs, Colorado, 80907

  • Delta Waves, Inc. /ID# 164776

    Colorado Springs, Colorado, 80918

  • Gastro Center of Maryland /ID# 171161

    Columbia, Maryland, 21045

  • The Ohio State University /ID# 170141

    Columbus, Ohio, 43210

  • Optimed Research, Ltd. /ID# 205624

    Columbus, Ohio, 43235

  • Advanced Research - Coral Springs /ID# 218021

    Coral Springs, Florida, 33067-3173

  • Southern California Res. Ctr. /ID# 169655

    Coronado, California, 92118-1408

  • Citrus Valley Gastroenterology /ID# 166173

    Covina, California, 91722-3797

  • Tri-State Gastroenterology /ID# 165496

    Crestview Hills, Kentucky, 41017

  • Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 170144

    Dallas, Texas, 75246

  • Hometown Urgent Care and Resea /ID# 201291

    Dayton, Ohio, 45424

  • DuPage Medical Group /ID# 205328

    Downers Grove, Illinois, 60515-5509

  • AGA Clinical Research Associates, LLC /ID# 164769

    Egg Harbor, New Jersey, 08234

  • Dayton Gastroenterology, Inc. /ID# 167627

    Englewood, Ohio, 45415

  • MediSphere Medical Research Center /ID# 166175

    Evansville, Indiana, 47714-8011

  • Plains Clinical Research Center, LLC /ID# 170140

    Fargo, North Dakota, 58104-5925

  • Digestive Health Associates (DHA) - Farmington Hills /ID# 205793

    Farmington Hills, Michigan, 48334-3230

  • Gastro One /ID# 164826

    Germantown, Tennessee, 38138

  • Gastroenterology Associates, P.A. of Greenville /ID# 164771

    Greenville, South Carolina, 29615-3593

  • Medical Research Center of CT /ID# 164926

    Hamden, Connecticut, 06518

  • CroNOLA, LLC /ID# 164823

    Houma, Louisiana, 70360

  • CliniCore International, LLC /ID# 164902

    Houston, Texas, 77027-6812

  • Baylor College of Medicine - Baylor Medical Center /ID# 164947

    Houston, Texas, 77030-3411

  • Centex Studies, Inc. - Houston /ID# 201214

    Houston, Texas, 77058

  • GI Specialists of Houston /ID# 202339

    Houston, Texas, 77070-4347

  • Indianapolis Gastroenterology /ID# 164938

    Indianapolis, Indiana, 46237

  • University of Iowa Hospitals and Clinics /ID# 165436

    Iowa City, Iowa, 52242

  • Hoag Memorial Hosp Presbyterian /ID# 222540

    Irvine, California, 92618

  • Southern Therapy and Advanced Research (STAR) LLC /ID# 165343

    Jackson, Mississippi, 39216

  • Encore Borland-Groover Clinical Research /Id# 203499

    Jacksonville, Florida, 32256

  • United Health Services Hospitals, Inc /ID# 217485

    Johnson City, New York, 13790-2107

  • East Tennessee Research Institute /ID# 203613

    Johnson City, Tennessee, 37604

  • NYU Langone Long Island Clinical Research Associates /ID# 164927

    Lake Success, New York, 11042

  • Las Vegas Medical Research /ID# 168588

    Las Vegas, Nevada, 89113

  • United Medical Doctors /ID# 207449

    Los Alamitos, California, 90720-3309

  • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164762

    Los Angeles, California, 90067-2001

  • University of Louisville /ID# 165366

    Louisville, Kentucky, 40202

  • University of Louisville /ID# 168572

    Louisville, Kentucky, 40202

  • Caprock Gastro Research, LLC /ID# 215438

    Lubbock, Texas, 79424-3017

  • Gastroenterology Associates of Central Georgia, LLC /ID# 165478

    Macon, Georgia, 31201

  • Ctr for Advanced Gastroenterol /ID# 165353

    Maitland, Florida, 32751-6108

  • Great Lakes Medical Research, LLC /ID# 202010

    Mentor, Ohio, 44060-6211

  • Crystal Pharmacology Research /ID# 166081

    Miami, Florida, 33165

  • Coral Research Clinic /ID# 164890

    Miami, Florida, 33186-4643

  • Facey Medical Foundation /ID# 203136

    Mission Hills, California, 91345

  • East View Medical Research, LLC /ID# 171176

    Mobile, Alabama, 36606

  • CB Flock Research Corporation /ID# 166185

    Mobile, Alabama, 36608

  • United Medical Doctors - Murrieta /ID# 164945

    Murrieta, California, 92563

  • Quality Medical Research /ID# 205263

    Nashville, Tennessee, 37211

  • Vanderbilt University Medical Center /ID# 164946

    Nashville, Tennessee, 37232-0011

  • Rutgers Robert Wood Johnson /ID# 166073

    New Brunswick, New Jersey, 08901

  • Nola Research Works, LLC /ID# 164759

    New Orleans, Louisiana, 70115

  • Advanced Research Institute, Inc /ID# 164921

    New Port Richey, Florida, 34653

  • The Mount Sinai Hospital /ID# 170257

    New York, New York, 10029

  • Columbia Univ Medical Center /ID# 164782

    New York, New York, 10032-3725

  • Advanced Research Institute /ID# 164784

    Ogden, Utah, 84403

  • Digestive Disease Specialists /ID# 201064

    Oklahoma City, Oklahoma, 73112

  • Quality Clinical Research Inc. /ID# 170137

    Omaha, Nebraska, 68114-3723

  • Duplicate_CHI Nebraska d/b/a CHI Health /ID# 168578

    Omaha, Nebraska, 68124

  • Endoscopic Research, Inc. /ID# 206136

    Orlando, Florida, 32803

  • Omega Research Maitland, LLC /ID# 203481

    Orlando, Florida, 32808

  • University of Pennsylvania /ID# 168430

    Philadelphia, Pennsylvania, 19104-5502

  • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164904

    Raleigh, North Carolina, 27612

  • Rapid City Medical Center - GI Research /ID# 201735

    Rapid City, South Dakota, 57701

  • Mayo Clinic - Rochester /ID# 164783

    Rochester, Minnesota, 55905-0001

  • Gastoenterology Group of Rochester /ID# 166177

    Rochester, New York, 14618-5703

  • Gastroenterology Consultants PC - Roswell /ID# 218220

    Roswell, Georgia, 30076-4913

  • Duplicate_Care Access Research /ID# 164794

    Salt Lake City, Utah, 84124-1377

  • Clinical Associates in Research Therapeutics of America, LLC /ID# 164786

    San Antonio, Texas, 78212

  • Southern Star Research Institute, LLC /ID# 169755

    San Antonio, Texas, 78229-5390

  • Ucsd /Id# 164910

    San Diego, California, 92103

  • Medical Assoc Research Grp /ID# 169706

    San Diego, California, 92123

  • Univ of California San Francis /ID# 164944

    San Francisco, California, 94158

  • Care Access Research /ID# 167767

    San Pablo, California, 94806

  • HonorHealth Research Institute - Shea /ID# 164821

    Scottsdale, Arizona, 85258

  • Virginia Mason Medical Center /ID# 164913

    Seattle, Washington, 98101

  • Louisana Research Center, LLC /ID# 164894

    Shreveport, Louisiana, 71105-6800

  • Richmond University Medical Center /ID# 201857

    Staten Island, New York, 10310-1664

  • Carl R. Meisner Medical Clinic /ID# 201061

    Sugar Land, Texas, 77478

  • Arizona Arthritis & Rheumatology Research, PLLC /ID# 164803

    Sun City, Arizona, 85306

  • Atlanta Gastroenterology Spec /ID# 164799

    Suwanee, Georgia, 30024

  • Clinical Research Trials of Florida, Inc. /ID# 203485

    Tampa, Florida, 33607

  • AdventHealth Tampa /ID# 171167

    Tampa, Florida, 33613-4680

  • Montefiore Medical Center - Moses Campus /ID# 166193

    The Bronx, New York, 10467

  • Advantage Clinical Trials /ID# 168546

    The Bronx, New York, 10468

  • Center for Digestive Health /ID# 164822

    Troy, Michigan, 48098-6363

  • Clin Res Inst of Michigan, LLC /ID# 170133

    Troy, Michigan, 48098

  • Options Health Research, LLC /ID# 164820

    Tulsa, Oklahoma, 74104

  • Healthcare Research Consultant /ID# 166195

    Tulsa, Oklahoma, 74135

  • Tyler Research Institute, LLC /ID# 168687

    Tyler, Texas, 75701-4464

  • The Vancouver Clinic, INC. PS /ID# 164918

    Vancouver, Washington, 98664

  • Gastro Health & Nutrition - Victoria /ID# 167812

    Victoria, Texas, 77904

  • Allegiance Research Specialists /ID# 165346

    Wauwatosa, Wisconsin, 53226

  • Velocity Clinical Research - Salt Lake City /ID# 166076

    West Jordan, Utah, 84088

  • Western States Clinical Res /ID# 164760

    Wheat Ridge, Colorado, 80033-2896

  • Wake Forest Baptist Medical Center /ID# 164908

    Winston-Salem, North Carolina, 27157-0001

Other trials in United States

Japan50 sites

  • Asahikawa Medical University Hospital /ID# 167120

    Asahikawa-shi, Hokkaido, 078-8510

  • Tokyo Medical And Dental University Hospital /ID# 165965

    Bunkyo-ku, Tokyo, 113-8519

  • Fukuoka University Chikushi Hospital /ID# 214404

    Chikushino-shi, Fukuoka, 818-8502

  • NHO Fukuyama Medical Center /ID# 167131

    Fukuyama-shi, Hiroshima, 720-8520

  • Tokai University Hachioji Hospital /ID# 165967

    Hachioji-shi, Tokyo, 192-0032

  • Hamamatsu University Hospital /ID# 224352

    Hamamatsu, Shizuoka, 431-3192

  • National Hospital Organization Hirosaki General Medical Center /ID# 165961

    Hirosaki-shi, Aomori, 036-8545

  • Hiroshima University Hospital /ID# 166014

    Hiroshima, Hiroshima, 734-8551

  • Imamura General Hospital /ID# 227137

    Kagoshima, Kagoshima-ken, 890-0064

  • Idzuro Imamura Hospital /ID# 206654

    Kagoshima, Kagoshima-ken, 892-0824

  • Sameshima Hospital /ID# 206675

    Kagoshima, Kagoshima-ken, 892-0846

  • Kanazawa University Hospital /ID# 169218

    Kanazawa, Ishikawa-ken, 920-8641

  • Nara Medical University Hospital /ID# 169219

    Kashihara-shi, Nara, 634-8522

  • Aoyama Clinic /ID# 166009

    Kobe, Hyōgo, 650-0015

  • Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 166010

    Kurashiki-shi, Okayama-ken, 710-0142

  • Kurume University Hospital /ID# 166012

    Kurume-shi, Fukuoka, 830-0011

  • Japanese Red Cross Kyoto Daiichi Hosital /ID# 165972

    Kyoto, Kyoto, 605-0981

  • Kyoto University Hospital /ID# 169889

    Kyoto, Kyoto, 606-8507

  • The Jikei University Hospital /ID# 167130

    Minato-ku, Tokyo, 105-8471

  • Kyorin University Hospital /ID# 165966

    Mitaka-shi, Tokyo, 181-8611

  • Iwate Medical University Uchimaru Medical Center /ID# 202464

    Morioka, Iwate, 020-8505

  • Aichi Medical University Hospital /ID# 165971

    Nagakute-shi, Aichi-ken, 480-1195

  • Nagoya University Hospital /ID# 165969

    Nagoya, Aichi-ken, 4668560

  • Nagoya City University Hospital /ID# 165970

    Nagoya, Aichi-ken, 467-8602

  • Niigata University Medical & Dental Hospital /ID# 170045

    Niigata, Niigata, 951-8520

  • Hyogo College of Medicine College Hospital /Id# 165973

    Nishinomiya-shi, Hyōgo, 663-8501

  • Ishida Clinic of IBD and Gastroenterology /ID# 167121

    Ōita, Oita Prefecture, 870-0823

  • Okayama University Hospital /ID# 167356

    Okayama, Okayama-ken, 700-8558

  • Kinshukai Infusion Clinic /ID# 218872

    Osaka, Osaka, 530-0011

  • Osaka Metropolitan University Hospital /ID# 166015

    Osaka, Osaka, 545-8586

  • Shiga University of Medical Science Hospital /ID# 167129

    Ōtsu, Shiga, 520-2192

  • Tokitokai Tokito clinic /ID# 165962

    Saitama-shi, Saitama, 336-0963

  • Toho University Sakura Medical Center /ID# 165963

    Sakura-shi, Chiba, 285-8741

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165960

    Sapporo, Hokkaido, 060-0033

  • Sapporo Medical University Hospital /ID# 167124

    Sapporo, Hokkaido, 060-8543

  • Sapporo IBD Clinic /ID# 223561

    Sapporo, Hokkaido, 064-0919

  • Tohoku University Hospital /ID# 167122

    Sendai, Miyagi, 9808574

  • Tokyo Women's Medical University Hospital /ID# 205980

    Shinjuku-ku, Tokyo, 162-8666

  • Osaka University Hospital /ID# 169663

    Suita-shi, Osaka, 565-0871

  • NHO Shizuoka Medical Center /ID# 167125

    Sunto-gun, Shizuoka, 411-8611

  • National Hospital Organization Takasaki General Medical Center /ID# 167127

    Takasaki-shi, Gunma, 370-0829

  • Osaka Medical and Pharmaceutical University Hospital /ID# 206326

    Takatsuki-shi, Osaka, 569-8686

  • Toyama Prefectural Central Hospital /ID# 217834

    Toyama, Toyama, 930-8550

  • Toyohashi Municipal Hospital /ID# 200175

    Toyohashi, Aichi-ken, 441-8570

  • Japanese Red Cross Wakayama Medical Center /ID# 200643

    Wakayama, Wakayama, 640-8558

  • Wakayama Medical University Hospital /ID# 169482

    Wakayama, Wakayama, 641-8510

  • Yamagata University Hospital /ID# 200157

    Yamagata, Yamagata, 990-9585

  • Kenseikai Dongo Hospital /ID# 208104

    Yamatotakada-shi, Nara, 635-0022

  • Yokkaichi Hazu Medical Center /ID# 167196

    Yokkaichi-shi, Mie-ken, 510-0016

  • Yokohama City University Medical Center /ID# 167128

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

Canada17 sites

  • University of Calgary /ID# 166974

    Calgary, Alberta, T2N 4Z6

  • Allen Whey Khye Lim Professional Corporation /ID# 168044

    Edmonton, Alberta, T5R 1W2

  • University of Alberta - Zeidler Ledcor Centre /ID# 166971

    Edmonton, Alberta, T6G 2X8

  • South Edmonton Gastroenterology Research Clinic /ID# 166978

    Edmonton, Alberta, T6K 4B2

  • Medicor Research Inc /ID# 166979

    Greater Sudbury, Ontario, P3A 1W8

  • QEII - Health Sciences Centre /ID# 169307

    Halifax, Nova Scotia, B3H 2Y9

  • CISSS de Chaudière-Appalaches, Hôpital Hotel-Dieu de Lévis /ID# 166969

    Lévis, Quebec, G6V 3Z1

  • London Health Sciences Center /ID# 221038

    London, Ontario, N6A 5W9

  • Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 170120

    Montreal, Quebec, H2X 0A9

  • Royal Victoria Hospital / McGill University Health Centre /ID# 170119

    Montreal, Quebec, H4A 3J1

  • Fraser Clinical Trials Inc /ID# 166968

    New Westminster, British Columbia, V3L 3W4

  • Scott Shulman Medicine Professional Corporation /ID# 169066

    North Bay, Ontario, P1B 2H3

  • Taunton Surgical Centre /ID# 168043

    Oshawa, Ontario, L1H 7K4

  • Ottawa Hospital Research Institute /ID# 212414

    Ottawa, Ontario, K1H 8L6

  • CIUSSS de l'Estrie - CHUS /ID# 170940

    Sherbrooke, Quebec, J1G 2E8

  • GIRI Gastrointestinal Research Institute /ID# 166975

    Vancouver, British Columbia, V6Z 2K5

  • Toronto Digestive Disease Asso /ID# 166972

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

China15 sites

  • Beijing Friendship Hospital /ID# 204173

    Beijing, 100032

  • The First Hospital of Jilin University /ID# 206868

    Changchun, Jilin, 130021

  • The Second Xiangya Hospital of Central South University /ID# 204082

    Changsha, 410011

  • The First Affiliated Hospital, Sun Yat-sen University /ID# 205228

    Guangzhou, Guangdong, 510080

  • Nanfang Hospital of Southern Medical University /ID# 204083

    Guangzhou, Guangdong, 510515

  • The Sixth Affiliated Hosp Sun /ID# 204077

    Guangzhou, Guangdong, 510655

  • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 204073

    Hangzhou, Zhejiang, 310009

  • Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204076

    Hangzhou, Zhejiang, 310018

  • The First Affiliated Hospital of Nanchang University /ID# 204092

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital /ID# 204900

    Nanjing, Jiangsu, 210008

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204091

    Shanghai, Shanghai Municipality, 200065

  • Duplicate_Tianjin Med Univ General Hosp /ID# 206994

    Tianjin, 300052

  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204081

    Wuhan, Hubei, 430022

  • Tongji Hospital Tongji Medical College of HUST /ID# 204088

    Wuhan, 430030

  • Zhongshan Hospital Xiamen University /ID# 204984

    Xiamen, Fujian, 361004

Other trials in China

Italy14 sites

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 168187

    Bologna, 40138

  • A.O. Per L'Emergenza Cannizzaro /ID# 168190

    Catania, 95126

  • Policlinico San Martino/Univer /ID# 168191

    Genova, 16132

  • ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168181

    Milan, 20121

  • ASST Grande Ospedale Metropolitano Niguarda /ID# 170849

    Milan, 20162

  • Azienda Ospedaliero-Universitaria di Modena /ID# 201897

    Modena, 41124

  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168186

    Negrar, Verona, 37024

  • A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168189

    Palermo, 90146

  • Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202421

    Pisa, 56125

  • Policlinico Universitario Campus Bio-Medico /ID# 168183

    Rome, Lazio, 00128

  • Azienda Ospedaliera San Camillo Forlanini /ID# 168184

    Rome, Lazio, 00152

  • Fondazione PTV Policlinico Tor Vergata /ID# 168188

    Rome, Roma, 00133

  • Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 168182

    Rome, Roma, 00168

  • Istituto Clinico Humanitas /ID# 168185

    Rozzano, Milano, 20089

Other trials in Italy

Russia12 sites

  • Immanuel Kant Baltic Federal University /ID# 203811

    Kaliningrad, Kaliningrad Oblast, 236016

  • Kazan State Medical University /ID# 169638

    Kazan', Tatarstan, Respublika, 420012

  • Olla-Med Clinic /ID# 208720

    Moscow, 105554

  • P.A. Bayandin Murmansk Regiona /ID# 169639

    Murmansk, 183047

  • LLC Medical Center /ID# 209236

    Novosibirsk, Novosibirsk Oblast, 630099

  • Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202990

    Perm, Permskiy Kray, 614109

  • Republican hospital named after V.A. Baranov /ID# 206488

    Petrozavodsk, 185019

  • Euromedservice /ID# 206610

    Pushkin, 196603

  • LLC Novaya Klinika /ID# 206616

    Pyatigorsk, Stavropol Kray, 357500

  • X7 Clinical Research Center /ID# 216350

    Saint Petersburg, 194156

  • City Clinical Hospital No. 31 /ID# 208868

    Saint Petersburg, 197110

  • Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202997

    Stavropol, Stavropol Kray, 355012

Other trials in Russia

United Kingdom12 sites

  • Royal United Hospitals Bath /ID# 169074

    Bath, BA1 3NG

  • South Eastern Health and Social Care Trust /ID# 205323

    Belfast, Antrim, BT16 1RH

  • University Hospitals Birmingham NHS Foundation Trust /ID# 169070

    Birmingham, B15 2TH

  • The Dudley Group NHS Foundation Trust /ID# 169069

    Dudley, DY1 2HQ

  • King's College Hospital NHS Foundation Trust /ID# 169072

    London, SE5 9RS

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169075

    Newcastle upon Tyne, NE7 7DN

  • Stockport NHS foundation trust /ID# 208719

    Stockport, SK2 7JE

  • Taunton and Somerset NHS Foundation Trust /ID# 209665

    Taunton, TA1 5DA

  • St George's University Hospitals NHS Foundation Trust /ID# 205552

    Tooting, SW17 0QT

  • Warrington and Halton Hospitals NHS Foundation Trust /ID# 171383

    Warrington, Cheshire West And Chester, WA5 1QG

  • Warrington and Halton Hospitals NHS Foundation Trust /ID# 209086

    Warrington, Cheshire West And Chester, WA5 1QG

  • The Royal Wolverhampton NHS Trust /ID# 171382

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Germany11 sites

  • Gastroenterologie am Mexikoplatz /ID# 203575

    Berlin, 14163

  • Universitaetsklinikum Erlangen /ID# 203552

    Erlangen, Bavaria, 91054

  • Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203570

    Essen, 45239

  • Universitaetsklinikum Frankfurt /ID# 203566

    Frankfurt am Main, Hesse, 60590

  • Agaplesion Markus Krankenhaus /ID# 168758

    Frankfurt am Main, 60431

  • Universitaetsklinikum Halle (Saale) /ID# 207455

    Halle, 06120

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168757

    Kiel, Schleswig-Holstein, 24105

  • Universitatsklinikum Mannheim /ID# 168759

    Mannheim, Baden-Wurttemberg, 68167

  • Medizinisches Versorgungszentrum Portal 10 /ID# 200214

    Münster, 48155

  • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206741

    Saarbrücken, Saarland, 66111

  • Universitaetsklinikum Ulm /ID# 203560

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Hungary11 sites

  • Obudai Egeszsegugyi Centrum Kft. /ID# 201892

    Budapest, Pest County, 1036

  • Semmelweis Egyetem /ID# 210167

    Budapest, 1085

  • Magyar Honvedseg Egeszsegugyi Kozpont /ID# 201724

    Budapest, 1134

  • Debreceni Egyetem Klinikai Kozpont /ID# 216419

    Debrecen, Hajdú-Bihar, 4032

  • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 201723

    Debrecen, 4031

  • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205547

    Encs, Borsod-Abauj Zemplen county, 3860

  • Bugat Pal Korhaz /ID# 201893

    Gyöngyös, Heves County, 3200

  • Pest Megyei Flor Ferenc Korhaz /ID# 206154

    Kistarcsa, 2143

  • Mohacsi Korhaz /ID# 209441

    Mohács, Baranya, 7700

  • Mentahaz Maganorvosi Kozpont /ID# 201895

    Székesfehérvár, 8000

  • Szent Borbala Korhaz /ID# 209897

    Tatabánya, Komárom-Esztergom, 2800

Other trials in Hungary

Spain11 sites

  • Hospital Universitario A Coruna - CHUAC /ID# 203910

    A Coruña, 15006

  • Hospital Clinic de Barcelona /ID# 201990

    Barcelona, 08036

  • Hospital Universitario de Girona Doctor Josep Trueta /ID# 202645

    Girona, 17007

  • Hospital Juan Ramon Jimenez /ID# 201995

    Huelva, 21005

  • Hospital Universitario La Paz /ID# 201994

    Madrid, 28046

  • Hospital Universitari Son Espases /ID# 201998

    Palma de Mallorca, Balearic Islands, 07120

  • Hospital Universitario de Navarra /ID# 202355

    Pamplona, Navarre, 31008

  • Hospital Universitario de Salamanca /ID# 206358

    Salamanca, 37711

  • Hospital Universitario Virgen Macarena /ID# 201993

    Seville, 41009

  • Hospital Clinico Universitario de Valencia /ID# 209657

    Valencia, 46010

  • Hospital Universitario y Politecnico La Fe /ID# 201992

    Valencia, 46026

Other trials in Spain

South Korea10 sites

  • Inje University Haeundae Hospital /ID# 202630

    Busan, 48108

  • Dong-A University Hospital /ID# 167591

    Busan, 49201

  • Pusan National University Hospital /ID# 167589

    Busan, 49241

  • Kyungpook National University Hospital /ID# 207019

    Daegu, 41944

  • Hayang University GuriHospital /ID# 167587

    Guri-si, Gyeonggido, 11923

  • CHA University Bundang Medical Center /ID# 167592

    Seongnam-si, Gyeonggido, 13496

  • Kangbuk Samsung Hospital /ID# 167586

    Seoul, Seoul Teugbyeolsi, 03181

  • Yonsei University Health System Severance Hospital /ID# 167590

    Seoul, Seoul Teugbyeolsi, 03722

  • Samsung Medical Center /ID# 167588

    Seoul, 06351

  • Chung-Ang University Hostipal /ID# 207018

    Seoul, 06973

Other trials in South Korea

Turkey (Türkiye)10 sites

  • Ankara Univ Medical Faculty /ID# 206409

    Ankara, 06590

  • Inonu Universitesi Turgut Ozal /ID# 201268

    Battalgazi/malatya, 44280

  • Mustafa Kemal University Medic /ID# 171336

    Hatay, 31001

  • Istanbul University Istanbul Medical Faculty /ID# 171364

    Istanbul, 34093

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171332

    Istanbul, 34899

  • Acibadem Kozyatagi Hospital /ID# 209406

    Kadıköy, Istanbul, 34742

  • Erciyes University Medical Fac /ID# 171331

    Melikgazi, Kayseri, 38030

  • Mersin University Medical /ID# 171338

    Mersin, 33343

  • Sisli Etfal Train & Res Hosp /ID# 171334

    Şişli, 34371

  • Gazi Universitesi Tip Fakultes /ID# 217444

    Yenimahalle, 06560

Other trials in Turkey (Türkiye)

Brazil7 sites

  • Upeclin Fmb - Unesp /Id# 166867

    Botucatu, São Paulo, 18618-686

  • Hospital Nossa Senhora das Graças /ID# 166863

    Curitiba, Paraná, 80810-040

  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166852

    Goiânia, Goiás, 74535-170

  • Hospital de Clinicas de Porto Alegre /ID# 166862

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 166866

    Ribeirão Preto, São Paulo, 14051-140

  • Faculdade de Medicina do ABC /ID# 208323

    Santo André, São Paulo, 09060-870

  • Kaiser Clinica e Hospital Dia /ID# 166865

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

Other trials in Brazil

Argentina6 sites

  • Hospital Italiano de Buenos Aires /ID# 215541

    Ciudad Autonoma Buenos Aires, Ciuadad Autonoma de Buenos Aires, 1199

  • Gedyt /ID# 210020

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

  • Cemic /Id# 169182

    Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1431

  • Hospital Privado Univesitario /ID# 169230

    Córdoba, 5016

  • Hospital Provincial del Centenario /ID# 171252

    Rosario, Santa Fe Province, 2000

  • Cardio Alem /ID# 211285

    San Isidro, Buenos Aires, 1642

Other trials in Argentina

Australia6 sites

  • Royal Adelaide Hospital /ID# 171514

    Adelaide, South Australia, 5000

  • Box Hill Hospital /ID# 203736

    Box Hill, Victoria, 3128

  • Concord Repatriation General Hospital /ID# 171512

    Concord, New South Wales, 2139

  • Fiona Stanley Hospital /ID# 171513

    Murdoch, Western Australia, 6150

  • Coral Sea Clinical Research institute /ID# 212988

    North Mackay, Queensland, 4740

  • Mater Misericordiae Limited /ID# 204909

    South Brisbane, Queensland, 4101

Other trials in Australia

Croatia6 sites

  • UHC Split /ID# 171191

    Split, 21000

  • Zadar General Hospital /ID# 205536

    Zadar, 23000

  • Clinical Hospital Dubrava /ID# 171185

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Sestre milosrdnice /ID# 205535

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 171203

    Zagreb, City of Zagreb, 10000

  • Poliklinika Solmed /ID# 211519

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Egypt6 sites

  • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171012

    Alexandria, 21131

  • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171013

    Alexandria, 21131

  • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 209564

    Alexandria, 21131

  • National Hepatology and Tropical Medicine Research Institute /ID# 170989

    Cairo, 11559

  • Air Force Specialized Hospital /ID# 170996

    Cairo

  • National Liver Institute /ID# 170988

    Menoufiya, 35111

Other trials in Egypt

Israel6 sites

  • Assaf Harofeh Medical Center /ID# 204872

    Be’er Ya‘aqov, 70300

  • Soroka University Medical Center /ID# 169913

    Beersheba, Southern District, 8443901

  • Hadassah Medical Center-Hebrew University /ID# 169928

    Jerusalem, 91120

  • Rabin Medical Center /ID# 202636

    Petah Tikva, 4941492

  • Kaplan Medical Center /ID# 170276

    Rehovot, 7661041

  • Tel Aviv Sourasky Medical Center /ID# 204877

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Serbia6 sites

  • Clinical Hosp Center Zvezdara /ID# 168214

    Belgrade, Beograd, 11000

  • Military Medical Academy /ID# 168783

    Belgrade, Beograd, 11000

  • University Clinical Center Serbia /ID# 168215

    Belgrade, Beograd, 11000

  • Clin Hosp Ctr Bezanijska Kosa /ID# 168750

    Belgrade, Beograd, 11080

  • University Clinical Center Kragujevac /ID# 205859

    Kragujevac, Sumadijski Okrug, 34000

  • Clinical Center Vojvodina /ID# 168213

    Novi Sad, Vojvodina, 21000

Other trials in Serbia

South Africa6 sites

  • Farmovs (Pty) Ltd /Id# 207535

    Bloemfontein, Free State, 9301

  • Allergy & Immunology (AIU) /ID# 171431

    Cape Town, Western Cape, 7700

  • Dr JP Wright /ID# 170887

    Cape Town, Western Cape, 7708

  • Private Practice Dr MN Rajabally /ID# 169853

    Cape Town, Western Cape, 7800

  • Lenasia Clinical Trial Centre /ID# 205145

    Johannesburg, Gauteng, 1820

  • Wits Clinical Research Site /ID# 170852

    Johannesburg, Gauteng, 2193

Other trials in South Africa

Ukraine6 sites

  • Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 167907

    Kharkiv, 61037

  • Medical Centre of "Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV" /ID# 203738

    Kyiv, Kyivska Oblast, 01030

  • Kyiv Municipal Clinical Hospital #18 /ID# 207889

    Kyiv, 01030

  • MNI KRC Kyiv Regional Clinical Hospital /ID# 202454

    Kyiv, 04107

  • Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 167908

    Lviv, 79000

  • CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 222110

    Vinnytsia, 21028

Other trials in Ukraine

Chile5 sites

  • Hospital Guillermo Grant Benavente de Concepción /ID# 212423

    Concepción, 4070038

  • CTR Estudios Clinicos /ID# 203941

    Providencia, 7500571

  • M y F Estudios Clínicos /ID# 169984

    Santiago, Region Metropolitana Santiago, 7750495

  • Research Group /ID# 203179

    Santiago, Santiago Metropolitan, 2540364

  • Hospital Clinico Universidad De Los Andes /ID# 207466

    Santiago, 7501504

Other trials in Chile

Greece5 sites

  • General Hospital of Athens Ippokratio /ID# 167045

    Athens, Attica, 11527

  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202104

    Athens, Attica, 11527

  • University General Hospital of Heraklion PA.G.N.I /ID# 167044

    Heraklion, Crete, 71500

  • Tzaneio general hospital of Piraeus /ID# 206433

    Piraeus, Attica, 18536

  • General Hospital of Thessaloniki Hippokrateio /ID# 208825

    Thessaloniki, 54642

Other trials in Greece

Netherlands5 sites

  • Onze Lieve Vrouwe Gasthuis /ID# 166929

    Amsterdam, 1091 AC

  • Academisch Medisch Centrum /ID# 166927

    Amsterdam, 1105 AZ

  • Medisch Spectrum Twente /ID# 170298

    Enschede, 7512 KZ

  • Zuyderland Medisch Centrum /ID# 169700

    Heerlen, Limburg, 6419 PC

  • Radboud Universitair Medisch Centrum /ID# 166928

    Nijmegen, Gelderland, 6525 GA

Other trials in Netherlands

Poland5 sites

  • Malopolskie Centrum Kliniczne /ID# 202167

    Krakow, Lesser Poland Voivodeship, 30-149

  • Centrum Zdrowia MDM /ID# 200491

    Warsaw, Masovian Voivodeship, 00-635

  • WIP Warsaw IBD Point Profesor Kierkus /ID# 224301

    Warsaw, Masovian Voivodeship, 00-728

  • Centrum Medyczne Reuma Park /ID# 200490

    Warsaw, Masovian Voivodeship, 02-665

  • Vistamed /ID# 208572

    Wroclaw, Lower Silesian Voivodeship, 53-149

Other trials in Poland

Portugal5 sites

  • Hospital Garcia de Orta, EPE /ID# 170241

    Almada, 2805-267

  • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170245

    Guimarães, Braga District, 4835-044

  • Hospital Egas Moniz /ID# 170253

    Lisbon, Porto District, 1349-019

  • Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 200607

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

  • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170248

    Porto, 4200-319

Other trials in Portugal

Sweden5 sites

  • Alingsas lasarett /ID# 170826

    Alingsås, Västra Götaland County, 441 33

  • Sodra Alvsborgs sjukhus /ID# 203077

    Borås, Västra Götaland County, 501 82

  • Sahlgrenska University Hospital /ID# 169171

    Gothenburg, Västra Götaland County, 413 46

  • Hallands Hospital Halmstad /ID# 170828

    Halmstad, Halland County, 302 33

  • Karolinska University Hospital Solna /ID# 224488

    Solna, Stockholm County, 171 64

Other trials in Sweden

Bosnia and Herzegovina4 sites

  • University Clinical Centre of the Republic of Srpska /ID# 208051

    Banja Luka, Republika Srpska, 78000

  • Clinical Center University of Sarajevo /ID# 203887

    Sarajevo, 71000

  • Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217842

    Sarajevo, 71000

  • University Clinical Center Tuzla /ID# 210325

    Tuzla, Tuzlanski, 75000

Other trials in Bosnia and Herzegovina

Czechia4 sites

  • Nemocnice Ceske Budejovice a.s. /ID# 224389

    České Budějovice, 370 01

  • Hepato-Gastroenterologie HK, s.r.o. /ID# 171401

    Hradec Králové, 500 12

  • ARTROSCAN s.r.o. /ID# 200790

    Ostrava, 722 00

  • ResTrial s.r.o. /ID# 208653

    Prague, 143 00

Other trials in Czechia

Denmark4 sites

  • Herlev Hospital /ID# 202423

    Herlev, Capital Region, 2730

  • Nordsjaellands Hospital /ID# 202424

    Hilleroed, Capital Region, 3600

  • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 202425

    Hvidovre, Capital Region, 2650

  • Duplicate_Sjaellands Universitets Hospital /ID# 209445

    Roskilde, Region Sjælland, 4000

Other trials in Denmark

Belgium3 sites

  • AZ Sint-Lucas /ID# 200302

    Ghent, 9000

  • CHU de Liege Sart Tilman /ID# 217534

    Liège, Liege, 4000

  • UCL Saint-Luc /ID# 200303

    Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

Bulgaria3 sites

  • UMHAT Kaspela EOOD /ID# 167613

    Plovdiv, 4001

  • Duplicate_Second MHAT Sofia /ID# 167614

    Sofia, 1202

  • MHAT Trakia /ID# 201679

    Stara Zagora, 6004

Other trials in Bulgaria

France3 sites

  • CHU Grenoble - Hopital Michallon /ID# 219034

    La Tronche, 38700

  • Clinique Jules Verne /ID# 219073

    Nantes, 44300

  • CH Valenciennes /ID# 219035

    Valenciennes, 59300

Other trials in France

Latvia3 sites

  • VCA Polyclinic Aura /ID# 169498

    Riga, 1035

  • Pauls Stradins Clinical University Hospital /ID# 169519

    Riga, LV- 1002

  • Digestive Disease Center Gastro /ID# 169508

    Riga, LV-1079

Other trials in Latvia

Malaysia3 sites

  • Hospital Sultanah Bahiyah /ID# 202626

    Alor Star, Kedah, 05460

  • Universiti Sains Malaysia /ID# 200102

    Kelantan, Kelantan, 16150

  • Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170773

    Kuala Lumpur, Selangor, 56000

Other trials in Malaysia

Mexico3 sites

  • Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207579

    Durango, Durango, 34000

  • Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 207238

    Guadalajara, Jalisco, 44650

  • Morales Vargas Centro de Investigacion S.C. /ID# 203494

    León, Guanajuato, 37000

Other trials in Mexico

Romania3 sites

  • Clinica GASTRO MED SRL /ID# 206369

    Cluj-Napoca, Cluj, 400380

  • Institutul Clinic Fundeni /ID# 167817

    Sector 2, Bucharest, 022328

  • Cabinet Particular Policlinic Algomed /ID# 167818

    Timișoara, 300002

Other trials in Romania

Singapore3 sites

  • KL Ling Gastroenterology and Liver Clinic /ID# 217962

    Singapore, 228510

  • Gleneagles Medical Centre /ID# 206531

    Singapore, 258499

  • Tan Tock Seng Hospital /ID# 203160

    Singapore, 308433

Other trials in Singapore

Taiwan3 sites

  • China Medical University Hospital /ID# 169791

    Taichung, 40447

  • Taichung Veterans General Hospital /ID# 169790

    Taichung, 40705

  • National Taiwan University Hospital /ID# 169792

    Taipei, 100

Other trials in Taiwan

Austria2 sites

  • Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 214470

    Salzburg, 5020

  • Medizinische Universitaet Wien /ID# 169465

    Vienna, State of Vienna, 1090

Other trials in Austria

Colombia2 sites

  • Hospital Pablo Tobon Uribe /ID# 202404

    Medellín, Antioquia, 50034

  • Hospital Universitario San Vic /ID# 200029

    Medellín, 50010

Other trials in Colombia

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 206936

    Kaunas, 50161

  • Vilnius University Hospital Santaros Klinikos /ID# 203286

    Vilnius, 08661

Other trials in Lithuania

Puerto Rico2 sites

  • Mindful Medical Research /ID# 203358

    San Juan, 00918-3756

  • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166771

    San Juan, 00935

Other trials in Puerto Rico

Slovakia2 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169958

    Banská Bystrica, 975 17

  • KM Management, spol. s.r.o. /ID# 170201

    Nitra, 949 01

Other trials in Slovakia

Switzerland2 sites

  • Inselspital, Universitätsspital Bern /ID# 170997

    Bern, 3010

  • Universitätsspital Zürich /ID# 170998

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Estonia1 site

  • West Tallinn Central Hospital /ID# 202785

    Tallinn, 10617

Other trials in Estonia

Hong Kong1 site

  • Tuen Mun Hospital /ID# 171218

    Hong Kong

Other trials in Hong Kong

Ireland1 site

  • Mercy University Hospital /ID# 206511

    Cork, T12 WE28

Other trials in Ireland

Slovenia1 site

  • Univ Medical Ctr Ljubljana /ID# 217795

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in adults with moderately and severely active Crohn's disease (CD).

Read the detailed description

This study includes two parts:

  • Part 1: a randomized double-blind placebo-controlled induction period and
  • Part 2: an extended treatment period for non-responders from Part 1.

In Part 1, participants will be randomized in a 2:1 ratio to upadacitinib 45 mg once daily (QD) or matching placebo for 12 weeks. The randomization will be stratified by baseline corticosteroid use (yes or no), endoscopic disease severity (Simplified Endoscopic Score for Crohn's disease [SES-CD] < 15 and ≥ 15), and number of prior biologics with prior inadequate response or intolerance (0, 1, > 1).

Participants who do not achieve clinical response at Week 12 will be able to enroll in Part 2 to receive a double-blind extended treatment with upadacitinib until Week 24. Clinical response is defined as a ≥ 30% decrease in average daily very soft or liquid stool frequency (SF) and/or ≥ 30% decrease in average daily abdominal pain (AP) score (both not worse than Baseline).

Participants who achieve clinical response at Week 12 may be eligible to enter the 52-week, double-blind, maintenance portion of Study M14-430 (NCT03345823).

Conditions
Crohn's Disease
Being tested
Upadacitinib, Placebo for Upadacitinib
Keywords
Upadacitinib, ABT-494, Efficacy, Safety, Crohn's Disease
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 NCT03345849
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants will receive placebo once daily for 12 weeks in Part 1. Clinical non-responders will receive 45 mg upadacitinib once daily for 12 weeks in Part 2.
Receives: Drug: Upadacitinib; Drug: Placebo for Upadacitinib
UpadacitinibExperimentalParticipants will receive 45 mg upadacitinib once daily for 12 weeks in Part 1. Clinical non-responders will receive 30 mg upadacitinib once daily for 12 weeks in Part 2.
Receives: Drug: Upadacitinib

What is being measured

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

  1. Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 12

    The co-primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was clinical remission based on CDAI at Week 12.

    CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as a CDAI score less than 150.

    Measured: Week 12

  2. Percentage of Participants With Clinical Remission Per Patient-Reported Outcomes (PROs) at Week 12

    The co-primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was clinical remission defined based on two patient reported outcomes, average daily stool frequency (SF) and average daily abdominal pain score (APS). Clinical remission per PROs was defined as average daily very soft or liquid SF ≤ 2.8 and average daily APS ≤ 1.0 and neither worse than Baseline.

    Participants recorded APS and the number of very soft or liquid SF daily in an electronic diary. Abdominal pain was rated on a scale from 0 (none) to 3 (severe).

    The average daily very soft or liquid SF and APS were calculated using the 4-7 most recent useable days of patient-report outcomes (i.e., excluding days with missing entries or associated with endoscopy procedures) out of the last 14 days prior to the Week 12 visit.

    Measured: Week 12

  3. Percentage of Participants With Endoscopic Response at Week 12

    Endoscopic response at Week 12 was a co-primary endpoint for both the US/FDA and EU/EMA regulatory purposes. Endoscopic response was defined as greater than 50% decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline of the induction study (or for participants with an SES-CD of 4 at Baseline, at least a 2-point reduction from Baseline), as scored by independent external and blinded central readers.

    The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

    Measured: Baseline and Week 12

Secondary outcomes (11)

  1. Percentage of Participants With Endoscopic Remission at Week 12

    Endoscopic remission is defined as an SES-CD ≤ 4 and at least 2 point reduction from Baseline and no subscore > 1 in any individual variable,as scored by independent external and blinded central readers.

    The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

    Measured: Baseline and Week 12

  2. Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease and Achieved Clinical Remission Per CDAI at Week 12

    Corticosteroid-free clinical remission is defined as participants who discontinued corticosteroid use for CD and achieved clinical remission per CDAI at Week 12, assessed for participants taking corticosteroids for CD at Baseline.

    CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as CDAI score less than 150.

    Measured: Week 12

  3. Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 12

    The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.

    Measured: Baseline and Week 12

  4. Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12

    The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with inflammatory bowel disease. 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 and Week 12

  5. Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 2

    Clinical response 100 (CR-100) is defined as a decrease of at least 100 points in CDAI from Baseline.

    CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease.

    Measured: Baseline and Week 2

  6. Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 12

    Clinical response 100 (CR-100) is defined as a decrease of at least 100 points in CDAI from Baseline.

    CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease.

    Measured: Baseline and Week 12

  7. Percentage of Participants With Clinical Remission Per CDAI at Week 4

    CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as CDAI score less than 150.

    Measured: Week 4

  8. Percentage of Participants With Hospitalizations Due to Crohn's Disease (CD) During the 12-Week Induction Period

    This was assessed by reviewing participant's hospitalization data.

    Measured: 12 weeks

  9. Percentage of Participants With Resolution of Extra-Intestinal Manifestation (EIMs) at Week 12

    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.

    Only participants with any EIM present at Baseline were included in the analysis of resolution of EIMs. Resolution of EIMs was defined as absence of all EIMs at the Week 12 visit.

    Measured: Week 12

  10. Percentage of Participants With Clinical Remission Per PROs at Week 4

    Clinical remission per PROs was defined as average daily very soft or liquid SF ≤ 2.8 and average daily APS ≤ 1.0 and neither worse than Baseline.

    Participants recorded APS and the number of liquid or very soft SF daily in an electronic diary. Abdominal pain was rated on a scale from 0 (none) to 3 (severe).

    The average daily very soft or liquid SF and APS were calculated using the 4-7 most recent useable days of patient-reported outcomes (i.e., excluding days with missing entries or associated with endoscopy procedures) out of the last 14 days prior to the Week 4 visit.

    Measured: Week 4

  11. Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease and Achieved Clinical Remission Per PROs at Week 12

    Corticosteroid-free clinical remission is defined as participants who discontinued corticosteroid use for CD and achieved clinical remission per PROs at Week 12, assessed for participants taking corticosteroids for CD at Baseline.

    Clinical remission per PROs was defined as average daily very soft or liquid stool frequency (SF) ≤ 2.8 and average daily APS ≤ 1.0 and neither worse than Baseline.

    Participants recorded APS and the number of liquid or very soft SF daily in an electronic diary. Abdominal pain was rated on a scale from 0 (none) to 3 (severe).

    The average daily liquid or very soft SF and APS were calculated using the 4-7 most recent useable days of patient-reported outcomes (i.e., excluding days with missing entries or associated with endoscopy procedures) out of the last 14 days prior to the Week 12 visit.

    Measured: Week 12

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 start7 Dec 2017
  3. Primary completion15 Oct 2021
  4. Study completion13 Jan 2022

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
526 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03345849
Sponsor's protocol ID
M14-433
Other IDs
2017-001240-35, 2017
Acronym
U-EXCEL
Status last verified
Oct 2022
First submitted
15 Nov 2017
Last updated
23 Nov 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, analyses plans, 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

  • 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

  • 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 432 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 6 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 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 432 sites in United States, Japan, Canada, China, Italy 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Nov 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?

Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 12 (time frame: Week 12). 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 NCT03345849, which also lists 9 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 23 Nov 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in