AzTrials
AzTrials

Crohn's DiseasePhase 3NCT03345836

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

A Phase 3 study testing Upadacitinib in people with Crohn's Disease, run by AbbVie at 428 sites in 48 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 participants 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
624 participants
Where
428 sitesin 48 countries
Study dates
29 Nov 2017to 11 Aug 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

  • Ages 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 any biologic therapy for infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.
  • 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, 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 protocol pre-specified analyses show abnormal results.

Trial locations and contacts

428 sites in 48 countries.

428 sites in 48 countries

United States119 sites

  • University of Michigan Health Systems /ID# 164844

    Ann Arbor, Michigan, 48109

  • TX Clinical Research Institute /ID# 164848

    Arlington, Texas, 76012

  • Johns Hopkins University School of Medicine /ID# 211940

    Baltimore, Maryland, 21287-0010

  • Inquest Clinical Research /ID# 164865

    Baytown, Texas, 77521-2415

  • Washington Gastroenterology Associates /ID# 164721

    Bellevue, Washington, 98004

  • HP Clinical Research /ID# 164929

    Bountiful, Utah, 84010

  • NY Scientific /ID# 164833

    Brooklyn, New York, 11235

  • Lahey Hospital and Medical Center /ID# 214725

    Burlington, Massachusetts, 01805

  • Texas Digestive Disease Consultants /ID# 209952

    Cedar Park, Texas, 78613-5028

  • Texas Digestive Disease Consultants /ID# 209802

    Cedar Park, Texas, 78613

  • Delsol Research Management, Ll /Id# 170179

    Chandler, Arizona, 85224

  • Pharmacorp Clinical Trials /ID# 164809

    Charleston, South Carolina, 29412

  • Atrium Health Carolinas Medical Center /ID# 164834

    Charlotte, North Carolina, 28203

  • PMG Research of Charlotte /ID# 171170

    Charlotte, North Carolina, 28209

  • Clin Res Inst of Michigan, LLC /ID# 170178

    Chesterfield, Michigan, 48047

  • MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164835

    Chevy Chase, Maryland, 20815

  • University of Chicago Medicine /ID# 165472

    Chicago, Illinois, 60637-1426

  • Consultants for Clinical Research /ID# 164855

    Cincinnati, Ohio, 45219

  • University of Cincinnati /ID# 164720

    Cincinnati, Ohio, 45267-0585

  • Clinical Research of West Florida, Inc /ID# 205825

    Clearwater, Florida, 33765

  • Clinical Research of West Florida, Inc /ID# 208117

    Clearwater, Florida, 33765

  • Cleveland Clinic Main Campus /ID# 208220

    Cleveland, Ohio, 44195

  • Peak Gastroenterology Associates, PC /ID# 170181

    Colorado Springs, Colorado, 80907

  • Delta Waves, Inc. /ID# 164872

    Colorado Springs, Colorado, 80918

  • Gastro Center of Maryland /ID# 171171

    Columbia, Maryland, 21045

  • The Ohio State University /ID# 170174

    Columbus, Ohio, 43210

  • Optimed Research, Ltd. /ID# 205618

    Columbus, Ohio, 43235

  • Advanced Research - Coral Springs /ID# 218020

    Coral Springs, Florida, 33067-3173

  • Southern California Res. Ctr. /ID# 169654

    Coronado, California, 92118-1408

  • Citrus Valley Gastroenterology /ID# 166201

    Covina, California, 91722-3797

  • Tri-State Gastroenterology /ID# 165484

    Crestview Hills, Kentucky, 41017

  • Hometown Urgent Care and Resea /ID# 201290

    Dayton, Ohio, 45424

  • DuPage Medical Group /ID# 205303

    Downers Grove, Illinois, 60515-5509

  • AGA Clinical Research Associates, LLC /ID# 164883

    Egg Harbor, New Jersey, 08234

  • Dayton Gastroenterology, Inc. /ID# 167624

    Englewood, Ohio, 45415

  • MediSphere Medical Research Center /ID# 166209

    Evansville, Indiana, 47714-8011

  • Plains Clinical Research Center, LLC /ID# 170184

    Fargo, North Dakota, 58104-5925

  • Digestive Health Associates (DHA) - Farmington Hills /ID# 206099

    Farmington Hills, Michigan, 48334-3230

  • Gastro One /ID# 164718

    Germantown, Tennessee, 38138

  • Gastroenterology Associates, P.A. of Greenville /ID# 164880

    Greenville, South Carolina, 29615-3593

  • Medical Research Center of CT /ID# 164829

    Hamden, Connecticut, 06518

  • CroNOLA, LLC /ID# 164722

    Houma, Louisiana, 70360

  • CliniCore International, LLC /ID# 164662

    Houston, Texas, 77027-6812

  • Baylor College of Medicine - Baylor Medical Center /ID# 164847

    Houston, Texas, 77030-3411

  • Centex Studies, Inc. - Houston /ID# 201213

    Houston, Texas, 77058

  • GI Specialists of Houston /ID# 202338

    Houston, Texas, 77070-4347

  • Indianapolis Gastroenterology /ID# 164837

    Indianapolis, Indiana, 46237

  • University of Iowa Hospitals and Clinics /ID# 165330

    Iowa City, Iowa, 52242

  • Southern Therapy and Advanced Research (STAR) LLC /ID# 165318

    Jackson, Mississippi, 39216

  • Encore Borland-Groover Clinical Research /Id# 203498

    Jacksonville, Florida, 32256

  • East Tennessee Research Institute /ID# 203612

    Johnson City, Tennessee, 37604

  • NYU Langone Long Island Clinical Research Associates /ID# 164830

    Lake Success, New York, 11042

  • Las Vegas Medical Research /ID# 168562

    Las Vegas, Nevada, 89113

  • United Medical Doctors /ID# 207452

    Los Alamitos, California, 90720-3309

  • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164887

    Los Angeles, California, 90067-2001

  • University of Louisville /ID# 168536

    Louisville, Kentucky, 40202

  • University of Louisville /ID# 208093

    Louisville, Kentucky, 40202

  • Caprock Gastro Research /ID# 215437

    Lubbock, Texas, 79424-3017

  • Gastroenterology Associates of Central Georgia, LLC /ID# 165460

    Macon, Georgia, 31201

  • Ctr for Advanced Gastroenterol /ID# 165332

    Maitland, Florida, 32751-6108

  • Great Lakes Medical Research, LLC /ID# 202007

    Mentor, Ohio, 44060-6211

  • Crystal Pharmacology Research /ID# 166101

    Miami, Florida, 33165

  • Coral Research Clinic /ID# 164657

    Miami, Florida, 33186-4643

  • Froedtert Memorial Lutheran Hospital /ID# 202286

    Milwaukee, Wisconsin, 53226-3522

  • Facey Medical Foundation /ID# 203137

    Mission Hills, California, 91345

  • East View Medical Research, LLC /ID# 171133

    Mobile, Alabama, 36606

  • CB Flock Research Corporation /ID# 166220

    Mobile, Alabama, 36608

  • United Medical Doctors - Murrieta /ID# 164845

    Murrieta, California, 92563

  • Quality Medical Research /ID# 205262

    Nashville, Tennessee, 37211

  • Vanderbilt University Medical Center /ID# 164846

    Nashville, Tennessee, 37232-0011

  • Aquiant Research /ID# 205504

    New Albany, Indiana, 47150-4053

  • Rutgers Robert Wood Johnson /ID# 166092

    New Brunswick, New Jersey, 08901

  • Nola Research Works, LLC /ID# 164897

    New Orleans, Louisiana, 70115

  • Advanced Research Institute, Inc /ID# 164814

    New Port Richey, Florida, 34653

  • The Mount Sinai Hospital /ID# 170172

    New York, New York, 10029

  • Columbia Univ Medical Center /ID# 164870

    New York, New York, 10032-3725

  • Advanced Research Institute /ID# 164866

    Ogden, Utah, 84403

  • Digestive Disease Specialists /ID# 201062

    Oklahoma City, Oklahoma, 73112

  • Quality Clinical Research Inc. /ID# 170177

    Omaha, Nebraska, 68114-3723

  • CHI Health Research Center /ID# 168545

    Omaha, Nebraska, 68124

  • Endoscopic Research, Inc. /ID# 205893

    Orlando, Florida, 32803

  • Omega Research Maitland, LLC /ID# 203480

    Orlando, Florida, 32810-2907

  • University of Pennsylvania /ID# 168402

    Philadelphia, Pennsylvania, 19104-5502

  • Thomas Jefferson University /ID# 168014

    Philadelphia, Pennsylvania, 19107-4414

  • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164663

    Raleigh, North Carolina, 27612

  • Rapid City Medical Center - GI Research /ID# 201734

    Rapid City, South Dakota, 57701

  • Mayo Clinic - Rochester /ID# 164868

    Rochester, Minnesota, 55905-0001

  • Gastro Group of Rochester /ID# 166216

    Rochester, New York, 14618-5703

  • Gastroenterology Consultants PC - Roswell /ID# 218219

    Roswell, Georgia, 30076-4913

  • Duplicate_Care Access Research /ID# 164853

    Salt Lake City, Utah, 84124-1377

  • Clinical Associates in Research Therapeutics of America, LLC /ID# 164863

    San Antonio, Texas, 78212

  • Southern Star Research Institute, LLC /ID# 169754

    San Antonio, Texas, 78229-5390

  • Ucsd /Id# 164679

    San Diego, California, 92103

  • Medical Assoc Research Grp /ID# 169705

    San Diego, California, 92123

  • UCSF Center for Colitis and Crohn's Disease /ID# 202373

    San Francisco, California, 94115-3011

  • Univ of California San Francis /ID# 164843

    San Francisco, California, 94158

  • Care Access Research /ID# 167766

    San Pablo, California, 94806

  • HonorHealth Research Institute - Shea /ID# 164734

    Scottsdale, Arizona, 85258

  • Virginia Mason - Seattle Orthapedics /ID# 164680

    Seattle, Washington, 98101

  • University of Washington /ID# 164875

    Seattle, Washington, 98109

  • Louisana Research Center, LLC /ID# 164659

    Shreveport, Louisiana, 71105-6800

  • Richmond University Medical Center /ID# 201855

    Staten Island, New York, 10310-1664

  • Carl R. Meisner Medical Clinic /ID# 201060

    Sugar Land, Texas, 77478

  • Arizona Arthritis & Rheumatology Research, PLLC /ID# 203891

    Sun City, Arizona, 85306

  • Atlanta Gastroenterology Spec /ID# 164780

    Suwanee, Georgia, 30024

  • Clinical Research Trials of Florida, Inc. /ID# 203484

    Tampa, Florida, 33607

  • AdventHealth Tampa /ID# 171175

    Tampa, Florida, 33613-4680

  • Montefiore Medical Center - Moses Campus /ID# 166226

    The Bronx, New York, 10467

  • Advantage Clinical Trials /ID# 168557

    The Bronx, New York, 10468

  • Center for Digestive Health /ID# 164733

    Troy, Michigan, 48098-6363

  • Options Health Research, LLC /ID# 164737

    Tulsa, Oklahoma, 74104

  • Healthcare Research Consultant /ID# 166228

    Tulsa, Oklahoma, 74135

  • Tyler Research Institute, LLC /ID# 168681

    Tyler, Texas, 75701-4464

  • The Vancouver Clinic, INC. PS /ID# 164811

    Vancouver, Washington, 98664

  • Gastro Health & Nutrition - Victoria /ID# 167813

    Victoria, Texas, 77904

  • Allegiance Research Specialists /ID# 165321

    Wauwatosa, Wisconsin, 53226

  • Velocity Clinical Research - Salt Lake City /ID# 166095

    West Jordan, Utah, 84088

  • Duplicate_Western States Clinical Research, Inc. /ID# 164895

    Wheat Ridge, Colorado, 80033-2896

  • Wake Forest Baptist Medical Center /ID# 201225

    Winston-Salem, North Carolina, 27157-0001

Other trials in United States

Japan46 sites

  • Asahikawa Medical University Hospital /ID# 167133

    Asahikawa-shi, Hokkaido, 078-8510

  • Tokyo Medical And Dental University, Medical Hospital /ID# 165948

    Bunkyo-ku, Tokyo, 113-8519

  • NHO Fukuyama Medical Center /ID# 167139

    Fukuyama-shi, Hiroshima, 720-8520

  • Duplicate_Tokai University Hachioji Hospital /ID# 165951

    Hachioji-shi, Tokyo, 192-0032

  • Hirosaki National Hospital /ID# 165944

    Hirosaki-shi, Aomori, 036-8545

  • Hiroshima University Hospital /ID# 166006

    Hiroshima, Hiroshima, 734-8551

  • Imamura General Hospital /ID# 227136

    Kagoshima, Kagoshima-ken, 890-0064

  • Idzuro Imamura Hospital /ID# 206651

    Kagoshima, Kagoshima-ken, 892-0824

  • Sameshima Hospital /ID# 206674

    Kagoshima, Kagoshima-ken, 892-0846

  • Kanazawa University Hospital /ID# 169215

    Kanazawa, Ishikawa-ken, 920-8641

  • Nara Medical University Hospital /ID# 169216

    Kashihara-shi, Nara, 634-8522

  • Aoyama Clinic /ID# 166001

    Kobe, Hyōgo, 650-0015

  • Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 166002

    Kurashiki-shi, Okayama-ken, 710-0142

  • Kurume University Hospital /ID# 166004

    Kurume-shi, Fukuoka, 830-0011

  • Japanese Red Cross Kyoto Daiichi Hosital /ID# 165958

    Kyoto, Kyoto, 605-0981

  • Kyoto University Hospital /ID# 169888

    Kyoto, Kyoto, 606-8507

  • The Jikei University Hospital /ID# 167142

    Minato-ku, Tokyo, 105-8471

  • Kyorin University Hospital /ID# 165950

    Mitaka-shi, Tokyo, 181-8611

  • Iwate Medical University Uchimaru Medical Center /ID# 202407

    Morioka, Iwate, 020-8505

  • Aichi Medical University Hospital /ID# 165957

    Nagakute-shi, Aichi-ken, 480-1195

  • Nagoya University Hospital /ID# 165955

    Nagoya, Aichi-ken, 4668560

  • Nagoya City University Hospital /ID# 165956

    Nagoya, Aichi-ken, 467-8602

  • Niigata University Medical & Dental Hospital /ID# 170044

    Niigata, Niigata, 951-8520

  • Hyogo College of Medicine College Hospital /Id# 200173

    Nishinomiya-shi, Hyōgo, 663-8501

  • Ishida Clinic of IBD and Gastroenterology /ID# 167134

    Ōita, Oita Prefecture, 870-0823

  • Okayama University Hospital /ID# 167355

    Okayama, Okayama-ken, 700-8558

  • Kinshukai Infusion Clinic /ID# 218871

    Osaka, Osaka, 530-0011

  • Osaka City University Hospital /ID# 166007

    Osaka, Osaka, 545-8586

  • Shiga University of Medical Science Hospital /ID# 167141

    Ōtsu, Shiga, 520-2192

  • Tokitokai Tokito clinic /ID# 165945

    Saitama-shi, Saitama, 336-0963

  • Toho University Sakura Medical Center /ID# 165949

    Sakura-shi, Chiba, 285-8741

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165943

    Sapporo, Hokkaido, 060-0033

  • Sapporo Medical University Hospital /ID# 167137

    Sapporo, Hokkaido, 060-8543

  • Tohoku University Hospital /ID# 167135

    Sendai, Miyagi, 9808574

  • Tokyo Women's Medical University Hospital /ID# 205981

    Shinjuku-ku, Tokyo, 162-8666

  • Osaka University Hospital /ID# 169662

    Suita-shi, Osaka, 565-0871

  • NHO Shizuoka Medical Center /ID# 167138

    Sunto-gun, Shizuoka, 411-8611

  • National Hospital Organization Takasaki General Medical Center /ID# 167136

    Takasaki-shi, Gunma, 370-0829

  • Osaka Medical and Pharmaceutical University Hospital /ID# 206324

    Takatsuki-shi, Osaka, 569-8686

  • Toyama Prefectural Central Hospital /ID# 217833

    Toyama, Toyama, 930-8550

  • Toyohashi Municipal Hospital /ID# 200174

    Toyohashi, Aichi-ken, 441-8570

  • Japanese Red Cross Wakayama Medical Center /ID# 200638

    Wakayama, Wakayama, 640-8558

  • Wakayama Medical University Hospital /ID# 169481

    Wakayama, Wakayama, 641-8510

  • Yamagata University Hospital /ID# 200156

    Yamagata, Yamagata, 990-9585

  • Kenseikai Dongo Hospital /ID# 208103

    Yamatotakada-shi, Nara, 635-0022

  • Yokkaichi Hazu Medical Center /ID# 167191

    Yokkaichi-shi, Mie-ken, 510-0016

Other trials in Japan

Canada15 sites

  • University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 166963

    Calgary, Alberta, T2N 4Z6

  • Allen Whey Khye Lim Professional Corporation /ID# 168041

    Edmonton, Alberta, T5R 1W2

  • Covenant Health /ID# 166966

    Edmonton, Alberta, T6K 4B2

  • Medicor Research Inc /ID# 166967

    Greater Sudbury, Ontario, P3A 1W8

  • QEII - Health Sciences Centre /ID# 169306

    Halifax, Nova Scotia, B3H 2Y9

  • CHAU- Hotel-Dieu de Levis /ID# 166958

    Lévis, Quebec, G6V 3Z1

  • Crchum /Id# 170121

    Montreal, Quebec, H2X 0A9

  • Montreal General Hospital - McGill University Health Center /ID# 170010

    Montreal, Quebec, H3G 1A4

  • Fraser Clinical Trials Inc /ID# 166957

    New Westminster, British Columbia, V3L 3W4

  • Scott Shulman Medicine Professional Corporation /ID# 169064

    North Bay, Ontario, P1B 2H3

  • Taunton Surgical Centre /ID# 168039

    Oshawa, Ontario, L1H 7K4

  • The Ottawa Hospital /ID# 212413

    Ottawa, Ontario, K1H 8L6

  • CIUSSS de l'Estrie - CHUS /ID# 170935

    Sherbrooke, Quebec, J1G 2E8

  • GIRI Gastrointestinal Research Institute /ID# 166964

    Vancouver, British Columbia, V6Z 2K5

  • Toronto Digestive Disease Asso /ID# 166961

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

China15 sites

  • Beijing Friendship Hospital /ID# 204536

    Beijing, 100032

  • The First Hospital of Jilin University /ID# 206867

    Changchun, Jilin, 130021

  • The Second Hospital Central South University /ID# 204075

    Changsha, 410011

  • Zhongshan Hospital Xiamen University /ID# 204985

    Fujian, Anhui, 361004

  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 205226

    Guangzhou, Guangdong, 510120

  • The Sixth Affiliated Hosp Sun /ID# 204049

    Guangzhou, Guangdong, 510655

  • Nanfang Hospital of Southern Medical University /ID# 204074

    Guangzhou, 510080

  • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 204078

    Hangzhou, Zhejiang, 310009

  • Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204068

    Hangzhou, Zhejiang, 310018

  • The First Affiliated Hospital of Nanchang University /ID# 204070

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital /ID# 204869

    Nanjing, Jiangsu, 210008

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204072

    Shanghai, Shanghai Municipality, 200065

  • Duplicate_Tianjin Med Univ General Hosp /ID# 206993

    Tianjin, 300052

  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204096

    Wuhan, Hubei, 430022

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 204069

    Wuhan, 430030

Other trials in China

Italy14 sites

  • A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 168173

    Bologna, 40138

  • A.O. Per L'Emergenza Cannizzaro /ID# 168176

    Catania, 95126

  • University of Catanzaro /ID# 201920

    Catanzaro, Calabria, 88100

  • Policlinico San Martino/Univer /ID# 168177

    Genova, 16132

  • ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168167

    Milan, 20121

  • Azienda Ospedaliero-Universitaria di Modena /ID# 200008

    Modena, 41124

  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168172

    Negrar, Verona, 37024

  • A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168175

    Palermo, 90146

  • Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202420

    Pisa, 56125

  • Policlinico Universitario Campus Bio-Medico /ID# 168169

    Rome, Lazio, 00128

  • Azienda Ospedaliera San Camillo Forlanini /ID# 168170

    Rome, Lazio, 00152

  • Fondazione PTV Policlinico Tor Vergata /ID# 168174

    Rome, Roma, 00133

  • Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 168168

    Rome, Roma, 00168

  • Istituto Clinico Humanitas /ID# 168171

    Rozzano, Milano, 20089

Other trials in Italy

United Kingdom14 sites

  • Royal United Hospitals Bath /ID# 169084

    Bath, BA1 3NG

  • South Eastern Health and Social Care Trust /ID# 205322

    Belfast, Antrim, BT16 1RH

  • University Hospitals Birmingham NHS Foundation Trust /ID# 169080

    Birmingham, B15 2TH

  • The Dudley Group NHS Foundation Trust /ID# 169079

    Dudley, DY1 2HQ

  • London North West University Healthcare NHS Trust /ID# 169078

    Harrow, HA1 3UJ

  • Barts Health NHS Trust /ID# 218829

    London, London, City of, E1 2ES

  • King's College Hospital NHS Foundation Trusts /ID# 169082

    London, SE5 9RS

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169085

    Newcastle upon Tyne, NE7 7DN

  • Stockport NHS foundation trust /ID# 208718

    Stockport, SK2 7JE

  • Taunton and Somerset NHS Foundation Trust /ID# 209664

    Taunton, TA1 5DA

  • St George's University Hospitals NHS Foundation Trust /ID# 205551

    Tooting, SW17 0QT

  • Warrington and Halton Hospitals NHS Foundation Trust /ID# 171388

    Warrington, Cheshire West And Chester, WA5 1QG

  • Warrington and Halton Hospitals NHS Foundation Trust /ID# 209085

    Warrington, Cheshire West And Chester, WA5 1QG

  • The Royal Wolverhampton NHS Trust /ID# 171387

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

France13 sites

  • CHU Amiens-Picardie Site Sud /ID# 171016

    Amiens, Somme, 80054

  • CHRU Tours - Hopital Trousseau /ID# 169786

    Chambray-lès-Tours, 37170

  • Hopital Beaujon /ID# 171011

    Clichy, Île-de-France Region, 92110

  • Duplicate_CHU Henri Mondor /ID# 169787

    Créteil, 94000

  • CHRU Lille - Hopital Claude Huriez /ID# 206539

    Lille, Hauts-de-France, 59037

  • Duplicate_Hopital Saint Eloi /ID# 170646

    Montpellier, Herault, 34295

  • Chu de Nice-Hopital L'Archet Ii /Id# 171009

    Nice, Alpes-Maritimes, 06200

  • Polyclinique Grand Sud /ID# 170649

    Nîmes, 30932

  • CHU Bordeaux - Hopital Haut Lévêque /ID# 207414

    Pessac, Gironde, 33604

  • HCL - Hôpital Lyon Sud /ID# 171014

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • CHU de SAINT ETIENNE - Hopital Nord /ID# 171018

    Saint Priest EN Jarez, Pays de la Loire Region, 42270

  • CHU Toulouse - Hopital Rangueil /ID# 169785

    Toulouse, 31400

  • CHRU Nancy - Hôpitaux de Brabois /ID# 170985

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

Other trials in France

Germany12 sites

  • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 169067

    Berlin, 12203

  • Gastroenterologie am Mexikoplatz /ID# 203573

    Berlin, 14163

  • Universitaetsklinikum Erlangen /ID# 203551

    Erlangen, Bavaria, 91054

  • Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203571

    Essen, 45239

  • Universitaetsklinikum Frankfurt /ID# 203565

    Frankfurt am Main, Hesse, 60590

  • Agaplesion Markus Krankenhaus /ID# 168777

    Frankfurt am Main, 60431

  • Universitaetsklinikum Halle (Saale) /ID# 207454

    Halle, 06120

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168779

    Kiel, Schleswig-Holstein, 24105

  • Universitatsklinikum Mannheim /ID# 168778

    Mannheim, Baden-Wurttemberg, 68167

  • Medizinisches Versorgungszentrum Portal 10 /ID# 200213

    Münster, 48155

  • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206740

    Saarbrücken, Saarland, 66111

  • Universitaetsklinikum Ulm /ID# 203563

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Russia12 sites

  • Immanuel Kant Baltic Federal University /ID# 202128

    Kaliningrad, Kaliningrad Oblast, 236016

  • Kazan State Medical University /ID# 169574

    Kazan', Tatarstan, Respublika, 420012

  • Olla-Med Clinic /ID# 208721

    Moscow, 105554

  • P.A. Bayandin Murmansk Regiona /ID# 169575

    Murmansk, 183047

  • LLC Medical Center /ID# 209233

    Novosibirsk, Novosibirsk Oblast, 630099

  • Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202988

    Perm, Permskiy Kray, 614109

  • Republican hospital named after V.A. Baranov /ID# 206487

    Petrozavodsk, 185019

  • Euromedservice /ID# 206609

    Pushkin, 196603

  • LLC Novaya Klinika /ID# 206615

    Pyatigorsk, Stavropol Kray, 357500

  • X7 Clinical Research Center /ID# 216349

    Saint Petersburg, 194156

  • City Clinical Hospital No. 31 /ID# 208870

    Saint Petersburg, 197110

  • Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202995

    Stavropol, Stavropol Kray, 355012

Other trials in Russia

Spain12 sites

  • Hospital Universitario A Coruna - CHUAC /ID# 203908

    A Coruña, 15006

  • Hospital Universitario Vall d'Hebron /ID# 171237

    Barcelona, 08035

  • Hospital Clinic de Barcelona /ID# 171242

    Barcelona, 08036

  • Hospital Universitario de Girona Doctor Josep Trueta /ID# 202040

    Girona, 17007

  • Hospital Juan Ramon Jimenez /ID# 171243

    Huelva, 21005

  • Hospital Universitario Dr. Negrin /ID# 171238

    Las Palmas de Gran Canaria, Las Palmas, 35010

  • Hospital Universitario La Paz /ID# 171241

    Madrid, 28046

  • Hospital Universitari Son Espases /ID# 201997

    Palma de Mallorca, Balearic Islands, 07120

  • Complejo Hospitalario de Navarra /ID# 202038

    Pamplona, Navarre, 31008

  • Hospital Unversitario Marques de Valdecilla /ID# 202039

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen Macarena /ID# 171240

    Seville, 41009

  • Hospital Universitario y Politecnico La Fe /ID# 201988

    Valencia, 46026

Other trials in Spain

South Korea10 sites

  • Inje University Haeundae Hospital /ID# 202629

    Busan, 48108

  • Dong-A University Hospital /ID# 167582

    Busan, 49201

  • Pusan National University Hospital /ID# 167580

    Busan, 49241

  • Kyungpook National Univ Hosp /ID# 207015

    Daegu, 41944

  • Hayang University GuriHospital /ID# 167578

    Guri-si, Gyeonggido, 11923

  • CHA University Bundang Medical Center /ID# 167583

    Seongnam-si, Gyeonggido, 13496

  • Kangbuk Samsung Hospital /ID# 167577

    Seoul, Seoul Teugbyeolsi, 03181

  • Yonsei University Health System Severance Hospital /ID# 167581

    Seoul, Seoul Teugbyeolsi, 03722

  • Samsung Medical Center /ID# 167579

    Seoul, 06351

  • Chung-Ang University Hostipal /ID# 207017

    Seoul, 06973

Other trials in South Korea

Turkey (Türkiye)10 sites

  • Ankara Univ Medical Faculty /ID# 206412

    Ankara, 06590

  • Inonu Universitesi Turgut Ozal /ID# 201267

    Battalgazi/malatya, 44280

  • Mustafa Kemal University Medic /ID# 171318

    Hatay, 31001

  • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 200280

    Istanbul, 34098

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171316

    Istanbul, 34899

  • Acibadem Kozyatagi Hospital /ID# 209405

    Kadıköy, Istanbul, 34742

  • Erciyes University Medical Fac /ID# 171321

    Melikgazi, Kayseri, 38030

  • Mersin University Medical /ID# 171320

    Mersin, 33343

  • Sisli Etfal Train & Res Hosp /ID# 171317

    Şişli, 34371

  • Gazi Universitesi Tip Fakultes /ID# 217443

    Yenimahalle, 06560

Other trials in Turkey (Türkiye)

Brazil7 sites

  • Upeclin Fmb - Unesp /Id# 166876

    Botucatu, São Paulo, 18618-686

  • Hospital Nossa Senhora das Graças /ID# 166869

    Curitiba, Paraná, 80810-040

  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166870

    Goiânia, Goiás, 74535-170

  • Hospital de Clinicas de Porto Alegre /ID# 166872

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 166874

    Ribeirão Preto, São Paulo, 14051-140

  • Faculdade de Medicina do ABC /ID# 208327

    Santo André, São Paulo, 09060-870

  • Kaiser Clinica e Hospital Dia /ID# 166873

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

Other trials in Brazil

Israel7 sites

  • Barzilai Medical Center /ID# 223372

    Ashkelon, 7830604

  • Assaf Harofeh Medical Center /ID# 204870

    Be’er Ya‘aqov, 70300

  • Soroka University Medical Center /ID# 169912

    Beersheba, Southern District, 8443901

  • Hadassah Medical Center-Hebrew University /ID# 169927

    Jerusalem, 91120

  • Rabin Medical Center /ID# 202635

    Petah Tikva, 4941492

  • Kaplan Medical Center /ID# 170277

    Rehovot, 7661041

  • Tel Aviv Sourasky Medical Center /ID# 204876

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Argentina6 sites

  • Hospital Italiano de Buenos Aires /ID# 215543

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

  • Gedyt /ID# 210019

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

  • Cemic /Id# 169184

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

  • Hospital Privado Univesitario /ID# 169228

    Córdoba, 5016

  • Hospital Provincial del Centenario /ID# 171254

    Rosario, Santa Fe Province, 2000

  • Cardio Alem /ID# 211284

    San Isidro, Buenos Aires, 1642

Other trials in Argentina

Australia6 sites

  • Royal Adelaide Hospital /ID# 171511

    Adelaide, South Australia, 5000

  • Box Hill Hospital /ID# 203734

    Box Hill, Victoria, 3128

  • Concord Repatriation General Hospital /ID# 171509

    Concord, New South Wales, 2139

  • Fiona Stanley Hospital /ID# 171510

    Murdoch, Western Australia, 6150

  • Coral Sea Clinical Research institute /ID# 212987

    North Mackay, Queensland, 4740

  • Mater Misericordiae Limited /ID# 204908

    South Brisbane, Queensland, 4101

Other trials in Australia

Croatia6 sites

  • UHC Split /ID# 171206

    Split, 21000

  • Zadar General Hospital /ID# 205534

    Zadar, 23000

  • Clinical Hospital Dubrava /ID# 171186

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Sestre milosrdnice /ID# 171190

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 171201

    Zagreb, City of Zagreb, 10000

  • Poliklinika Solmed /ID# 211518

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Egypt6 sites

  • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171010

    Alexandria, 21131

  • Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171015

    Alexandria, 21131

  • Clinical Research Center, Faculty of Medicine, Cairo university /ID# 209557

    Cairo, 11559

  • National Hepatology and Tropical Medicine Research Institute /ID# 170990

    Cairo, 11559

  • Faculty of Medicine Ain Shams Research Institute- Clinical Research Centre /ID# 209565

    Cairo, 11566

  • Air Force Specialized Hospital /ID# 170995

    Cairo

Other trials in Egypt

Greece6 sites

  • General Hospital of Athens Ippokratio /ID# 167036

    Athens, Attica, 11527

  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202103

    Athens, Attica, 11527

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 167037

    Athens, 10676

  • University General Hospital of Heraklion PA.G.N.I /ID# 167035

    Heraklion, Crete, 71500

  • Tzaneio general hospital of Piraeus /ID# 206432

    Piraeus, Attica, 18536

  • Genl Hosp Thess Ippokrateio /ID# 208824

    Thessaloniki, 54642

Other trials in Greece

Hungary6 sites

  • Obudai Egeszsegugyi Centrum Kft. /ID# 201891

    Budapest, Pest County, 1036

  • Magyar Honvedseg Egeszsegugyi Kozpont /ID# 201719

    Budapest, 1134

  • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 201720

    Debrecen, 4031

  • Bugat Pal Korhaz /ID# 201889

    Gyöngyös, Heves County, 3200

  • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205546

    Miskolc, Borsod-Abauj Zemplen county, 3529

  • Mentahaz Maganorvosi Kozpont /ID# 201890

    Székesfehérvár, 8000

Other trials in Hungary

Serbia6 sites

  • Clinical Hosp Center Zvezdara /ID# 168221

    Belgrade, Beograd, 11000

  • Military Medical Academy /ID# 168784

    Belgrade, Beograd, 11000

  • University Clinical Center Serbia /ID# 168220

    Belgrade, Beograd, 11000

  • Clin Hosp Ctr Bezanijska Kosa /ID# 168799

    Belgrade, Beograd, 11080

  • University Clinical Center Kragujevac /ID# 205858

    Kragujevac, Sumadijski Okrug, 34000

  • Clinical Center Vojvodina /ID# 168222

    Novi Sad, Vojvodina, 21000

Other trials in Serbia

Belgium5 sites

  • AZ Sint-Lucas /ID# 200301

    Ghent, 9000

  • CHU UCL Namur - site Godinne /ID# 200300

    Godinne, Namur, 5530

  • Universitair Ziekenhuis Leuven /ID# 200298

    Leuven, Vlaams-Brabant, 3000

  • CHU de Liege Sart Tilman /ID# 200299

    Liège, Liege, 4000

  • UCL Saint-Luc /ID# 200297

    Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

Chile5 sites

  • Hospital Guillermo Grant Benavente de Concepción /ID# 212422

    Concepción, 4070038

  • CTR Estudios Clinicos /ID# 200650

    Providencia, 7500571

  • M y F Estudios Clínicos /ID# 169995

    Santiago, Region Metropolitana Santiago, 7750495

  • Research Group /ID# 203180

    Santiago, Santiago Metropolitan, 2540364

  • Hospital Clinico Universidad De Los Andes /ID# 207465

    Santiago, 7501504

Other trials in Chile

Poland5 sites

  • Malopolskie Centrum Kliniczne /ID# 202166

    Krakow, Lesser Poland Voivodeship, 30-149

  • Centrum Zdrowia MDM /ID# 200486

    Warsaw, Masovian Voivodeship, 00-635

  • WIP Warsaw IBD Point Profesor Kierkus /ID# 224300

    Warsaw, Masovian Voivodeship, 00-728

  • Centrum Medyczne Reuma Park w Warszawie /ID# 200488

    Warsaw, Masovian Voivodeship, 02-691

  • Vistamed /ID# 208570

    Wroclaw, Lower Silesian Voivodeship, 53-149

Other trials in Poland

Portugal5 sites

  • Hospital Garcia de Orta, EPE /ID# 170234

    Almada, 2805-267

  • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170225

    Guimarães, Braga District, 4835-044

  • Hospital Egas Moniz /ID# 170249

    Lisbon, Porto District, 1349-019

  • Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 200606

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

  • Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170231

    Porto, 4200-319

Other trials in Portugal

South Africa5 sites

  • Farmovs (Pty) Ltd /Id# 207536

    Bloemfontein, Free State, 9301

  • Dr JP Wright /ID# 170885

    Cape Town, Western Cape, 7708

  • Private Practice Dr MN Rajabally /ID# 169852

    Cape Town, Western Cape, 7800

  • Lenasia Clinical Trial Centre /ID# 205144

    Johannesburg, Gauteng, 1820

  • Wits Clinical Research Site /ID# 170851

    Johannesburg, Gauteng, 2193

Other trials in South Africa

Bosnia and Herzegovina4 sites

  • University Clinical Centre of the Republic of Srpska /ID# 208050

    Banja Luka, Republika Srpska, 78000

  • Clinical Center University of Sarajevo /ID# 203885

    Sarajevo, 71000

  • Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217841

    Sarajevo, 71000

  • University Clinical Center Tuzla /ID# 210324

    Tuzla, Tuzlanski, 75000

Other trials in Bosnia and Herzegovina

Denmark4 sites

  • Nordsjaellands Hospital /ID# 200613

    Frederikssund, Capital Region, 3600

  • Herlev Hospital /ID# 200782

    Herlev, Capital Region, 2730

  • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 200611

    Hvidovre, Capital Region, 2650

  • Duplicate_Sjaellands Universitets Hospital /ID# 200783

    Roskilde, Region Sjælland, 4000

Other trials in Denmark

Netherlands4 sites

  • Academisch Medisch Centrum /ID# 166924

    Amsterdam, 1105 AZ

  • Medisch Spectrum Twente /ID# 170297

    Enschede, 7512 KZ

  • Zuyderland Medisch Centrum /ID# 169698

    Heerlen, Limburg, 6419 PC

  • Radboud Universitair Medisch Centrum /ID# 166925

    Nijmegen, Gelderland, 6525 GA

Other trials in Netherlands

Sweden4 sites

  • Alingsas lasarett /ID# 170838

    Alingsås, Västra Götaland County, 441 33

  • Sodra Alvsborgs sjukhus /ID# 202889

    Borås, Västra Götaland County, 501 82

  • Sahlgrenska University Hospital /ID# 169031

    Gothenburg, Västra Götaland County, 413 46

  • Hallands Hospital Halmstad /ID# 170840

    Halmstad, Halland County, 302 33

Other trials in Sweden

Austria3 sites

  • Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 214467

    Salzburg, 5020

  • Klinik Landstrasse /ID# 203437

    Vienna, State of Vienna, 1030

  • Medizinische Universitaet Wien /ID# 169462

    Vienna, State of Vienna, 1090

Other trials in Austria

Bulgaria3 sites

  • UMHAT Kaspela EOOD /ID# 167617

    Plovdiv, 4001

  • Duplicate_Second MHAT Sofia /ID# 167618

    Sofia, 1202

  • MHAT Trakia /ID# 201678

    Stara Zagora, 6004

Other trials in Bulgaria

Czechia3 sites

  • Hepato-Gastroenterologie HK, s.r.o. /ID# 171566

    Hradec Králové, 500 12

  • ResTrial s.r.o. /ID# 208652

    Prague, 143 00

  • ARTROSCAN s.r.o. /ID# 171592

    Třebovice, 722 00

Other trials in Czechia

Latvia3 sites

  • Pauls Stradins Clinical University Hospital /ID# 169493

    Riga, 1002

  • Digestive Disease Center Gastro /ID# 169517

    Riga, LV-1079

  • Riga East Clinical University Hospital /ID# 169496

    Riga, LV-1079

Other trials in Latvia

Mexico3 sites

  • Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207143

    Durango, Durango, 34000

  • Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 206779

    Guadalajara, Jalisco, 44650

  • Morales Vargas Centro de Investigacion S.C. /ID# 203495

    León, Guanajuato, 37000

Other trials in Mexico

Romania3 sites

  • Clinica GASTRO MED SRL /ID# 206367

    Cluj-Napoca, Cluj, 400380

  • Institutul Clinic Fundeni /ID# 167826

    Sector 2, Bucharest, 022328

  • Cabinet Particular Policlinic Algomed /ID# 167827

    Timișoara, 300002

Other trials in Romania

Singapore3 sites

  • KL Ling Gastroenterology and Liver Clinic /ID# 217963

    Singapore, 228510

  • Gleneagles Medical Centre /ID# 206530

    Singapore, 258499

  • Tan Tock Seng Hospital /ID# 203159

    Singapore, 308433

Other trials in Singapore

Colombia2 sites

  • Hospital Pablo Tobon Uribe /ID# 202405

    Medellín, Antioquia, 50034

  • Hospital San Vicente de Paul /ID# 200028

    Medellín, Antioquia, 50034

Other trials in Colombia

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207263

    Kaunas, 50161

  • Vilnius University Hospital Santaros Klinikos /ID# 203285

    Vilnius, 08661

Other trials in Lithuania

Malaysia2 sites

  • Hospital Sultanah Bahiyah /ID# 202627

    Alor Star, Kedah, 05460

  • Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170778

    Kuala Lumpur, Selangor, 56000

Other trials in Malaysia

Puerto Rico2 sites

  • Mindful Medical Research /ID# 203357

    San Juan, 00918-3756

  • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166770

    San Juan, 00935

Other trials in Puerto Rico

Slovakia2 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169952

    Banská Bystrica, 975 17

  • KM Management, spol. s.r.o. /ID# 170199

    Nitra, 949 01

Other trials in Slovakia

Switzerland2 sites

  • Inselspital, Universitätsspital Bern /ID# 171006

    Bern, 3010

  • Universitätsspital Zürich /ID# 170999

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Taiwan2 sites

  • National Taiwan University Hospital /ID# 169789

    Taipei, 100

  • Linkou Chang Gung Memorial Ho /ID# 169788

    Taoyuan City, 333

Other trials in Taiwan

Estonia1 site

  • Tartu University Hospital /ID# 203140

    Tartu, Tartu, 50406

Other trials in Estonia

Hong Kong1 site

  • Queen Mary Hospital /ID# 171217

    Hong Kong, 999077

Other trials in Hong Kong

Ireland1 site

  • Mercy University Hospital /ID# 206510

    Cork, T12 WE28

Other trials in Ireland

Slovenia1 site

  • Univ Medical Ctr Ljubljana /ID# 211042

    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 Biologic Therapy

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

Conditions
Crohn's Disease
Being tested
Matching Placebo for Upadacitinib, Upadacitinib
Keywords
Upadacitinib, Crohn's Disease, Efficacy, Safety
Medical subject headings
Crohn Disease

What participants receive

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

  • Matching Placebo for UpadacitinibDrug

    Matching placebo tablets

  • UpadacitinibDrug

    Also called ABT-494, RINVOQ®

    Upadacitinib tablets

Study groups in NCT03345836
Study groupRoleWhat they receive
Part 1 (Double-blind): PlaceboPlacebo comparatorParticipants received upadacitinib matching placebo tablets, orally, once daily (QD) for 12 weeks during the Double-blind (DB) Induction Period.
Receives: Drug: Matching Placebo for Upadacitinib
Part 1 (Double-blind): Upadacitinib 45 mgExperimentalParticipants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
Receives: Drug: Upadacitinib
Part 2 (Open-label): Upadacitinib 45 mgExperimentalParticipants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
Receives: Drug: Upadacitinib
Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB PlaceboExperimentalParticipants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
Receives: Drug: Upadacitinib
Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mgExperimentalParticipants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
Receives: Drug: Upadacitinib
Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mgExperimentalParticipants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
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 CDAI was used to evaluate the activity of Crohn's disease. Clinical remission per CDAI is defined as CDAI <150. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C).

    Measured: Week 12

  2. Percentage of Participants With Endoscopic Response at Week 12

    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 of the induction study, at least a 2-point reduction from Baseline), as scored by Central Reviewer. SES-CD is calculated based on the sum of individual segment values for four endoscopic variables (presence and size of ulcers, ulcerated surface, affected surface and presence of narrowing). Each variable in each segment is scored 0 to 3 resulting in SES-CD values ranging from 0 to 56 with higher scores indicating more severe disease. Results were based on NRI-C.

    Measured: Baseline to Week 12

  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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.

    Measured: From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)

Secondary outcomes (10)

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

    Clinical remission per PROs was defined as average daily very soft or liquid stool frequency (SF) ≤2.8 and average daily abdominal pain (AP) score ≤1.0 and both not greater than Baseline. The number of soft or liquid stools and abdominal pain rated on a scale of 0=none to 3=severe were recorded in an electronic diary. Results were based on NRI-C.

    Measured: Baseline to Week 12

  2. Percentage of Participants With Endoscopic Remission at Week 12

    Endoscopic remission was defined per SES-CD. SES-CD ≤4 and at least 2-point reduction from Baseline and no subscore >1 in any individual variable, as scored by Central Reviewer. SES-CD is calculated based on the sum of individual segment values for four endoscopic variables (presence and size of ulcers, ulcerated surface, affected surface and presence of narrowing). Each variable in each segment is scored 0 to 3 resulting in SES-CD values ranging from 0 to 56 with higher scores indicating more severe disease. Results were based on NRI-C.

    Measured: Baseline to Week 12

  3. Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease (CD) and Achieved Clinical Remission Per CDAI at Week 12, in Participants Taking Corticosteroids at Baseline

    As prespecified in the protocol, this outcome measure was planned to be assessed in participants taking corticosteroids at Baseline. Clinical remission per CDAI: CDAI <150. The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.

    Measured: Week 12

  4. Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Week 12

    The FACIT-F questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. The responses to the 13 items on the FACIT-F questionnaire are each measured on a 5-point Likert scale. The responses to the answers are the following: 0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4=very much. Thus, the total score ranges from 0 to 52. High scores represent less fatigue. A positive change from Baseline indicates improvement.

    Measured: Baseline and Week 12

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

    The IBDQ is a disease-specific instrument composed of 32 Likert-scaled items. The IBDQ scale contains 4 component subscales: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function(5 items). Each item is scored on a 7-point scale where: 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

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

    CR-100 is defined as a decrease of at least 100 points in CDAI from Baseline at Week 2. The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.

    Measured: Baseline to Week 2

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

    CR-100 is defined as a decrease of at least 100 points in CDAI from Baseline at Week 12. The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.

    Measured: Baseline to Week 12

  8. Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 4

    The CDAI was used to evaluate the activity of Crohn's disease. Clinical remission per CDAI is defined as CDAI <150. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.

    Measured: Week 4

  9. Percentage of Participants With Hospitalizations Due to Crohn's Disease (CD) During Part 1 (12-week Double-blind Induction Period)

    Measured: Up to Week 12 in Part 1: Double-blind Induction Period

  10. Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs) at Week 12, 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. Results were based on NRI-C.

    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 start29 Nov 2017
  3. Primary completion11 Aug 2021
  4. Study completion11 Aug 2021

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
624 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03345836
Sponsor's protocol ID
M14-431
Other IDs
2017-001226-18, 2017
Status last verified
Jul 2022
First submitted
15 Nov 2017
Last updated
15 Aug 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

  • 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

  • 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

  • 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 428 sites in 48 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 5 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 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 428 sites in United States, Japan, Canada, China, Italy and 43 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 15 Aug 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 NCT03345836, 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 15 Aug 2022.

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