AzTrials
AzTrials

Crohn's Disease (CD)Phase 3SEQUENCENCT04524611

Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)

A Phase 3 study testing Risankizumab and Ustekinumab in people with Crohn's Disease (CD), run by AbbVie at 300 sites in 31 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Crohn's Disease (CD)
What is being tested?
Risankizumab and Ustekinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
527 participants
Where
300 sitesin 31 countries
Study dates
30 Sep 2020to Feb 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

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

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of Crohn's disease (CD) for at least 3 months prior to Baseline.
  • Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.
  • Confirmed diagnosis of moderate to severe Crohn's Disease as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD (SES-CD).
  • Demonstrated intolerance or inadequate response to one or more anti-tumor necrosis factor (TNF) therapies.

Who cannot join

  • Current diagnosis of ulcerative colitis or indeterminate colitis.
  • Receipt of CD approved biologic agents prior to Baseline (as detailed in protocol), or any investigational biologic or other agent or procedure prior to Baseline (as detailed in protocol).
  • Prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab).
  • Currently know complications of CD (strictures, short bowel, etc).

Trial locations and contacts

300 sites in 31 countries.

300 sites in 31 countries

United States72 sites

  • Univ New Mexico /ID# 223515

    Albuquerque, New Mexico, 87131

  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 223597

    Ann Arbor, Michigan, 48109

  • Atlanta Gastro Assoc /ID# 223537

    Atlanta, Georgia, 30342

  • GI Alliance /ID# 223508

    Baton Rouge, Louisiana, 70809

  • Massachusetts General Hospital /Id# 224335

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center /ID# 228094

    Boston, Massachusetts, 02215-5400

  • NY Scientific /ID# 223479

    Brooklyn, New York, 11235

  • University of Vermont Medical Center /ID# 224047

    Burlington, Vermont, 05401-1473

  • Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 224048

    Burnt Hills, New York, 12027

  • Advanced Gastroenterology, P.C /ID# 224396

    Chandler, Arizona, 85224-1636

  • Univ NC Chapel Hill /ID# 224405

    Chapel Hill, North Carolina, 27514-4220

  • Medical University of South Carolina /ID# 223485

    Charleston, South Carolina, 29425

  • Duplicate_MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 223499

    Chevy Chase, Maryland, 20815

  • Duplicate_The University of Chicago DCAM /ID# 223520

    Chicago, Illinois, 60637

  • University of Cincinnati Medical Center /ID# 224614

    Cincinnati, Ohio, 45219-2364

  • Cleveland Clinic Main Campus /ID# 223691

    Cleveland, Ohio, 44195

  • Gastro Center of Maryland /ID# 223518

    Columbia, Maryland, 21045

  • Consultants in Gastroenterology - Columbia NE /ID# 224263

    Columbia, South Carolina, 29203-8902

  • Gastro One /ID# 223539

    Cordova, Tennessee, 38018

  • Southern California Res. Ctr. /ID# 223484

    Coronado, California, 92118-1408

  • Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 223512

    Dallas, Texas, 75246

  • Duplicate_Western Connecticut Medical Group /ID# 223478

    Danbury, Connecticut, 06810

  • Omega Research Maitland, LLC /ID# 223463

    DeBary, Florida, 32713-2260

  • NorthShore University-Endeavor Health Evanston Hospital /ID# 223538

    Evanston, Illinois, 60201

  • Plains Clinical Research Center, LLC /ID# 223522

    Fargo, North Dakota, 58104-5925

  • AA Medical Research Center - Flint /ID# 224384

    Flint, Michigan, 48504

  • Intercity Advanced Gastroentertology Center /ID# 224313

    Fresh Meadows, New York, 11366

  • Duplicate_DHAT Research Institute /ID# 223521

    Garland, Texas, 75044-2208

  • Gastroenterology Associates, P.A. of Greenville /ID# 223497

    Greenville, South Carolina, 29607

  • Duplicate_Medical Research Center of CT /ID# 223540

    Hamden, Connecticut, 06518

  • Penn State Milton S. Hershey Medical Center /ID# 224216

    Hershey, Pennsylvania, 17033-2360

  • Vilo Research Group Inc /ID# 223513

    Houston, Texas, 77017-2337

  • Duplicate_Baylor College of Medicine - Baylor Medical Center /ID# 223488

    Houston, Texas, 77030-3411

  • Nature Coast Clinical Research - Inverness /ID# 223600

    Inverness, Florida, 34452-4717

  • Hoag Memorial Hosp Presbyterian /ID# 224373

    Irvine, California, 92618

  • Las Vegas Medical Research /ID# 223533

    Las Vegas, Nevada, 89113

  • United Medical Doctors /ID# 223486

    Los Alamitos, California, 90720-3309

  • TLC Clinical Research Inc /ID# 223467

    Los Angeles, California, 90048

  • University of Louisville Hospital /ID# 223471

    Louisville, Kentucky, 40202

  • Gastroenterology Associates of Central Georgia, LLC /ID# 223525

    Macon, Georgia, 31201

  • University of Miami /ID# 223496

    Miami, Florida, 33136

  • West Virginia University Hospitals /ID# 223501

    Morgantown, West Virginia, 26506

  • Gastroenterology Group Naples /ID# 223516

    Naples, Florida, 34102

  • Vanderbilt University Medical Center /ID# 224610

    Nashville, Tennessee, 37232-0011

  • Yale Univ Digestive Diseases /ID# 224463

    New Haven, Connecticut, 06510

  • North Shore University Hospital /ID# 224356

    New Hyde Park, New York, 11040

  • Nola Research Works, LLC /ID# 223489

    New Orleans, Louisiana, 70115

  • Advanced Research Institute, Inc /ID# 223470

    New Port Richey, Florida, 34653

  • The Mount Sinai Hospital /ID# 223687

    New York, New York, 10029

  • Columbia Univ Medical Center /ID# 224215

    New York, New York, 10032-3725

  • Lenox Hill Hospital /ID# 223534

    New York, New York, 10075

  • Southwest Gastroenterology /ID# 223509

    Oak Lawn, Illinois, 60453

  • Hightower Clinical /ID# 223566

    Oklahoma City, Oklahoma, 73102

  • Digestive Disease Specialists /ID# 223528

    Oklahoma City, Oklahoma, 73112

  • Endoscopic Research, Inc. /ID# 223505

    Orlando, Florida, 32803

  • Richmond VA Medical Center /ID# 223586

    Richmond, Virginia, 23249

  • Mayo Clinic - Rochester /ID# 223506

    Rochester, Minnesota, 55905-0001

  • Duplicate_UC Davis Medical Center /ID# 225700

    Sacramento, California, 95817

  • Clinical Associates in Research Therapeutics of America, LLC /ID# 223510

    San Antonio, Texas, 78212

  • Southern Star Research Institute, LLC /ID# 223598

    San Antonio, Texas, 78229-5390

  • Duplicate_University of California, San Francisco /ID# 223621

    San Francisco, California, 94158

  • Guthrie Medical Group, PC /ID# 223910

    Sayre, Pennsylvania, 18840

  • Virginia Mason Hospital & Medical Center /ID# 224253

    Seattle, Washington, 98101

  • Harborview Medical Center /ID# 224464

    Seattle, Washington, 98104-2420

  • Louisiana Research Center, LLC /ID# 223503

    Shreveport, Louisiana, 71105-6800

  • Texas Digestive Disease Consultants - Southlake /ID# 224264

    Southlake, Texas, 76092

  • DSI Research, LLC /ID# 234116

    Springboro, Ohio, 45066-1615

  • Duplicate_University of South Florida /ID# 224733

    Tampa, Florida, 33612

  • Tyler Research Institute, LLC /ID# 223469

    Tyler, Texas, 75701

  • Duplicate_Atrium Health Wake Forest Baptist Medical Center /ID# 224406

    Winston-Salem, North Carolina, 27157-0001

  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 223465

    Wyoming, Michigan, 49519

  • Digestive Disease Associates, LTD - Wyomissing /ID# 223462

    Wyomissing, Pennsylvania, 19610

Other trials in United States

China21 sites

  • Peking University Third Hospital /ID# 224479

    Beijing, Beijing Municipality, 100191

  • The Second Xiangya Hospital Of Central South University /ID# 224684

    Changsha, Hunan, 410011

  • Duplicate_The Third Xiangya Hospital of Central South University /ID# 224754

    Changsha, Hunan, 410013

  • Changzhou No.2 Peoples Hospital /ID# 238965

    Changzhou, Jiangsu, 213000

  • West China Hospital, Sichuan University /ID# 224786

    Chengdu, Sichuan, 610041

  • Chongqing General Hospital /ID# 232305

    Chongqing, Chongqing Municipality, 400013

  • Zhujiang Hospital of Southern Medical University /ID# 224524

    Guangzhou, Guangdong, 510280

  • The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 224416

    Guangzhou, Guangdong, 510655

  • The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 224662

    Hangzhou, Zhejiang, 310009

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 224421

    Hangzhou, Zhejiang, 310018

  • Anhui Provincial Hospital /ID# 224832

    Hefei, Anhui, 230001

  • The First Affiliated Hospital of Nanchang University /ID# 224507

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital /ID# 224746

    Nanjing, Jiangsu, 210008

  • Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 224420

    Shanghai, Shanghai Municipality, 200127

  • Shengjing Hospital of China Medical University /ID# 224478

    Shenyang, Liaoning, 110022

  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 224545

    Wuhan, Hubei, 430022

  • Tongji Hospital Tongji Medical College of HUST /ID# 224428

    Wuhan, Hubei, 430030

  • Renmin Hospital of Wuhan University /ID# 224525

    Wuhan, Hubei, 430060

  • Wuxi People's Hospital /ID# 224426

    Wuxi, Jiangsu, 214023

  • Zhongshan Hospital Xiamen University /ID# 224663

    Xiamen, Fujian, 361004

  • The Second Affiliated Hospital of Zhengzhou University /ID# 224528

    Zhengzhou, Henan, 450014

Other trials in China

Germany21 sites

  • Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 229110

    Berlin, 10318

  • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 223411

    Berlin, 10825

  • Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 223405

    Berlin, 13353

  • DRK Kliniken Berlin Westend /ID# 223412

    Berlin, 14050

  • Krankenhaus Waldfriede /ID# 223397

    Berlin-Zehlendorf, 14163

  • Duplicate_Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 223403

    Dresden, Saxony, 01307

  • Universitaetsklinikum Erlangen /ID# 223404

    Erlangen, Bavaria, 91054

  • Duplicate_Agaplesion Markus Krankenhaus /ID# 223673

    Frankfurt am Main, Hesse, 60431

  • Duplicate_Universitaetsklinikum Frankfurt /ID# 223396

    Frankfurt am Main, Hesse, 60590

  • Universitaetsklinikum Freiburg /ID# 223406

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Praxiszentrum fuer Gastroenterologie /ID# 223409

    Grevenbroich, North Rhine-Westphalia, 41515

  • Medizinische Hochschule Hannover /ID# 223402

    Hanover, Lower Saxony, 30625

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 223395

    Kiel, Schleswig-Holstein, 24105

  • Eugastro /ID# 223401

    Leipzig, Saxony, 04103

  • Klinikum Lueneburg /ID# 223408

    Lüneburg, Lower Saxony, 21339

  • Otto-von-Guericke-Universitaet /ID# 223413

    Magdeburg, Saxony-Anhalt, 39120

  • Universitatsklinikum Mannheim /ID# 223410

    Mannheim, Baden-Wurttemberg, 68167

  • Medizinisches Versorgungszentrum Portal 10 /ID# 224552

    Münster, 48155

  • Universitatsklinik Regensburg /ID# 223407

    Regensburg, Bavaria, 93053

  • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 223482

    Saarbrücken, Saarland, 66111

  • Universitaetsklinikum Ulm /ID# 223400

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

United Kingdom17 sites

  • Belfast Health and Social Care Trust /ID# 224023

    Belfast, BT9 7AB

  • Addenbrookes Hospital /ID# 223648

    Cambridge, Cambridgeshire, CB2 2QQ

  • Western General Hospital - NHS Lothian /ID# 223646

    Edinburgh, Edinburgh, City of, EH4 2XU

  • Royal Devon & Exeter Hospital /ID# 223644

    Exeter, Devon, EX2 5DW

  • Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde /ID# 223653

    Glasgow, Lanarkshire, G51 4TF

  • Calderdale and Huddersfield NHS Foundation Trust /ID# 223654

    Huddersfield, HX3 0PW

  • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 223651

    London, Greater London, E1 2ES

  • St Thomas' Hospital - Guy's and St Thomas' NHS Foundation Trust /ID# 223647

    London, Greater London, SE1 7EH

  • Kings College Hospital NHS Foundation Trust /ID# 223649

    London, Greater London, SE5 9RS

  • St George University Hospitals NHS Foundation Trust /ID# 223656

    London, Greater London, SW17 0QT

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 223655

    Newcastle upon Tyne, NE3 3HD

  • Duplicate_Nottingham University Hospitals NHS Trust /ID# 224179

    Nottingham, Nottinghamshire, NG5 1PB

  • Oxford University Hospitals NHS Foundation Trust /ID# 223645

    Oxford, Oxfordshire, OX3 9DU

  • Northern Care Alliance NHS Group /ID# 223650

    Salford, M6 8HD

  • University Hospital Southampton NHS Foundation Trust /ID# 224351

    Southampton, Hampshire, SO16 6YD

  • East and North Hertfordshire NHS Trust /ID# 224607

    Stevenage, Hertfordshire, SG1 4AB

  • NHS Forth Valley /ID# 224657

    Stirling, FK9 4SW

Other trials in United Kingdom

France16 sites

  • CHU Clermont-Ferrand /ID# 224529

    Clermont, Auvergne-Rhône-Alpes, 63100

  • Hopital Beaujon /ID# 223863

    Clichy, Île-de-France Region, 92110

  • Duplicate_CHU Grenoble - Hopital Michallon /ID# 224091

    La Tronche, Isere, 38700

  • CHRU Lille - Hopital Claude Huriez /ID# 223765

    Lille, Nord, 59037

  • APHM - Hopital Nord /ID# 223869

    Marseille, Bouches-du-Rhone, 13015

  • CHU Montpellier - Hopital Saint Eloi /ID# 223860

    Montpellier, Herault, 34295

  • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 241098

    Nantes, Pays de la Loire Region, 44000

  • Clinique Jules Verne /ID# 223870

    Nantes, 44300

  • Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 249859

    Neuilly-sur-Seine, Île-de-France Region, 92200

  • Chu de Nice-Hopital Larchet Ii /Id# 223763

    Nice, Alpes-Maritimes, 06202

  • Polyclinique Grand Sud /ID# 224092

    Nîmes, 30932

  • Duplicate_CHU Bordeaux - Hopital Haut Leveque /ID# 223764

    Pessac, Gironde, 33604

  • CHU Reims - Hôpital Robert Debre /ID# 224530

    Reims, Marne, 51092

  • Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 223768

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

  • Hopital Universitaire Purpan Hopital Rangueil /ID# 224732

    Toulouse, 31059

  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 223767

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511

Other trials in France

Spain16 sites

  • Hospital General Universitario de Alicante Doctor Balmis /ID# 223552

    Alicante, 03010

  • Hospital Universitario Germans Trias i Pujol /ID# 223436

    Badalona, Barcelona, 08916

  • Hospital Clinic de Barcelona /ID# 223355

    Barcelona, 08036

  • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 223356

    Ferrol, A Coruna, 15405

  • Hospital Universitario de Fuenlabrada /ID# 223371

    Fuenlabrada, Madrid, 28942

  • Duplicate_Hospital Universitario de Bellvitge /ID# 225719

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital General Universitario Gregorio Maranon /ID# 223317

    Madrid, 28007

  • Hospital Clinico San Carlos /ID# 223367

    Madrid, 28040

  • Hospital Universitario La Paz /ID# 223318

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 223319

    Majadahonda, Madrid, 28222

  • Hospital Universitario Central de Asturias /ID# 223368

    Oviedo, Principality of Asturias, 33011

  • Duplicate_Hospital Clínico Universitario de Santiago-CHUS /ID# 226554

    Santiago de Compostela, A Coruna, 15706

  • Hospital Universitario Virgen Macarena /ID# 223315

    Seville, 41009

  • Hospital Universitario Virgen del Rocio /ID# 223476

    Seville, 41013

  • Hospital Clinico Universitario de Valencia /ID# 223321

    Valencia, 46010

  • Hospital Universitario y Politecnico La Fe /ID# 223314

    Valencia, 46026

Other trials in Spain

Canada14 sites

  • Duplicate_University of Calgary /ID# 223750

    Calgary, Alberta, T2N 4Z6

  • Allen Whey Khye Lim Professional Corporation /ID# 223755

    Edmonton, Alberta, T5R 1W2

  • Covenant Health /ID# 223753

    Edmonton, Alberta, T6K 4B2

  • CISSS de la Monteregie /ID# 224399

    Greenfield Park, Quebec, J4V 2H1

  • QEII - Health Sciences Centre /ID# 223748

    Halifax, Nova Scotia, B3H 2Y9

  • CSSS Alphonse-Desjardins, CHAU de Levis /ID# 223744

    Lévis, Quebec, G6V 3Z1

  • London Health Sciences Centre - University Hospital /ID# 223741

    London, Ontario, N6A 5A5

  • Montreal General Hospital- McGill University Health Center /ID# 223743

    Montreal, Quebec, H3G 1A4

  • Fraser Clinical Trials Inc /ID# 223742

    New Westminster, British Columbia, V3L 3W4

  • Scott Shulman Medicine Professional Corporation /ID# 223754

    North Bay, Ontario, P1B 2H3

  • Duplicate_Duplicate_CHUS - Hopital Fleurimont /ID# 224819

    Sherbrooke, Quebec, J1H 5N4

  • Mount Sinai Hospital /ID# 223752

    Toronto, Ontario, M5G 1X5

  • Axler, Toronto, ON. Canada /ID# 223740

    Toronto, Ontario, M9V 0A9

  • Percuro Clinical Research, Ltd /ID# 223747

    Victoria, British Columbia, V8V 3M9

Other trials in Canada

Italy13 sites

  • Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 223330

    Bologna, Emilia-Romagna, 40138

  • Azienda Ospedaliera G. Brotzu /ID# 241165

    Cagliari, 09121

  • Duplicate_Ospedale San Giovanni Di Dio - Cagliari /ID# 223474

    Cagliari, 09124

  • Duplicate_Ospedale Policlinico San Martino /ID# 223329

    Genoa, Genova, 16132

  • Duplicate_Ospedale San Raffaele IRCCS /ID# 241167

    Milan, Milano, 20132

  • ASST Fatebenefratelli Sacco /ID# 223322

    Milan, Milano, 20157

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 223324

    Milan, 20122

  • Duplicate_IRCCS Ospedale Sacro Cuore Don Calabria /ID# 223327

    Negrar, Verona, 37024

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 223333

    Palermo, 90146

  • ASST Rhodense/Presidio Ospedaliero di Rho /ID# 223335

    Rho, Milano, 20017

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 223332

    Rome, Roma, 00133

  • Azienda Ospedaliera San Camillo Forlanini /ID# 223325

    Rome, Roma, 00149

  • Duplicate_Policlinico Agostino Gemelli /ID# 223323

    Rome, Roma, 00168

Other trials in Italy

Belgium11 sites

  • Universite Libre de Bruxelles - Hopital Erasme /ID# 223902

    Anderlecht, Brussels Capital, 1070

  • Cliniques Universitaires UCL Saint-Luc /ID# 223900

    Brussels, Brussels Capital, 1200

  • UZ Gent /ID# 223899

    Ghent, Oost-Vlaanderen, 9000

  • AZ Maria Middelares /ID# 223908

    Ghent, 9000

  • Duplicate_CHU UCL Namur - site Godinne /ID# 223905

    Godinne, Namur, 5530

  • Universitair Ziekenhuis Leuven /ID# 223901

    Leuven, Vlaams-Brabant, 3000

  • Groupe Sante CHC - Clinique du MontLegia /ID# 223898

    Liège, Liege, 4000

  • Duplicate_CHU de Liege /ID# 223904

    Liège, 4000

  • ZAS Palfijn /ID# 223907

    Merksem, Antwerpen, 2170

  • AZ-Delta. /ID# 223896

    Roeselare, West-Vlaanderen, 8800

  • Vitaz /Id# 224511

    Sint-Niklaas, Oost-Vlaanderen, 9100

Other trials in Belgium

Argentina7 sites

  • Hospital Italiano de Buenos Aires /ID# 224550

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

  • Hospital Britanico de Buenos Aires /ID# 223432

    Ciudad Autonoma de Buenos Aire, Buenos Aires, 1280

  • CINME Centro de Investigaciones Metabolicas /ID# 223447

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1027

  • Gedyt /ID# 224698

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

  • Duplicate_CEMIC /ID# 223670

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1431

  • Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 223433

    Córdoba, 5016

  • Duplicate_Sanatorio 9 de Julio /ID# 226086

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Greece7 sites

  • General Hospital of Athens Ippokratio /ID# 223344

    Athens, Attica, 11527

  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 223342

    Athens, Attica, 11527

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 223338

    Athens, 10676

  • University General Hospital of Heraklion PA.G.N.I /ID# 223336

    Heraklion, Crete, 71500

  • University General Hospital of Ioannina /ID# 223339

    Ioannina, 45500

  • General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 223340

    Nikaia, Attica, 18454

  • General Hospital of Thessaloniki Hippokrateio /ID# 223887

    Thessaloniki, 54642

Other trials in Greece

Israel7 sites

  • The Edith Wolfson Medical Center /ID# 227652

    Ashkelon, Southern District, 5822000

  • Soroka University Medical Center /ID# 223556

    Beersheba, Southern District, 8410101

  • Shaare Zedek Medical Center /ID# 223549

    Jerusalem, Jerusalem, 91031

  • Rabin Medical Center. /ID# 223558

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center /ID# 223557

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 223551

    Tel Aviv, Tel Aviv, 6423906

  • Yitzhak Shamir Medical Center /ID# 224686

    Ẕerifin, Central District, 70300

Other trials in Israel

Romania7 sites

  • Duplicate_Institutul Clinic Fundeni /ID# 223914

    Bucharest, Bucharest, 022328

  • Duplicate_Univ Emergency Hosp Bucharest /ID# 223579

    Bucharest, Bucharest, 050098

  • Sana Monitoring /Id# 223682

    Bucharest, 011025

  • Spitalul Clinic Colentina /ID# 223680

    Bucharest, 020121

  • Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 224017

    Târgu Mureş, 540136

  • Targu Mures Emergency Clinical County Hospital /ID# 223613

    Târgu Mureş, 540136

  • Cabinet Particular Policlinic Algomed /ID# 223578

    Timișoara, 300002

Other trials in Romania

Czechia6 sites

  • Nemocnice Ceske Budejovice a.s. /ID# 224219

    České Budějovice, 370 01

  • Hepato-Gastroenterologie HK, s.r.o. /ID# 223277

    Hradec Králové, 500 12

  • Nemocnice Pardubickeho kraje, a.s. /ID# 223256

    Pardubice, 530 03

  • Iscare Klinické Centrum /ID# 223279

    Prague, Praha 9, 190 00

  • Axon Clinical, s.r.o. /ID# 223260

    Prague, 140 00

  • Nemocnice Horovice - NH Hospital a.s /ID# 223276

    Prague, 155 00

Other trials in Czechia

Australia5 sites

  • Monash Health - Monash Medical Centre /ID# 224599

    Clayton, Victoria, 3168

  • Lyell McEwin Hospital /ID# 223643

    Elizabeth Vale, South Australia, 5112

  • Mater Misericordiae Limited /ID# 223642

    South Brisbane, Queensland, 4101

  • Griffith University /ID# 223641

    Southport, Queensland, 4222

  • Wollongong Hospital /ID# 224688

    Wollongong, New South Wales, 2500

Other trials in Australia

Hungary5 sites

  • Clinexpert Kft /ID# 223775

    Budapest, 1033

  • Semmelweis Egyetem /ID# 223772

    Budapest, 1085

  • Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 223773

    Debrecen, Hajdú-Bihar, 4032

  • Duplicate_Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 223774

    Szeged, Csongrád megye, 6725

  • Duplicate_Clinfan Szolgaltato Kft. /ID# 224751

    Szekszárd, Tolna County, 7100

Other trials in Hungary

Mexico5 sites

  • BRCR Global Mexico /ID# 223970

    Guadalajara, Jalisco, 44600

  • Medical Care & Research SA de CV /ID# 223974

    Mérida, Yucatán, 97070

  • Centro de Investigacion en Artritis y Osteoporosis S.C. /ID# 227179

    Mexicali, Estado de Baja California, 21200

  • Centro Medico Zambrano Hellion /ID# 224025

    San Pedro Garza García, Nuevo León, 66278

  • Faicic S de Rl de Cv /Id# 226990

    Veracruz, 91900

Other trials in Mexico

Brazil4 sites

  • Upeclin Fmb - Unesp /Id# 223234

    Botucatu, São Paulo, 18618-686

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 223233

    Ribeirão Preto, São Paulo, 14049-900

  • Faculdade de Medicina do ABC /ID# 223231

    Santo André, La Spezia, 09060-870

  • Kaiser Clinica e Hospital Dia /ID# 223232

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

Other trials in Brazil

Bulgaria4 sites

  • Umbal Kaspela /ID# 223415

    Plovdiv, 4001

  • MHAT Knyaginya Klementina /ID# 223425

    Sofia, 1233

  • Acibadem City Clinic Tokuda University Hospital EAD /ID# 223757

    Sofia, 1407

  • Hospital Tsaritsa Yoanna /ID# 223822

    Sofiya, Sofia, 1527

Other trials in Bulgaria

Netherlands4 sites

  • Amsterdam UMC, locatie AMC /ID# 223228

    Amsterdam, North Holland, 1105 AZ

  • Radboud Universitair Medisch Centrum /ID# 233750

    Nijmegen, Gelderland, 6525 GA

  • Elisabeth Tweesteden Ziekenhuis /ID# 223229

    Tilburg, North Brabant, 5022 GC

  • Universitair Medisch Centrum Utrecht /ID# 223696

    Utrecht, 3584 CX

Other trials in Netherlands

Slovakia4 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 223302

    Banská Bystrica, Banská Bystrica Region, 975 17

  • KM Management, spol. s.r.o. /ID# 223304

    Nitra, Nitra Region, 949 01

  • Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224580

    Nové Zámky, Nitra Region, 940 34

  • Duplicate_GASTRO I., s.r.o. /ID# 223303

    Prešov, Presov, 080 01

Other trials in Slovakia

South Africa4 sites

  • Dr MJ Prins /ID# 224304

    Cape Town, Western Cape, 7500

  • Private Practice Dr MN Rajabally /ID# 223805

    Cape Town, Western Cape, 7800

  • Spoke Research Inc /ID# 223803

    CAPE TOWN Milnerton, Western Cape, 7441

  • Lenasia Clinical Trial Centre /ID# 224306

    Johannesburg, Gauteng, 1820

Other trials in South Africa

South Korea4 sites

  • Duplicate_The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 223456

    Junggu, Daejeon Gwang Yeogsi, 34943

  • Duplicate_Kangbuk Samsung Hospital /ID# 223452

    Seoul, Seoul Teugbyeolsi, 03181

  • Samsung Medical Center /ID# 223453

    Seoul, Seoul Teugbyeolsi, 06351

  • Duplicate_Dong-A University Hospital /ID# 223455

    서구, Gyeongsangnam-do, 49201

Other trials in South Korea

Sweden4 sites

  • Duplicate_Falu Lasarett /ID# 227222

    Falun, 791 31

  • Karolinska University Hospital Solna /ID# 223423

    Solna, Stockholm County, 171 64

  • GHP Stockholm Gastro Center /ID# 223420

    Stockholm, Stockholm County, 114 28

  • Danderyds sjukhus AB /ID# 223363

    Stockholm, 182 88

Other trials in Sweden

Turkey (Türkiye)4 sites

  • Ankara Univ Medical Faculty /ID# 223388

    Ankara, 06590

  • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 223387

    Istanbul, 34098

  • Mersin University Medical /ID# 223385

    Mersin, 33343

  • Gazi Universitesi Tip Fakultes /ID# 223386

    Yenimahalle, Ankara, 06560

Other trials in Turkey (Türkiye)

Austria3 sites

  • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 223440

    Linz, Upper Austria, 4010

  • Universitaetsklinikum St. Poelten /ID# 223437

    Sankt Pölten, Lower Austria, 3100

  • Medizinische Universitaet Wien /ID# 223438

    Vienna, State of Vienna, 1090

Other trials in Austria

Chile3 sites

  • Hospital Guillermo Grant Benavente de Concepción /ID# 223668

    Concepción, Biobio, 4070038

  • Sociedad de Servicios Medicos Walsen Galmez Ltda. /ID# 224032

    Providencia, Region Metropolitana Santiago, 7510086

  • Hospital Las Higueras /ID# 223669

    Talcahuano, Biobio, 1740000

Other trials in Chile

Poland3 sites

  • Malopolskie Centrum Kliniczne /ID# 223708

    Krakow, Lesser Poland Voivodeship, 30-149

  • Gastromed Sp. z o.o /ID# 223705

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Vivamed Sp. z o.o. /ID# 223706

    Warsaw, Masovian Voivodeship, 03-580

Other trials in Poland

Russia3 sites

  • Immanuel Kant Baltic Federal University /ID# 224224

    Kaliningrad, Kaliningrad Oblast, 236016

  • National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 224222

    Moscow, 123423

  • City Clinical Hospital No. 31 /ID# 224223

    Saint Petersburg, 197110

Other trials in Russia

Switzerland3 sites

  • University Hospital Basel /ID# 223711

    Basel Town, Canton of Basel-City, 4031

  • Inselspital, Universitaetsspital Bern /ID# 223590

    Bern, 3010

  • Duplicate_Universitatsspital Zurich /ID# 223712

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Ukraine3 sites

  • Kyiv City Clinical Hospital No.18 /ID# 223700

    Kyiv, 01030

  • Lviv Regional Clinical Hospital /ID# 223661

    Lviv, Lviv Oblast, 79010

  • Medical Center of LLC DIASERVIS /ID# 224249

    Zaporizhzhya, 69076

Other trials in Ukraine

About this study

Official title: A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI).

Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide.

Read more

In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Being tested
Risankizumab, Ustekinumab
Keywords
Crohn's Disease (CD), Risankizumab, Ustekinumab, SKYRIZI
Medical subject headings
Crohn Disease

What participants receive

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

  • RisankizumabDrug

    Also called ABBV-066, SKYRIZI

    Intravenous (IV) Infusion

  • RisankizumabDrug

    Also called ABBV-066, SKYRIZI

    Subcutaneous (SC) Injection

  • UstekinumabDrug

    Intravenous (IV) infusion

  • UstekinumabDrug

    Subcutaneous (SC) injection

Study groups in NCT04524611
Study groupRoleWhat they receive
Risankizumab Dose A Followed by Dose BExperimentalParticipants will receive intravenous risankizumab dose A at Week 0, 4 ,8 followed by subcutaneous (SC) risankizumab dose B every 8 weeks through Week 48. Participants who complete the Week 48 visit will continue SC risankizumab for up to an additional 220 weeks.
Receives: Drug: Risankizumab
UstekinumabActive comparatorParticipants will receive weight-based intravenous ustekinumab at Week 0 followed by subcutaneous ustekinumab every 8 weeks through Week 48.
Receives: Drug: Ustekinumab

What is being measured

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

  1. Percentage of Participants Achieving Clinical Remission at Week 24

    Clinical remission is defined as Crohn's disease activity index (CDAI)<150.

    Measured: Week 24

  2. Percentage of Participants Achieving Endoscopic Remission

    Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) <= 4 and at least a 2-point reduction versus Baseline and no sub score greater than 1 in any individual variable, as scored by a central reviewer.

    Measured: Week 48

  3. Number of Participants Reporting Adverse Events

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

    Measured: Up to 220 Weeks

Secondary outcomes (5)

  1. Percentage of Participants Achieving Clinical Remission at Week 48

    Clinical remission is defined as Crohn's disease activity index (CDAI)<150.

    Measured: Week 48

  2. Percentage of Participants Achieving Endoscopic Response at Week 48

    Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).

    Measured: Week 48

  3. Percentage of Participants Achieving Endoscopic Response at Week 24

    Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).

    Measured: Week 24

  4. Percentage of Participants Achieving Steroid-Free Endoscopic Remission

    Steroid-free endoscopic remission is defined as participants with endoscopic remission and not receiving steroids at Week 48.

    Measured: Week 48

  5. Percentage of Participants Achieving Steroid-Free Clinical Remission

    Steroid-free clinical remission is defined as participants with clinical remission and not receiving steroids at Week 48.

    Measured: Week 48

Timeline

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

  1. First posted24 Aug 2020
  2. Study start30 Sep 2020
  3. Primary completionFeb 2028 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
527 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04524611
Sponsor's protocol ID
M20-259
Other IDs
2020-002674-26, 2022-501645-70-00
Acronym
SEQUENCE
Status last verified
Apr 2026
First submitted
20 Aug 2020
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Publications

  • Raine T, Danese S, Schreiber S, Gao X, Hanauer S, Torres J, Cunneen C, Kligys K, Huang X, Garrison A, Neimark E, Anschutz T, Crowley J, Cross RK. Corticosteroid-sparing effects of risankizumab versus ustekinumab in patients with moderately to severely active Crohn's disease: post hoc results from the phase 3b SEQUENCE trial. J Crohns Colitis. 2026 Jul 7;20(7):jjag104. doi: 10.1093/ecco-jcc/jjag104.

    PubMed 42479626

  • Peyrin-Biroulet L, Atreya R, Danese S, Lindsay JO, Chapman JC, Anschutz T, Huang X, Zambrano J, van Haaren S, Joshi N, Duan WR, Cross RK. Efficacy and safety of risankizumab in patients with moderately to severely active Crohn's disease: interim results from the SEQUENCE open-label extension study. J Crohns Colitis. 2025 Dec 23;19(12):jjaf213. doi: 10.1093/ecco-jcc/jjaf213.

    PubMed 41344313

  • Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4.

    PubMed 40357993

  • Peyrin-Biroulet L, Chapman JC, Colombel JF, Caprioli F, D'Haens G, Ferrante M, Schreiber S, Atreya R, Danese S, Lindsay JO, Bossuyt P, Siegmund B, Irving PM, Panaccione R, Cao Q, Neimark E, Wallace K, Anschutz T, Kligys K, Duan WR, Pivorunas V, Huang X, Berg S, Shu L, Dubinsky M; SEQUENCE Study Group. Risankizumab versus Ustekinumab for Moderate-to-Severe Crohn's Disease. N Engl J Med. 2024 Jul 18;391(3):213-223. doi: 10.1056/NEJMoa2314585.

    PubMed 39018531

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Risankizumab and Ustekinumab in people with Crohn's Disease (CD), run by AbbVie at 300 sites in 31 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 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 300 sites in United States, China, Germany, United Kingdom, France and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

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

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

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

What does the primary outcome measure?

Percentage of Participants Achieving Clinical Remission at Week 24 (time frame: Week 24). 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 NCT04524611, which also lists 4 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 13 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in