AzTrials
AzTrials

Ulcerative ColitisPhase 3REVAMPNCT06880744

A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab

A Phase 3 study testing Risankizumab and Vedolizumab in people with Ulcerative Colitis, run by AbbVie at 270 sites in 31 countries.

Active, not recruiting

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

Official record
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Trial summary

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will evaluate how safe and effective risankizumab is compared to vedolizumab in treating adult participants with moderate to severe UC who are naive… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Risankizumab and Vedolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
573 participants
Where
270 sitesin 31 countries
Study dates
17 Jun 2025to Aug 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

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

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

Who may be able to join

  • Participant has confirmed diagnosis of Ulcerative Colitis (UC) for at least 3 months prior to Baseline.
  • Participant has active UC with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader).
  • Participant has demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates, oral locally acting steroids, systemic steroids (prednisone or equivalent), and immunomodulators.

Who cannot join

  • Participant has received any targeted therapies (TaTs) for UC, including but not limited to infliximab, etanercept, adalimumab, natalizumab, golimumab, ozanimod, ustekinumab, etrolizumab, vedolizumab, tofacitinib, filgotinib, etrasimod, guselkumab, mirikizumab, upadacitinib, and risankizumab.
  • Participant with a current diagnosis of Crohn's disease (CD) or Irritable Bowel Disease (IBD)-unclassified or a history of radiation colitis or ischemic colitis.
  • Currently known complications of UC such as: fulminant colitis and/or toxic megacolon, acute severe UC, previous colectomy (total or subtotal), or any other manifestation that might require surgery while in the study
  • Active systemic infection/clinically important infection during the last 2 weeks prior to Baseline Visit as assessed by the investigator.

Trial locations and contacts

270 sites in 31 countries.

270 sites in 31 countries

United States74 sites

  • Huron Gastroenterology /ID# 274998

    Ann Arbor, Michigan, 48197

  • Digestive Health Partners - Biltmore Office /ID# 273594

    Asheville, North Carolina, 28801

  • Emory University School Of Medicine - Atlanta /ID# 273522

    Atlanta, Georgia, 30322

  • Dayton Gastroenterology - Beavercreek /ID# 273528

    Beavercreek, Ohio, 45440

  • Gi Alliance - Bellevue /ID# 274264

    Bellevue, Washington, 98004

  • Gastro Health Research - St. Vincent'S East /ID# 275089

    Birmingham, Alabama, 35235

  • Brigham and Womens Hospital /ID# 275266

    Boston, Massachusetts, 02115

  • Digestive Disease Consultants - Brunswick /ID# 276445

    Brunswick, Ohio, 44212

  • Arizona Health Research /ID# 274366

    Chandler, Arizona, 85225

  • Atrium Health - Morehead /ID# 274245

    Charlotte, North Carolina, 28204

  • Charlotte Gastroenterology And Hepatology - Randolph Road /ID# 274553

    Charlotte, North Carolina, 28207

  • Gastroenterology Associates Of Tidewater - Chesapeake /ID# 276440

    Chesapeake, Virginia, 23320

  • Gastro Health - Cincinnati /ID# 275082

    Cincinnati, Ohio, 45219

  • University Of Cincinnati Medical Center /ID# 273524

    Cincinnati, Ohio, 45219

  • Novum Research /ID# 273587

    Clermont, Florida, 34711

  • Iowa Digestive Disease Center - Clive /ID# 274558

    Clive, Iowa, 50325

  • The Ohio State University /ID# 274743

    Columbus, Ohio, 43210

  • Gastro One - Walnut Run Road /ID# 273551

    Cordova, Tennessee, 38018

  • Danbury Hospital, Western Connecticut Health Network /ID# 275277

    Danbury, Connecticut, 06810

  • Hillcrest Medical Research /ID# 273593

    DeLand, Florida, 32720

  • Digestive Health Specialists /ID# 274785

    Dothan, Alabama, 36301

  • Gi Associates - Gia And Endoscopy Center - Flowood /ID# 274285

    Flowood, Mississippi, 39232

  • Amel Med /ID# 276439

    Georgetown, Texas, 78628

  • Gi Alliance - Glenview /ID# 274270

    Glenview, Illinois, 60026

  • Carolina Digestive Diseases And Endoscopy Center /ID# 274256

    Greenville, North Carolina, 27834

  • Illinois Gastroenterology Group /ID# 274280

    Gurnee, Illinois, 60031

  • Tandem Clinical Research - Houma /ID# 274562

    Houma, Louisiana, 70363

  • Digestive & Liver Disease Consultants /ID# 276454

    Houston, Texas, 77090

  • Skyline Gastroenterology of West Tennessee /ID# 276461

    Jackson, Tennessee, 38301

  • GI associates of Northeast Tennessee /ID# 273758

    Johnson City, Tennessee, 37604

  • Katy Integrative Gastroenterology /ID# 274645

    Katy, Texas, 77494

  • Tri-Cities Gastroenterology /ID# 275067

    Kingsport, Tennessee, 37663

  • Gastrointestinal Associates - Knoxville - Dowell Springs Boulevard /ID# 276447

    Knoxville, Tennessee, 37909

  • UC San Diego Health System /ID# 273538

    La Jolla, California, 92037

  • Florida Research Institute /ID# 275196

    Lakewood Rch, Florida, 34211

  • Gastro Care Institute /ID# 274873

    Lancaster, California, 93534

  • Emeritas Research Group /ID# 276457

    Lansdowne Town Center, Virginia, 20176

  • UCLA Health - Digestive Health & Nutrition Clinic /ID# 274827

    Los Angeles, California, 90024

  • Gastroenterology Health Partners /ID# 276441

    Louisville, Kentucky, 40218

  • Caprock Gastro Research - Lubbock /ID# 273778

    Lubbock, Texas, 79424

  • GI Alliance - Mansfield /ID# 274272

    Mansfield, Texas, 76063

  • Metropolitan Gastroenterology Associates - Metairie /ID# 274282

    Metairie, Louisiana, 70006

  • Sanchez Clinical Research /ID# 273727

    Miami, Florida, 33157

  • Medical Professional Clinical Research /ID# 275208

    Miami, Florida, 33165

  • East View Medical Research /ID# 276222

    Mobile, Alabama, 36606

  • Quality Medical Research /ID# 273733

    Nashville, Tennessee, 37211

  • Gastroenterology Health Partners /ID# 276434

    New Albany, Indiana, 47150

  • Lucida Clinical Trials /ID# 275235

    New Bedford, Massachusetts, 02740

  • Columbia University Medical Center /ID# 273518

    New York, New York, 10032

  • New York Gastroenterology Associates - Upper East Side /ID# 273520

    New York, New York, 10075

  • Hoag Memorial Hospital Presbyterian /ID# 274364

    Newport Beach, California, 92663

  • California Medical Research Associates /ID# 274787

    Northridge, California, 91324

  • Southwest Gastroenterology - Oak Lawn /ID# 273596

    Oak Lawn, Illinois, 60453

  • Sarkis Clinical Trials - Ocala /ID# 273595

    Ocala, Florida, 34474

  • Care Access - Ogden /ID# 274361

    Ogden, Utah, 84403

  • Gastroenterology Associates of Orangeburg /ID# 274559

    Orangeburg, South Carolina, 29118

  • Endoscopic Research, Inc. /ID# 273548

    Orlando, Florida, 32803

  • Digestive And Liver Center Of Florida - Orlando /ID# 276432

    Orlando, Florida, 32825

  • Linq Research - Pearland /ID# 274917

    Pearland, Texas, 77584

  • OSF St. Francis Medical Center /ID# 274391

    Peoria, Illinois, 61637-0001

  • Mayo Clinic-Rochester /ID# 273606

    Rochester, Minnesota, 55905

  • Gastroenterology Group of Rochester /ID# 274283

    Rochester, New York, 14618

  • Velocity Clinical Research, Rockville /ID# 273599

    Rockville, Maryland, 20854-2931

  • uc davis medical center - patient support services building /ID# 274251

    Sacramento, California, 95817

  • Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 273527

    San Diego, California, 92103

  • Virginia Mason Hospital and Medical Center /ID# 274810

    Seattle, Washington, 98101

  • Pinnacle Gastroenterology /ID# 274991

    Shreveport, Louisiana, 71103

  • Louisiana Research Center, LLC /ID# 276443

    Shreveport, Louisiana, 71105

  • Delta Gastroenterology & Endoscopy Center /ID# 275005

    Southaven, Mississippi, 38671

  • Springfield Clinic Main Campus /ID# 273547

    Springfield, Illinois, 62703-2403

  • Washington Gastroenterology - Tacoma /ID# 274551

    Tacoma, Washington, 98405

  • Cotton O'Neil Digestive Health Center /ID# 274394

    Topeka, Kansas, 66606-1539

  • Tyler Research Institute /ID# 273585

    Tyler, Texas, 75701

  • Digestive Disease Associates, LTD - Wyomissing /ID# 273603

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Germany20 sites

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 274545

    Berlin, 10117

  • Drk Kliniken Berlin - Kopenick /ID# 273514

    Berlin, 12559

  • Krankenhaus Waldfriede /ID# 273708

    Berlin, 14163

  • Medizinisches Versorgungszentrum Dachau /ID# 273458

    Dachau, Bavaria, 85221

  • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 273448

    Dresden, Saxony, 01307

  • Universitaetsklinikum Erlangen /ID# 273504

    Erlangen, Bavaria, 91054

  • Universitaetsmedizin Essen /ID# 273505

    Essen, North Rhine-Westphalia, 45147

  • Markus Krankenhaus /ID# 273436

    Frankfurt am Main, Hesse, 60431

  • Universitaetsklinikum Frankfurt /ID# 273462

    Frankfurt am Main, Hesse, 60590

  • Universitaetsklinikum Freiburg /ID# 274763

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Studiengesellschaft Mitteldeutschland GmbH /ID# 273457

    Halle, Saxony-Anhalt, 06108

  • GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 273459

    Herne, 44623

  • Praxisgemeinschaft Jerichow Schulze /ID# 273433

    Jerichow, Saxony-Anhalt, 39319

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel /ID# 273463

    Kiel, Schleswig-Holstein, 24105

  • Eugastro /ID# 273573

    Leipzig, Saxony, 04103

  • Praxis fuer Gastroenterologie - Lubeck /ID# 274546

    Lübeck, Schleswig-Holstein, 23560

  • Gastroenterologische Gemeinschaftspraxis Minden /ID# 273447

    Minden, North Rhine-Westphalia, 32423

  • Universitaetsklinikum Regensburg /ID# 273519

    Regensburg, Bavaria, 93042

  • Magen-Darm-Zentrum-Remscheid /ID# 273435

    Remscheid, North Rhine-Westphalia, 42859

  • Universitaetsklinikum Ulm /ID# 273411

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

China17 sites

  • Peking Union Medical College Hospital East - Dongdan Campus /ID# 274886

    Beijing, Beijing Municipality, 100730

  • The First Hospital of Jilin University - Changchun /ID# 274784

    Changchun, Jilin, 130021

  • The Second Xiangya Hospital Of Central South University /ID# 274712

    Changsha, Hunan, 410011

  • West China Hospital of Sichuan University /ID# 275478

    Chengdu, Sichuan, 610041

  • Chongqing General Hospital /ID# 274564

    Chongqing, Chongqing Municipality, 400013

  • The First Affiliated Hospital, Sun-Yat Sen University /ID# 274823

    Guangzhou, Guangdong, 510080

  • The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 274843

    Guangzhou, Guangdong, 510655

  • The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 274849

    Hangzhou, Zhejiang, 310009

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 274689

    Hangzhou, Zhejiang, 310018

  • The First Affiliated Hospital Of Anhui Medical University /ID# 274786

    Hefei, Anhui, 230022

  • The First Affiliated Hospital of Nanchang University /ID# 274801

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital /ID# 274710

    Nanjing, Jiangsu, 210008

  • Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 275658

    Shanghai, Shanghai Municipality, 200127

  • The Second Hospital Of Hebei Medical University /ID# 274822

    Shijiazhuang, Hebei, 050035

  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 274563

    Wuhan, Hubei, 430022

  • Renmin Hospital of Wuhan University /ID# 274616

    Wuhan, Hubei, 430060

  • The Second Affiliated Hospital Of Zhengzhou University /ID# 274569

    Zhengzhou, Henan, 450014

Other trials in China

Spain12 sites

  • Hospital Universitario Fundacion Alcorcon /ID# 274309

    Alcorcón, Madrid, 28922

  • Hospital Clinic de Barcelona /ID# 274262

    Barcelona, 08036

  • Hospital de Cabuenes /ID# 274254

    Gijón, Principality of Asturias, 33394

  • Hospital General De Granollers /ID# 274384

    Granollers, Barcelona, 08402

  • Hospital Universitario de Gran Canaria Doctor Negrin /ID# 274277

    Las Palmas de Gran Canaria, Las Palmas, 35010

  • Hospital Universitario Puerta De Hierro /ID# 274271

    Majadahonda, Madrid, 28222

  • Sant Joan de Deu de Manresa /ID# 274288

    Manresa, Barcelona, 08423

  • Complejo Hospitalario Universitario de Pontevedra /ID# 274269

    Pontevedra, 36071

  • Complejo Hospitalario Universitario de Santiago /ID# 274266

    Santiago de Compostela, A Coruna, 15706

  • Hospital Universitario Virgen Macarena /ID# 274258

    Seville, Sevilla, 41009

  • Consorci Hospital General Universitario de Valencia /ID# 274275

    Valencia, 46014

  • Hospital Universitario Doctor Peset /ID# 274385

    Valencia, 46017

Other trials in Spain

Canada10 sites

  • Barrie GI Associates /ID# 275211

    Barrie, Ontario, L4M 7G1

  • Brampton Gastroenterology Inc /Id# 276187

    Brampton, Ontario, L6S 0C1

  • GNRR Digestive Clinics and Research Center Inc. /ID# 275820

    Brampton, Ontario, L6S 0E2

  • University Of Calgary - Health Sciences Centre /ID# 274237

    Calgary, Alberta, T2N 4N1

  • Gastroenterology and Internal Medicine Research Institute /ID# 274239

    Edmonton, Alberta, T5R 1W2

  • South Edmonton Gastroenterology /ID# 274184

    Edmonton, Alberta, T6L 6K3

  • Montreal General Hospital /ID# 275201

    Montreal, Quebec, H3G 1A4

  • The Oakville Endoscopy Centre /ID# 275213

    Oakville, Ontario, L6L 5L7

  • Diex Recherche Quebec Inc. /ID# 274268

    Québec, G1V 4T3

  • Toronto Immune & Digestive Health Institute /ID# 274259

    Toronto, Ontario, M6A 3B4

Other trials in Canada

Italy10 sites

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 274520

    Bologna, 40138

  • IRCCS Ospedale San Raffaele /ID# 274516

    Milan, Milano, 20132

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 274517

    Milan, 20122

  • Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 274683

    Monserrato, Cagliari, 09042

  • Azienda Ospedaliera Universitaria Federico II - Naples /ID# 274828

    Naples, Napoli, 80131

  • Azienda Ospedale-Universita Padova /ID# 274519

    Padova, 35128

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 274824

    Palermo, 90127

  • Azienda Ospedaliero Universitaria Pisana /ID# 274829

    Pisa, 56126

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274685

    Rome, Roma, 00168

  • IRCCS Istituto Clinico Humanitas /ID# 274518

    Rozzano, Lombardy, 20089

Other trials in Italy

Poland10 sites

  • Osrodek Badan Klinicznych Clinsante - Bydgoszcz /ID# 274190

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-794

  • Novamed Robert Koteras /ID# 274547

    Bytom, Silesian Voivodeship, 41-902

  • Centrum Medyczne Lukamed Sp. z o.o /ID# 274193

    Chojnice, Pomeranian Voivodeship, 89-600

  • PROMED P. Lach, R. Glowacki S.j /ID# 274392

    Krakow, Lesser Poland Voivodeship, 31-513

  • RIVERMED Sp. z o. o. /ID# 274420

    Poznan, Greater Poland Voivodeship, 61-441

  • Twoja Przychodnia Szczecinskie Centrum Medyczne /ID# 274187

    Szczecin, West Pomeranian Voivodeship, 71-434

  • Centrum Zdrowia Mdm /ID# 274192

    Warsaw, Masovian Voivodeship, 00-189

  • Panstwowy Instytut Medyczny MSWiA /ID# 274538

    Warsaw, Masovian Voivodeship, 02-507

  • WSD MEDI Clinical Sp. z o.o. /ID# 274194

    Warsaw, Masovian Voivodeship, 02-786

  • EMC Instytut Medyczny S.A /ID# 275113

    Wroclaw, Lower Silesian Voivodeship, 54-144

Other trials in Poland

South Korea10 sites

  • Inje University Haeundae Paik Hospital /ID# 274435

    Busan, Busan Gwang Yeogsi, 48108

  • Kyungpook National University Hospital /ID# 274439

    Daegu, Daegu Gwang Yeogsi, 41944

  • The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 274429

    Daejeon, Daejeon Gwang Yeogsi, 34943

  • Chosun University Hospital /ID# 276672

    Gwangju, Jeonranamdo, 61453

  • Seoul National University Bundang Hospital /ID# 274441

    Seongnam-si, Gyeonggido, 13620

  • Seoul National University Hospital /ID# 274438

    Seoul, Seoul Teugbyeolsi, 03080

  • Yonsei University Health System Severance Hospital /ID# 274431

    Seoul, Seoul Teugbyeolsi, 03722

  • Gangnam Severance Hospital /ID# 274436

    Seoul, Seoul Teugbyeolsi, 06273

  • Samsung Medical Center /ID# 274440

    Seoul, Seoul Teugbyeolsi, 06351

  • The Catholic University Of Korea St. Vincent's Hospital /ID# 274433

    Suwon, Gyeonggido, 16247

Other trials in South Korea

Hungary9 sites

  • Obudai Egeszsegugyi Centrum /ID# 274919

    Budapest, 1036

  • Eszak-Pesti Centrumkorhaz - Honvedkorhaz - Podmaniczky Utca /ID# 275722

    Budapest, 1062

  • Semmelweis Egyetem /ID# 274872

    Budapest, 1085

  • Semmelweis Egyetem /ID# 274883

    Budapest, 1085

  • Pannonia Maganorvosi Centrum /ID# 275723

    Budapest, 1136

  • Debreceni Egyetem /ID# 275083

    Debrecen, 4032

  • Szegedi Tudomanyegyetem /ID# 275185

    Szeged, Csongrád megye, 6720

  • Clinfan /ID# 274904

    Szekszárd, Tolna County, 7100

  • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 275077

    Szombathely, Vas County, 9700

Other trials in Hungary

United Kingdom8 sites

  • Queen Elizabeth Hospital Birmingham /ID# 275287

    Birmingham, B15 2TH

  • Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde /ID# 274758

    Glasgow, Lanarkshire, G51 4TF

  • Barts Health NHS Trust - The Royal London Hospital /ID# 274959

    London, Greater London, E1 1BB

  • King's College Hospital /ID# 275223

    London, Greater London, SE5 9RS

  • Fairfield General Hospital /ID# 274947

    Manchester, Lancashire, BL9 7TD

  • Velocity North London /ID# 275581

    North Finchley, Greater London, N12 8BU

  • The John Radcliffe Hospital /ID# 274757

    Oxford, Oxfordshire, OX3 9DU

  • Stepping Hill Hospital-Stockport NHS foundation trust /ID# 275838

    Stockport, SK2 7JE

Other trials in United Kingdom

Israel7 sites

  • Assuta Ashdod Medical Center /ID# 274686

    Ashdod, Southern District, 7747600

  • Soroka Medical Center /ID# 273350

    Beersheba, Southern District, 8410101

  • Rambam Health Care Campus- Haifa /ID# 273347

    Haifa, 3109601

  • Rabin Medical Center. /ID# 280537

    Petah Tikva, Central District, 4941492

  • The Chaim Sheba Medical Center /ID# 273348

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 273351

    Tel Aviv, Tel Aviv, 6423906

  • Yitzhak Shamir Medical Center /ID# 275525

    Tsrifin, Central District, 7030000

Other trials in Israel

Netherlands7 sites

  • OLVG - Locatie Oost /ID# 274809

    Amsterdam, North Holland, 1091 AC

  • Amsterdam University Medical Center /ID# 274939

    Amsterdam, North Holland, 1105 AZ

  • Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 274936

    Dordrecht, South Holland, 3318 AT

  • Radboudumc /ID# 274797

    Nijmegen, Gelderland, 6525 GA

  • Erasmus Medisch Centrum /ID# 274795

    Rotterdam, South Holland, 3015 CE

  • Franciscus Gasthuis & Vlietland, Locatie Gasthuis /ID# 274806

    Rotterdam, South Holland, 3045 PM

  • Elisabeth TweeSteden Ziekenhuis /ID# 274940

    Tilburg, North Brabant, 5022 GC

Other trials in Netherlands

Bulgaria6 sites

  • Umbal Kaspela /ID# 274721

    Plovdiv, 4001

  • MHAT Knyaginya Klementina /ID# 274722

    Sofia, 1233

  • Mhat Doverie /ID# 274798

    Sofia, 1632

  • Hospital Tsaritsa Yoanna /ID# 274723

    Sofiya, Sofia, 1527

  • Umhat Sveti Ivan Rilsky /ID# 274794

    Sofiya, Sofia, 1606

  • Acibadem City Clinic UMHAT Mladost /ID# 274804

    Sofiya, Sofia, 1784

Other trials in Bulgaria

Ireland6 sites

  • Portiuncula University Hospital /ID# 273782

    Ballinasloe, Galway, H53 T971

  • Our Lady of Lourdes Hospital - Drogheda /ID# 273783

    Drogheda, Louth, A92 VW28

  • St. Vincent's University Hospital /ID# 274617

    Dublin, D04 T6F4

  • Beaumont Hospital /ID# 273787

    Dublin, D09 XR63

  • Connolly Hospital /ID# 274173

    Dublin, D15 X40D

  • Midland Regional Hospital Mullingar /ID# 273784

    Mullingar, Westmeath, N91 NA43

Other trials in Ireland

Romania6 sites

  • Memorial Healthcare International /ID# 276040

    Bucharest, Bucharest, 013823

  • Spitalul Clinic Colentina /ID# 275892

    Bucharest, Bucharest, 020125

  • Fundeni Clinical Institute /ID# 275893

    Bucharest, Bucharest, 022328

  • Monza-Ares S.R.L. /Id# 276048

    Bucharest, 021967

  • Clinica Gastro Med SRL /ID# 275891

    Cluj-Napoca, Cluj, 400380

  • OncoHelp Association /ID# 275889

    Timișoara, Timiș County, 300239

Other trials in Romania

Austria5 sites

  • Medizinische Universitaet Graz /ID# 274428

    Graz, Styria, 8010

  • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 274318

    Linz, Upper Austria, 4010

  • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 273611

    Salzburg, 5020

  • Medizinische Universitaet Wien /ID# 273612

    Vienna, 1090

  • Klinikum Wels-Grieskirchen Gmbh /ID# 274172

    Wels, Upper Austria, 4600

Other trials in Austria

Croatia5 sites

  • Klinicki Bolnicki Centar Zagreb /ID# 273316

    Grad Zagreb, City of Zagreb, 10000

  • Poliklinika Borzan d.o.o. /ID# 273324

    Osijek, County of Osijek-Baranja, 31000

  • Specialty Hospital Medico /ID# 273334

    Rijeka, Primorje-Gorski Kotar County, 51000

  • Klinicki Bolnicki Centar Split /ID# 273327

    Split, Split-Dalmatia County, 21000

  • Poliklinika Solmed /ID# 273323

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

France5 sites

  • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 278633

    Créteil, Paris, 94010

  • CHU de Montpellier - Hopital Saint Eloi /ID# 278594

    Montpellier, Herault, 34295

  • Chu de Nice-Hopital Larchet Ii /Id# 278595

    Nice, Alpes-Maritimes, 06202

  • Hopital Saint Antoine /ID# 278593

    Paris, 75012

  • Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 278587

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

Other trials in France

Sweden5 sites

  • Alingsas Lasarett /ID# 274399

    Alingsås, Västra Götaland County, 441 83

  • Danderyds Sjukhus - Danderyd /ID# 274401

    Danderyd, Stockholm County, 182 88

  • Linkoping University Hospital /ID# 274932

    Linköping, Östergötland County, 581 85

  • Universitetssjukhuset Orebro /ID# 274386

    Örebro, Örebro County, 701 85

  • Karolinska University Hospital Solna /ID# 274379

    Solna, Stockholm County, 171 64

Other trials in Sweden

Taiwan5 sites

  • China Medical University Hospital /ID# 273641

    Taichung, 40447

  • National Taiwan University Hospital /ID# 273632

    Taipei, 100

  • Mackay Memorial Hospital /ID# 273643

    Taipei, 104

  • Taipei Veterans General Hospital /ID# 274717

    Taipei, 112

  • Linkou Chang Gung Memorial Hospital /ID# 273640

    Taoyuan City, 333

Other trials in Taiwan

Lithuania4 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 273590

    Kaunas, 50161

  • Panevezys Republican Hospital /ID# 273592

    Panevezys, 35144

  • Vilnius University Hospital Santaros Klinikos /ID# 273591

    Vilnius, 08661

  • Inlita - Lazdynai CTC /ID# 273725

    Vilnius, LT-04130

Other trials in Lithuania

Saudi Arabia4 sites

  • King Fahad Specialist Hospital /ID# 274820

    Dammam, 32253

  • King Abdulaziz Medical City- National Guard Hospital /ID# 274817

    Riyadh, Riyadh Region, 11426

  • King Saud University /ID# 274818

    Riyadh, Riyadh Region, 12372

  • King Faisal Specialist Hospital and Research Center /ID# 274819

    Riyadh, Riyadh Region, 12713

Other trials in Saudi Arabia

Estonia3 sites

  • Parnu Hospital /ID# 273584

    Pärnu, Pärnumaa, 80010

  • West Tallinn Central Hospital /ID# 273722

    Tallinn, Harju, 10617

  • East Tallinn Central Hospital /ID# 273723

    Tallinn, 10138

Other trials in Estonia

Latvia3 sites

  • Liepaja Regional Hospital /ID# 275164

    Liepāja, LV-3414

  • Pauls Stradins Clinical University Hospital /ID# 273586

    Riga, LV-1002

  • Digestive Diseases Center GASTRO /ID# 273589

    Riga, LV-1079

Other trials in Latvia

Puerto Rico3 sites

  • ISIS Clinical Research Center /ID# 274859

    Guaynabo, 00969-2806

  • Caribbean Medical Research Center Headlands /ID# 274832

    San Juan, 00918-3501

  • Fdi Clinical Research /ID# 275337

    San Juan, 00927

Other trials in Puerto Rico

Slovakia3 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 274740

    Banská Bystrica, Banská Bystrica Region, 975 17

  • Endomed /ID# 274734

    Košice, Košice Region, 040 13

  • KM Management, spol. s.r.o. /ID# 274733

    Nitra, Nitra Region, 949 01

Other trials in Slovakia

Slovenia3 sites

  • General Hospital Celje /ID# 275127

    Celje, 3000

  • University Medical Centre Ljubljana /ID# 273636

    Ljubljana, 1000

  • Splosna Bolnisnica Nova Gorica /ID# 275635

    Šempeter Pri Gorici, Urban Municipality of Nova Gorica, 5290

Other trials in Slovenia

Switzerland3 sites

  • Inselspital, Universitaetsspital Bern /ID# 273364

    Bern, 3010

  • Luzern Kantonsspital /ID# 275415

    Lucerne, Canton of Lucerne, 6000

  • Kantonsspital St.Gallen /ID# 273382

    Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

United Arab Emirates3 sites

  • Burjeel Medical City /ID# 274749

    Abu Dhabi, 0

  • Sheikh Shakhbout Medical City /ID# 274643

    Abu Dhabi, 11001

  • Sheikh Khalifa Medical City /ID# 274777

    Abu Dhabi

Other trials in United Arab Emirates

Czechia2 sites

  • Nemocnice Ceske Budejovice /ID# 276530

    České Budějovice, 370 01

  • Hepato-Gastroenterologie HK /ID# 276654

    Hradec Králové, Hradec Kralove, 500 12

Other trials in Czechia

Finland2 sites

  • Kuopion Yliopistollinen Sairaala /ID# 274856

    Kuopio, Northern Savonia, 70210

  • Turku University Hospital /ID# 274312

    Turku, Southwest Finland, 20520

Other trials in Finland

About this study

Official title: Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who Are Naïve to Targeted Therapies

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will evaluate how safe and effective risankizumab is compared to vedolizumab in treating adult participants with moderate to severe UC who are naive to targeted therapies (TaTs).

Risankizumab and vedolizumab are approved medications for moderate to severe UC in multiple countries. Participants who meet the eligibility criteria will be randomized in a 1:1 ratio to receive open label risankizumab or vedolizumab. Approximately 530 adult participants with moderate to severe UC who are naïve to targeted therapies (TaTs) will be enrolled at 285 sites worldwide.

Read more

For participants randomized to risankizumab, drug will be administered intravenous(IV) during the induction period followed by subcutaneous injection during the maintenance period. Participants randomized to vedolizumab will receive drug IV throughout the study.

The duration of the study is approximately 69 weeks for participants randomized to risankizumab and 71 weeks for participants randomized to vedolizumab. This includes up to a 35-day screening period followed by a treatment period of 44 weeks for risankizumab and 46 weeks for vedolizumab.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect and safety of the treatment will be checked by medical assessments, evaluation of side effects and completing questionnaires.

Being tested
Risankizumab, Vedolizumab
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • RisankizumabDrug

    Intravenous (IV) Infusion

  • RisankizumabDrug

    Subcutaneous (SC) injection

  • VedolizumabDrug

    Intravenous (IV) infusion

Study groups in NCT06880744
Study groupRoleWhat they receive
Risankizumab GroupActive comparatorAn induction dose of risankizumab intravenous (IV) will be administered at Baseline and Weeks 4 and 8. Starting at Week 12, participants will then receive either a lower or higher subcutaneous (SC) risankizumab maintenance dose, followed by the same dose every 8 weeks with the last dose at Week 44.
Receives: Drug: Risankizumab
Vedolizumab GroupActive comparatorVedolizumab IV will be administered at Baseline, Weeks 2 and 6, and every 8 weeks with the last dose of vedolizumab IV at Week 46.
Receives: Drug: Vedolizumab

What is being measured

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

  1. Percentage of Risankizumab Group Participants Achieving Endoscopic Improvement As Compared to The Vedolizumab Group

    Endoscopic improvement is defined as endoscopy subscore of 0 or 1. Endoscopies assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).

    Measured: At Week 48

Secondary outcomes (1)

  1. Percentage of Risankizumab Group Participants who Achieve Clinical Remission As Compared to The Vedolizumab Group Per Modified Mayo Score (mMS)

    Clinical remission on the mMS is defined as Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore <= 1, AND not greater than baseline. The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease [spontaneous bleeding, ulceration]). The overall mMS ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.

    Measured: At 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 posted18 Mar 2025
  2. Study start17 Jun 2025
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
573 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06880744
Sponsor's protocol ID
M25-540
Other IDs
2024-518998-33-00
Acronym
REVAMP
Status last verified
Aug 2026
First submitted
12 Mar 2025
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
No
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Risankizumab and Vedolizumab in people with Ulcerative Colitis, run by AbbVie at 270 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 3 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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 270 sites in United States, Germany, China, Spain, Canada 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 Risankizumab Group Participants Achieving Endoscopic Improvement As Compared to The Vedolizumab Group (time frame: At Week 48). 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 NCT06880744.

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 4 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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