A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab
REVAMP
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
2 other identifiers
interventional
530
29 countries
255
Brief 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 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2025
Typical duration for phase_3
255 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2025
CompletedFirst Posted
Study publicly available on registry
March 18, 2025
CompletedStudy Start
First participant enrolled
June 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
March 16, 2026
March 1, 2026
3.2 years
March 12, 2025
March 13, 2026
Conditions
Outcome Measures
Primary Outcomes (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).
At Week 48
Secondary Outcomes (1)
Percentage of Risankizumab Group Participants who Achieve Clinical Remission As Compared to The Vedolizumab Group Per Modified Mayo Score (mMS)
At Week 48
Study Arms (2)
Risankizumab Group
ACTIVE 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.
Vedolizumab Group
ACTIVE 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (270)
Gastro Health Research - St. Vincent'S East /ID# 275089
Birmingham, Alabama, 35235, United States
Digestive Health Specialists /ID# 274785
Dothan, Alabama, 36301, United States
East View Medical Research /ID# 276222
Mobile, Alabama, 36606, United States
Arizona Health Research /ID# 274366
Chandler, Arizona, 85225, United States
UC San Diego Health System /ID# 273538
La Jolla, California, 92037, United States
Gastro Care Institute /ID# 274873
Lancaster, California, 93534, United States
UCLA Health - Digestive Health & Nutrition Clinic /ID# 274827
Los Angeles, California, 90024, United States
Hoag Memorial Hospital Presbyterian /ID# 274364
Newport Beach, California, 92663, United States
California Medical Research Associates /ID# 274787
Northridge, California, 91324, United States
uc davis medical center - patient support services building /ID# 274251
Sacramento, California, 95817, United States
Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 273527
San Diego, California, 92103, United States
Danbury Hospital, Western Connecticut Health Network /ID# 275277
Danbury, Connecticut, 06810, United States
Novum Research /ID# 273587
Clermont, Florida, 34711, United States
Hillcrest Medical Research /ID# 273593
DeLand, Florida, 32720, United States
Florida Research Institute /ID# 275196
Lakewood Rch, Florida, 34211, United States
Sanchez Clinical Research /ID# 273727
Miami, Florida, 33157, United States
Medical Professional Clinical Research /ID# 275208
Miami, Florida, 33165, United States
Sarkis Clinical Trials - Ocala /ID# 273595
Ocala, Florida, 34474, United States
Endoscopic Research, Inc. /ID# 273548
Orlando, Florida, 32803, United States
Digestive And Liver Center Of Florida - Orlando /ID# 276432
Orlando, Florida, 32825, United States
Emory University School Of Medicine - Atlanta /ID# 273522
Atlanta, Georgia, 30322, United States
Gi Alliance - Glenview /ID# 274270
Glenview, Illinois, 60026, United States
Illinois Gastroenterology Group /ID# 274280
Gurnee, Illinois, 60031, United States
Southwest Gastroenterology - Oak Lawn /ID# 273596
Oak Lawn, Illinois, 60453, United States
OSF St. Francis Medical Center /ID# 274391
Peoria, Illinois, 61637-0001, United States
Springfield Clinic Main Campus /ID# 273547
Springfield, Illinois, 62703-2403, United States
Gastroenterology Health Partners /ID# 276434
New Albany, Indiana, 47150, United States
Iowa Digestive Disease Center - Clive /ID# 274558
Clive, Iowa, 50325, United States
Cotton O'Neil Digestive Health Center /ID# 274394
Topeka, Kansas, 66606-1539, United States
Gastroenterology Health Partners, PLLC /ID# 276441
Louisville, Kentucky, 40218, United States
Tandem Clinical Research - Houma /ID# 274562
Houma, Louisiana, 70363, United States
Metropolitan Gastroenterology Associates - Metairie /ID# 274282
Metairie, Louisiana, 70006, United States
Pinnacle Gastroenterology /ID# 274991
Shreveport, Louisiana, 71103, United States
Louisiana Research Center, LLC /ID# 276443
Shreveport, Louisiana, 71105, United States
Velocity Clinical Research, Rockville /ID# 273599
Rockville, Maryland, 20854-2931, United States
Brigham & Womens Hospital /ID# 275266
Boston, Massachusetts, 02115, United States
Lucida Clinical Trials /ID# 275235
New Bedford, Massachusetts, 02740, United States
Huron Gastroenterology /ID# 274998
Ann Arbor, Michigan, 48197, United States
Mayo Clinic-Rochester /ID# 273606
Rochester, Minnesota, 55905, United States
Gi Associates - Gia And Endoscopy Center - Flowood /ID# 274285
Flowood, Mississippi, 39232, United States
Delta Gastroenterology & Endoscopy Center /ID# 275005
Southaven, Mississippi, 38671, United States
Columbia University Medical Center /ID# 273518
New York, New York, 10032, United States
New York Gastroenterology Associates - Upper East Side /ID# 273520
New York, New York, 10075, United States
Gastroenterology Group of Rochester /ID# 274283
Rochester, New York, 14618, United States
Digestive Health Partners - Biltmore Office /ID# 273594
Asheville, North Carolina, 28801, United States
Atrium Health - Morehead /ID# 274245
Charlotte, North Carolina, 28204, United States
Charlotte Gastroenterology And Hepatology - Randolph Road /ID# 274553
Charlotte, North Carolina, 28207, United States
Carolina Digestive Diseases And Endoscopy Center /ID# 274256
Greenville, North Carolina, 27834, United States
Digestive Disease Consultants - Brunswick /ID# 276445
Brunswick, Ohio, 44212, United States
Gastro Health /ID# 275082
Cincinnati, Ohio, 45219, United States
University Of Cincinnati Medical Center /ID# 273524
Cincinnati, Ohio, 45219, United States
The Ohio State University - Wexner Medical Center /ID# 274743
Columbus, Ohio, 43212, United States
Dayton Gastroenterology, Inc /ID# 273528
Dayton, Ohio, 45415, United States
Digestive Disease Associates, LTD - Wyomissing /ID# 273603
Wyomissing, Pennsylvania, 19610, United States
Gastroenterology Associates of Orangeburg /ID# 274559
Orangeburg, South Carolina, 29118, United States
Gastro One - Walnut Run Road /ID# 273551
Cordova, Tennessee, 38018, United States
Skyline Gastroenterology of West Tennessee /ID# 276461
Jackson, Tennessee, 38301, United States
GI associates of Northeast Tennessee /ID# 273758
Johnson City, Tennessee, 37604, United States
Tri-Cities Gastroenterology /ID# 275067
Kingsport, Tennessee, 37663, United States
Gastrointestinal Associates - Knoxville - Dowell Springs Boulevard /ID# 276447
Knoxville, Tennessee, 37909, United States
Quality Medical Research /ID# 273733
Nashville, Tennessee, 37211, United States
Amel Med /ID# 276439
Georgetown, Texas, 78628, United States
Digestive & Liver Disease Consultants /ID# 276454
Houston, Texas, 77090, United States
Katy Integrative Gastroenterology /ID# 274645
Katy, Texas, 77494, United States
Caprock Gastro Research - Lubbock - 80th Street /ID# 273778
Lubbock, Texas, 79424, United States
GI Alliance: Mansfield /ID# 274272
Mansfield, Texas, 76063, United States
Linq Research /ID# 274917
Pearland, Texas, 77584, United States
Tyler Research Institute, LLC /ID# 273585
Tyler, Texas, 75701, United States
Care Access - Ogden /ID# 274361
Ogden, Utah, 84403, United States
Gastroenterology Associates Of Tidewater - Chesapeake /ID# 276440
Chesapeake, Virginia, 23320, United States
Emeritas Research Group /ID# 276457
Lansdowne Town Center, Virginia, 20176, United States
Gi Alliance - Bellevue /ID# 274264
Bellevue, Washington, 98004, United States
Virginia Mason Hospital & Medical Center /ID# 274810
Seattle, Washington, 98101, United States
Washington Gastroenterology - Tacoma /ID# 274551
Tacoma, Washington, 98405, United States
Medizinische Universitaet Graz /ID# 274428
Graz, Styria, 8010, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 274318
Linz, Upper Austria, 4010, Austria
Klinikum Wels-Grieskirchen GmbH /ID# 274172
Wels, Upper Austria, 4600, Austria
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 273611
Salzburg, 5020, Austria
Medizinische Universitaet Wien /ID# 273612
Vienna, 1090, Austria
Hospital Tsaritsa Yoanna /ID# 274723
Sofiya, Sofia, 1527, Bulgaria
Umhat Sveti Ivan Rilsky /ID# 274794
Sofiya, Sofia, 1606, Bulgaria
Acibadem City Clinic UMHAT Mladost /ID# 274804
Sofiya, Sofia, 1784, Bulgaria
Umbal Kaspela /ID# 274721
Plovdiv, 4001, Bulgaria
MHAT Knyaginya Klementina /ID# 274722
Sofia, 1233, Bulgaria
Mhat Doverie /ID# 274798
Sofia, 1632, Bulgaria
University Of Calgary - Health Sciences Centre /ID# 274237
Calgary, Alberta, T2N 4N1, Canada
Gastroenterology and Internal Medicine Research Institute /ID# 274239
Edmonton, Alberta, T5R 1W2, Canada
South Edmonton Gastroenterology /ID# 274184
Edmonton, Alberta, T6L 6K3, Canada
Barrie GI Associates /ID# 275211
Barrie, Ontario, L4M 7G1, Canada
Brampton Gastroenterology Inc /Id# 276187
Brampton, Ontario, L6S 0C1, Canada
GNRR Digestive Clinics and Research Center Inc. /ID# 275820
Brampton, Ontario, L6S 0E2, Canada
The Oakville Endoscopy Centre /ID# 275213
Oakville, Ontario, L6L 5L7, Canada
Toronto Immune & Digestive Health Institute /ID# 274259
Toronto, Ontario, M6A 3B4, Canada
Montreal General Hospital /ID# 275201
Montreal, Quebec, H3G 1A4, Canada
Diex Recherche Quebec Inc. /ID# 274268
Québec, G1V 4T3, Canada
The First Affiliated Hospital Of Anhui Medical University /ID# 274786
Hefei, Anhui, 230022, China
Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 274886
Beijing, Beijing Municipality, 100730, China
Chongqing General Hospital /ID# 274564
Chongqing, Chongqing Municipality, 400013, China
The First Affiliated Hospital, Sun-Yat Sen University /ID# 274823
Guangzhou, Guangdong, 510080, China
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 274843
Guangzhou, Guangdong, 510655, China
The Second Hospital Of Hebei Medical University /ID# 274822
Shijiazhuang, Hebei, 050035, China
The Second Affiliated Hospital Of Zhengzhou University /ID# 274569
Zhengzhou, Henan, 450014, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 274563
Wuhan, Hubei, 430022, China
Renmin Hospital of Wuhan University /ID# 274616
Wuhan, Hubei, 430060, China
The Second Xiangya Hospital Of Central South University /ID# 274712
Changsha, Hunan, 410011, China
Nanjing Drum Tower Hospital /ID# 274710
Nanjing, Jiangsu, 210008, China
The First Affiliated Hospital of Nanchang University /ID# 274801
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University /ID# 274784
Changchun, Jilin, 130021, China
Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 275658
Shanghai, Shanghai Municipality, 200127, China
West China Hospital of Sichuan University /ID# 275478
Chengdu, Sichuan, 610041, China
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 274849
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 274689
Hangzhou, Zhejiang, 310018, China
Klinicki Bolnicki Centar Zagreb /ID# 273316
Grad Zagreb, City of Zagreb, 10000, Croatia
Poliklinika Solmed /ID# 273323
Zagreb, City of Zagreb, 10000, Croatia
Poliklinika Borzan d.o.o. /ID# 273324
Osijek, County of Osijek-Baranja, 31000, Croatia
Specialty Hospital Medico /ID# 273334
Rijeka, Primorje-Gorski Kotar County, 51000, Croatia
Klinicki Bolnicki Centar (KBC) Split /ID# 273327
Split, Split-Dalmatia County, 21000, Croatia
Hepato-Gastroenterologie HK /ID# 276654
Hradec Králové, Hradec Kralove, 500 12, Czechia
Nemocnice Ceske Budejovice /ID# 276530
České Budějovice, 370 01, Czechia
Parnu Hospital /ID# 273584
Pärnu, 80010, Estonia
East Tallinn Central Hospital /ID# 273723
Tallinn, 10138, Estonia
West Tallinn Central Hospital /ID# 273722
Tallinn, 10617, Estonia
Kuopion Yliopistollinen Sairaala /ID# 274856
Kuopio, Northern Savonia, 70210, Finland
Turku University Hospital /ID# 274312
Turku, Southwest Finland, 20520, Finland
Chu de Nice-Hopital Larchet Ii /Id# 278595
Nice, Alpes-Maritimes, 06202, France
CHU de Montpellier - Hopital Saint Eloi /ID# 278594
Montpellier, Herault, 34295, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 278633
Créteil, Paris, 94010, France
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 278587
St-Priest-en-Jarez, Pays de la Loire Region, 42270, France
Hopital Saint Antoine /ID# 278593
Paris, 75012, France
Universitaetsklinikum Freiburg /ID# 274763
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Universitaetsklinikum Ulm /ID# 273411
Ulm, Baden-Wurttemberg, 89081, Germany
Medizinisches Versorgungszentrum Dachau /ID# 273458
Dachau, Bavaria, 85221, Germany
Universitaetsklinikum Erlangen /ID# 273504
Erlangen, Bavaria, 91054, Germany
Markus Krankenhaus /ID# 273436
Frankfurt am Main, Hesse, 60431, Germany
Universitaetsklinikum Frankfurt /ID# 273462
Frankfurt am Main, Hesse, 60590, Germany
Universitaetsmedizin Essen /ID# 273505
Essen, North Rhine-Westphalia, 45147, Germany
Gastroenterologische Gemeinschaftspraxis Minden /ID# 273447
Minden, North Rhine-Westphalia, 32423, Germany
Magen-Darm-Zentrum-Remscheid /ID# 273435
Remscheid, North Rhine-Westphalia, 42859, Germany
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 273448
Dresden, Saxony, 01307, Germany
Eugastro /ID# 273573
Leipzig, Saxony, 04103, Germany
Studiengesellschaft BSF Unternehmergesellschaft /ID# 273457
Halle, Saxony-Anhalt, 06108, Germany
Praxisgemeinschaft Jerichow Schulze /ID# 273433
Jerichow, Saxony-Anhalt, 39319, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel /ID# 273463
Kiel, Schleswig-Holstein, 24105, Germany
Praxis fuer Gastroenterologie /ID# 274546
Lübeck, Schleswig-Holstein, 23560, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 274545
Berlin, 10117, Germany
Drk Kliniken Berlin - Köpenick /ID# 273514
Berlin, 12559, Germany
Krankenhaus Waldfriede /ID# 273708
Berlin, 14163, Germany
GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 273459
Herne, 44623, Germany
Universitaetsklinikum Regensburg /ID# 273519
Regensburg, 93042, Germany
Debreceni Egyetem-Klinikai Kozpont /ID# 275083
Debrecen, Hajdú-Bihar, 4032, Hungary
Clinfan /ID# 274904
Szekszárd, Tolna County, 7100, Hungary
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 275077
Szombathely, Vas County, 9700, Hungary
Obudai Egeszsegugyi Centrum /ID# 274919
Budapest, 1036, Hungary
Eszak-Pesti Centrumkorhaz - Honvedkorhaz - Podmaniczky Utca /ID# 275722
Budapest, 1062, Hungary
Semmelweis Egyetem /ID# 274872
Budapest, 1085, Hungary
Semmelweis Egyetem /ID# 274883
Budapest, 1085, Hungary
Pannónia Magánorvosi Centrum /ID# 275723
Budapest, 1136, Hungary
Szegedi Tudomanyegyetem /ID# 275185
Szeged, 6720, Hungary
Portiuncula University Hospital /ID# 273782
Ballinasloe, Galway, H53 T971, Ireland
Our Lady of Lourdes Hospital - Drogheda /ID# 273783
Drogheda, Louth, A92 VW28, Ireland
Midland Regional Hospital Mullingar /ID# 273784
Mullingar, Westmeath, N91 NA43, Ireland
St. Vincent's University Hospital /ID# 274617
Dublin, D04 T6F4, Ireland
Beaumont Hospital /ID# 273787
Dublin, D09 XR63, Ireland
Connolly Hospital /ID# 274173
Dublin, D15 X40D, Ireland
Yitzhak Shamir Medical Center /ID# 275525
Ẕerifin, Central District, 7030000, Israel
Assuta Ashdod Medical Center /ID# 274686
Ashdod, Southern District, 7747600, Israel
Soroka Medical Center /ID# 273350
Beersheba, Southern District, 8410101, Israel
The Chaim Sheba Medical Center /ID# 273348
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 273351
Tel Aviv, Tel Aviv, 6423906, Israel
Rambam Health Care Campus- Haifa /ID# 273347
Haifa, 3525408, Israel
Rabin Medical Center. /ID# 280537
Petah Tikva, 4941492, Israel
Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 274683
Monserrato, Cagliari, 09042, Italy
IRCCS Istituto Clinico Humanitas /ID# 274518
Rozzano, Lombardy, 20089, Italy
IRCCS Ospedale San Raffaele /ID# 274516
Milan, Milano, 20132, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 274828
Naples, Napoli, 80131, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274685
Rome, Roma, 00168, Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 274520
Bologna, 40138, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 274517
Milan, 20122, Italy
Azienda Ospedale-Universita Padova /ID# 274519
Padua, 35128, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 274824
Palermo, 90127, Italy
Azienda Ospedaliero Universitaria Pisana /ID# 274829
Pisa, 56126, Italy
Liepaja Regional Hospital /ID# 275164
Liepāja, LV-3414, Latvia
Pauls Stradins Clinical University Hospital /ID# 273586
Riga, LV-1002, Latvia
Digestive Diseases Center GASTRO /ID# 273589
Riga, LV-1079, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 273590
Kaunas, 50161, Lithuania
Panevezys Republican Hospital /ID# 273592
Panevezys, 35144, Lithuania
Vilnius University Hospital Santaros Klinikos /ID# 273591
Vilnius, 08661, Lithuania
Inlita - Lazdynai CTC /ID# 273725
Vilnius, LT-04130, Lithuania
Radboudumc /ID# 274797
Nijmegen, Gelderland, 6525 GA, Netherlands
Elisabeth TweeSteden Ziekenhuis /ID# 274940
Tilburg, North Brabant, 5022 GC, Netherlands
OLVG - Locatie Oost /ID# 274809
Amsterdam, North Holland, 1091 AC, Netherlands
Amsterdam UMC, locatie AMC /ID# 274939
Amsterdam, North Holland, 1105 AZ, Netherlands
Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 274936
Dordrecht, South Holland, 3318 AT, Netherlands
Erasmus Medisch Centrum /ID# 274795
Rotterdam, South Holland, 3015 CE, Netherlands
Franciscus Gasthuis & Vlietland, Locatie Gasthuis /ID# 274806
Rotterdam, South Holland, 3045 PM, Netherlands
RIVERMED Sp. z o. o. /ID# 274420
Poznan, Greater Poland Voivodeship, 61-441, Poland
Osrodek Badan Klinicznych Clinsante /ID# 274190
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-794, Poland
PROMED P. Lach, R. Glowacki S.j /ID# 274392
Krakow, Lesser Poland Voivodeship, 31-513, Poland
EMC Instytut Medyczny S.A /ID# 275113
Wroclaw, Lower Silesian Voivodeship, 54-144, Poland
Centrum Zdrowia Mdm /ID# 274192
Warsaw, Masovian Voivodeship, 00-189, Poland
Panstwowy Instytut Medyczny MSWiA /ID# 274538
Warsaw, Masovian Voivodeship, 02-507, Poland
WSD MEDI Clinical Sp. z o.o. /ID# 274194
Warsaw, Masovian Voivodeship, 02-786, Poland
Centrum Medyczne Lukamed Sp. z o.o /ID# 274193
Chojnice, Pomeranian Voivodeship, 89-600, Poland
Novamed Robert Koteras /ID# 274547
Bytom, Silesian Voivodeship, 41-902, Poland
Twoja Przychodnia Szczecińskie Centrum Medyczne /ID# 274187
Szczecin, West Pomeranian Voivodeship, 71-434, Poland
ISIS Clinical Research Center /ID# 274859
Guaynabo, 00969-2806, Puerto Rico
CMRC Headlands LLC /ID# 274832
San Juan, 00918-3501, Puerto Rico
Fdi Clinical Research /ID# 275337
San Juan, 00927, Puerto Rico
Memorial Healthcare International S.R.L. /Id# 276040
Bucharest, București, 013823, Romania
Spitalul Clinic Colentina /ID# 275892
Bucharest, București, 020125, Romania
Fundeni Clinical Institute /ID# 275893
Bucharest, București, 022328, Romania
Clinica Gastro Med SRL /ID# 275891
Cluj-Napoca, Cluj, 400380, Romania
OncoHelp Association /ID# 275889
Timișoara, Timiș County, 300239, Romania
Monza-Ares S.R.L. /Id# 276048
Bucharest, 021967, Romania
King Abdulaziz Medical City- National Guard Hospital /ID# 274817
Riyadh, Riyadh Region, 11426, Saudi Arabia
King Saud University /ID# 274818
Riyadh, Riyadh Region, 12372, Saudi Arabia
King Faisal Specialist Hospital and Research Center /ID# 274819
Riyadh, Riyadh Region, 12713, Saudi Arabia
King Fahad Specialist Hospital /ID# 274820
Dammam, 32253, Saudi Arabia
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 274740
Banská Bystrica, Banská Bystrica Region, 975 17, Slovakia
KM Management, spol. s.r.o. /ID# 274733
Nitra, Nitra Region, 949 01, Slovakia
ENDOMED s.r.o /ID# 274734
Košice, 040 01, Slovakia
Splosna Bolnisnica Nova Gorica /ID# 275635
Šempeter Pri Gorici, Urban Municipality of Nova Gorica, 5290, Slovenia
General Hospital Celje /ID# 275127
Celje, 3000, Slovenia
University Medical Centre Ljubljana /ID# 273636
Ljubljana, 1000, Slovenia
Inje University Haeundae Paik Hospital /ID# 274435
Busan, Busan Gwang Yeogsi, 48108, South Korea
Kyungpook National University Hospital /ID# 274439
Daegu, Daegu Gwang Yeogsi, 41944, South Korea
The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 274429
Daejeon, Daejeon Gwang Yeogsi, 34943, South Korea
Seoul National University Bundang Hospital /ID# 274441
Seongnam-si, Gyeonggido, 13620, South Korea
The Catholic University Of Korea St. Vincent's Hospital /ID# 274433
Suwon, Gyeonggido, 16247, South Korea
Chosun University Hospital /ID# 276672
Gwangju, Jeonranamdo, 61453, South Korea
Seoul National University Hospital /ID# 274438
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Yonsei University Health System Severance Hospital /ID# 274431
Seoul, Seoul Teugbyeolsi, 03722, South Korea
Gangnam Severance Hospital /ID# 274436
Seoul, Seoul Teugbyeolsi, 06273, South Korea
Samsung Medical Center /ID# 274440
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 274266
Santiago de Compostela, A Coruna, 15706, Spain
Hospital General De Granollers /ID# 274384
Granollers, Barcelona, 08402, Spain
Sant Joan de Deu de Manresa /ID# 274288
Manresa, Barcelona, 08423, Spain
Hospital Universitario de Gran Canaria Doctor Negrín /ID# 274277
Las Palmas de Gran Canaria, Las Palmas, 35010, Spain
Hospital Universitario Fundación Alcorcón /ID# 274309
Alcorcón, Madrid, 28922, Spain
Hospital Universitario Puerta De Hierro /ID# 274271
Majadahonda, Madrid, 28222, Spain
Hospital de Cabueñes /ID# 274254
Gijón, Principality of Asturias, 33394, Spain
Hospital Universitario Virgen Macarena /ID# 274258
Seville, Sevilla, 41009, Spain
Hospital Clinic de Barcelona /ID# 274262
Barcelona, 08036, Spain
Complejo Hospitalario Universitario de Pontevedra /ID# 274269
Pontevedra, 36071, Spain
Consorci Hospital General Universitario de Valencia /ID# 274275
Valencia, 46014, Spain
Hospital Universitario Doctor Peset /ID# 274385
Valencia, 46017, Spain
Danderyds Sjukhus - Danderyd /ID# 274401
Danderyd, Stockholm County, 182 88, Sweden
Karolinska University Hospital Solna /ID# 274379
Solna, Stockholm County, 171 64, Sweden
Alingsås Lasarett /ID# 274399
Alingsås, Västra Götaland County, 441 33, Sweden
Universitetssjukhuset Örebro /ID# 274386
Örebro, Örebro County, 701 85, Sweden
Linkoping University Hospital /ID# 274932
Linköping, Östergötland County, 581 85, Sweden
Luzern Kantonsspital /ID# 275415
Lucerne, Canton of Lucerne, 6000, Switzerland
Kantonsspital St.Gallen /ID# 273382
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
Inselspital, Universitaetsspital Bern /ID# 273364
Bern, 3010, Switzerland
China Medical University Hospital /ID# 273641
Taichung, 40447, Taiwan
National Taiwan University Hospital /ID# 273632
Taipei, 100, Taiwan
Mackay Memorial Hospital /ID# 273643
Taipei, 104, Taiwan
Taipei Veterans General Hospital /ID# 274717
Taipei, 112, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 273640
Taoyuan, 333, Taiwan
Burjeel Medical City /ID# 274749
Abu Dhabi, 0, United Arab Emirates
Sheikh Shakhbout Medical City /ID# 274643
Abu Dhabi, 11001, United Arab Emirates
Sheikh Khalifa Medical City /ID# 274777
Abu Dhabi, United Arab Emirates
Barts Health NHS Trust - The Royal London Hospital /ID# 274959
London, Greater London, E1 1BB, United Kingdom
King'S College Hospital /ID# 275223
London, Greater London, SE5 9RS, United Kingdom
Velocity North London /ID# 275581
North Finchley, Greater London, N12 8BU, United Kingdom
Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde /ID# 274758
Glasgow, Lanarkshire, G51 4TF, United Kingdom
Fairfield General Hospital /ID# 274947
Manchester, Lancashire, BL9 7TD, United Kingdom
The John Radcliffe Hospital /ID# 274757
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Queen Elizabeth Hospital Birmingham /ID# 275287
Birmingham, B15 2TH, United Kingdom
Stepping Hill Hospital-Stockport NHS foundation trust /ID# 275838
Stockport, SK2 7JE, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2025
First Posted
March 18, 2025
Study Start
June 17, 2025
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.