A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab
NCT ID: NCT06880744
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
530 participants
INTERVENTIONAL
2025-06-17
2028-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Risankizumab Group
An 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.
Risankizumab
Intravenous (IV) Infusion
Risankizumab
Subcutaneous (SC) injection
Vedolizumab Group
Vedolizumab IV will be administered at Baseline, Weeks 2 and 6, and every 8 weeks with the last dose of vedolizumab IV at Week 46.
Vedolizumab
Intravenous (IV) infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Risankizumab
Intravenous (IV) Infusion
Risankizumab
Subcutaneous (SC) injection
Vedolizumab
Intravenous (IV) infusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gastro Health Research - St. Vincent'S East /ID# 275089
Birmingham, Alabama, United States
Digestive Health Specialists /ID# 274785
Dothan, Alabama, United States
East View Medical Research /ID# 276222
Mobile, Alabama, United States
Arizona Health Research /ID# 274366
Chandler, Arizona, United States
UC San Diego Health System /ID# 273538
La Jolla, California, United States
Gastro Care Institute /ID# 274873
Lancaster, California, United States
Hoag Memorial Hospital Presbyterian /ID# 274364
Newport Beach, California, United States
California Medical Research Associates /ID# 274787
Northridge, California, United States
Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 273527
San Diego, California, United States
Danbury Hospital, Western Connecticut Health Network /ID# 275277
Danbury, Connecticut, United States
Novum Research /ID# 273587
Clermont, Florida, United States
Hillcrest Medical Research /ID# 273593
DeLand, Florida, United States
Florida Research Institute /ID# 275196
Lakewood Rch, Florida, United States
Sanchez Clinical Research /ID# 273727
Miami, Florida, United States
Medical Professional Clinical Research /ID# 275208
Miami, Florida, United States
Sarkis Clinical Trials - Ocala /ID# 273595
Ocala, Florida, United States
Endoscopic Research, Inc. /ID# 273548
Orlando, Florida, United States
Digestive And Liver Center Of Florida - Orlando /ID# 276432
Orlando, Florida, United States
Emory University School Of Medicine - Atlanta /ID# 273522
Atlanta, Georgia, United States
Gi Alliance - Glenview /ID# 274270
Glenview, Illinois, United States
Illinois Gastroenterology Group /ID# 274280
Gurnee, Illinois, United States
Southwest Gastroenterology - Oak Lawn /ID# 273596
Oak Lawn, Illinois, United States
OSF St. Francis Medical Center /ID# 274391
Peoria, Illinois, United States
Springfield Clinic Main Campus /ID# 273547
Springfield, Illinois, United States
Gastroenterology Health Partners /ID# 276434
New Albany, Indiana, United States
Iowa Digestive Disease Center - Clive /ID# 274558
Clive, Iowa, United States
Cotton O'Neil Digestive Health Center /ID# 274394
Topeka, Kansas, United States
Gastroenterology Health Partners, PLLC /ID# 276441
Louisville, Kentucky, United States
Tandem Clinical Research - Houma /ID# 274562
Houma, Louisiana, United States
Metropolitan Gastroenterology Associates - Metairie /ID# 274282
Metairie, Louisiana, United States
Pinnacle Gastroenterology /ID# 274991
Shreveport, Louisiana, United States
Louisiana Research Center, LLC /ID# 276443
Shreveport, Louisiana, United States
Velocity Clinical Research, Rockville /ID# 273599
Rockville, Maryland, United States
Lucida Clinical Trials /ID# 275235
New Bedford, Massachusetts, United States
Huron Gastroenterology /ID# 274998
Ann Arbor, Michigan, United States
Mayo Clinic-Rochester /ID# 273606
Rochester, Minnesota, United States
Gi Associates - Gia And Endoscopy Center - Flowood /ID# 274285
Flowood, Mississippi, United States
Delta Gastroenterology & Endoscopy Center /ID# 275005
Southaven, Mississippi, United States
New York Gastroenterology Associates - Upper East Side /ID# 273520
New York, New York, United States
Gastroenterology Group of Rochester /ID# 274283
Rochester, New York, United States
Digestive Health Partners - Biltmore Office /ID# 273594
Asheville, North Carolina, United States
Carolina Digestive Diseases And Endoscopy Center /ID# 274256
Greenville, North Carolina, United States
Digestive Disease Consultants - Brunswick /ID# 276445
Brunswick, Ohio, United States
Gastro Health /ID# 275082
Cincinnati, Ohio, United States
University Of Cincinnati Medical Center /ID# 273524
Cincinnati, Ohio, United States
The Ohio State University - Wexner Medical Center /ID# 274743
Columbus, Ohio, United States
Dayton Gastroenterology, Inc /ID# 273528
Dayton, Ohio, United States
Digestive Disease Associates, LTD - Wyomissing /ID# 273603
Wyomissing, Pennsylvania, United States
Gastroenterology Associates of Orangeburg /ID# 274559
Orangeburg, South Carolina, United States
Gastro One - Walnut Run Road /ID# 273551
Cordova, Tennessee, United States
Skyline Gastroenterology of West Tennessee /ID# 276461
Jackson, Tennessee, United States
GI associates of Northeast Tennessee /ID# 273758
Johnson City, Tennessee, United States
Tri-Cities Gastroenterology /ID# 275067
Kingsport, Tennessee, United States
Gastrointestinal Associates - Knoxville - Dowell Springs Boulevard /ID# 276447
Knoxville, Tennessee, United States
Quality Medical Research /ID# 273733
Nashville, Tennessee, United States
Amel Med /ID# 276439
Georgetown, Texas, United States
Digestive & Liver Disease Consultants /ID# 276454
Houston, Texas, United States
Katy Integrative Gastroenterology /ID# 274645
Katy, Texas, United States
Caprock Gastro Research - Lubbock - 80th Street /ID# 273778
Lubbock, Texas, United States
GI Alliance: Mansfield /ID# 274272
Mansfield, Texas, United States
Linq Research /ID# 274917
Pearland, Texas, United States
Tyler Research Institute, LLC /ID# 273585
Tyler, Texas, United States
Care Access - Ogden /ID# 274361
Ogden, Utah, United States
Gastroenterology Associates Of Tidewater - Chesapeake /ID# 276440
Chesapeake, Virginia, United States
Emeritas Research Group /ID# 276457
Lansdowne Town Center, Virginia, United States
Gi Alliance - Bellevue /ID# 274264
Bellevue, Washington, United States
Washington Gastroenterology - Tacoma /ID# 274551
Tacoma, Washington, United States
Medizinische Universitaet Graz /ID# 274428
Graz, Styria, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 274318
Linz, Upper Austria, Austria
Klinikum Wels-Grieskirchen GmbH /ID# 274172
Wels, Upper Austria, Austria
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 273611
Salzburg, , Austria
Medizinische Universitaet Wien /ID# 273612
Vienna, , Austria
Hospital Tsaritsa Yoanna /ID# 274723
Sofiya, Sofia, Bulgaria
Umhat Sveti Ivan Rilsky /ID# 274794
Sofiya, Sofia, Bulgaria
Acibadem City Clinic UMHAT Mladost /ID# 274804
Sofiya, Sofia, Bulgaria
Umbal Kaspela /ID# 274721
Plovdiv, , Bulgaria
2nd Mhat /ID# 274722
Sofia, , Bulgaria
Mhat Doverie /ID# 274798
Sofia, , Bulgaria
University Of Calgary - Health Sciences Centre /ID# 274237
Calgary, Alberta, Canada
South Edmonton Gastroenterology /ID# 274184
Edmonton, Alberta, Canada
Barrie GI Associates /ID# 275211
Barrie, Ontario, Canada
Brampton Gastroenterology Inc /Id# 276187
Brampton, Ontario, Canada
GNRR Digestive Clinics and Research Center Inc. /ID# 275820
Brampton, Ontario, Canada
The Oakville Endoscopy Centre /ID# 275213
Oakville, Ontario, Canada
Toronto Immune & Digestive Health Institute /ID# 274259
Toronto, Ontario, Canada
Diex Recherche Quebec Inc. /ID# 274268
Québec, , Canada
The First Affiliated Hospital, Sun-Yat Sen University /ID# 274823
Guangzhou, Guangdong, China
Poliklinika Solmed /ID# 273323
Zagreb, City of Zagreb, Croatia
Poliklinika Borzan d.o.o. /ID# 273324
Osijek, County of Osijek-Baranja, Croatia
Specialty Hospital Medico /ID# 273334
Rijeka, Primorje-Gorski Kotar County, Croatia
Klinicki Bolnicki Centar (KBC) Split /ID# 273327
Split, Split-Dalmatia County, Croatia
Parnu Hospital /ID# 273584
Pärnu, , Estonia
East Tallinn Central Hospital /ID# 273723
Tallinn, , Estonia
West Tallinn Central Hospital /ID# 273722
Tallinn, , Estonia
Kuopion Yliopistollinen Sairaala /ID# 274856
Kuopio, Northern Savonia, Finland
Turku University Hospital /ID# 274312
Turku, Southwest Finland, Finland
Universitaetsklinikum Ulm /ID# 273411
Ulm, Baden-Wurttemberg, Germany
Medizinisches Versorgungszentrum Dachau /ID# 273458
Dachau, Bavaria, Germany
Universitaetsklinikum Erlangen /ID# 273504
Erlangen, Bavaria, Germany
Universitaetsklinikum Frankfurt /ID# 273462
Frankfurt am Main, Hesse, Germany
Gastroenterologische Gemeinschaftspraxis Minden /ID# 273447
Minden, North Rhine-Westphalia, Germany
Magen-Darm-Zentrum-Remscheid /ID# 273435
Remscheid, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 273448
Dresden, Saxony, Germany
Eugastro /ID# 273573
Leipzig, Saxony, Germany
Studiengesellschaft BSF Unternehmergesellschaft /ID# 273457
Halle, Saxony-Anhalt, Germany
Praxisgemeinschaft Jerichow Schulze /ID# 273433
Jerichow, Saxony-Anhalt, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel /ID# 273463
Kiel, Schleswig-Holstein, Germany
Praxis fuer Gastroenterologie /ID# 274546
Lübeck, Schleswig-Holstein, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 274545
Berlin, , Germany
Drk Kliniken Berlin - Köpenick /ID# 273514
Berlin, , Germany
Krankenhaus Waldfriede /ID# 273708
Berlin, , Germany
GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 273459
Herne, , Germany
Universitaetsklinikum Regensburg /ID# 273519
Regensburg, , Germany
Debreceni Egyetem-Klinikai Kozpont /ID# 275083
Debrecen, Hajdú-Bihar, Hungary
Clinfan /ID# 274904
Szekszárd, Tolna County, Hungary
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 275077
Szombathely, Vas County, Hungary
Obudai Egeszsegugyi Centrum /ID# 274919
Budapest, , Hungary
Eszak-Pesti Centrumkorhaz - Honvedkorhaz - Podmaniczky Utca /ID# 275722
Budapest, , Hungary
Semmelweis Egyetem /ID# 274872
Budapest, , Hungary
Semmelweis Egyetem /ID# 274883
Budapest, , Hungary
Pannónia Magánorvosi Centrum /ID# 275723
Budapest, , Hungary
Szegedi Tudomanyegyetem /ID# 275185
Szeged, , Hungary
Portiuncula University Hospital /ID# 273782
Ballinasloe, Galway, Ireland
Our Lady of Lourdes Hospital - Drogheda /ID# 273783
Drogheda, Louth, Ireland
Midland Regional Hospital Mullingar /ID# 273784
Mullingar, Westmeath, Ireland
St. Vincent's University Hospital /ID# 274617
Dublin, , Ireland
Beaumont Hospital /ID# 273787
Dublin, , Ireland
Connolly Hospital /ID# 274173
Dublin, , Ireland
Yitzhak Shamir Medical Center /ID# 275525
Ẕerifin, Central District, Israel
Assuta Ashdod Medical Center /ID# 274686
Ashdod, Southern District, Israel
Soroka Medical Center /ID# 273350
Beersheba, Southern District, Israel
The Chaim Sheba Medical Center /ID# 273348
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 273351
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus /ID# 273347
Haifa, , Israel
Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 274683
Monserrato, Cagliari, Italy
IRCCS Istituto Clinico Humanitas /ID# 274518
Rozzano, Lombardy, Italy
IRCCS Ospedale San Raffaele /ID# 274516
Milan, Milano, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 274685
Rome, Roma, Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 274520
Bologna, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 274517
Milan, , Italy
Azienda Ospedale-Universita Padova /ID# 274519
Padua, , Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 274824
Palermo, , Italy
Liepaja Regional Hospital /ID# 275164
Liepāja, , Latvia
Pauls Stradins Clinical University Hospital /ID# 273586
Riga, , Latvia
Digestive Diseases Center GASTRO /ID# 273589
Riga, , Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 273590
Kaunas, , Lithuania
Panevezys Republican Hospital /ID# 273592
Panevezys, , Lithuania
Vilnius University Hospital Santaros Klinikos /ID# 273591
Vilnius, , Lithuania
Inlita - Lazdynai CTC /ID# 273725
Vilnius, , Lithuania
Radboudumc /ID# 274797
Nijmegen, Gelderland, Netherlands
Elisabeth TweeSteden Ziekenhuis /ID# 274940
Tilburg, North Brabant, Netherlands
Amsterdam UMC, locatie AMC /ID# 274939
Amsterdam, North Holland, Netherlands
Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 274936
Dordrecht, South Holland, Netherlands
RIVERMED Sp. z o. o. /ID# 274420
Poznan, Greater Poland Voivodeship, Poland
Osrodek Badan Klinicznych Clinsante /ID# 274190
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
PROMED P. Lach, R. Glowacki S.j /ID# 274392
Krakow, Lesser Poland Voivodeship, Poland
EMC Instytut Medyczny S.A /ID# 275113
Wroclaw, Lower Silesian Voivodeship, Poland
Centrum Zdrowia Mdm /ID# 274192
Warsaw, Masovian Voivodeship, Poland
Panstwowy Instytut Medyczny MSWiA /ID# 274538
Warsaw, Masovian Voivodeship, Poland
WSD MEDI Clinical Sp. z o.o. /ID# 274194
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne Lukamed Sp. z o.o /ID# 274193
Chojnice, Pomeranian Voivodeship, Poland
Novamed Robert Koteras /ID# 274547
Bytom, Silesian Voivodeship, Poland
Twoja Przychodnia Szczecińskie Centrum Medyczne /ID# 274187
Szczecin, West Pomeranian Voivodeship, Poland
Isis Clinical Res. Ctr P.S.C. /ID# 274859
Guaynabo, , Puerto Rico
CMRC Headlands LLC /ID# 274832
San Juan, , Puerto Rico
Fdi Clinical Research /ID# 275337
San Juan, , Puerto Rico
King Saud University /ID# 274818
Riyadh, Riyadh Region, Saudi Arabia
King Fahad Specialist Hospital /ID# 274820
Dammam, , Saudi Arabia
General Hospital Celje /ID# 275127
Celje, , Slovenia
University Medical Centre Ljubljana /ID# 273636
Ljubljana, , Slovenia
Inje University Haeundae Paik Hospital /ID# 274435
Busan, Busan Gwang Yeogsi, South Korea
Kyungpook National University Hospital /ID# 274439
Daegu, Daegu Gwang Yeogsi, South Korea
Chosun University Hospital /ID# 276672
Gwangju, Jeonranamdo, South Korea
Seoul National University Hospital /ID# 274438
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 274431
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 274440
Seoul, Seoul Teugbyeolsi, South Korea
Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 274266
Santiago de Compostela, A Coruna, Spain
Hospital General De Granollers /ID# 274384
Granollers, Barcelona, Spain
Sant Joan de Deu de Manresa /ID# 274288
Manresa, Barcelona, Spain
Hospital Universitario de Gran Canaria Doctor Negrín /ID# 274277
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario Fundación Alcorcón /ID# 274309
Alcorcón, Madrid, Spain
Hospital Universitario Puerta De Hierro /ID# 274271
Majadahonda, Madrid, Spain
Hospital de Cabueñes /ID# 274254
Gijón, Principality of Asturias, Spain
Hospital Universitario Virgen Macarena /ID# 274258
Seville, Sevilla, Spain
Hospital Clinic de Barcelona /ID# 274262
Barcelona, , Spain
Complejo Hospitalario Universitario de Pontevedra /ID# 274269
Pontevedra, , Spain
Consorci Hospital General Universitario de Valencia /ID# 274275
Valencia, , Spain
Hospital Universitario Doctor Peset /ID# 274385
Valencia, , Spain
Karolinska University Hospital Solna /ID# 274379
Solna, Stockholm County, Sweden
Alingsås Lasarett /ID# 274399
Alingsås, Västra Götaland County, Sweden
Universitetssjukhuset Örebro /ID# 274386
Örebro, Örebro County, Sweden
Linkoping University Hospital /ID# 274932
Linköping, Östergötland County, Sweden
Luzern Kantonsspital /ID# 275415
Lucerne, Canton of Lucerne, Switzerland
Kantonsspital St.Gallen /ID# 273382
Sankt Gallen, Canton of St. Gallen, Switzerland
Inselspital, Universitaetsspital Bern /ID# 273364
Bern, , Switzerland
National Taiwan University Hospital /ID# 273632
Taipei City, Taipei, Taiwan
China Medical University Hospital /ID# 273641
Taichung, , Taiwan
Mackay Memorial Hospital /ID# 273643
Taipei, , Taiwan
Taipei Veterans General Hospital /ID# 274717
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 273640
Taoyuan, , Taiwan
Sheikh Shakhbout Medical City /ID# 274643
Abu Dhabi, , United Arab Emirates
Barts Health NHS Trust - The Royal London Hospital /ID# 274959
London, Greater London, United Kingdom
King'S College Hospital /ID# 275223
London, Greater London, United Kingdom
Velocity North London /ID# 275581
North Finchley, Greater London, United Kingdom
Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde /ID# 274758
Glasgow, Lanarkshire, United Kingdom
Stepping Hill Hospital-Stockport NHS foundation trust /ID# 275838
Stockport, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M25-540
Identifier Type: -
Identifier Source: org_study_id