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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Risankizumab; Drug: Risankizumab; Drug: Vedolizumab

• Study Type: Interventional
• Enrollment (Actual): 573
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 273611
  • Vienna, Austria, 1090
    • Medizinische Universitaet Wien /ID# 273612
  • Styria
    • Graz, Styria, Austria, 8010
      • Medizinische Universitaet Graz /ID# 274428
  • Upper Austria
    • Linz, Upper Austria, Austria, 4010
      • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 274318
    • Wels, Upper Austria, Austria, 4600
      • Klinikum Wels-Grieskirchen GmbH /ID# 274172
• Bulgaria
  • Plovdiv, Bulgaria, 4001
    • Umbal Kaspela /ID# 274721
  • Sofia, Bulgaria, 1233
    • MHAT Knyaginya Klementina /ID# 274722
  • Sofia, Bulgaria, 1632
    • Mhat Doverie /ID# 274798
  • Sofia
    • Sofiya, Sofia, Bulgaria, 1527
      • Hospital Tsaritsa Yoanna /ID# 274723
    • Sofiya, Sofia, Bulgaria, 1606
      • Umhat Sveti Ivan Rilsky /ID# 274794
    • Sofiya, Sofia, Bulgaria, 1784
      • Acibadem City Clinic UMHAT Mladost /ID# 274804
• Canada
  • Québec, Canada, G1V 4T3
    • Diex Recherche Quebec Inc. /ID# 274268
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • University Of Calgary - Health Sciences Centre /ID# 274237
    • Edmonton, Alberta, Canada, T5R 1W2
      • Gastroenterology and Internal Medicine Research Institute /ID# 274239
    • Edmonton, Alberta, Canada, T6L 6K3
      • South Edmonton Gastroenterology /ID# 274184
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Barrie GI Associates /ID# 275211
    • Brampton, Ontario, Canada, L6S 0C1
      • Brampton Gastroenterology Inc /Id# 276187
    • Brampton, Ontario, Canada, L6S 0E2
      • GNRR Digestive Clinics and Research Center Inc. /ID# 275820
    • Oakville, Ontario, Canada, L6L 5L7
      • The Oakville Endoscopy Centre /ID# 275213
    • Toronto, Ontario, Canada, M6A 3B4
      • Toronto Immune & Digestive Health Institute /ID# 274259
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital /ID# 275201
• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • The First Affiliated Hospital Of Anhui Medical University /ID# 274786
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Peking Union Medical College Hospital East - Dongdan Campus /ID# 274886
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400013
      • Chongqing General Hospital /ID# 274564
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital, Sun-Yat Sen University /ID# 274823
    • Guangzhou, Guangdong, China, 510655
      • The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 274843
  • Hebei
    • Shijiazhuang, Hebei, China, 050035
      • The Second Hospital Of Hebei Medical University /ID# 274822
  • Henan
    • Zhengzhou, Henan, China, 450014
      • The Second Affiliated Hospital Of Zhengzhou University /ID# 274569
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 274563
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University /ID# 274616
  • Hunan
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital Of Central South University /ID# 274712
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital /ID# 274710
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University /ID# 274801
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University - Changchun /ID# 274784
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200127
      • Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 275658
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University /ID# 275478
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 274849
    • Hangzhou, Zhejiang, China, 310018
      • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 274689
• Croatia
  • City of Zagreb
    • Grad Zagreb, City of Zagreb, Croatia, 10000
      • Klinicki Bolnicki Centar Zagreb /ID# 273316
    • Zagreb, City of Zagreb, Croatia, 10000
      • Poliklinika Solmed /ID# 273323
  • County of Osijek-Baranja
    • Osijek, County of Osijek-Baranja, Croatia, 31000
      • Poliklinika Borzan d.o.o. /ID# 273324
  • Primorje-Gorski Kotar County
    • Rijeka, Primorje-Gorski Kotar County, Croatia, 51000
      • Specialty Hospital Medico /ID# 273334
  • Split-Dalmatia County
    • Split, Split-Dalmatia County, Croatia, 21000
      • Klinicki Bolnicki Centar (KBC) Split /ID# 273327
• Czechia
  • České Budějovice, Czechia, 370 01
    • Nemocnice Ceske Budejovice /ID# 276530
  • Hradec Kralove
    • Hradec Králové, Hradec Kralove, Czechia, 500 12
      • Hepato-Gastroenterologie HK /ID# 276654
• Estonia
  • Pärnu, Estonia, 80010
    • Parnu Hospital /ID# 273584
  • Tallinn, Estonia, 10138
    • East Tallinn Central Hospital /ID# 273723
  • Tallinn, Estonia, 10617
    • West Tallinn Central Hospital /ID# 273722
• Finland
  • Northern Savonia
    • Kuopio, Northern Savonia, Finland, 70210
      • Kuopion Yliopistollinen Sairaala /ID# 274856
  • Southwest Finland
    • Turku, Southwest Finland, Finland, 20520
      • Turku University Hospital /ID# 274312
• France
  • Paris, France, 75012
    • Hopital Saint Antoine /ID# 278593
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06202
      • Chu de Nice-Hopital Larchet Ii /Id# 278595
  • Herault
    • Montpellier, Herault, France, 34295
      • CHU de Montpellier - Hopital Saint Eloi /ID# 278594
  • Paris
    • Créteil, Paris, France, 94010
      • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 278633
  • Pays de la Loire Region
    • St-Priest-en-Jarez, Pays de la Loire Region, France, 42270
      • Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 278587
• Germany
  • Berlin, Germany, 10117
    • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 274545
  • Berlin, Germany, 12559
    • Drk Kliniken Berlin - Köpenick /ID# 273514
  • Berlin, Germany, 14163
    • Krankenhaus Waldfriede /ID# 273708
  • Herne, Germany, 44623
    • GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 273459
  • Baden-Wurttemberg
    • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
      • Universitaetsklinikum Freiburg /ID# 274763
    • Ulm, Baden-Wurttemberg, Germany, 89081
      • Universitaetsklinikum Ulm /ID# 273411
  • Bavaria
    • Dachau, Bavaria, Germany, 85221
      • Medizinisches Versorgungszentrum Dachau /ID# 273458
    • Erlangen, Bavaria, Germany, 91054
      • Universitaetsklinikum Erlangen /ID# 273504
    • Regensburg, Bavaria, Germany, 93042
      • Universitaetsklinikum Regensburg /ID# 273519
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60431
      • Markus Krankenhaus /ID# 273436
    • Frankfurt am Main, Hesse, Germany, 60590
      • Universitaetsklinikum Frankfurt /ID# 273462
  • North Rhine-Westphalia
    • Essen, North Rhine-Westphalia, Germany, 45147
      • Universitaetsmedizin Essen /ID# 273505
    • Minden, North Rhine-Westphalia, Germany, 32423
      • Gastroenterologische Gemeinschaftspraxis Minden /ID# 273447
    • Remscheid, North Rhine-Westphalia, Germany, 42859
      • Magen-Darm-Zentrum-Remscheid /ID# 273435
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 273448
    • Leipzig, Saxony, Germany, 04103
      • Eugastro /ID# 273573
  • Saxony-Anhalt
    • Halle, Saxony-Anhalt, Germany, 06108
      • Studiengesellschaft BSF Unternehmergesellschaft /ID# 273457
    • Jerichow, Saxony-Anhalt, Germany, 39319
      • Praxisgemeinschaft Jerichow Schulze /ID# 273433
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitaetsklinikum Schleswig-Holstein - Campus Kiel /ID# 273463
    • Lübeck, Schleswig-Holstein, Germany, 23560
      • Praxis fuer Gastroenterologie - Lubeck /ID# 274546
• Hungary
  • Budapest, Hungary, 1036
    • Obudai Egeszsegugyi Centrum /ID# 274919
  • Budapest, Hungary, 1062
    • Eszak-Pesti Centrumkorhaz - Honvedkorhaz - Podmaniczky Utca /ID# 275722
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem /ID# 274872
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem /ID# 274883
  • Budapest, Hungary, 1136
    • Pannónia Magánorvosi Centrum /ID# 275723
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem /ID# 275083
  • Csongrád megye
    • Szeged, Csongrád megye, Hungary, 6720
      • Szegedi Tudomanyegyetem /ID# 275185
  • Tolna County
    • Szekszárd, Tolna County, Hungary, 7100
      • Clinfan /ID# 274904
  • Vas County
    • Szombathely, Vas County, Hungary, 9700
      • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 275077
• Ireland
  • Dublin, Ireland, D04 T6F4
    • St. Vincent's University Hospital /ID# 274617
  • Dublin, Ireland, D09 XR63
    • Beaumont Hospital /ID# 273787
  • Dublin, Ireland, D15 X40D
    • Connolly Hospital /ID# 274173
  • Galway
    • Ballinasloe, Galway, Ireland, H53 T971
      • Portiuncula University Hospital /ID# 273782
  • Louth
    • Drogheda, Louth, Ireland, A92 VW28
      • Our Lady of Lourdes Hospital - Drogheda /ID# 273783
  • Westmeath
    • Mullingar, Westmeath, Ireland, N91 NA43
      • Midland Regional Hospital Mullingar /ID# 273784
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus- Haifa /ID# 273347
  • Central District
    • Petah Tikva, Central District, Israel, 4941492
      • Rabin Medical Center. /ID# 280537
    • Ẕerifin, Central District, Israel, 7030000
      • Yitzhak Shamir Medical Center /ID# 275525
  • Southern District
    • Ashdod, Southern District, Israel, 7747600
      • Assuta Ashdod Medical Center /ID# 274686
    • Beersheba, Southern District, Israel, 8410101
      • Soroka Medical Center /ID# 273350
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 273348
    • Tel Aviv, Tel Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 273351
• Italy
  • Bologna, Italy, 40138
    • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 274520
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 274517
  • Padova, Italy, 35128
    • Azienda Ospedale-Universita Padova /ID# 274519
  • Palermo, Italy, 90127
    • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 274824
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana /ID# 274829
  • Cagliari
    • Monserrato, Cagliari, Italy, 09042
      • Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 274683
  • Lombardy
    • Rozzano, Lombardy, Italy, 20089
      • IRCCS Istituto Clinico Humanitas /ID# 274518
  • Milano
    • Milan, Milano, Italy, 20132
      • IRCCS Ospedale San Raffaele /ID# 274516
  • Napoli
    • Naples, Napoli, Italy, 80131
      • Azienda Ospedaliera Universitaria Federico II - Naples /ID# 274828
  • Roma
    • Rome, Roma, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274685
• Latvia
  • Liepāja, Latvia, LV-3414
    • Liepaja Regional Hospital /ID# 275164
  • Riga, Latvia, LV-1002
    • Pauls Stradins Clinical University Hospital /ID# 273586
  • Riga, Latvia, LV-1079
    • Digestive Diseases Center GASTRO /ID# 273589
• Lithuania
  • Kaunas, Lithuania, 50161
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 273590
  • Panevezys, Lithuania, 35144
    • Panevezys Republican Hospital /ID# 273592
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital Santaros Klinikos /ID# 273591
  • Vilnius, Lithuania, LT-04130
    • Inlita - Lazdynai CTC /ID# 273725
• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboudumc /ID# 274797
  • North Brabant
    • Tilburg, North Brabant, Netherlands, 5022 GC
      • Elisabeth TweeSteden Ziekenhuis /ID# 274940
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1091 AC
      • OLVG - Locatie Oost /ID# 274809
    • Amsterdam, North Holland, Netherlands, 1105 AZ
      • Amsterdam UMC, locatie AMC /ID# 274939
  • South Holland
    • Dordrecht, South Holland, Netherlands, 3318 AT
      • Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 274936
    • Rotterdam, South Holland, Netherlands, 3015 CE
      • Erasmus Medisch Centrum /ID# 274795
    • Rotterdam, South Holland, Netherlands, 3045 PM
      • Franciscus Gasthuis & Vlietland, Locatie Gasthuis /ID# 274806
• Poland
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 61-441
      • RIVERMED Sp. z o. o. /ID# 274420
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-794
      • Osrodek Badan Klinicznych Clinsante - Bydgoszcz /ID# 274190
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 31-513
      • PROMED P. Lach, R. Glowacki S.j /ID# 274392
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 54-144
      • EMC Instytut Medyczny S.A /ID# 275113
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 00-189
      • Centrum Zdrowia Mdm /ID# 274192
    • Warsaw, Masovian Voivodeship, Poland, 02-507
      • Panstwowy Instytut Medyczny MSWiA /ID# 274538
    • Warsaw, Masovian Voivodeship, Poland, 02-786
      • WSD MEDI Clinical Sp. z o.o. /ID# 274194
  • Pomeranian Voivodeship
    • Chojnice, Pomeranian Voivodeship, Poland, 89-600
      • Centrum Medyczne Lukamed Sp. z o.o /ID# 274193
  • Silesian Voivodeship
    • Bytom, Silesian Voivodeship, Poland, 41-902
      • Novamed Robert Koteras /ID# 274547
  • West Pomeranian Voivodeship
    • Szczecin, West Pomeranian Voivodeship, Poland, 71-434
      • Twoja Przychodnia Szczecińskie Centrum Medyczne /ID# 274187
• Puerto Rico
  • Guaynabo, Puerto Rico, 00969-2806
    • ISIS Clinical Research Center /ID# 274859
  • San Juan, Puerto Rico, 00918-3501
    • CMRC Headlands LLC /ID# 274832
  • San Juan, Puerto Rico, 00927
    • Fdi Clinical Research /ID# 275337
• Romania
  • Bucharest, Romania, 021967
    • Monza-Ares S.R.L. /Id# 276048
  • Bucharest
    • Bucharest, Bucharest, Romania, 013823
      • Memorial Healthcare International S.R.L. /Id# 276040
    • Bucharest, Bucharest, Romania, 020125
      • Spitalul Clinic Colentina /ID# 275892
    • Bucharest, Bucharest, Romania, 022328
      • Fundeni Clinical Institute /ID# 275893
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400380
      • Clinica Gastro Med SRL /ID# 275891
  • Timiș County
    • Timișoara, Timiș County, Romania, 300239
      • OncoHelp Association /ID# 275889
• Saudi Arabia
  • Dammam, Saudi Arabia, 32253
    • King Fahad Specialist Hospital /ID# 274820
  • Riyadh Region
    • Riyadh, Riyadh Region, Saudi Arabia, 11426
      • King Abdulaziz Medical City- National Guard Hospital /ID# 274817
    • Riyadh, Riyadh Region, Saudi Arabia, 12372
      • King Saud University /ID# 274818
    • Riyadh, Riyadh Region, Saudi Arabia, 12713
      • King Faisal Specialist Hospital and Research Center /ID# 274819
• Slovakia
  • Banská Bystrica Region
    • Banská Bystrica, Banská Bystrica Region, Slovakia, 975 17
      • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 274740
  • Košice Region
    • Košice, Košice Region, Slovakia, 040 01
      • Endomed /ID# 274734
  • Nitra Region
    • Nitra, Nitra Region, Slovakia, 949 01
      • KM Management, spol. s.r.o. /ID# 274733
• Slovenia
  • Celje, Slovenia, 3000
    • General Hospital Celje /ID# 275127
  • Ljubljana, Slovenia, 1000
    • University Medical Centre Ljubljana /ID# 273636
  • Urban Municipality of Nova Gorica
    • Šempeter Pri Gorici, Urban Municipality of Nova Gorica, Slovenia, 5290
      • Splosna Bolnisnica Nova Gorica /ID# 275635
• South Korea
  • Busan Gwang Yeogsi
    • Busan, Busan Gwang Yeogsi, South Korea, 48108
      • Inje University Haeundae Paik Hospital /ID# 274435
  • Daegu Gwang Yeogsi
    • Daegu, Daegu Gwang Yeogsi, South Korea, 41944
      • Kyungpook National University Hospital /ID# 274439
  • Daejeon Gwang Yeogsi
    • Daejeon, Daejeon Gwang Yeogsi, South Korea, 34943
      • The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 274429
  • Gyeonggido
    • Seongnam-si, Gyeonggido, South Korea, 13620
      • Seoul National University Bundang Hospital /ID# 274441
    • Suwon, Gyeonggido, South Korea, 16247
      • The Catholic University Of Korea St. Vincent's Hospital /ID# 274433
  • Jeonranamdo
    • Gwangju, Jeonranamdo, South Korea, 61453
      • Chosun University Hospital /ID# 276672
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Seoul National University Hospital /ID# 274438
    • Seoul, Seoul Teugbyeolsi, South Korea, 03722
      • Yonsei University Health System Severance Hospital /ID# 274431
    • Seoul, Seoul Teugbyeolsi, South Korea, 06273
      • Gangnam Severance Hospital /ID# 274436
    • Seoul, Seoul Teugbyeolsi, South Korea, 06351
      • Samsung Medical Center /ID# 274440
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona /ID# 274262
  • Pontevedra, Spain, 36071
    • Complejo Hospitalario Universitario de Pontevedra /ID# 274269
  • Valencia, Spain, 46014
    • Consorci Hospital General Universitario de Valencia /ID# 274275
  • Valencia, Spain, 46017
    • Hospital Universitario Doctor Peset /ID# 274385
  • A Coruna
    • Santiago de Compostela, A Coruna, Spain, 15706
      • Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 274266
  • Barcelona
    • Granollers, Barcelona, Spain, 08402
      • Hospital General De Granollers /ID# 274384
    • Manresa, Barcelona, Spain, 08423
      • Sant Joan de Deu de Manresa /ID# 274288
  • Las Palmas
    • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
      • Hospital Universitario de Gran Canaria Doctor Negrín /ID# 274277
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Hospital Universitario Fundacion Alcorcon /ID# 274309
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta De Hierro /ID# 274271
  • Principality of Asturias
    • Gijón, Principality of Asturias, Spain, 33394
      • Hospital de Cabuenes /ID# 274254
  • Sevilla
    • Seville, Sevilla, Spain, 41009
      • Hospital Universitario Virgen Macarena /ID# 274258
• Sweden
  • Stockholm County
    • Danderyd, Stockholm County, Sweden, 182 88
      • Danderyds Sjukhus - Danderyd /ID# 274401
    • Solna, Stockholm County, Sweden, 171 64
      • Karolinska University Hospital Solna /ID# 274379
  • Västra Götaland County
    • Alingsås, Västra Götaland County, Sweden, 441 33
      • Alingsås Lasarett /ID# 274399
  • Örebro County
    • Örebro, Örebro County, Sweden, 701 85
      • Universitetssjukhuset Orebro /ID# 274386
  • Östergötland County
    • Linköping, Östergötland County, Sweden, 581 85
      • Linkoping University Hospital /ID# 274932
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, Universitaetsspital Bern /ID# 273364
  • Canton of Lucerne
    • Lucerne, Canton of Lucerne, Switzerland, 6000
      • Luzern Kantonsspital /ID# 275415
  • Canton of St. Gallen
    • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
      • Kantonsspital St.Gallen /ID# 273382
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital /ID# 273641
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital /ID# 273632
  • Taipei, Taiwan, 104
    • Mackay Memorial Hospital /ID# 273643
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital /ID# 274717
  • Taoyuan City, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital /ID# 273640
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Burjeel Medical City /ID# 274749
  • Abu Dhabi, United Arab Emirates, 11001
    • Sheikh Shakhbout Medical City /ID# 274643
  • Abu Dhabi, United Arab Emirates
    • Sheikh Khalifa Medical City /ID# 274777
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Queen Elizabeth Hospital Birmingham /ID# 275287
  • Stockport, United Kingdom, SK2 7JE
    • Stepping Hill Hospital-Stockport NHS foundation trust /ID# 275838
  • Greater London
    • London, Greater London, United Kingdom, E1 1BB
      • Barts Health NHS Trust - The Royal London Hospital /ID# 274959
    • London, Greater London, United Kingdom, SE5 9RS
      • King's College Hospital /ID# 275223
    • North Finchley, Greater London, United Kingdom, N12 8BU
      • Velocity North London /ID# 275581
  • Lanarkshire
    • Glasgow, Lanarkshire, United Kingdom, G51 4TF
      • Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde /ID# 274758
  • Lancashire
    • Manchester, Lancashire, United Kingdom, BL9 7TD
      • Fairfield General Hospital /ID# 274947
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • The John Radcliffe Hospital /ID# 274757
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Gastro Health Research - St. Vincent'S East /ID# 275089
    • Dothan, Alabama, United States, 36301
      • Digestive Health Specialists /ID# 274785
    • Mobile, Alabama, United States, 36606
      • East View Medical Research /ID# 276222
  • Arizona
    • Chandler, Arizona, United States, 85225
      • Arizona Health Research /ID# 274366
  • California
    • La Jolla, California, United States, 92037
      • UC San Diego Health System /ID# 273538
    • Lancaster, California, United States, 93534
      • Gastro Care Institute /ID# 274873
    • Los Angeles, California, United States, 90024
      • UCLA Health - Digestive Health & Nutrition Clinic /ID# 274827
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Presbyterian /ID# 274364
    • Northridge, California, United States, 91324
      • California Medical Research Associates /ID# 274787
    • Sacramento, California, United States, 95817
      • uc davis medical center - patient support services building /ID# 274251
    • San Diego, California, United States, 92103
      • Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 273527
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Danbury Hospital, Western Connecticut Health Network /ID# 275277
  • Florida
    • Clermont, Florida, United States, 34711
      • Novum Research /ID# 273587
    • DeLand, Florida, United States, 32720
      • Hillcrest Medical Research /ID# 273593
    • Lakewood Rch, Florida, United States, 34211
      • Florida Research Institute /ID# 275196
    • Miami, Florida, United States, 33157
      • Sanchez Clinical Research /ID# 273727
    • Miami, Florida, United States, 33165
      • Medical Professional Clinical Research /ID# 275208
    • Ocala, Florida, United States, 34474
      • Sarkis Clinical Trials - Ocala /ID# 273595
    • Orlando, Florida, United States, 32803
      • Endoscopic Research, Inc. /ID# 273548
    • Orlando, Florida, United States, 32825
      • Digestive And Liver Center Of Florida - Orlando /ID# 276432
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University School Of Medicine - Atlanta /ID# 273522
  • Illinois
    • Glenview, Illinois, United States, 60026
      • Gi Alliance - Glenview /ID# 274270
    • Gurnee, Illinois, United States, 60031
      • Illinois Gastroenterology Group /ID# 274280
    • Oak Lawn, Illinois, United States, 60453
      • Southwest Gastroenterology - Oak Lawn /ID# 273596
    • Peoria, Illinois, United States, 61637-0001
      • OSF St. Francis Medical Center /ID# 274391
    • Springfield, Illinois, United States, 62703-2403
      • Springfield Clinic Main Campus /ID# 273547
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Gastroenterology Health Partners /ID# 276434
  • Iowa
    • Clive, Iowa, United States, 50325
      • Iowa Digestive Disease Center - Clive /ID# 274558
  • Kansas
    • Topeka, Kansas, United States, 66606-1539
      • Cotton O'Neil Digestive Health Center /ID# 274394
  • Kentucky
    • Louisville, Kentucky, United States, 40218
      • Gastroenterology Health Partners /ID# 276441
  • Louisiana
    • Houma, Louisiana, United States, 70363
      • Tandem Clinical Research - Houma /ID# 274562
    • Metairie, Louisiana, United States, 70006
      • Metropolitan Gastroenterology Associates - Metairie /ID# 274282
    • Shreveport, Louisiana, United States, 71103
      • Pinnacle Gastroenterology /ID# 274991
    • Shreveport, Louisiana, United States, 71105
      • Louisiana Research Center, LLC /ID# 276443
  • Maryland
    • Rockville, Maryland, United States, 20854-2931
      • Velocity Clinical Research, Rockville /ID# 273599
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Womens Hospital /ID# 275266
    • New Bedford, Massachusetts, United States, 02740
      • Lucida Clinical Trials /ID# 275235
  • Michigan
    • Ann Arbor, Michigan, United States, 48197
      • Huron Gastroenterology /ID# 274998
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic-Rochester /ID# 273606
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Gi Associates - Gia And Endoscopy Center - Flowood /ID# 274285
    • Southaven, Mississippi, United States, 38671
      • Delta Gastroenterology & Endoscopy Center /ID# 275005
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center /ID# 273518
    • New York, New York, United States, 10075
      • New York Gastroenterology Associates - Upper East Side /ID# 273520
    • Rochester, New York, United States, 14618
      • Gastroenterology Group of Rochester /ID# 274283
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Digestive Health Partners - Biltmore Office /ID# 273594
    • Charlotte, North Carolina, United States, 28204
      • Atrium Health - Morehead /ID# 274245
    • Charlotte, North Carolina, United States, 28207
      • Charlotte Gastroenterology And Hepatology - Randolph Road /ID# 274553
    • Greenville, North Carolina, United States, 27834
      • Carolina Digestive Diseases And Endoscopy Center /ID# 274256
  • Ohio
    • Beavercreek, Ohio, United States, 45440
      • Dayton Gastroenterology - Beavercreek /ID# 273528
    • Brunswick, Ohio, United States, 44212
      • Digestive Disease Consultants - Brunswick /ID# 276445
    • Cincinnati, Ohio, United States, 45219
      • Gastro Health - Cincinnati /ID# 275082
    • Cincinnati, Ohio, United States, 45219
      • University Of Cincinnati Medical Center /ID# 273524
    • Columbus, Ohio, United States, 43210
      • The Ohio State University /ID# 274743
  • Pennsylvania
    • Wyomissing, Pennsylvania, United States, 19610
      • Digestive Disease Associates, LTD - Wyomissing /ID# 273603
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • Gastroenterology Associates of Orangeburg /ID# 274559
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Gastro One - Walnut Run Road /ID# 273551
    • Jackson, Tennessee, United States, 38301
      • Skyline Gastroenterology of West Tennessee /ID# 276461
    • Johnson City, Tennessee, United States, 37604
      • GI associates of Northeast Tennessee /ID# 273758
    • Kingsport, Tennessee, United States, 37663
      • Tri-Cities Gastroenterology /ID# 275067
    • Knoxville, Tennessee, United States, 37909
      • Gastrointestinal Associates - Knoxville - Dowell Springs Boulevard /ID# 276447
    • Nashville, Tennessee, United States, 37211
      • Quality Medical Research /ID# 273733
  • Texas
    • Georgetown, Texas, United States, 78628
      • Amel Med /ID# 276439
    • Houston, Texas, United States, 77090
      • Digestive & Liver Disease Consultants /ID# 276454
    • Katy, Texas, United States, 77494
      • Katy Integrative Gastroenterology /ID# 274645
    • Lubbock, Texas, United States, 79424
      • Caprock Gastro Research - Lubbock - 80th Street /ID# 273778
    • Mansfield, Texas, United States, 76063
      • GI Alliance: Mansfield /ID# 274272
    • Pearland, Texas, United States, 77584
      • Linq Research - Pearland /ID# 274917
    • Tyler, Texas, United States, 75701
      • Tyler Research Institute /ID# 273585
  • Utah
    • Ogden, Utah, United States, 84403
      • Care Access - Ogden /ID# 274361
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Gastroenterology Associates Of Tidewater - Chesapeake /ID# 276440
    • Lansdowne Town Center, Virginia, United States, 20176
      • Emeritas Research Group /ID# 276457
  • Washington
    • Bellevue, Washington, United States, 98004
      • Gi Alliance - Bellevue /ID# 274264
    • Seattle, Washington, United States, 98101
      • Virginia Mason Hospital & Medical Center /ID# 274810
    • Tacoma, Washington, United States, 98405
      • Washington Gastroenterology - Tacoma /ID# 274551

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Risankizumab; Subcutaneous (SC) injection; Drug: Risankizumab; Intravenous (IV) Infusion
Active Comparator: 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.	Drug: Vedolizumab; Intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At Week 48

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 18, 2025

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Immunologic Factors; Physiological Effects of Drugs; Gastrointestinal Agents; risankizumab; vedolizumab
• Other Study ID Numbers: M25-540; 2024-518998-33-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No