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

Status: Recruiting
Location: See all (164) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Gastro Health Research - St. Vincent'S East /ID# 275089
RECRUITING
Birmingham
Digestive Health Specialists /ID# 274785
RECRUITING
Dothan
East View Medical Research /ID# 276222
RECRUITING
Mobile
Arizona
Arizona Health Research /ID# 274366
RECRUITING
Chandler
California
Gastro Care Institute /ID# 274873
RECRUITING
Lancaster
Hoag Memorial Hospital Presbyterian /ID# 274364
RECRUITING
Newport Beach
California Medical Research Associates /ID# 274787
RECRUITING
Northridge
Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 273527
RECRUITING
San Diego
Florida
Novum Research /ID# 273587
RECRUITING
Clermont
Hillcrest Medical Research /ID# 273593
RECRUITING
Deland
Florida Research Institute /ID# 275196
RECRUITING
Lakewood Rch
Medical Professional Clinical Research /ID# 275208
RECRUITING
Miami
Sanchez Clinical Research /ID# 273727
RECRUITING
Miami
Sarkis Clinical Trials - Ocala /ID# 273595
RECRUITING
Ocala
Digestive And Liver Center Of Florida - Orlando /ID# 276432
RECRUITING
Orlando
Endoscopic Research, Inc. /ID# 273548
RECRUITING
Orlando
Iowa
Iowa Digestive Disease Center - Clive /ID# 274558
RECRUITING
Clive
Illinois
Gi Alliance - Glenview /ID# 274270
RECRUITING
Glenview
Illinois Gastroenterology Group /ID# 274280
RECRUITING
Gurnee
Southwest Gastroenterology - Oak Lawn /ID# 273596
RECRUITING
Oak Lawn
OSF St. Francis Medical Center /ID# 274391
RECRUITING
Peoria
Springfield Clinic Main Campus /ID# 273547
RECRUITING
Springfield
Indiana
Gastroenterology Health Partners /ID# 276434
RECRUITING
New Albany
Kansas
Cotton O'Neil Digestive Health Center /ID# 274394
RECRUITING
Topeka
Kentucky
Gastroenterology Health Partners, PLLC /ID# 276441
RECRUITING
Louisville
Louisiana
Tandem Clinical Research - Houma /ID# 274562
RECRUITING
Houma
Metropolitan Gastroenterology Associates - Metairie /ID# 274282
RECRUITING
Metairie
Louisiana Research Center, LLC /ID# 276443
RECRUITING
Shreveport
Pinnacle Gastroenterology /ID# 274991
RECRUITING
Shreveport
Massachusetts
Lucida Clinical Trials /ID# 275235
RECRUITING
New Bedford
Maryland
Velocity Clinical Research, Rockville /ID# 273599
RECRUITING
Rockville
Minnesota
Mayo Clinic-Rochester /ID# 273606
RECRUITING
Rochester
Mississippi
Gi Associates - Gia And Endoscopy Center - Flowood /ID# 274285
RECRUITING
Flowood
Delta Gastroenterology & Endoscopy Center /ID# 275005
RECRUITING
Southaven
North Carolina
Digestive Health Partners - Biltmore Office /ID# 273594
RECRUITING
Asheville
Carolina Digestive Diseases And Endoscopy Center /ID# 274256
RECRUITING
Greenville
New York
New York Gastroenterology Associates - Upper East Side /ID# 273520
RECRUITING
New York
Gastroenterology Group of Rochester /ID# 274283
RECRUITING
Rochester
Ohio
Digestive Disease Consultants - Brunswick /ID# 276445
RECRUITING
Brunswick
Gastro Health /ID# 275082
RECRUITING
Cincinnati
University Of Cincinnati Medical Center /ID# 273524
RECRUITING
Cincinnati
The Ohio State University - Wexner Medical Center /ID# 274743
RECRUITING
Columbus
Dayton Gastroenterology, Inc /ID# 273528
RECRUITING
Dayton
Pennsylvania
Digestive Disease Associates, LTD - Wyomissing /ID# 273603
RECRUITING
Wyomissing
South Carolina
Gastroenterology Associates of Orangeburg /ID# 274559
RECRUITING
Orangeburg
Tennessee
Gastro One - Walnut Run Road /ID# 273551
RECRUITING
Cordova
Skyline Gastroenterology of West Tennessee /ID# 276461
RECRUITING
Jackson
GI associates of Northeast Tennessee /ID# 273758
RECRUITING
Johnson City
Tri-Cities Gastroenterology /ID# 275067
RECRUITING
Kingsport
Gastrointestinal Associates - Knoxville - Dowell Springs Boulevard /ID# 276447
RECRUITING
Knoxville
Quality Medical Research /ID# 273733
RECRUITING
Nashville
Texas
Amel Med /ID# 276439
RECRUITING
Georgetown
Digestive & Liver Disease Consultants /ID# 276454
RECRUITING
Houston
Katy Integrative Gastroenterology /ID# 274645
RECRUITING
Katy
Caprock Gastro Research - Lubbock - 80th Street /ID# 273778
RECRUITING
Lubbock
GI Alliance: Mansfield /ID# 274272
RECRUITING
Mansfield
Linq Research /ID# 274917
RECRUITING
Pearland
Tyler Research Institute, LLC /ID# 273585
RECRUITING
Tyler
Utah
Care Access - Ogden /ID# 274361
RECRUITING
Ogden
Virginia
Gastroenterology Associates Of Tidewater - Chesapeake /ID# 276440
RECRUITING
Chesapeake
Emeritas Research Group /ID# 276457
RECRUITING
Lansdowne Town Center
Washington
Gi Alliance - Bellevue /ID# 274264
RECRUITING
Bellevue
Washington Gastroenterology - Tacoma /ID# 274551
RECRUITING
Tacoma
Other Locations
Austria
Medizinische Universitaet Graz /ID# 274428
RECRUITING
Graz
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 274318
RECRUITING
Linz
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 273611
RECRUITING
Salzburg
Medizinische Universitaet Wien /ID# 273612
RECRUITING
Vienna
Klinikum Wels-Grieskirchen GmbH /ID# 274172
RECRUITING
Wels
Bulgaria
Umbal Kaspela /ID# 274721
RECRUITING
Plovdiv
2nd Mhat /ID# 274722
RECRUITING
Sofia
Mhat Doverie /ID# 274798
RECRUITING
Sofia
Acibadem City Clinic UMHAT Mladost /ID# 274804
RECRUITING
Sofiya
Hospital Tsaritsa Yoanna /ID# 274723
RECRUITING
Sofiya
Canada
Barrie GI Associates /ID# 275211
RECRUITING
Barrie
South Edmonton Gastroenterology /ID# 274184
RECRUITING
Edmonton
The Oakville Endoscopy Centre /ID# 275213
RECRUITING
Oakville
Diex Recherche Quebec Inc. /ID# 274268
RECRUITING
Québec
Toronto Immune & Digestive Health Institute /ID# 274259
RECRUITING
Toronto
Croatia
Poliklinika Borzan d.o.o. /ID# 273324
RECRUITING
Osijek
Specialty Hospital Medico /ID# 273334
RECRUITING
Rijeka
Klinicki Bolnicki Centar (KBC) Split /ID# 273327
RECRUITING
Split
Poliklinika Solmed /ID# 273323
RECRUITING
Zagreb
Estonia
Parnu Hospital /ID# 273584
RECRUITING
Pärnu
West Tallinn Central Hospital /ID# 273722
RECRUITING
Tallinn
Finland
Kuopion Yliopistollinen Sairaala /ID# 274856
RECRUITING
Kuopio
Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 274545
RECRUITING
Berlin
Drk Kliniken Berlin - Köpenick /ID# 273514
RECRUITING
Berlin
Krankenhaus Waldfriede /ID# 273708
RECRUITING
Berlin
Medizinisches Versorgungszentrum Dachau /ID# 273458
RECRUITING
Dachau
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 273448
RECRUITING
Dresden
Universitaetsklinikum Erlangen /ID# 273504
RECRUITING
Erlangen
Studiengesellschaft BSF Unternehmergesellschaft /ID# 273457
RECRUITING
Halle
GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 273459
RECRUITING
Herne
Praxisgemeinschaft Jerichow Schulze /ID# 273433
RECRUITING
Jerichow
Eugastro /ID# 273573
RECRUITING
Leipzig
Praxis fuer Gastroenterologie /ID# 274546
RECRUITING
Lübeck
Gastroenterologische Gemeinschaftspraxis Minden /ID# 273447
RECRUITING
Minden
Universitaetsklinikum Ulm /ID# 273411
RECRUITING
Ulm
Hungary
Eszak-Pesti Centrumkorhaz - Honvedkorhaz - Podmaniczky Utca /ID# 275722
RECRUITING
Budapest
Obudai Egeszsegugyi Centrum /ID# 274919
RECRUITING
Budapest
Pannónia Magánorvosi Centrum /ID# 275723
RECRUITING
Budapest
Semmelweis Egyetem /ID# 274872
RECRUITING
Budapest
Semmelweis Egyetem /ID# 274883
RECRUITING
Budapest
Debreceni Egyetem-Klinikai Kozpont /ID# 275083
RECRUITING
Debrecen
Szegedi Tudományegyetem /ID# 275185
RECRUITING
Szeged
Clinfan /ID# 274904
RECRUITING
Szekszárd
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 275077
RECRUITING
Szombathely
Ireland
Portiuncula University Hospital /ID# 273782
RECRUITING
Ballinasloe
Our Lady of Lourdes Hospital - Drogheda /ID# 273783
RECRUITING
Drogheda
Beaumont Hospital /ID# 273787
RECRUITING
Dublin
Connolly Hospital /ID# 274173
RECRUITING
Dublin
Midland Regional Hospital Mullingar /ID# 273784
RECRUITING
Mullingar
Israel
Assuta Ashdod Medical Center /ID# 274686
RECRUITING
Ashdod
Rambam Health Care Campus /ID# 273347
RECRUITING
Haifa
The Chaim Sheba Medical Center /ID# 273348
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center /ID# 273351
RECRUITING
Tel Aviv
Yitzhak Shamir Medical Center /ID# 275525
RECRUITING
Ẕerifin
Italy
IRCCS Ospedale San Raffaele /ID# 274516
RECRUITING
Milan
Azienda Ospedale-Universita Padova /ID# 274519
RECRUITING
Padua
IRCCS Istituto Clinico Humanitas /ID# 274518
RECRUITING
Rozzano
Latvia
Liepaja Regional Hospital /ID# 275164
RECRUITING
Liepāja
Pauls Stradins Clinical University Hospital /ID# 273586
RECRUITING
Riga
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 273590
RECRUITING
Kaunas
Panevezys Republican Hospital /ID# 273592
RECRUITING
Panevezys
Inlita - Lazdynai CTC /ID# 273725
RECRUITING
Vilnius
Vilnius University Hospital Santaros Klinikos /ID# 273591
RECRUITING
Vilnius
Netherlands
Amsterdam UMC, locatie AMC /ID# 274939
RECRUITING
Amsterdam
Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 274936
RECRUITING
Dordrecht
Radboudumc /ID# 274797
RECRUITING
Nijmegen
Elisabeth TweeSteden Ziekenhuis /ID# 274940
RECRUITING
Tilburg
Poland
Novamed Robert Koteras /ID# 274547
RECRUITING
Bytom
Centrum Medyczne Lukamed Sp. z o.o /ID# 274193
RECRUITING
Chojnice
PROMED P. Lach, R. Glowacki S.j /ID# 274392
RECRUITING
Krakow
RIVERMED Sp. z o. o. /ID# 274420
RECRUITING
Poznan
Twoja Przychodnia Szczecińskie Centrum Medyczne /ID# 274187
RECRUITING
Szczecin
Centrum Zdrowia Mdm /ID# 274192
RECRUITING
Warsaw
Panstwowy Instytut Medyczny MSWiA /ID# 274538
RECRUITING
Warsaw
WSD MEDI Clinical Sp. z o.o. /ID# 274194
RECRUITING
Warsaw
EMC Instytut Medyczny S.A /ID# 275113
RECRUITING
Wroclaw
Puerto Rico
Caribbean Medical Research Center /ID# 274832
RECRUITING
San Juan
Fdi Clinical Research /ID# 275337
RECRUITING
San Juan
Slovenia
General Hospital Celje /ID# 275127
RECRUITING
Celje
University Medical Centre Ljubljana /ID# 273636
RECRUITING
Ljubljana
Spain
Hospital Clinic de Barcelona /ID# 274262
RECRUITING
Barcelona
Hospital de Cabueñes /ID# 274254
RECRUITING
Gijón
Hospital Universitario de Gran Canaria Doctor Negrín /ID# 274277
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario Puerta De Hierro /ID# 274271
RECRUITING
Majadahonda
Sant Joan de Deu de Manresa /ID# 274288
RECRUITING
Manresa
Complejo Hospitalario Universitario de Pontevedra /ID# 274269
RECRUITING
Pontevedra
Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 274266
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen Macarena /ID# 274258
RECRUITING
Seville
Consorci Hospital General Universitario de Valencia /ID# 274275
RECRUITING
Valencia
Hospital Universitario Doctor Peset /ID# 274385
RECRUITING
Valencia
Sweden
Alingsås Lasarett /ID# 274399
RECRUITING
Alingsås
Universitetssjukhuset Örebro /ID# 274386
RECRUITING
Örebro
Switzerland
Inselspital, Universitaetsspital Bern /ID# 273364
RECRUITING
Bern
Luzern Kantonsspital /ID# 275415
RECRUITING
Lucerne
Kantonsspital St.Gallen /ID# 273382
RECRUITING
Sankt Gallen
Taiwan
China Medical University Hospital /ID# 273641
RECRUITING
Taichung
Mackay Memorial Hospital /ID# 273643
RECRUITING
Taipei
Taipei Veterans General Hospital /ID# 274717
RECRUITING
Taipei
National Taiwan University Hospital /ID# 273632
RECRUITING
Taipei City
Linkou Chang Gung Memorial Hospital /ID# 273640
RECRUITING
Taoyuan
United Kingdom
Velocity North London /ID# 275581
RECRUITING
North Finchley
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2025-06-17
Estimated Completion Date: 2028-09
Participants
Target number of participants: 530
Treatments
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.
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.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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