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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
    Intravenous (IV) Infusion
  • Drug: Risankizumab
    Subcutaneous (SC) injection
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

Recruiting Locations

Gastro Health Research - St. Vincent'S East /ID# 275089
Birmingham 4049979, Alabama 4829764 35235
Contact:
Site Coordinator
205-838-3034

Digestive Health Specialists /ID# 274785
Dothan 4059102, Alabama 4829764 36301

East View Medical Research /ID# 276222
Mobile 4076598, Alabama 4829764 36606

Arizona Health Research /ID# 274366
Chandler 5289282, Arizona 5551752 85225

UC San Diego Health System /ID# 273538
La Jolla 5363943, California 5332921 92037

Gastro Care Institute /ID# 274873
Lancaster 5364940, California 5332921 93534

Hoag Memorial Hospital Presbyterian /ID# 274364
Newport Beach 5376890, California 5332921 92663

California Medical Research Associates /ID# 274787
Northridge 5377985, California 5332921 91324
Contact:
Site Coordinator
818-349-1974

uc davis medical center - patient support services building /ID# 274251
Sacramento 5389489, California 5332921 95817

Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 273527
San Diego 5391811, California 5332921 92103

Danbury Hospital, Western Connecticut Health Network /ID# 275277
Danbury 4832353, Connecticut 4831725 06810

Novum Research /ID# 273587
Clermont 4151352, Florida 4155751 34711

Hillcrest Medical Research /ID# 273593
DeLand 4152890, Florida 4155751 32720
Contact:
Site Coordinator
321-999-7616

Florida Research Institute /ID# 275196
Lakewood Rch 7255365, Florida 4155751 34211
Contact:
Site Coordinator
941-727-7772

Sanchez Clinical Research /ID# 273727
Miami 4164138, Florida 4155751 33157

Medical Professional Clinical Research /ID# 275208
Miami 4164138, Florida 4155751 33165

Sarkis Clinical Trials - Ocala /ID# 273595
Ocala 4166673, Florida 4155751 34474

Endoscopic Research, Inc. /ID# 273548
Orlando 4167147, Florida 4155751 32803
Contact:
Site Coordinator
407-241-3217 EXT.314

Digestive And Liver Center Of Florida - Orlando /ID# 276432
Orlando 4167147, Florida 4155751 32825

Emory University School Of Medicine - Atlanta /ID# 273522
Atlanta 4180439, Georgia 4197000 30322

Gi Alliance - Glenview /ID# 274270
Glenview 4893886, Illinois 4896861 60026

Illinois Gastroenterology Group /ID# 274280
Gurnee 4894861, Illinois 4896861 60031

Southwest Gastroenterology - Oak Lawn /ID# 273596
Oak Lawn 4904365, Illinois 4896861 60453

OSF St. Francis Medical Center /ID# 274391
Peoria 4905687, Illinois 4896861 61637-0001

Springfield Clinic Main Campus /ID# 273547
Springfield 4250542, Illinois 4896861 62703-2403
Contact:
Site Coordinator
217-528-7541

Gastroenterology Health Partners /ID# 276434
New Albany 4262045, Indiana 4921868 47150

Iowa Digestive Disease Center - Clive /ID# 274558
Clive 4852065, Iowa 4862182 50325
Contact:
Site Coordinator
515-564-3979

Cotton O'Neil Digestive Health Center /ID# 274394
Topeka 4280539, Kansas 4273857 66606-1539

Gastroenterology Health Partners, PLLC /ID# 276441
Louisville 4299276, Kentucky 6254925 40218

Tandem Clinical Research - Houma /ID# 274562
Houma 4328010, Louisiana 4331987 70363

Metropolitan Gastroenterology Associates - Metairie /ID# 274282
Metairie 4333177, Louisiana 4331987 70006

Pinnacle Gastroenterology /ID# 274991
Shreveport 4341513, Louisiana 4331987 71103
Contact:
Site Coordinator
318-212-8130

Louisiana Research Center, LLC /ID# 276443
Shreveport 4341513, Louisiana 4331987 71105

Velocity Clinical Research, Rockville /ID# 273599
Rockville 4367175, Maryland 4361885 20854-2931

Brigham & Womens Hospital /ID# 275266
Boston 4930956, Massachusetts 6254926 02115

Lucida Clinical Trials /ID# 275235
New Bedford 4945121, Massachusetts 6254926 02740

Huron Gastroenterology /ID# 274998
Ann Arbor 4984247, Michigan 5001836 48197

Mayo Clinic-Rochester /ID# 273606
Rochester 5043473, Minnesota 5037779 55905
Contact:
Site Coordinator
507-266-4728

Gi Associates - Gia And Endoscopy Center - Flowood /ID# 274285
Flowood 4426822, Mississippi 4436296 39232

Delta Gastroenterology & Endoscopy Center /ID# 275005
Southaven 4446675, Mississippi 4436296 38671

Columbia University Medical Center /ID# 273518
New York 5128581, New York 5128638 10032

New York Gastroenterology Associates - Upper East Side /ID# 273520
New York 5128581, New York 5128638 10075

Gastroenterology Group of Rochester /ID# 274283
Rochester 5134086, New York 5128638 14618

Digestive Health Partners - Biltmore Office /ID# 273594
Asheville 4453066, North Carolina 4482348 28801

Atrium Health - Morehead /ID# 274245
Charlotte 4460243, North Carolina 4482348 28204
Contact:
Site Coordinator
704-355-0282

Charlotte Gastroenterology And Hepatology - Randolph Road /ID# 274553
Charlotte 4460243, North Carolina 4482348 28207
Contact:
Site Coordinator
704-375-9485

Carolina Digestive Diseases And Endoscopy Center /ID# 274256
Greenville 4469160, North Carolina 4482348 27834

Digestive Disease Consultants - Brunswick /ID# 276445
Brunswick 5148480, Ohio 5165418 44212

Gastro Health /ID# 275082
Cincinnati 4508722, Ohio 5165418 45219
Contact:
Site Coordinator
513-872-4549

University Of Cincinnati Medical Center /ID# 273524
Cincinnati 4508722, Ohio 5165418 45219

The Ohio State University - Wexner Medical Center /ID# 274743
Columbus 4509177, Ohio 5165418 43212
Contact:
Site Coordinator
614-293-6255

Dayton Gastroenterology, Inc /ID# 273528
Dayton 4509884, Ohio 5165418 45415

Digestive Disease Associates, LTD - Wyomissing /ID# 273603
Wyomissing 5220248, Pennsylvania 6254927 19610

Gastroenterology Associates of Orangeburg /ID# 274559
Orangeburg 4590184, South Carolina 4597040 29118
Contact:
Site Coordinator
803-539-2005

Gastro One - Walnut Run Road /ID# 273551
Cordova 4050552, Tennessee 4662168 38018
Contact:
Site Coordinator
901-755-9110

Skyline Gastroenterology of West Tennessee /ID# 276461
Jackson 4632595, Tennessee 4662168 38301

GI associates of Northeast Tennessee /ID# 273758
Johnson City 4633419, Tennessee 4662168 37604

Tri-Cities Gastroenterology /ID# 275067
Kingsport 4634662, Tennessee 4662168 37663

Gastrointestinal Associates - Knoxville - Dowell Springs Boulevard /ID# 276447
Knoxville 4634946, Tennessee 4662168 37909

Quality Medical Research /ID# 273733
Nashville 4644585, Tennessee 4662168 37211

Amel Med /ID# 276439
Georgetown 4693342, Texas 4736286 78628

Digestive & Liver Disease Consultants /ID# 276454
Houston 4699066, Texas 4736286 77090

Katy Integrative Gastroenterology /ID# 274645
Katy 4702732, Texas 4736286 77494

Caprock Gastro Research - Lubbock - 80th Street /ID# 273778
Lubbock 5525577, Texas 4736286 79424

GI Alliance: Mansfield /ID# 274272
Mansfield 4709013, Texas 4736286 76063

Linq Research /ID# 274917
Pearland 4718097, Texas 4736286 77584

Tyler Research Institute, LLC /ID# 273585
Tyler 4738214, Texas 4736286 75701

Care Access - Ogden /ID# 274361
Ogden 5779206, Utah 5549030 84403

Gastroenterology Associates Of Tidewater - Chesapeake /ID# 276440
Chesapeake 4752186, Virginia 6254928 23320

Emeritas Research Group /ID# 276457
Lansdowne Town Center 7309207, Virginia 6254928 20176

Gi Alliance - Bellevue /ID# 274264
Bellevue 5786882, Washington 5815135 98004

Washington Gastroenterology - Tacoma /ID# 274551
Tacoma 5812944, Washington 5815135 98405

Isis Clinical Res. Ctr P.S.C. /ID# 274859
Guaynabo 4565119, Puerto Rico 00968
Contact:
Site Coordinator
939-363-0841

CMRC Headlands LLC /ID# 274832
San Juan 4568127, Puerto Rico 00918-3501

Fdi Clinical Research /ID# 275337
San Juan 4568127, Puerto Rico 00927
Contact:
Site Coordinator
787-722-1248

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.