A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab
Public ClinicalTrials.gov record NCT06880744. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT06880744
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 573 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 17, 2025 (Actual)
- Primary completion
- Aug 2027 (Estimated)
- Completion
- Aug 2027 (Estimated)
- Last update posted
- Aug 4, 2026
2025 – 2027
United States locations
- U.S. sites
- 74
- U.S. states
- 27
- U.S. cities
- 68
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Gastro Health Research - St. Vincent'S East /ID# 275089 | Birmingham | Alabama | 35235 | — |
| Digestive Health Specialists /ID# 274785 | Dothan | Alabama | 36301 | — |
| East View Medical Research /ID# 276222 | Mobile | Alabama | 36606 | — |
| Arizona Health Research /ID# 274366 | Chandler | Arizona | 85225 | — |
| UC San Diego Health System /ID# 273538 | La Jolla | California | 92037 | — |
| Gastro Care Institute /ID# 274873 | Lancaster | California | 93534 | — |
| UCLA Health - Digestive Health & Nutrition Clinic /ID# 274827 | Los Angeles | California | 90024 | — |
| Hoag Memorial Hospital Presbyterian /ID# 274364 | Newport Beach | California | 92663 | — |
| California Medical Research Associates /ID# 274787 | Northridge | California | 91324 | — |
| uc davis medical center - patient support services building /ID# 274251 | Sacramento | California | 95817 | — |
| Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 273527 | San Diego | California | 92103 | — |
| Danbury Hospital, Western Connecticut Health Network /ID# 275277 | Danbury | Connecticut | 06810 | — |
| Novum Research /ID# 273587 | Clermont | Florida | 34711 | — |
| Hillcrest Medical Research /ID# 273593 | DeLand | Florida | 32720 | — |
| Florida Research Institute /ID# 275196 | Lakewood Rch | Florida | 34211 | — |
| Sanchez Clinical Research /ID# 273727 | Miami | Florida | 33157 | — |
| Medical Professional Clinical Research /ID# 275208 | Miami | Florida | 33165 | — |
| Sarkis Clinical Trials - Ocala /ID# 273595 | Ocala | Florida | 34474 | — |
| Endoscopic Research, Inc. /ID# 273548 | Orlando | Florida | 32803 | — |
| Digestive And Liver Center Of Florida - Orlando /ID# 276432 | Orlando | Florida | 32825 | — |
| Emory University School Of Medicine - Atlanta /ID# 273522 | Atlanta | Georgia | 30322 | — |
| Gi Alliance - Glenview /ID# 274270 | Glenview | Illinois | 60026 | — |
| Illinois Gastroenterology Group /ID# 274280 | Gurnee | Illinois | 60031 | — |
| Southwest Gastroenterology - Oak Lawn /ID# 273596 | Oak Lawn | Illinois | 60453 | — |
| OSF St. Francis Medical Center /ID# 274391 | Peoria | Illinois | 61637-0001 | — |
| Springfield Clinic Main Campus /ID# 273547 | Springfield | Illinois | 62703-2403 | — |
| Gastroenterology Health Partners /ID# 276434 | New Albany | Indiana | 47150 | — |
| Iowa Digestive Disease Center - Clive /ID# 274558 | Clive | Iowa | 50325 | — |
| Cotton O'Neil Digestive Health Center /ID# 274394 | Topeka | Kansas | 66606-1539 | — |
| Gastroenterology Health Partners /ID# 276441 | Louisville | Kentucky | 40218 | — |
| Tandem Clinical Research - Houma /ID# 274562 | Houma | Louisiana | 70363 | — |
| Metropolitan Gastroenterology Associates - Metairie /ID# 274282 | Metairie | Louisiana | 70006 | — |
| Pinnacle Gastroenterology /ID# 274991 | Shreveport | Louisiana | 71103 | — |
| Louisiana Research Center, LLC /ID# 276443 | Shreveport | Louisiana | 71105 | — |
| Velocity Clinical Research, Rockville /ID# 273599 | Rockville | Maryland | 20854-2931 | — |
| Brigham and Womens Hospital /ID# 275266 | Boston | Massachusetts | 02115 | — |
| Lucida Clinical Trials /ID# 275235 | New Bedford | Massachusetts | 02740 | — |
| Huron Gastroenterology /ID# 274998 | Ann Arbor | Michigan | 48197 | — |
| Mayo Clinic-Rochester /ID# 273606 | Rochester | Minnesota | 55905 | — |
| Gi Associates - Gia And Endoscopy Center - Flowood /ID# 274285 | Flowood | Mississippi | 39232 | — |
| Delta Gastroenterology & Endoscopy Center /ID# 275005 | Southaven | Mississippi | 38671 | — |
| Columbia University Medical Center /ID# 273518 | New York | New York | 10032 | — |
| New York Gastroenterology Associates - Upper East Side /ID# 273520 | New York | New York | 10075 | — |
| Gastroenterology Group of Rochester /ID# 274283 | Rochester | New York | 14618 | — |
| Digestive Health Partners - Biltmore Office /ID# 273594 | Asheville | North Carolina | 28801 | — |
| Atrium Health - Morehead /ID# 274245 | Charlotte | North Carolina | 28204 | — |
| Charlotte Gastroenterology And Hepatology - Randolph Road /ID# 274553 | Charlotte | North Carolina | 28207 | — |
| Carolina Digestive Diseases And Endoscopy Center /ID# 274256 | Greenville | North Carolina | 27834 | — |
| Dayton Gastroenterology - Beavercreek /ID# 273528 | Beavercreek | Ohio | 45440 | — |
| Digestive Disease Consultants - Brunswick /ID# 276445 | Brunswick | Ohio | 44212 | — |
| Gastro Health - Cincinnati /ID# 275082 | Cincinnati | Ohio | 45219 | — |
| University Of Cincinnati Medical Center /ID# 273524 | Cincinnati | Ohio | 45219 | — |
| The Ohio State University /ID# 274743 | Columbus | Ohio | 43210 | — |
| Digestive Disease Associates, LTD - Wyomissing /ID# 273603 | Wyomissing | Pennsylvania | 19610 | — |
| Gastroenterology Associates of Orangeburg /ID# 274559 | Orangeburg | South Carolina | 29118 | — |
| Gastro One - Walnut Run Road /ID# 273551 | Cordova | Tennessee | 38018 | — |
| Skyline Gastroenterology of West Tennessee /ID# 276461 | Jackson | Tennessee | 38301 | — |
| GI associates of Northeast Tennessee /ID# 273758 | Johnson City | Tennessee | 37604 | — |
| Tri-Cities Gastroenterology /ID# 275067 | Kingsport | Tennessee | 37663 | — |
| Gastrointestinal Associates - Knoxville - Dowell Springs Boulevard /ID# 276447 | Knoxville | Tennessee | 37909 | — |
| Quality Medical Research /ID# 273733 | Nashville | Tennessee | 37211 | — |
| Amel Med /ID# 276439 | Georgetown | Texas | 78628 | — |
| Digestive & Liver Disease Consultants /ID# 276454 | Houston | Texas | 77090 | — |
| Katy Integrative Gastroenterology /ID# 274645 | Katy | Texas | 77494 | — |
| Caprock Gastro Research - Lubbock /ID# 273778 | Lubbock | Texas | 79424 | — |
| GI Alliance - Mansfield /ID# 274272 | Mansfield | Texas | 76063 | — |
| Linq Research - Pearland /ID# 274917 | Pearland | Texas | 77584 | — |
| Tyler Research Institute /ID# 273585 | Tyler | Texas | 75701 | — |
| Care Access - Ogden /ID# 274361 | Ogden | Utah | 84403 | — |
| Gastroenterology Associates Of Tidewater - Chesapeake /ID# 276440 | Chesapeake | Virginia | 23320 | — |
| Emeritas Research Group /ID# 276457 | Lansdowne Town Center | Virginia | 20176 | — |
| Gi Alliance - Bellevue /ID# 274264 | Bellevue | Washington | 98004 | — |
| Virginia Mason Hospital and Medical Center /ID# 274810 | Seattle | Washington | 98101 | — |
| Washington Gastroenterology - Tacoma /ID# 274551 | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 196 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06880744, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 4, 2026 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06880744 live on ClinicalTrials.gov.