A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab

Running, not enrolling · Phase 3

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT06880744

Run by

AbbVie

People needed

573

Starts

2025-06-17

Expected to finish

2027-08-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• UCLA Health - Digestive Health & Nutrition Clinic /ID# 274827 — Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian /ID# 274364 — Newport Beach, California, United States
• California Medical Research Associates /ID# 274787 — Northridge, California, United States
• uc davis medical center - patient support services building /ID# 274251 — Sacramento, 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
• Gastro Health Research - St. Vincent'S East /ID# 275089 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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