Status:
RECRUITING
A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab
Lead Sponsor:
AbbVie
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 ef...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
530 Patients enrolled
Trial Details
Trial ID
NCT06880744
Start Date
June 17 2025
End Date
September 1 2028
Last Update
January 5 2026
Active Locations (256)
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1
Gastro Health Research - St. Vincent'S East /ID# 275089
Birmingham, Alabama, United States, 35235
2
Digestive Health Specialists /ID# 274785
Dothan, Alabama, United States, 36301
3
East View Medical Research /ID# 276222
Mobile, Alabama, United States, 36606
4
Arizona Health Research /ID# 274366
Chandler, Arizona, United States, 85225