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

Launched by ABBVIE · Mar 12, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how well a medication called risankizumab works compared to another medication called vedolizumab in treating adults with moderate to severe ulcerative colitis (UC). Ulcerative colitis is a disease that causes inflammation and bleeding in the large intestine. The study will include about 530 adults who have had UC for at least three months and have not yet tried certain targeted therapies. Participants will be randomly assigned to receive either risankizumab or vedolizumab, with risankizumab given through an IV during the initial treatment and then as a self-injection later on, while vedolizumab will be given through an IV throughout the study.

To participate, individuals must have active UC that has not responded well to other treatments, such as steroids or immunomodulators. They cannot have previously received any targeted therapy for UC. Throughout the study, participants will attend regular visits to monitor their health and any side effects. The entire study will last about 69 to 71 weeks, including a screening period to ensure eligibility. It's important for potential participants to know that this trial may involve more frequent visits and treatments compared to standard care.

Gender

ALL

Eligibility criteria

• 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.