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

Study Identifier
M25-540
CT.gov Identifier
NCT06880744
EudraCT Identifier
Not available
EUCTIS ID
2024-518998-33-00
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
Sign up for trial alerts

Study Details

Medical Condition
  • Ulcerative Colitis (UC)
    • Study Drug
  • Risankizumab
  • Vedolizumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 80 Years
    Inclusion and Exclusion 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.

    Protocol 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 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 Locations

    Location
    Status
    Location
    Gastro Health Research - St. Vincent'S East /ID# 275089
    Birmingham, Alabama, United States, 35235
    Status
    Not applicable
    Location
    Digestive Health Specialists /ID# 274785
    Dothan, Alabama, United States, 36301
    Status
    Not applicable
    Location
    East View Medical Research /ID# 276222
    Mobile, Alabama, United States, 36606
    Status
    Not applicable
    Location
    Arizona Health Research /ID# 274366
    Chandler, Arizona, United States, 85225
    Status
    Not applicable
    Location
    UC San Diego Health System /ID# 273538
    La Jolla, California, United States, 92037
    Status
    Not applicable
    Location
    Gastro Care Institute /ID# 274873
    Lancaster, California, United States, 93534
    Status
    Not applicable
    Showing {first} - {last} of {total} Results