Study to Assess Change in Disease Activity of Risankizumab Treatment in Adult Participants With Moderate to Severe Ulcerative Colitis

Study Identifier
P25-544
CT.gov Identifier
NCT06764706
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
Sign up for trial alerts

Study Details

Medical Condition
  • Ulcerative Colitis (UC)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants with an endoscopically confirmed diagnosis of moderate to severe ulcerative colitis. * Participants initiating risankizumab at the investigator's discretion as part of their routine clinical care; the decision to administer risankizumab must be made prior to and independent of documentation for the study and according to the approved local label.
    Exclusion Criteria:
    * Participants previously exposed risankizumab * Participants who are currently participating in interventional research (not including noninterventional studies, post-marketing observational study (PMOS), or registry participation).

    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 assess the change in disease activity of risankizumab treatment in adult participants with moderate to severe UC in real-world clinical practice.

    Risankizumab is an approved drug for treating participants with ulcerative colitis. Approximately 200 participants who are prescribed risankizumab by their physician in accordance with local label will be enrolled in approximately multiple sites across Germany and Austria.

    Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 52 weeks.

    There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

    Study Locations

    Location
    Status
    Location
    Universitaetsklinikum Heidelberg /ID# 275906
    Heidelberg, Baden-Wurttemberg, Germany, 69120
    Status
    Recruiting
    Location
    Klinikum Ernst Von Bergmann /ID# 278268
    Potsdam, Brandenburg, Germany, 14467
    Status
    Recruiting
    Location
    Private Practice - Dr. Kempelmann /ID# 275726
    Tostedt, Free and Hanseatic City of Hamburg, Germany, 21255
    Status
    Recruiting
    Location
    Gastroenterologische Schwerpunktpraxis /ID# 276701
    Hanover, Lower Saxony, Germany, 30449
    Status
    Recruiting
    Location
    Medizinisches Versorgungszentrum Ahaus /ID# 280966
    Ahaus, North Rhine-Westphalia, Germany, 48683
    Status
    Recruiting
    Location
    Gastropraxis Bochum /ID# 281375
    Bochum, North Rhine-Westphalia, Germany, 44787
    Status
    Recruiting
    Showing {first} - {last} of {total} Results