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

Study Identifier
P25-797
CT.gov Identifier
NCT07136116
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Ulcerative Colitis (UC)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    15+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants with a diagnosis of moderate to severe Ulcerative Colitis (UC) commenced on Risankizumab (RZB) treatment prescribed as part of their routine clinical care at their clinical's discretion according to Japan approved label and treatment prescription recommendations/guidelines. * The decision to prescribe RZB is made prior to and independently of study participation. * Participants able to provide voluntary informed consent before any study-related activities or procedures (obtained/documented as per regulations). If the patient is under 18 years old, a patient's parent or legal guardian must be willing to give written informed consent. * Participants who can understand and communicate with the investigator and comply with the requirements of the study, including collection of PRO data using a smart device (i.e., mobile phone) and continued PRO data collection after cessation of RZB. * Participants without previous exposure to RZB. * Participants who are not currently participating in interventional research (not including non-interventional studies, PMOS, or registry participation).
    Exclusion Criteria:
    See Inclusion Criteria

    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 30 sites across Japan.

    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 156 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
    Aichi Medical University Hospital /ID# 278155
    Nagakute, Aichi-ken, Japan, 480-1195
    Status
    Recruiting
    Location
    Nagoya University Hospital /ID# 278159
    Nagoya, Aichi-ken, Japan, 466-8560
    Status
    Recruiting
    Location
    Hirosaki University Hospital /ID# 278153
    Hirosaki, Aomori, Japan, 036-8563
    Status
    Recruiting
    Location
    Chiba University Hospital /ID# 277669
    Chiba, Chiba, Japan, 260-8677
    Status
    Recruiting
    Location
    Tsujinaka Hospital - Kashiwanoha /ID# 277672
    Kashiwa-shi, Chiba, Japan, 277-0871
    Status
    Recruiting
    Location
    Toho University Sakura Medical Center /ID# 277536
    Sakura, Chiba, Japan, 285-0841
    Status
    Recruiting
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