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

Launched by ABBVIE · Aug 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well the medicine risankizumab works to reduce symptoms in adults with moderate to severe ulcerative colitis, a condition that causes inflammation and bleeding in the large intestine. The study will look at how the disease changes over time in people who are already prescribed risankizumab by their doctors as part of their regular treatment in Japan.

Adults with moderate to severe ulcerative colitis who have not taken risankizumab before and are starting this medicine through their doctor's usual care may be eligible to join. Participants will follow their normal treatment plan and visit their hospital or clinic as usual for up to three years (156 weeks). The study won’t require extra visits or procedures beyond what is typically done, and participants will also be asked to share how they’re feeling using a smartphone. This trial aims to understand the real-world effects of risankizumab in everyday medical practice.

Gender

ALL

Eligibility 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