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Status:

RECRUITING

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

Lead Sponsor:

AbbVie

Conditions:

Ulcerative Colitis

Eligibility:

All Genders

15+ years

Brief 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 di...

Eligibility Criteria

Inclusion

  • 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

  • See Inclusion Criteria

Key Trial Info

Start Date :

October 9 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

February 1 2030

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT07136116

Start Date

October 9 2025

End Date

February 1 2030

Last Update

January 9 2026

Active Locations (25)

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Page 1 of 7 (25 locations)

1

Aichi Medical University Hospital /ID# 278155

Nagakute, Aichi-ken, Japan, 480-1195

2

Nagoya University Hospital /ID# 278159

Nagoya, Aichi-ken, Japan, 466-8560

3

Hirosaki University Hospital /ID# 278153

Hirosaki, Aomori, Japan, 036-8563

4

Chiba University Hospital /ID# 277669

Chiba, Chiba, Japan, 260-8677