Study to Assess Change in Disease Activity of Risankizumab Treatment in Japanese Participants With Moderate to Severe Ulcerative Colitis
RISE UP
A Prospective, Real-World Study Evaluating the Impact of RISankizumab on BurdEn of Disease in Ulcerative Colitis in JaPan (RISE UP)
1 other identifier
observational
200
1 country
28
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2025
Longer than P75 for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2025
CompletedFirst Posted
Study publicly available on registry
August 22, 2025
CompletedStudy Start
First participant enrolled
October 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2030
April 13, 2026
April 1, 2026
4.3 years
August 15, 2025
April 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the achievement of clinical remission per Partial Adapted Mayo Score of Risankizumab treatment in participants with moderate to severe Ulcerative Colitis (UC)
Defined as stool frequency subscore \[SFS\] ≤1 and rectal bleeding subscore \[RBS\]=0
At Week 52
Study Arms (1)
Risankizumab
Participants will receive risankizumab as prescribed by their physician according to local label.
Eligibility Criteria
The study population will include adult participants with moderate to severe UC who are being treated with RZB according to the relevant approved license and who are eligible according to the study eligibility criteria.
You may qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (28)
Aichi Medical University Hospital /ID# 278155
Nagakute, Aichi-ken, 480-1195, Japan
Nagoya University Hospital /ID# 278159
Nagoya, Aichi-ken, 466-8560, Japan
Hirosaki University Hospital /ID# 278153
Hirosaki, Aomori, 036-8563, Japan
Chiba University Hospital /ID# 277669
Chiba, Chiba, 260-8677, Japan
Tsujinaka Hospital - Kashiwanoha /ID# 277672
Kashiwa-shi, Chiba, 277-0871, Japan
Toho University Sakura Medical Center /ID# 277536
Sakura, Chiba, 285-0841, Japan
Kyushu University Hospital /ID# 278077
Fukuoka, Fukuoka, 812-8582, Japan
Sapporo Medical University Hospital /ID# 277535
Sapporo, Hokkaido, 060-8543, Japan
Hokkaido University Hospital /ID# 277668
Sapporo, Hokkaido, 060-8648, Japan
Sapporo Higashi Tokushukai Hospital /ID# 278123
Sapporo, Hokkaido, 065-0033, Japan
Kobe University Hospital /ID# 278292
Kobe, Hyōgo, 650-0017, Japan
Hyogo Medical University Hospital /ID# 277676
Nishinomiya-shi, Hyōgo, 663-8501, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 277541
Kyoto, Kyoto, 602-8566, Japan
Kansai Medical University Hospital /ID# 278619
Hirakata-shi, Osaka, 573-1191, Japan
Saga University Hospital /ID# 278160
Saga, Saga-ken, 849-8501, Japan
Saitama Medical Center /ID# 278076
Kawagoe, Saitama, 350-8550, Japan
Shiga University of Medical Science Hospital /ID# 277540
Ōtsu, Shiga, 520-2192, Japan
Hamamatsu University Hospital /ID# 277539
Hamamatsu, Shizuoka, 431-3192, Japan
NHO Shizuoka Medical Center /ID# 278075
Sunto-gun, Shizuoka, 411-8611, Japan
Dokkyo Medical University Hospital /ID# 278152
Mibu, Tochigi, 321-0293, Japan
Institute of Science Tokyo Hospital /ID# 277538
Bunkyo-ku, Tokyo, 113-8519, Japan
Kitasato University Kitasato Institute Hospital /ID# 278154
Minato-ku, Tokyo, 108-8642, Japan
Kyorin University Hospital /ID# 277534
Mitaka-shi, Tokyo, 181-8611, Japan
Fukuoka University Hospital /ID# 277677
Fukuoka, 814-0180, Japan
Hiroshima University Hospital /ID# 277542
Hiroshima, 734-8551, Japan
Sapporo Kosei General Hospital /ID# 278048
Sapporo, 060-0033, Japan
The Jikei University Hospital /ID# 278122
Tokyo, 105-8461, Japan
Toyama University Hospital /ID# 277675
Toyama, 930-0194, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2025
First Posted
August 22, 2025
Study Start
October 9, 2025
Primary Completion (Estimated)
February 1, 2030
Study Completion (Estimated)
February 1, 2030
Last Updated
April 13, 2026
Record last verified: 2026-04