NCT07136116Recruiting
Study to Assess Change in Disease Activity of Risankizumab Treatment in Japanese Participants With Moderate to Severe Ulcerative Colitis
A Prospective, Real-World Study Evaluating the Impact of RISankizumab on BurdEn of Disease in Ulcerative Colitis in JaPan (RISE UP)
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 15 Aug 2025
- Start date
- 9 Oct 2025
- Primary completion date
- 28 Feb 2030
- Lead sponsor
- AbbVie
- Diseases
- Ulcerative colitis
- NCT number
- NCT07136116
What you commit to
- Study type: Observational
- Planned participants: 200
- From 9 Oct 2025 to the primary completion date, 28 Feb 2030
- 29 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- See Inclusion Criteria
Who the study is looking for
- 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).
Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Science Tokyo Hospital /ID# 277538 Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Recruiting |
| Chiba University Hospital /ID# 277669 Coordinator of this site? Confirm its status | Chiba | Japan | Recruiting |
| Fukuoka University Hospital /ID# 277677 Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| Kyushu University Hospital /ID# 278077 Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| Hamamatsu University Hospital /ID# 277539 Coordinator of this site? Confirm its status | Hamamatsu | Japan | Recruiting |
| Kansai Medical University Hospital /ID# 278619 Coordinator of this site? Confirm its status | Hirakata-shi | Japan | Recruiting |
| Hirosaki University Hospital /ID# 278153 Coordinator of this site? Confirm its status | Hirosaki | Japan | Recruiting |
| Hiroshima University Hospital /ID# 277542 Coordinator of this site? Confirm its status | Hiroshima | Japan | Recruiting |
| Tsujinaka Hospital - Kashiwanoha /ID# 277672 Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Recruiting |
| Saitama Medical Center /ID# 278076 Coordinator of this site? Confirm its status | Kawagoe | Japan | Recruiting |
| Kobe University Hospital /ID# 278292 Coordinator of this site? Confirm its status | Kobe | Japan | Recruiting |
| University Hospital Kyoto Prefectural University of Medicine /ID# 277541 Coordinator of this site? Confirm its status | Kyoto | Japan | Recruiting |
| Dokkyo Medical University Hospital /ID# 278152 Coordinator of this site? Confirm its status | Mibu | Japan | Recruiting |
| Kitasato University Kitasato Institute Hospital /ID# 278154 Coordinator of this site? Confirm its status | Minato-ku | Japan | Recruiting |
| Kyorin University Hospital /ID# 277534 Coordinator of this site? Confirm its status | Mitaka-shi | Japan | Recruiting |
| Aichi Medical University Hospital /ID# 278155 Coordinator of this site? Confirm its status | Nagakute | Japan | Recruiting |
| Nagoya University Hospital /ID# 278159 Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Hyogo Medical University Hospital /ID# 277676 Coordinator of this site? Confirm its status | Nishinomiya-shi | Japan | Recruiting |
| Okayama University Hospital /ID# 281615 Coordinator of this site? Confirm its status | Okayama | Japan | Recruiting |
| Shiga University of Medical Science Hospital /ID# 277540 Coordinator of this site? Confirm its status | Ōtsu | Japan | Recruiting |
| Saga University Hospital /ID# 278160 Coordinator of this site? Confirm its status | Saga | Japan | Recruiting |
| Toho University Sakura Medical Center /ID# 277536 Coordinator of this site? Confirm its status | Sakura | Japan | Recruiting |
| Sapporo Kosei General Hospital /ID# 278048 Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
| Sapporo Higashi Tokushukai Hospital /ID# 278123 Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
| Hokkaido University Hospital /ID# 277668 Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
| Sapporo Medical University Hospital /ID# 277535 Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
| NHO Shizuoka Medical Center /ID# 278075 Coordinator of this site? Confirm its status | Sunto-gun | Japan | Recruiting |
| The Jikei University Hospital /ID# 278122 Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Toyama University Hospital /ID# 277675 Coordinator of this site? Confirm its status | Toyama | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.