UCRecruiting
Study to Assess Change in Disease Activity of Risankizumab Treatment in Japanese Participants With Moderate to Severe Ulcerative Colitis
Observational · No treatment assigned · 29 sites · AbbVie
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 15 and older
- Any sex
Some of the main requirements, copied from the record:
- 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…
- 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…
Plus 3 more requirement(s). There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 200 participants are expected to take part.
- Start date: 2025-10-09.
- Main results expected around 2030-02 (estimate from the record).
- 29 study sites listed (29 marked recruiting) in Japan.
Main thing being measured
- To assess the achievement of clinical remission per Partial Adapted Mayo Score of Risankizumab treatment in participants with moderate to severe Ulcerative Colitis (UC) (At Week 52)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis |
| Lead sponsor | AbbVie |
| Enrollment | 200 (estimated) |
| Start date | 2025-10-09 |
| Primary completion (est.) | 2030-02 |
| First posted | 2025-08-22 |
| Last updated | 2026-08-14 |
| Official title | A Prospective, Real-World Study Evaluating the Impact of RISankizumab on BurdEn of Disease in Ulcerative Colitis in JaPan (RISE UP) |
| ClinicalTrials.gov ID | NCT07136116 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (29)
Show all 29 sites
| Site | City | Country | Site status |
|---|---|---|---|
| Fukuoka University Hospital /ID# 277677 | Fukuoka | Japan | Recruiting |
| Sapporo Kosei General Hospital /ID# 278048 | Sapporo | Japan | Recruiting |
| The Jikei University Hospital /ID# 278122 | Tokyo | Japan | Recruiting |
| Toyama University Hospital /ID# 277675 | Toyama | Japan | Recruiting |
| Aichi Medical University Hospital /ID# 278155 | Nagakute, Aichi-ken | Japan | Recruiting |
| Nagoya University Hospital /ID# 278159 | Nagoya, Aichi-ken | Japan | Recruiting |
| Hirosaki University Hospital /ID# 278153 | Hirosaki, Aomori | Japan | Recruiting |
| Chiba University Hospital /ID# 277669 | Chiba, Chiba | Japan | Recruiting |
| Tsujinaka Hospital - Kashiwanoha /ID# 277672 | Kashiwa-shi, Chiba | Japan | Recruiting |
| Toho University Sakura Medical Center /ID# 277536 | Sakura, Chiba | Japan | Recruiting |
| Kyushu University Hospital /ID# 278077 | Fukuoka, Fukuoka | Japan | Recruiting |
| Hiroshima University Hospital /ID# 277542 | Hiroshima, Hiroshima | Japan | Recruiting |
| Sapporo Medical University Hospital /ID# 277535 | Sapporo, Hokkaido | Japan | Recruiting |
| Hokkaido University Hospital /ID# 277668 | Sapporo, Hokkaido | Japan | Recruiting |
| Sapporo Higashi Tokushukai Hospital /ID# 278123 | Sapporo, Hokkaido | Japan | Recruiting |
| Kobe University Hospital /ID# 278292 | Kobe, Hyōgo | Japan | Recruiting |
| Hyogo Medical University Hospital /ID# 277676 | Nishinomiya-shi, Hyōgo | Japan | Recruiting |
| University Hospital Kyoto Prefectural University of Medicine /ID# 277541 | Kyoto, Kyoto | Japan | Recruiting |
| Okayama University Hospital /ID# 281615 | Okayama, Okayama-ken | Japan | Recruiting |
| Kansai Medical University Hospital /ID# 278619 | Hirakata-shi, Osaka | Japan | Recruiting |
| Saga University Hospital /ID# 278160 | Saga, Saga-ken | Japan | Recruiting |
| Saitama Medical Center /ID# 278076 | Kawagoe, Saitama | Japan | Recruiting |
| Shiga University of Medical Science Hospital /ID# 277540 | Ōtsu, Shiga | Japan | Recruiting |
| Hamamatsu University Hospital /ID# 277539 | Hamamatsu, Shizuoka | Japan | Recruiting |
| NHO Shizuoka Medical Center /ID# 278075 | Sunto-gun, Shizuoka | Japan | Recruiting |
| Dokkyo Medical University Hospital /ID# 278152 | Mibu, Tochigi | Japan | Recruiting |
| Institute of Science Tokyo Hospital /ID# 277538 | Bunkyo-ku, Tokyo | Japan | Recruiting |
| Kitasato University Kitasato Institute Hospital /ID# 278154 | Minato-ku, Tokyo | Japan | Recruiting |
| Kyorin University Hospital /ID# 277534 | Mitaka-shi, Tokyo | Japan | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.