Ulcerative ColitisRISE UPNCT07136116
Study to Assess Change in Disease Activity of Risankizumab Treatment in Japanese Participants With Moderate to Severe Ulcerative Colitis
An observational study of Ulcerative Colitis, run by AbbVie at 29 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Ulcerative Colitis
- How many people
- 200 participants
- Where
- 29 sitesJapan
- Study dates
- 9 Oct 2025to Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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).
Who cannot join
- See Inclusion Criteria
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
29 sites in 1 country
Japan29 sites, 29 recruiting
- Recruiting
Institute of Science Tokyo Hospital /ID# 277538
Bunkyo-ku, Tokyo, 113-8519
- Recruiting
Chiba University Hospital /ID# 277669
Chiba, Chiba, 260-8677
- Recruiting
Kyushu University Hospital /ID# 278077
Fukuoka, Fukuoka, 812-8582
- Recruiting
Fukuoka University Hospital /ID# 277677
Fukuoka, 814-0180
- Recruiting
Hamamatsu University Hospital /ID# 277539
Hamamatsu, Shizuoka, 431-3192
- Recruiting
Kansai Medical University Hospital /ID# 278619
Hirakata-shi, Osaka, 573-1191
- Recruiting
Hirosaki University Hospital /ID# 278153
Hirosaki, Aomori, 036-8563
- Recruiting
Hiroshima University Hospital /ID# 277542
Hiroshima, Hiroshima, 734-8551
- Recruiting
Tsujinaka Hospital - Kashiwanoha /ID# 277672
Kashiwa-shi, Chiba, 277-0871
- Recruiting
Saitama Medical Center /ID# 278076
Kawagoe, Saitama, 350-8550
- Recruiting
Kobe University Hospital /ID# 278292
Kobe, Hyōgo, 650-0017
- Recruiting
University Hospital Kyoto Prefectural University of Medicine /ID# 277541
Kyoto, Kyoto, 602-8566
- Recruiting
Dokkyo Medical University Hospital /ID# 278152
Mibu, Tochigi, 321-0293
- Recruiting
Kitasato University Kitasato Institute Hospital /ID# 278154
Minato-ku, Tokyo, 108-8642
- Recruiting
Kyorin University Hospital /ID# 277534
Mitaka-shi, Tokyo, 181-8611
- Recruiting
Aichi Medical University Hospital /ID# 278155
Nagakute, Aichi-ken, 480-1195
- Recruiting
Nagoya University Hospital /ID# 278159
Nagoya, Aichi-ken, 466-8560
- Recruiting
Hyogo Medical University Hospital /ID# 277676
Nishinomiya-shi, Hyōgo, 663-8501
- Recruiting
Okayama University Hospital /ID# 281615
Okayama, Okayama-ken, 700-8558
- Recruiting
Shiga University of Medical Science Hospital /ID# 277540
Ōtsu, Shiga, 520-2192
- Recruiting
Saga University Hospital /ID# 278160
Saga, Saga-ken, 849-8501
- Recruiting
Toho University Sakura Medical Center /ID# 277536
Sakura, Chiba, 285-0841
- Recruiting
Sapporo Medical University Hospital /ID# 277535
Sapporo, Hokkaido, 060-8543
- Recruiting
Hokkaido University Hospital /ID# 277668
Sapporo, Hokkaido, 060-8648
- Recruiting
Sapporo Higashi Tokushukai Hospital /ID# 278123
Sapporo, Hokkaido, 065-0033
- Recruiting
Sapporo Kosei General Hospital /ID# 278048
Sapporo, 060-0033
- Recruiting
NHO Shizuoka Medical Center /ID# 278075
Sunto-gun, Shizuoka, 411-8611
- Recruiting
The Jikei University Hospital /ID# 278122
Tokyo, 105-8461
- Recruiting
Toyama University Hospital /ID# 277675
Toyama, 930-0194
About this study
Official title: A Prospective, Real-World Study Evaluating the Impact of RISankizumab on BurdEn of Disease in Ulcerative Colitis in JaPan (RISE UP)
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.
Read more
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.
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis, Risankizumab, SKYRIZI
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Risankizumab | Participants will receive risankizumab as prescribed by their physician according to local label. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start9 Oct 2025
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136116
- Sponsor's protocol ID
- P25-797
- Acronym
- RISE UP
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- RISE UP / P25-797
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis, Risankizumab, SKYRIZI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Risankizumab | – | –Participants will receive risankizumab as prescribed by their physician according to local label. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- See Inclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the achievement of clinical remission per Partial Adapted Mayo Score of Risankizumab treatment in participants with moderate to severe Ulcerative Colitis (UC)
Time frame: At Week 52
Defined as stool frequency subscore [SFS] ≤1 and rectal bleeding subscore [RBS]=0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by AbbVie at 29 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AbbVie GK Clinical Trial Registration Desk (+81-3-4577-1111, abbvie_jpn_info_clingov@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the achievement of clinical remission per Partial Adapted Mayo Score of Risankizumab treatment in participants with moderate to severe Ulcerative Colitis (UC) (time frame: At Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.