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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
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

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institute of Science Tokyo Hospital /ID# 277538
Coordinator of this site? Confirm its status
Bunkyo-kuJapanRecruiting
Chiba University Hospital /ID# 277669
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ChibaJapanRecruiting
Fukuoka University Hospital /ID# 277677
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FukuokaJapanRecruiting
Kyushu University Hospital /ID# 278077
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FukuokaJapanRecruiting
Hamamatsu University Hospital /ID# 277539
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HamamatsuJapanRecruiting
Kansai Medical University Hospital /ID# 278619
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Hirakata-shiJapanRecruiting
Hirosaki University Hospital /ID# 278153
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HirosakiJapanRecruiting
Hiroshima University Hospital /ID# 277542
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HiroshimaJapanRecruiting
Tsujinaka Hospital - Kashiwanoha /ID# 277672
Coordinator of this site? Confirm its status
Kashiwa-shiJapanRecruiting
Saitama Medical Center /ID# 278076
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KawagoeJapanRecruiting
Kobe University Hospital /ID# 278292
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KobeJapanRecruiting
University Hospital Kyoto Prefectural University of Medicine /ID# 277541
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KyotoJapanRecruiting
Dokkyo Medical University Hospital /ID# 278152
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MibuJapanRecruiting
Kitasato University Kitasato Institute Hospital /ID# 278154
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Minato-kuJapanRecruiting
Kyorin University Hospital /ID# 277534
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Mitaka-shiJapanRecruiting
Aichi Medical University Hospital /ID# 278155
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NagakuteJapanRecruiting
Nagoya University Hospital /ID# 278159
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NagoyaJapanRecruiting
Hyogo Medical University Hospital /ID# 277676
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Nishinomiya-shiJapanRecruiting
Okayama University Hospital /ID# 281615
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OkayamaJapanRecruiting
Shiga University of Medical Science Hospital /ID# 277540
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ŌtsuJapanRecruiting
Saga University Hospital /ID# 278160
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SagaJapanRecruiting
Toho University Sakura Medical Center /ID# 277536
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SakuraJapanRecruiting
Sapporo Kosei General Hospital /ID# 278048
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SapporoJapanRecruiting
Sapporo Higashi Tokushukai Hospital /ID# 278123
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SapporoJapanRecruiting
Hokkaido University Hospital /ID# 277668
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SapporoJapanRecruiting
Sapporo Medical University Hospital /ID# 277535
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SapporoJapanRecruiting
NHO Shizuoka Medical Center /ID# 278075
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Sunto-gunJapanRecruiting
The Jikei University Hospital /ID# 278122
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TokyoJapanRecruiting
Toyama University Hospital /ID# 277675
Coordinator of this site? Confirm its status
ToyamaJapanRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.