Study to Assess Change in Disease Activity of Risankizumab Treatment in Japanese Participants With Moderate to Severe Ulcerative Colitis (RISE UP)

April 8, 2026 updated by: AbbVie

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.

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Fukuoka, Japan, 814-0180
        • Recruiting
        • Fukuoka University Hospital /ID# 277677
      • Hiroshima, Japan, 734-8551
        • Not yet recruiting
        • Hiroshima University Hospital /ID# 277542
      • Sapporo, Japan, 060-0033
        • Recruiting
        • Sapporo Kosei General Hospital /ID# 278048
      • Tokyo, Japan, 105-8461
        • Recruiting
        • The Jikei University Hospital /ID# 278122
      • Toyama, Japan, 930-0194
        • Recruiting
        • Toyama University Hospital /ID# 277675
    • Aichi-ken
      • Nagakute, Aichi-ken, Japan, 480-1195
        • Recruiting
        • Aichi Medical University Hospital /ID# 278155
      • Nagoya, Aichi-ken, Japan, 466-8560
        • Recruiting
        • Nagoya University Hospital /ID# 278159
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8563
        • Recruiting
        • Hirosaki University Hospital /ID# 278153
    • Chiba
      • Chiba, Chiba, Japan, 260-8677
        • Recruiting
        • Chiba University Hospital /ID# 277669
      • Kashiwa-shi, Chiba, Japan, 277-0871
        • Recruiting
        • Tsujinaka Hospital - Kashiwanoha /ID# 277672
      • Sakura, Chiba, Japan, 285-0841
        • Recruiting
        • Toho University Sakura Medical Center /ID# 277536
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital /ID# 278077
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8543
        • Recruiting
        • Sapporo Medical University Hospital /ID# 277535
      • Sapporo, Hokkaido, Japan, 065-0033
        • Recruiting
        • Sapporo Higashi Tokushukai Hospital /ID# 278123
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital /ID# 277668
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0017
        • Recruiting
        • Kobe University Hospital /ID# 278292
      • Nishinomiya-shi, Hyōgo, Japan, 663-8501
        • Recruiting
        • Hyogo Medical University Hospital /ID# 277676
    • Kyoto
      • Kyoto, Kyoto, Japan, 602-8566
        • Recruiting
        • University Hospital Kyoto Prefectural University of Medicine /ID# 277541
    • Osaka
      • Hirakata-shi, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital /ID# 278619
    • Saga-ken
      • Saga, Saga-ken, Japan, 849-8501
        • Recruiting
        • Saga University Hospital /ID# 278160
    • Saitama
      • Kawagoe, Saitama, Japan, 350-8550
        • Recruiting
        • Saitama Medical Center /ID# 278076
    • Shiga
      • Ōtsu, Shiga, Japan, 520-2192
        • Recruiting
        • Shiga University of Medical Science Hospital /ID# 277540
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Recruiting
        • Hamamatsu University Hospital /ID# 277539
      • Sunto-gun, Shizuoka, Japan, 411-8611
        • Recruiting
        • NHO Shizuoka Medical Center /ID# 278075
    • Tochigi
      • Mibu, Tochigi, Japan, 321-0293
        • Recruiting
        • Dokkyo Medical University Hospital /ID# 278152
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Recruiting
        • Institute of Science Tokyo Hospital /ID# 277538
      • Minato-ku, Tokyo, Japan, 108-8642
        • Recruiting
        • Kitasato University Kitasato Institute Hospital /ID# 278154
      • Mitaka-shi, Tokyo, Japan, 181-8611
        • Recruiting
        • Kyorin University Hospital /ID# 277534

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Risankizumab
Participants will receive risankizumab as prescribed by their physician according to local label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2025

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

February 1, 2030

Study Registration Dates

First Submitted

August 15, 2025

First Submitted That Met QC Criteria

August 15, 2025

First Posted (Actual)

August 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P25-797

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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