Risankizumab for moderate to severe ulcerative colitis in Japanese adults: change in disease activity

A Prospective, Real-World Study Evaluating the Impact of RISankizumab on BurdEn of Disease in Ulcerative Colitis in JaPan (RISE UP)

We will see if risankizumab, given as part of routine care, improves disease activity in Japanese adults with moderate to severe ulcerative colitis.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 15 Years and up
• Sex: All
• Sponsor: AbbVie (Industry-sponsored)
• Drugs / interventions: Risankizumab
• Locations: 28 sites (Nagakute, Aichi-ken and 27 other locations)
• Trial ID: NCT07136116 on ClinicalTrials.gov

What this trial studies

This is a non-interventional, observational follow-up of about 200 adult participants across roughly 30 sites in Japan who are prescribed risankizumab by their physician according to local label. Treatment decisions are made before and independently of enrollment, and participants will be followed for up to 156 weeks while receiving routine clinical care. Data collection includes regular clinic visits and patient-reported outcomes collected via a smart device, with no additional study-mandated treatments. The study focuses on real-world changes in disease activity and safety when risankizumab is used in everyday clinical practice.

Who should consider this trial

Good fit: Adults in Japan with moderate to severe ulcerative colitis who are starting risankizumab for the first time and can use a mobile device to report symptoms are ideal candidates.

Not a fit: Patients who have previously received risankizumab, cannot use a smartphone for symptom reporting, or whose doctors do not prescribe risankizumab under the local label are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could confirm that risankizumab improves symptoms and disease control for people with moderate to severe ulcerative colitis in routine Japanese practice.

How similar studies have performed: Randomized phase 3 trials of risankizumab have demonstrated efficacy in ulcerative colitis, and this observational study aims to add real-world evidence in a Japanese population.

Eligibility criteria

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

Where this trial is running

Nagakute, Aichi-ken and 27 other locations

• 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)
• 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)
• 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)
• Fukuoka University Hospital /ID# 277677 — Fukuoka, Japan (Recruiting)
• Hiroshima University Hospital /ID# 277542 — Hiroshima, Japan (Not_yet_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)

Study contacts

• Study coordinator: AbbVie GK Clinical Trial Registration Desk

Conditions Ulcerative Colitis; Ulcerative colitis; Risankizumab; SKYRIZI