RecruitingNCT07136116

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)

Sponsor

AbbVie

Enrollment

200 participants

Start Date

Oct 9, 2025

Study Type

OBSERVATIONAL

Conditions

Ulcerative Colitis

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 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.

Eligibility

Min Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking how well risankizumab (brand name Skyrizi) works in real-world clinical practice for people with moderate-to-severe ulcerative colitis (UC), an inflammatory bowel condition. It is an observational study, meaning participants receive care as decided by their doctor — the study just follows what happens. **You may be eligible if...** - You have been diagnosed with moderate to severe ulcerative colitis - Your doctor has decided to start you on risankizumab (Skyrizi) as part of your standard care - The decision to prescribe was made before and independently of your study participation - You can provide voluntary informed consent (or if under 18, a parent or guardian can) **You may NOT be eligible if...** - You are unable or unwilling to give informed consent - Your doctor has not independently decided risankizumab is appropriate for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(28)

Aichi Medical University Hospital /ID# 278155

Nagakute, Aichi-ken, Japan

Nagoya University Hospital /ID# 278159

Nagoya, Aichi-ken, Japan

Hirosaki University Hospital /ID# 278153

Hirosaki, Aomori, Japan

Chiba University Hospital /ID# 277669

Chiba, Chiba, Japan

Tsujinaka Hospital - Kashiwanoha /ID# 277672

Kashiwa-shi, Chiba, Japan

Toho University Sakura Medical Center /ID# 277536

Sakura, Chiba, Japan

Kyushu University Hospital /ID# 278077

Fukuoka, Fukuoka, Japan

Sapporo Medical University Hospital /ID# 277535

Sapporo, Hokkaido, Japan

Hokkaido University Hospital /ID# 277668

Sapporo, Hokkaido, Japan

Sapporo Higashi Tokushukai Hospital /ID# 278123

Sapporo, Hokkaido, Japan

Kobe University Hospital /ID# 278292

Kobe, Hyōgo, Japan

Hyogo Medical University Hospital /ID# 277676

Nishinomiya-shi, Hyōgo, Japan

University Hospital Kyoto Prefectural University of Medicine /ID# 277541

Kyoto, Kyoto, Japan

Kansai Medical University Hospital /ID# 278619

Hirakata-shi, Osaka, Japan

Saga University Hospital /ID# 278160

Saga, Saga-ken, Japan

Saitama Medical Center /ID# 278076

Kawagoe, Saitama, Japan

Shiga University of Medical Science Hospital /ID# 277540

Ōtsu, Shiga, Japan

Hamamatsu University Hospital /ID# 277539

Hamamatsu, Shizuoka, Japan

NHO Shizuoka Medical Center /ID# 278075

Sunto-gun, Shizuoka, Japan

Dokkyo Medical University Hospital /ID# 278152

Mibu, Tochigi, Japan

Institute of Science Tokyo Hospital /ID# 277538

Bunkyo-ku, Tokyo, Japan

Kitasato University Kitasato Institute Hospital /ID# 278154

Minato-ku, Tokyo, Japan

Kyorin University Hospital /ID# 277534

Mitaka-shi, Tokyo, Japan

Fukuoka University Hospital /ID# 277677

Fukuoka, Japan

Hiroshima University Hospital /ID# 277542

Hiroshima, Japan

Sapporo Kosei General Hospital /ID# 278048

Sapporo, Japan

The Jikei University Hospital /ID# 278122

Tokyo, Japan

Toyama University Hospital /ID# 277675

Toyama, Japan

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NCT07136116

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