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

Last updated: April 3, 2026
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colic

Inflammatory Bowel Disease

Ulcerative Colitis

Treatment

N/A

Clinical Study ID

NCT07136116
P25-797
  • Ages > 15
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Participants with a diagnosis of moderate to severe Ulcerative Colitis (UC)commenced on Risankizumab (RZB) treatment prescribed as part of their routineclinical care at their clinical's discretion according to Japan approved label andtreatment prescription recommendations/guidelines.

  • The decision to prescribe RZB is made prior to and independently of studyparticipation.

  • Participants able to provide voluntary informed consent before any study-relatedactivities or procedures (obtained/documented as per regulations). If the patient isunder 18 years old, a patient's parent or legal guardian must be willing to givewritten informed consent.

  • Participants who can understand and communicate with the investigator and complywith the requirements of the study, including collection of PRO data using a smartdevice (i.e., mobile phone) and continued PRO data collection after cessation ofRZB.

  • Participants without previous exposure to RZB.

  • Participants who are not currently participating in interventional research (notincluding non-interventional studies, PMOS, or registry participation).

Exclusion

Exclusion Criteria:

See Inclusion Criteria

Study Design

Total Participants: 200
Study Start date:
October 09, 2025
Estimated Completion Date:
February 28, 2030

Connect with a study center

  • Aichi Medical University Hospital /ID# 278155

    Nagakute, Aichi-ken 480-1195
    Japan

    Active - Recruiting

  • Nagoya University Hospital /ID# 278159

    Nagoya, Aichi-ken 466-8560
    Japan

    Active - Recruiting

  • Aichi Medical University Hospital /ID# 278155

    Nagakute 11611613, Aichi-ken 1865694 480-1195
    Japan

    Site Not Available

  • Nagoya University Hospital /ID# 278159

    Nagoya 1856057, Aichi-ken 1865694 466-8560
    Japan

    Site Not Available

  • Hirosaki University Hospital /ID# 278153

    Hirosaki, Aomori 036-8563
    Japan

    Active - Recruiting

  • Hirosaki University Hospital /ID# 278153

    Hirosaki 2130057, Aomori 2130656 036-8563
    Japan

    Site Not Available

  • Chiba University Hospital /ID# 277669

    Chiba, Chiba 260-8677
    Japan

    Active - Recruiting

  • Tsujinaka Hospital - Kashiwanoha /ID# 277672

    Kashiwa-shi, Chiba 277-0871
    Japan

    Active - Recruiting

  • Toho University Sakura Medical Center /ID# 277536

    Sakura, Chiba 285-0841
    Japan

    Active - Recruiting

  • Chiba University Hospital /ID# 277669

    Chiba 2113015, Chiba 2113014 260-8677
    Japan

    Site Not Available

  • Toho University Sakura Medical Center /ID# 277536

    Sakura 2111220, Chiba 2113014 285-0841
    Japan

    Site Not Available

  • Kyushu University Hospital /ID# 278077

    Fukuoka, Fukuoka 812-8582
    Japan

    Active - Recruiting

  • Kyushu University Hospital /ID# 278077

    Fukuoka 1863967, Fukuoka 1863958 812-8582
    Japan

    Active - Recruiting

  • Hokkaido University Hospital /ID# 277668

    Sapporo, Hokkaido 060-8648
    Japan

    Active - Recruiting

  • Sapporo Higashi Tokushukai Hospital /ID# 278123

    Sapporo, Hokkaido 065-0033
    Japan

    Active - Recruiting

  • Sapporo Medical University Hospital /ID# 277535

    Sapporo, Hokkaido 060-8543
    Japan

    Active - Recruiting

  • Hokkaido University Hospital /ID# 277668

    Sapporo 2128295, Hokkaido 2130037 060-8648
    Japan

    Site Not Available

  • Sapporo Higashi Tokushukai Hospital /ID# 278123

    Sapporo 2128295, Hokkaido 2130037 065-0033
    Japan

    Active - Recruiting

  • Sapporo Medical University Hospital /ID# 277535

    Sapporo 2128295, Hokkaido 2130037 060-8543
    Japan

    Active - Recruiting

  • Kobe University Hospital /ID# 278292

    Kobe, Hyōgo 650-0017
    Japan

    Active - Recruiting

  • Hyogo Medical University Hospital /ID# 277676

    Nishinomiya-shi, Hyōgo 663-8501
    Japan

    Active - Recruiting

  • Kobe University Hospital /ID# 278292

    Kobe 1859171, Hyōgo 1862047 650-0017
    Japan

    Site Not Available

  • University Hospital Kyoto Prefectural University of Medicine /ID# 277541

    Kyoto, Kyoto 602-8566
    Japan

    Active - Recruiting

  • University Hospital Kyoto Prefectural University of Medicine /ID# 277541

    Kyoto 1857910, Kyoto 1857907 602-8566
    Japan

    Site Not Available

  • Kansai Medical University Hospital /ID# 278619

    Hirakata-shi, Osaka 573-1191
    Japan

    Active - Recruiting

  • Saga University Hospital /ID# 278160

    Saga, Saga-ken 849-8501
    Japan

    Active - Recruiting

  • Saga University Hospital /ID# 278160

    Saga 1853303, Saga-ken 1853299 849-8501
    Japan

    Site Not Available

  • Saitama Medical Center /ID# 278076

    Kawagoe, Saitama 350-8550
    Japan

    Active - Recruiting

  • Saitama Medical Center /ID# 278076

    Kawagoe 1859740, Saitama 1853226 350-8550
    Japan

    Site Not Available

  • Shiga University of Medical Science Hospital /ID# 277540

    Ōtsu, Shiga 520-2192
    Japan

    Active - Recruiting

  • Shiga University of Medical Science Hospital /ID# 277540

    Ōtsu 1853574, Shiga 1852553 520-2192
    Japan

    Site Not Available

  • Hamamatsu University Hospital /ID# 277539

    Hamamatsu, Shizuoka 431-3192
    Japan

    Active - Recruiting

  • NHO Shizuoka Medical Center /ID# 278075

    Sunto-gun, Shizuoka 411-8611
    Japan

    Active - Recruiting

  • Hamamatsu University Hospital /ID# 277539

    Hamamatsu 1863289, Shizuoka 1851715 431-3192
    Japan

    Site Not Available

  • Dokkyo Medical University Hospital /ID# 278152

    Mibu, Tochigi 321-0293
    Japan

    Active - Recruiting

  • Dokkyo Medical University Hospital /ID# 278152

    Mibu 1857379, Tochigi 1850310 321-0293
    Japan

    Site Not Available

  • Institute of Science Tokyo Hospital /ID# 277538

    Bunkyo-ku, Tokyo 113-8519
    Japan

    Active - Recruiting

  • Kitasato University Kitasato Institute Hospital /ID# 278154

    Minato-ku, Tokyo 108-8642
    Japan

    Active - Recruiting

  • Kyorin University Hospital /ID# 277534

    Mitaka-shi, Tokyo 181-8611
    Japan

    Active - Recruiting

  • Fukuoka University Hospital /ID# 277677

    Fukuoka, 814-0180
    Japan

    Active - Recruiting

  • Fukuoka University Hospital /ID# 277677

    Fukuoka 1863967, 814-0180
    Japan

    Site Not Available

  • Sapporo Kosei General Hospital /ID# 278048

    Sapporo, 060-0033
    Japan

    Active - Recruiting

  • Sapporo Kosei General Hospital /ID# 278048

    Sapporo 2128295, 060-0033
    Japan

    Active - Recruiting

  • The Jikei University Hospital /ID# 278122

    Tokyo, 105-8461
    Japan

    Active - Recruiting

  • The Jikei University Hospital /ID# 278122

    Tokyo 1850147, 105-8461
    Japan

    Site Not Available

  • Toyama University Hospital /ID# 277675

    Toyama, 930-0194
    Japan

    Active - Recruiting

  • Toyama University Hospital /ID# 277675

    Toyama 1849876, 930-0194
    Japan

    Site Not Available

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