Study to Assess Change in Disease Activity of Risankizumab Treatment in Japanese Participants With Moderate to Severe Ulcerative Colitis
NCT ID: NCT07136116
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2025-10-09
2030-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Risankizumab
Participants will receive risankizumab as prescribed by their physician according to local label.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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).
15 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Sapporo Kosei General Hospital /ID# 278048
Sapporo, , Japan
Countries
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Central Contacts
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AbbVie GK Clinical Trial Registration Desk
Role: CONTACT
Phone: +81-3-4577-1111
Email: [email protected]
Related Links
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Other Identifiers
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P25-797
Identifier Type: -
Identifier Source: org_study_id