Study to Assess Change in Disease Activity of Risankizumab Treatment in Japanese Participants With Moderate to Severe Ulcerative Colitis
NCT07136116 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2026-04-13
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.
Conditions
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
ABBVIE INC. · AbbVie
Eligibility
- Min Age
- 15 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-09
- Primary Completion
- 2030-02-28
- Completion
- 2030-02-28
Countries
- Japan
Study Locations
More Related Trials
-
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
NCT03398148 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
An Observational Study to Assess Change in Disease Activity and Adverse Events of Rinvoq in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Japan
NCT05791526 ·Status: COMPLETED
-
Study of Oral Upadacitinib to Assess Change in Disease Activity in Adult Participants With Ulcerative Colitis
NCT05496348 ·Status: RECRUITING
-
A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
NCT03105128 ·Status: COMPLETED ·Phase: PHASE3
-
Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease
NCT06606808 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Efficacy, Safety and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Patients With Active, Moderate-to-severe Crohn's Disease.
NCT02031276 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.
NCT05567029 ·Status: COMPLETED ·Phase: PHASE1
-
Expanded Access to Risankizumab
NCT03914261 ·Status: NO_LONGER_AVAILABLE
-
A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
NCT04254783 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
NCT03104413 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis
NCT01461317 ·Status: COMPLETED ·Phase: PHASE2
-
An Observational Study to Assess Participant-Reported Real-World Experience of Risankizumab On-body Injector (OBI) for the Treatment of Crohn's Disease in Adult Participants in the United Kingdom (UK)
NCT06126146 ·Status: COMPLETED
-
Fluorescence Imaging of Adalimumab-680LT and Risankizumab-800CW in Inflammatory Bowel Disease
NCT07258641 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)
NCT04524611 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis
NCT06049017 ·Status: COMPLETED ·Phase: PHASE2
-
Risankizumab for Fibrostenotic Crohn's Disease Treatment
NCT07177118 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.
NCT06063967 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease
NCT03105102 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
NCT00307827 ·Status: TERMINATED ·Phase: PHASE2
-
An Observational Study to Assess Change in Disease Activity and Adverse Events of Upadacitinib in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Real-World Practice
NCT05494606 ·Status: ACTIVE_NOT_RECRUITING
-
Correlation Between RISANKIZUMAB's Trough Levels, Clinical and Biological Remission in Moderate to Severe Crohn's Disease: a Retrospective Multicentric Study
NCT06589895 ·Status: COMPLETED
-
Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis
NCT05570006 ·Status: COMPLETED ·Phase: PHASE2
-
Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
NCT02118584 ·Status: TERMINATED ·Phase: PHASE3
-
Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
NCT06548542 ·Status: RECRUITING ·Phase: PHASE2
-
Rituximab in Active Ulcerative Colitis
NCT00261118 ·Status: COMPLETED ·Phase: PHASE2/PHASE3