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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: AbbVie GK Clinical Trial Registration Desk
• Email: abbvie_jpn_info_clingov@abbvie.com
• Phone: +81-3-4577-1111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How risankizumab works in children and teens with ulcerative colitis

  This trial tests risankizumab in children and adolescents with moderate to severe ulcerative colitis to see how the medicine moves through their bodies and whether it is safe and helps their condition.

  Recruiting at 73 sites Phase 3 AbbVie · Phoenix, Arizona and 72 other locations · NCT07071519

• Assessing the effects of risankizumab on ulcerative colitis in adults

  This study is testing how well risankizumab works for adults with moderate to severe ulcerative colitis by looking at their progress over a year while they receive the treatment from their doctors.

  Recruiting at 57 sites AbbVie · Heidelberg, Baden-Wurttemberg and 56 other locations · NCT06764706

• Innovative Multidisciplinary and Virtual Care for IBD in Pregnancy

  This study tests a dedicated IBD pregnancy care model, including a new virtual approach, to see if it improves access and quality of care for pregnant people with Crohn's disease or ulcerative colitis.

  Recruiting at 5 sites Austin Health · Hobart and 6 other locations · NCT07916727

• Risankizumab for Refractory Perianal Fistulizing Crohn's Disease

  This study tests whether risankizumab can help people with Crohn’s disease who have draining perianal fistulas not responding to other treatments.

  Recruiting Phase 4 Hyogo Medical University · Nishinomiya and 3 other locations · NCT07872449

• A Probiotic Approach to Modulating Gut Microbiota in Mild-to-Moderate Ulcerative Colitis

  A specific probiotic given rectally will be tested in adults with mild-to-moderate ulcerative colitis to see if it can help manage symptoms.

  Recruiting Catholic University of the Sacred Heart · Roma, RM · NCT07724990

• Advanced therapies for moderately to severely active Crohn's disease or ulcerative colitis in adults

  This study tests combinations of risankizumab with either trosunilimab or ABBV-701 in adults with moderately to severely active Crohn's disease or ulcerative colitis.

  Recruiting at 66 sites Phase 2 AbbVie · Dothan, Alabama and 65 other locations · NCT07697456

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.