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

Recruiting

• Conditions: Ulcerative Colitis

• Registration Number: NCT06764706
• Lead Sponsor: AbbVie

Brief 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 multiple sites across Germany and Austria.

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 52 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

Not available

Study Timeline

• Study First Submitted: 2025-01-03
• Study First Submitted QC: 2025-01-03
• Study First Posted: 2025-01-08
• Study Start: 2025-02-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-18
• Primary Completion: 2028-07
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Participants with an endoscopically confirmed diagnosis of moderate to severe ulcerative colitis.
• Participants initiating risankizumab at the investigator's discretion as part of their routine clinical care; the decision to administer risankizumab must be made prior to and independent of documentation for the study and according to the approved local label.

Exclusion Criteria

• Participants previously exposed risankizumab
• Participants who are currently participating in interventional research (not including noninterventional studies, post-marketing observational study (PMOS), or registry participation).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Symptomatic Remission Responder Per Partial Adapted Mayo Score	Up to approximately 52 weeks	Symptomatic remission is defined as stool frequency (SFS) \<=1 and rectal bleeding subscore (RBS)=0

Trial Locations

Locations (26)

Gastroenterologie Rahlstedt /ID# 276408; 🇩🇪 Hamburg, Germany

Evangelisches Krankenhaus Kalk /ID# 276414; 🇩🇪 Cologne, Nordrhein-Westfalen, Germany

Dres. Kamp & Partner /ID# 275904; 🇩🇪 Minden, Nordrhein-Westfalen, Germany

Private Practice - Dr. Jaqueline Schumann /ID# 276126; 🇩🇪 Teuchern, Sachsen-Anhalt, Germany

Gesellschaft für klinische Studien /ID# 275867; 🇩🇪 Leipzig, Sachsen, Germany

Praxis Dr. Guenther-Tritsch /ID# 275886; 🇩🇪 Geesthacht, Schleswig-Holstein, Germany

Private Practice - Dr. Thormann & Dr. Bethge /ID# 275931; 🇩🇪 Kiel, Schleswig-Holstein, Germany

Praxis fuer Gastroenterologie /ID# 275903; 🇩🇪 Lübeck, Schleswig-Holstein, Germany

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 275884; 🇩🇪 Berlin, Germany

Gastro Studien GbR /ID# 275920; 🇩🇪 Berlin, Germany

Drk Kliniken Berlin - Köpenick /ID# 276277; 🇩🇪 Berlin, Germany

Private Practice - Dr. Jeannette Schwenzer & Dr. Sven Gruengreiff /ID# 276089; 🇩🇪 Berlin, Germany

Praxis Dr. Soellenboehmer /ID# 276183; 🇩🇪 Berlin, Germany

Krankenhaus Waldfriede /ID# 275913; 🇩🇪 Berlin, Germany

Praxis Dr. Spitz /ID# 275912; 🇩🇪 Berlin, Germany

GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 275874; 🇩🇪 Herne, Germany

Dres. Breitschwerdt/Glas/Gurtler /ID# 276057; 🇩🇪 Leipzig, Germany

Praxis fuer Gastroenterologie /ID# 275946; 🇩🇪 Schwerin, Germany

Gastroenterologische Gemeinschaftspraxis Im Loehr-Center Koblenz /ID# 275943; 🇩🇪 Koblenz, Rheinland-Pfalz, Germany

Praxis Jessen/Grimm /ID# 275933; 🇩🇪 Altenholz, Schleswig-Holstein, Germany

Praxis Heil & Mueller /ID# 275927; 🇩🇪 Andernach, Germany

Dres. Schick/Wesenberg /ID# 275878; 🇩🇪 Berlin, Germany

Dr. Janschek /ID# 275877; 🇩🇪 Dresden, Germany

Private Practice - Dr. Matthias Eichler /ID# 275875; 🇩🇪 Hamburg, Germany

Pc Docs /Id# 275876; 🇩🇪 Pirmasens, Germany

Praxis Dr. Kempelmann /ID# 275726; 🇩🇪 Tostedt, Germany