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

Recruiting now

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT06764706

Run by

AbbVie

People needed

200

Starts

2025-02-27

Expected to finish

2028-07-01

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Klinikum Ernst Von Bergmann /ID# 278268 — Potsdam, Brandenburg, Germany (enrolling)
• Private Practice - Dr. Kempelmann /ID# 275726 — Tostedt, Free and Hanseatic City of Hamburg, Germany (enrolling)
• Gastroenterologische Schwerpunktpraxis - Hannover /ID# 276701 — Hanover, Lower Saxony, Germany (enrolling)
• Praxis fuer Gastroenterologie - Schwerin /ID# 275946 — Schwerin, Mecklenburg-Vorpommern, Germany (enrolling)
• Medizinisches Versorgungszentrum Ahaus /ID# 280966 — Ahaus, North Rhine-Westphalia, Germany (enrolling)
• Gastropraxis Bochum /ID# 281375 — Bochum, North Rhine-Westphalia, Germany (enrolling)
• Katholisches Klinikum Bochum gGmbH /ID# 279486 — Bochum, North Rhine-Westphalia, Germany (enrolling)
• Evangelisches Krankenhaus Kalk /ID# 276414 — Cologne, North Rhine-Westphalia, Germany (enrolling)
• Dres. Kamp & Partner /ID# 275904 — Minden, North Rhine-Westphalia, Germany (enrolling)
• Gemeinschaftspraxis Innere Medizin /ID# 280068 — Witten, North Rhine-Westphalia, Germany (enrolling)
• Gastroenterologische Gemeinschaftspraxis Im Loehr-Center Koblenz /ID# 275943 — Koblenz, Rhineland-Palatinate, Germany (enrolling)
• Gastroenterologische Schwerpunkt Praxis /ID# 279856 — Ludwigshafen am Rhein, Rhineland-Palatinate, Germany (enrolling)
• Private Practice - Dr. Johannes Janschek /ID# 275877 — Dresden, Saxony, Germany (enrolling)
• Universitaetsklinikum Leipzig /ID# 276779 — Leipzig, Saxony, Germany (enrolling)
• Gesellschaft für klinische Studien /ID# 275867 — Leipzig, Saxony, Germany (enrolling)
• Private Practice - Dr. Thomas Zeisler /ID# 277933 — Halle, Saxony-Anhalt, Germany (enrolling)
• Studiengesellschaft BSF Unternehmergesellschaft /ID# 275905 — Halle, Saxony-Anhalt, Germany (enrolling)
• Praxisgemeinschaft Jerichow Schulze /ID# 275911 — Jerichow, Saxony-Anhalt, Germany (enrolling)
• Private Practice - Dr. Jaqueline Schumann /ID# 276126 — Teuchern, Saxony-Anhalt, Germany (enrolling)
• Gemeinschaftspraxis im Medicum /ID# 275933 — Altenholz, Schleswig-Holstein, Germany (enrolling)
• Praxis S. Tetzlaff /ID# 275882 — Buedelsdorf, Schleswig-Holstein, Germany (enrolling)
• Praxis Dr. Guenther-Tritsch /ID# 275886 — Geesthacht, Schleswig-Holstein, Germany (enrolling)
• Diabetologie Dithmarschen /ID# 281104 — Heide, Schleswig-Holstein, Germany (enrolling)
• Private Practice - Dr. Thormann & Dr. Bethge /ID# 275931 — Kiel, Schleswig-Holstein, Germany (enrolling)
• Universitaetsklinikum Heidelberg /ID# 275906 — Heidelberg, Baden-Wurttemberg, Germany (enrolling)

Full record on ClinicalTrials.gov

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