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Study to Assess Change in Disease Activity of Risankizumab Treatment in Adult Participants With Moderate to Severe Ulcerative Colitis
NCT06764706 · AbbVie
In plain English
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Official title
A Prospective, Real-World Study EvalUating the EffectiveNess and Safety of RISankizumab in PatiEnts With Ulcerative Colitis (SUNRISE-UC)
About this study
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.
Eligibility criteria
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
Enrollment target: 200 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-02-27
Estimated completion: 2028-07
Last updated: 2026-02-17
Primary outcomes
- • Percentage of Participants Achieving Symptomatic Remission Responder Per Partial Adapted Mayo Score (Up to approximately 52 weeks)
Sponsor
AbbVie · industry
Contacts & investigators
ContactMedical Information Germany · contact · medinfo.germany@abbvie.com · 49 611 1720 1520
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (55)
Universitaetsklinikum Heidelberg /ID# 275906Recruiting
Heidelberg, Baden-Wurttemberg, Germany
Klinikum Ernst Von Bergmann /ID# 278268Recruiting
Potsdam, Brandenburg, Germany
Private Practice - Dr. Kempelmann /ID# 275726Recruiting
Tostedt, Free and Hanseatic City of Hamburg, Germany
Gastroenterologische Schwerpunktpraxis /ID# 276701Recruiting
Hanover, Lower Saxony, Germany
Medizinisches Versorgungszentrum Ahaus /ID# 280966Recruiting
Ahaus, North Rhine-Westphalia, Germany
Gastropraxis Bochum /ID# 281375Recruiting
Bochum, North Rhine-Westphalia, Germany
Katholisches Klinikum Bochum gGmbH /ID# 279486Recruiting
Bochum, North Rhine-Westphalia, Germany
Evangelisches Krankenhaus Kalk /ID# 276414Recruiting
Cologne, North Rhine-Westphalia, Germany
Dres. Kamp & Partner /ID# 275904Recruiting
Minden, North Rhine-Westphalia, Germany
Gemeinschaftspraxis Innere Medizin /ID# 280068Recruiting
Witten, North Rhine-Westphalia, Germany
Gastroenterologische Gemeinschaftspraxis Im Loehr-Center Koblenz /ID# 275943Recruiting
Koblenz, Rhineland-Palatinate, Germany
Gastroenterologische Schwerpunkt Praxis /ID# 279856Recruiting
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Private Practice - Dr. Johannes Janschek /ID# 275877Recruiting
Dresden, Saxony, Germany
Universitaetsklinikum Leipzig /ID# 276779Recruiting
Leipzig, Saxony, Germany
Gesellschaft für klinische Studien /ID# 275867Recruiting
Leipzig, Saxony, Germany
Private Practice - Dr. Thomas Zeisler /ID# 277933Recruiting
Halle, Saxony-Anhalt, Germany
Studiengesellschaft BSF Unternehmergesellschaft /ID# 275905Recruiting
Halle, Saxony-Anhalt, Germany
Praxisgemeinschaft Jerichow Schulze /ID# 275911Recruiting
Jerichow, Saxony-Anhalt, Germany
Private Practice - Dr. Jaqueline Schumann /ID# 276126Recruiting
Teuchern, Saxony-Anhalt, Germany
Gemeinschaftspraxis im Medicum /ID# 275933Recruiting
Altenholz, Schleswig-Holstein, Germany
Praxis S. Tetzlaff /ID# 275882Recruiting
Buedelsdorf, Schleswig-Holstein, Germany
Praxis Dr. Guenther-Tritsch /ID# 275886Recruiting
Geesthacht, Schleswig-Holstein, Germany
Diabetologie Dithmarschen /ID# 281104Recruiting
Heide, Schleswig-Holstein, Germany
Private Practice - Dr. Thormann & Dr. Bethge /ID# 275931Recruiting
Kiel, Schleswig-Holstein, Germany
Praxis fuer Gastroenterologie /ID# 275903Recruiting
Lübeck, Schleswig-Holstein, Germany
Fek - Friedrich-Ebert-Krankenhaus Neumünster /ID# 276105Recruiting
Neumünster, Schleswig-Holstein, Germany
Dr. Jack Peter-Stein /ID# 276815Recruiting
Jena, Thuringia, Germany
Tumorzentrum Nordthuringen Medizinisches Versorgungszentrum /ID# 280072Recruiting
Nordhausen, Thuringia, Germany
Praxis Heil & Mueller /ID# 275927Recruiting
Andernach, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 275884Recruiting
Berlin, Germany
Facharztpraxis fur Gastroenterologie Karlshorst /ID# 277966Recruiting
Berlin, Germany
Private Practice- Dr. Andreas Horn /ID# 281448Recruiting
Berlin, Germany
Gastroenterologie im Mühlenbergviertel /ID# 275883Recruiting
Berlin, Germany
Dres. Schick/Wesenberg /ID# 275878Recruiting
Berlin, Germany
Gastro Studien GbR /ID# 275920Recruiting
Berlin, Germany
Drk Kliniken Berlin - Köpenick /ID# 276277Recruiting
Berlin, Germany
Private Practice - Dr. Jeannette Schwenzer & Dr. Sven Gruengreiff /ID# 276089Recruiting
Berlin, Germany
Praxis Dr. Soellenboehmer /ID# 276183Recruiting
Berlin, Germany
Krankenhaus Waldfriede /ID# 275913Recruiting
Berlin, Germany
Praxis Dr. Spitz /ID# 275912Recruiting
Berlin, Germany
Universitaetsklinikum Duesseldorf /ID# 280409Recruiting
Düsseldorf, Germany
Dres. Bauer/Doerflinger /ID# 276093Recruiting
Freiburg im Breisgau, Germany
Private Practice - Dr. Matthias Eichler /ID# 275875Recruiting
Hamburg, Germany
Gastroenterologie Rahlstedt /ID# 276408Recruiting
Hamburg, Germany
GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 275874Recruiting
Herne, Germany
Gastroenterologe am Ettlinger Tor /ID# 279854Recruiting
Karlsruhe, Germany
Dres. Breitschwerdt/Glas/Gurtler /ID# 276057Recruiting
Leipzig, Germany
MVZ Gastroenterologie Leverkusen /ID# 275901Recruiting
Leverkusen, Germany
Gastropraxis Magdeburg /ID# 275885Recruiting
Magdeburg, Germany
Bettenworth & Partner /ID# 275900Recruiting
Münster, Germany
Pc Docs /Id# 275876Recruiting
Pirmasens, Germany
Praxis fuer Gastroenterologie /ID# 275946Recruiting
Schwerin, Germany
Dres. Rehbehn/Skusa /ID# 276090Recruiting
Solingen, Germany
Private Practice - Dr. Markus Braunfels /ID# 277129Recruiting
Wesseling, Germany
Dr. Schirin-Sokhan /ID# 276982Recruiting
Würselen, Germany