Study to Assess Change in Disease Activity of Risankizumab Treatment in Adult Participants With Moderate to Severe Ulcerative Colitis
A Prospective, Real-World Study EvalUating the EffectiveNess and Safety of RISankizumab in PatiEnts With Ulcerative Colitis (SUNRISE-UC)
1 other identifier
observational
200
1 country
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
Typical duration for all trials
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2025
CompletedFirst Posted
Study publicly available on registry
January 8, 2025
CompletedStudy Start
First participant enrolled
February 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
May 12, 2026
May 1, 2026
3.3 years
January 3, 2025
May 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Symptomatic Remission Responder Per Partial Adapted Mayo Score
Symptomatic remission is defined as stool frequency (SFS) \<=1 and rectal bleeding subscore (RBS)=0
Up to approximately 52 weeks
Study Arms (1)
Risankizumab
Participants will receive risankizumab as prescribed by their physician according to local label.
Eligibility Criteria
Adult participants with moderate to severe ulcerative colitis being treated with risankizumab.
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (55)
Universitaetsklinikum Heidelberg /ID# 275906
Heidelberg, Baden-Wurttemberg, 69120, Germany
Klinikum Ernst Von Bergmann /ID# 278268
Potsdam, Brandenburg, 14467, Germany
Private Practice - Dr. Kempelmann /ID# 275726
Tostedt, Free and Hanseatic City of Hamburg, 21255, Germany
Gastroenterologische Schwerpunktpraxis /ID# 276701
Hanover, Lower Saxony, 30449, Germany
Medizinisches Versorgungszentrum Ahaus /ID# 280966
Ahaus, North Rhine-Westphalia, 48683, Germany
Gastropraxis Bochum /ID# 281375
Bochum, North Rhine-Westphalia, 44787, Germany
Katholisches Klinikum Bochum gGmbH /ID# 279486
Bochum, North Rhine-Westphalia, 44791, Germany
Evangelisches Krankenhaus Kalk /ID# 276414
Cologne, North Rhine-Westphalia, 51103, Germany
Dres. Kamp & Partner /ID# 275904
Minden, North Rhine-Westphalia, 32423, Germany
Gemeinschaftspraxis Innere Medizin /ID# 280068
Witten, North Rhine-Westphalia, 58445, Germany
Gastroenterologische Gemeinschaftspraxis Im Loehr-Center Koblenz /ID# 275943
Koblenz, Rhineland-Palatinate, 56068, Germany
Gastroenterologische Schwerpunkt Praxis /ID# 279856
Ludwigshafen am Rhein, Rhineland-Palatinate, 67071, Germany
Private Practice - Dr. Johannes Janschek /ID# 275877
Dresden, Saxony, 01309, Germany
Universitaetsklinikum Leipzig /ID# 276779
Leipzig, Saxony, 04103, Germany
Gesellschaft für klinische Studien /ID# 275867
Leipzig, Saxony, 04105, Germany
Private Practice - Dr. Thomas Zeisler /ID# 277933
Halle, Saxony-Anhalt, 06108, Germany
Studiengesellschaft BSF Unternehmergesellschaft /ID# 275905
Halle, Saxony-Anhalt, 06108, Germany
Praxisgemeinschaft Jerichow Schulze /ID# 275911
Jerichow, Saxony-Anhalt, 39319, Germany
Private Practice - Dr. Jaqueline Schumann /ID# 276126
Teuchern, Saxony-Anhalt, 06682, Germany
Gemeinschaftspraxis im Medicum /ID# 275933
Altenholz, Schleswig-Holstein, 24161, Germany
Praxis S. Tetzlaff /ID# 275882
Buedelsdorf, Schleswig-Holstein, 24782, Germany
Praxis Dr. Guenther-Tritsch /ID# 275886
Geesthacht, Schleswig-Holstein, 21502, Germany
Diabetologie Dithmarschen /ID# 281104
Heide, Schleswig-Holstein, 25746, Germany
Private Practice - Dr. Thormann & Dr. Bethge /ID# 275931
Kiel, Schleswig-Holstein, 24105, Germany
Praxis fuer Gastroenterologie /ID# 275903
Lübeck, Schleswig-Holstein, 23560, Germany
Fek - Friedrich-Ebert-Krankenhaus Neumünster /ID# 276105
Neumünster, Schleswig-Holstein, 24534, Germany
Dr. Jack Peter-Stein /ID# 276815
Jena, Thuringia, 07743, Germany
Tumorzentrum Nordthuringen Medizinisches Versorgungszentrum /ID# 280072
Nordhausen, Thuringia, 99734, Germany
Praxis Heil & Mueller /ID# 275927
Andernach, 56626, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 275884
Berlin, 10117, Germany
Facharztpraxis fur Gastroenterologie Karlshorst /ID# 277966
Berlin, 10318, Germany
Private Practice- Dr. Andreas Horn /ID# 281448
Berlin, 10369, Germany
Gastroenterologie im Mühlenbergviertel /ID# 275883
Berlin, 10409, Germany
Dres. Schick/Wesenberg /ID# 275878
Berlin, 10437, Germany
Gastro Studien GbR /ID# 275920
Berlin, 10825, Germany
Drk Kliniken Berlin - Köpenick /ID# 276277
Berlin, 12559, Germany
Private Practice - Dr. Jeannette Schwenzer & Dr. Sven Gruengreiff /ID# 276089
Berlin, 12683, Germany
Praxis Dr. Soellenboehmer /ID# 276183
Berlin, 14052, Germany
Krankenhaus Waldfriede /ID# 275913
Berlin, 14163, Germany
Praxis Dr. Spitz /ID# 275912
Berlin, 14163, Germany
Universitaetsklinikum Duesseldorf /ID# 280409
Düsseldorf, 40225, Germany
Dres. Bauer/Doerflinger /ID# 276093
Freiburg im Breisgau, 79102, Germany
Private Practice - Dr. Matthias Eichler /ID# 275875
Hamburg, 22041, Germany
Gastroenterologie Rahlstedt /ID# 276408
Hamburg, 22143, Germany
GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 275874
Herne, 44623, Germany
Gastroenterologe am Ettlinger Tor /ID# 279854
Karlsruhe, 76133, Germany
Dres. Breitschwerdt/Glas/Gurtler /ID# 276057
Leipzig, 04107, Germany
MVZ Gastroenterologie Leverkusen /ID# 275901
Leverkusen, 51375, Germany
Gastropraxis Magdeburg /ID# 275885
Magdeburg, 39104, Germany
Bettenworth & Partner /ID# 275900
Münster, 48149, Germany
Pc Docs /Id# 275876
Pirmasens, 66953, Germany
Praxis fuer Gastroenterologie /ID# 275946
Schwerin, 19057, Germany
Dres. Rehbehn/Skusa /ID# 276090
Solingen, 42651, Germany
Private Practice - Dr. Markus Braunfels /ID# 277129
Wesseling, 50389, Germany
Dr. Schirin-Sokhan /ID# 276982
Würselen, 52146, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2025
First Posted
January 8, 2025
Study Start
February 27, 2025
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
May 12, 2026
Record last verified: 2026-05