Study to Assess Change in Disease Activity of Risankizumab Treatment in Adult Participants With Moderate to Severe Ulcerative Colitis
Observational · No treatment assigned · 56 sites · AbbVie
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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…
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 200 participants are expected to take part.
- Start date: 2025-02-27.
- Main results expected around 2028-07 (estimate from the record).
- 56 study sites listed (56 marked recruiting) in Germany.
Main thing being measured
- Percentage of Participants Achieving Symptomatic Remission Responder Per Partial Adapted Mayo Score (Up to approximately 52 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis |
| Lead sponsor | AbbVie |
| Enrollment | 200 (estimated) |
| Start date | 2025-02-27 |
| Primary completion (est.) | 2028-07 |
| First posted | 2025-01-08 |
| Last updated | 2026-06-18 |
| Official title | A Prospective, Real-World Study EvalUating the EffectiveNess and Safety of RISankizumab in PatiEnts With Ulcerative Colitis (SUNRISE-UC) |
| ClinicalTrials.gov ID | NCT06764706 |
Interventions
- None listed
Full eligibility criteria (from the record)
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).
Locations (56)
Show all 56 sites
| Site | City | Country | Site status |
|---|---|---|---|
| Praxis Heil & Mueller /ID# 275927 | Andernach | Germany | Recruiting |
| Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 275884 | Berlin | Germany | Recruiting |
| Facharztpraxis fur Gastroenterologie Karlshorst /ID# 277966 | Berlin | Germany | Recruiting |
| Private Practice- Dr. Andreas Horn /ID# 281448 | Berlin | Germany | Recruiting |
| Gastroenterologie im Mühlenbergviertel /ID# 275883 | Berlin | Germany | Recruiting |
| Dres. Schick/Wesenberg /ID# 275878 | Berlin | Germany | Recruiting |
| Gastro Studien GbR /ID# 275920 | Berlin | Germany | Recruiting |
| Drk Kliniken Berlin - Köpenick /ID# 276277 | Berlin | Germany | Recruiting |
| Private Practice - Dr. Jeannette Schwenzer & Dr. Sven Gruengreiff /ID# 276089 | Berlin | Germany | Recruiting |
| Praxis Dr. Soellenboehmer /ID# 276183 | Berlin | Germany | Recruiting |
| Krankenhaus Waldfriede /ID# 275913 | Berlin | Germany | Recruiting |
| Praxis Dr. Spitz /ID# 275912 | Berlin | Germany | Recruiting |
| Universitaetsklinikum Duesseldorf /ID# 280409 | Düsseldorf | Germany | Recruiting |
| Dres. Bauer/Doerflinger /ID# 276093 | Freiburg im Breisgau | Germany | Recruiting |
| Private Practice - Dr. Matthias Eichler /ID# 275875 | Hamburg | Germany | Recruiting |
| Gastroenterologie Rahlstedt /ID# 276408 | Hamburg | Germany | Recruiting |
| GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 275874 | Herne | Germany | Recruiting |
| Gastroenterologe am Ettlinger Tor /ID# 279854 | Karlsruhe | Germany | Recruiting |
| Dres. Breitschwerdt/Glas/Gurtler /ID# 276057 | Leipzig | Germany | Recruiting |
| MVZ Gastroenterologie Leverkusen /ID# 275901 | Leverkusen | Germany | Recruiting |
| Gastropraxis Magdeburg /ID# 275885 | Magdeburg | Germany | Recruiting |
| Bettenworth & Partner /ID# 275900 | Münster | Germany | Recruiting |
| Pc Docs /Id# 275876 | Pirmasens | Germany | Recruiting |
| Dres. Rehbehn/Skusa /ID# 276090 | Solingen | Germany | Recruiting |
| Private Practice - Dr. Markus Braunfels /ID# 277129 | Wesseling | Germany | Recruiting |
| Dr. Schirin-Sokhan /ID# 276982 | Würselen | Germany | Recruiting |
| Universitaetsklinikum Heidelberg /ID# 275906 | Heidelberg, Baden-Wurttemberg | Germany | Recruiting |
| Klinikum Ernst Von Bergmann /ID# 278268 | Potsdam, Brandenburg | Germany | Recruiting |
| Private Practice - Dr. Kempelmann /ID# 275726 | Tostedt, Free and Hanseatic City of Hamburg | Germany | Recruiting |
| Gastroenterologische Schwerpunktpraxis - Hannover /ID# 276701 | Hanover, Lower Saxony | Germany | Recruiting |
| Praxis fuer Gastroenterologie - Schwerin /ID# 275946 | Schwerin, Mecklenburg-Vorpommern | Germany | Recruiting |
| Medizinisches Versorgungszentrum Ahaus /ID# 280966 | Ahaus, North Rhine-Westphalia | Germany | Recruiting |
| Gastropraxis Bochum /ID# 281375 | Bochum, North Rhine-Westphalia | Germany | Recruiting |
| Katholisches Klinikum Bochum gGmbH /ID# 279486 | Bochum, North Rhine-Westphalia | Germany | Recruiting |
| Evangelisches Krankenhaus Kalk /ID# 276414 | Cologne, North Rhine-Westphalia | Germany | Recruiting |
| Dres. Kamp & Partner /ID# 275904 | Minden, North Rhine-Westphalia | Germany | Recruiting |
| Gemeinschaftspraxis Innere Medizin /ID# 280068 | Witten, North Rhine-Westphalia | Germany | Recruiting |
| Gastroenterologische Gemeinschaftspraxis Im Loehr-Center Koblenz /ID# 275943 | Koblenz, Rhineland-Palatinate | Germany | Recruiting |
| Gastroenterologische Schwerpunkt Praxis /ID# 279856 | Ludwigshafen am Rhein, Rhineland-Palatinate | Germany | Recruiting |
| Private Practice - Dr. Johannes Janschek /ID# 275877 | Dresden, Saxony | Germany | Recruiting |
| Universitaetsklinikum Leipzig /ID# 276779 | Leipzig, Saxony | Germany | Recruiting |
| Gesellschaft für klinische Studien /ID# 275867 | Leipzig, Saxony | Germany | Recruiting |
| Private Practice - Dr. Thomas Zeisler /ID# 277933 | Halle, Saxony-Anhalt | Germany | Recruiting |
| Studiengesellschaft BSF Unternehmergesellschaft /ID# 275905 | Halle, Saxony-Anhalt | Germany | Recruiting |
| Praxisgemeinschaft Jerichow Schulze /ID# 275911 | Jerichow, Saxony-Anhalt | Germany | Recruiting |
| Private Practice - Dr. Jaqueline Schumann /ID# 276126 | Teuchern, Saxony-Anhalt | Germany | Recruiting |
| Gemeinschaftspraxis im Medicum /ID# 275933 | Altenholz, Schleswig-Holstein | Germany | Recruiting |
| Praxis S. Tetzlaff /ID# 275882 | Buedelsdorf, Schleswig-Holstein | Germany | Recruiting |
| Praxis Dr. Guenther-Tritsch /ID# 275886 | Geesthacht, Schleswig-Holstein | Germany | Recruiting |
| Diabetologie Dithmarschen /ID# 281104 | Heide, Schleswig-Holstein | Germany | Recruiting |
| Private Practice - Dr. Thormann & Dr. Bethge /ID# 275931 | Kiel, Schleswig-Holstein | Germany | Recruiting |
| Praxis fuer Gastroenterologie - Lubeck /ID# 275903 | Lübeck, Schleswig-Holstein | Germany | Recruiting |
| Fek - Friedrich-Ebert-Krankenhaus Neumünster /ID# 276105 | Neumünster, Schleswig-Holstein | Germany | Recruiting |
| Klinikum Altenburger Land /ID# 283912 | Altenburg, Thuringia | Germany | Recruiting |
| Dr. Jack Peter-Stein /ID# 276815 | Jena, Thuringia | Germany | Recruiting |
| Tumorzentrum Nordthuringen Medizinisches Versorgungszentrum /ID# 280072 | Nordhausen, Thuringia | Germany | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.