Clinical trial NCT06764706: Study to Assess Change in Disease Activity of Risankizumab Treatment in Adult Participants With Moderate to Severe Ulcerative Colitis
Official title: A Prospective, Real-World Study EvalUating the EffectiveNess and Safety of RISankizumab in PatiEnts With Ulcerative Colitis (SUNRISE-UC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
Risankizumab
SKYRIZI
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-01-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with moderate to severe ulcerative colitis being treated with risankizumab.

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.


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).

Primary outcomes:
measure: Percentage of Participants Achieving Symptomatic Remission Responder Per Partial Adapted Mayo Score
timeFrame: Up to approximately 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hanover
country: Germany
facility: Gastroenterologische Schwerpunktpraxis /ID# 276701
state: Niedersachsen
city: Cologne
country: Germany
facility: Evangelisches Krankenhaus Kalk /ID# 276414
state: Nordrhein-Westfalen
city: Minden
country: Germany
facility: Dres. Kamp & Partner /ID# 275904
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Im Loehr-Center Koblenz /ID# 275943
state: Rheinland-Pfalz
city: Halle (Saale)
country: Germany
facility: Studiengesellschaft BSF Unternehmergesellschaft /ID# 275905
state: Sachsen-Anhalt
city: Jerichow
country: Germany
facility: Praxisgemeinschaft Jerichow Schulze /ID# 275911
state: Sachsen-Anhalt
city: Teuchern
country: Germany
facility: Private Practice - Dr. Jaqueline Schumann /ID# 276126
state: Sachsen-Anhalt
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig /ID# 276779
state: Sachsen
city: Leipzig
country: Germany
facility: Gesellschaft für klinische Studien /ID# 275867
state: Sachsen
city: Altenholz
country: Germany
facility: Praxis Jessen/Grimm /ID# 275933
state: Schleswig-Holstein
city: Büdelsdorf
country: Germany
facility: Praxis S. Tetzlaff /ID# 275882
state: Schleswig-Holstein
city: Geesthacht
country: Germany
facility: Praxis Dr. Guenther-Tritsch /ID# 275886
state: Schleswig-Holstein
city: Kiel
country: Germany
facility: Private Practice - Dr. Thormann & Dr. Bethge /ID# 275931
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: Praxis fuer Gastroenterologie /ID# 275903
state: Schleswig-Holstein
city: Jena
country: Germany
facility: Dr. Jack Peter-Stein /ID# 276815
state: Thueringen
city: Andernach
country: Germany
facility: Praxis Heil & Mueller /ID# 275927
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 275884
city: Berlin
country: Germany
facility: Gastroenterologie im Mühlenbergviertel /ID# 275883
city: Berlin
country: Germany
facility: Dres. Schick/Wesenberg /ID# 275878
city: Berlin
country: Germany
facility: Gastro Studien GbR /ID# 275920
city: Berlin
country: Germany
facility: Drk Kliniken Berlin - Köpenick /ID# 276277
city: Berlin
country: Germany
facility: Private Practice - Dr. Jeannette Schwenzer & Dr. Sven Gruengreiff /ID# 276089
city: Berlin
country: Germany
facility: Praxis Dr. Soellenboehmer /ID# 276183
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede /ID# 275913
city: Berlin
country: Germany
facility: Praxis Dr. Spitz /ID# 275912
city: Dresden
country: Germany
facility: Dr. Janschek /ID# 275877
city: Hamburg
country: Germany
facility: Private Practice - Dr. Matthias Eichler /ID# 275875
city: Hamburg
country: Germany
facility: Gastroenterologie Rahlstedt /ID# 276408
city: Herne
country: Germany
facility: GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 275874
city: Leipzig
country: Germany
facility: Dres. Breitschwerdt/Glas/Gurtler /ID# 276057
city: Leverkusen
country: Germany
facility: MVZ Gastroenterologie Leverkusen /ID# 275901
city: Magdeburg
country: Germany
facility: Gastropraxis Magdeburg /ID# 275885
city: Pirmasens
country: Germany
facility: Pc Docs /Id# 275876
city: Schwerin
country: Germany
facility: Praxis fuer Gastroenterologie /ID# 275946
city: Solingen
country: Germany
facility: Dres. Rehbehn/Skusa /ID# 276090
city: Tostedt
country: Germany
facility: Praxis Dr. Kempelmann /ID# 275726
city: Wesseling
country: Germany
facility: Private Practice - Dr. Markus Braunfels /ID# 277129
city: Würselen
country: Germany
facility: Dr. Schirin-Sokhan /ID# 276982
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: