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

NCT ID: NCT06764706

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-27

Study Completion Date

2028-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ulcerative Colitis

Keywords

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Ulcerative colitis Risankizumab SKYRIZI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Risankizumab

Participants will receive risankizumab as prescribed by their physician according to local label.

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Universitaetsklinikum Heidelberg /ID# 275906

Heidelberg, Baden-Wurttemberg, Germany

Site Status RECRUITING

Klinikum Ernst Von Bergmann /ID# 278268

Potsdam, Brandenburg, Germany

Site Status RECRUITING

Private Practice - Dr. Kempelmann /ID# 275726

Tostedt, Hamburg, Germany

Site Status RECRUITING

Gastroenterologische Schwerpunktpraxis /ID# 276701

Hanover, Lower Saxony, Germany

Site Status RECRUITING

Katholisches Klinikum Bochum gGmbH /ID# 279486

Bochum, North Rhine-Westphalia, Germany

Site Status RECRUITING

Evangelisches Krankenhaus Kalk /ID# 276414

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Dres. Kamp & Partner /ID# 275904

Minden, North Rhine-Westphalia, Germany

Site Status RECRUITING

Gemeinschaftspraxis Innere Medizin /ID# 280068

Witten, North Rhine-Westphalia, Germany

Site Status RECRUITING

Gastroenterologische Gemeinschaftspraxis Im Loehr-Center Koblenz /ID# 275943

Koblenz, Rhineland-Palatinate, Germany

Site Status RECRUITING

Gastroenterologische Schwerpunkt Praxis /ID# 279856

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Site Status RECRUITING

Private Practice - Dr. Johannes Janschek /ID# 275877

Dresden, Saxony, Germany

Site Status RECRUITING

Universitaetsklinikum Leipzig /ID# 276779

Leipzig, Saxony, Germany

Site Status RECRUITING

Gesellschaft für klinische Studien /ID# 275867

Leipzig, Saxony, Germany

Site Status RECRUITING

Private Practice - Dr. Thomas Zeisler /ID# 277933

Halle, Saxony-Anhalt, Germany

Site Status RECRUITING

Studiengesellschaft BSF Unternehmergesellschaft /ID# 275905

Halle, Saxony-Anhalt, Germany

Site Status RECRUITING

Praxisgemeinschaft Jerichow Schulze /ID# 275911

Jerichow, Saxony-Anhalt, Germany

Site Status RECRUITING

Private Practice - Dr. Jaqueline Schumann /ID# 276126

Teuchern, Saxony-Anhalt, Germany

Site Status RECRUITING

Gemeinschaftspraxis im Medicum /ID# 275933

Altenholz, Schleswig-Holstein, Germany

Site Status RECRUITING

Praxis S. Tetzlaff /ID# 275882

Buedelsdorf, Schleswig-Holstein, Germany

Site Status RECRUITING

Praxis Dr. Guenther-Tritsch /ID# 275886

Geesthacht, Schleswig-Holstein, Germany

Site Status RECRUITING

Private Practice - Dr. Thormann & Dr. Bethge /ID# 275931

Kiel, Schleswig-Holstein, Germany

Site Status RECRUITING

Praxis fuer Gastroenterologie /ID# 275903

Lübeck, Schleswig-Holstein, Germany

Site Status RECRUITING

Fek - Friedrich-Ebert-Krankenhaus Neumünster /ID# 276105

Neumünster, Schleswig-Holstein, Germany

Site Status RECRUITING

Dr. Jack Peter-Stein /ID# 276815

Jena, Thuringia, Germany

Site Status RECRUITING

Tumorzentrum Nordthuringen Medizinisches Versorgungszentrum /ID# 280072

Nordhausen, Thuringia, Germany

Site Status RECRUITING

Praxis Heil & Mueller /ID# 275927

Andernach, , Germany

Site Status RECRUITING

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 275884

Berlin, , Germany

Site Status RECRUITING

Facharztpraxis fur Gastroenterologie Karlshorst /ID# 277966

Berlin, , Germany

Site Status RECRUITING

Gastroenterologie im Mühlenbergviertel /ID# 275883

Berlin, , Germany

Site Status RECRUITING

Dres. Schick/Wesenberg /ID# 275878

Berlin, , Germany

Site Status RECRUITING

Gastro Studien GbR /ID# 275920

Berlin, , Germany

Site Status RECRUITING

Drk Kliniken Berlin - Köpenick /ID# 276277

Berlin, , Germany

Site Status RECRUITING

Private Practice - Dr. Jeannette Schwenzer & Dr. Sven Gruengreiff /ID# 276089

Berlin, , Germany

Site Status RECRUITING

Praxis Dr. Soellenboehmer /ID# 276183

Berlin, , Germany

Site Status RECRUITING

Krankenhaus Waldfriede /ID# 275913

Berlin, , Germany

Site Status RECRUITING

Praxis Dr. Spitz /ID# 275912

Berlin, , Germany

Site Status RECRUITING

Dres. Bauer/Doerflinger /ID# 276093

Freiburg im Breisgau, , Germany

Site Status RECRUITING

Private Practice - Dr. Matthias Eichler /ID# 275875

Hamburg, , Germany

Site Status RECRUITING

Gastroenterologie Rahlstedt /ID# 276408

Hamburg, , Germany

Site Status RECRUITING

GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 275874

Herne, , Germany

Site Status RECRUITING

Gastroenterologe am Ettlinger Tor /ID# 279854

Karlsruhe, , Germany

Site Status RECRUITING

Dres. Breitschwerdt/Glas/Gurtler /ID# 276057

Leipzig, , Germany

Site Status RECRUITING

MVZ Gastroenterologie Leverkusen /ID# 275901

Leverkusen, , Germany

Site Status RECRUITING

Gastropraxis Magdeburg /ID# 275885

Magdeburg, , Germany

Site Status RECRUITING

Bettenworth & Partner /ID# 275900

Münster, , Germany

Site Status RECRUITING

Pc Docs /Id# 275876

Pirmasens, , Germany

Site Status RECRUITING

Praxis fuer Gastroenterologie /ID# 275946

Schwerin, , Germany

Site Status RECRUITING

Dres. Rehbehn/Skusa /ID# 276090

Solingen, , Germany

Site Status RECRUITING

Private Practice - Dr. Markus Braunfels /ID# 277129

Wesseling, , Germany

Site Status RECRUITING

Dr. Schirin-Sokhan /ID# 276982

Würselen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Medical Information Germany

Role: CONTACT

Phone: 49 611 1720 1520

Email: [email protected]

Related Links

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Other Identifiers

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P25-544

Identifier Type: -

Identifier Source: org_study_id