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

Last updated: May 21, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colic

Ulcerative Colitis

Inflammatory Bowel Disease

Treatment

N/A

Clinical Study ID

NCT06764706
P25-544
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Participants with an endoscopically confirmed diagnosis of moderate to severeulcerative colitis.

  • Participants initiating risankizumab at the investigator's discretion as part oftheir routine clinical care; the decision to administer risankizumab must be madeprior to and independent of documentation for the study and according to theapproved local label.

Exclusion

Exclusion Criteria:

  • Participants previously exposed risankizumab

  • Participants who are currently participating in interventional research (notincluding noninterventional studies, post-marketing observational study (PMOS), orregistry participation).

Study Design

Total Participants: 200
Study Start date:
February 27, 2025
Estimated Completion Date:
July 31, 2028

Connect with a study center

  • Gastroenterologische Schwerpunktpraxis /ID# 276701

    Hanover, Niedersachsen 30449
    Germany

    Active - Recruiting

  • Evangelisches Krankenhaus Kalk /ID# 276414

    Cologne, Nordrhein-Westfalen 51103
    Germany

    Active - Recruiting

  • Dres. Kamp & Partner /ID# 275904

    Minden, Nordrhein-Westfalen 32423
    Germany

    Active - Recruiting

  • Gastroenterologische Gemeinschaftspraxis Im Loehr-Center Koblenz /ID# 275943

    Koblenz, Rheinland-Pfalz 56068
    Germany

    Active - Recruiting

  • Gesellschaft für klinische Studien /ID# 275867

    Leipzig, Sachsen 04105
    Germany

    Active - Recruiting

  • Universitaetsklinikum Leipzig /ID# 276779

    Leipzig, Sachsen 04103
    Germany

    Active - Recruiting

  • Praxisgemeinschaft Jerichow Schulze /ID# 275911

    Jerichow, Sachsen-Anhalt 39319
    Germany

    Active - Recruiting

  • Private Practice - Dr. Jaqueline Schumann /ID# 276126

    Teuchern, Sachsen-Anhalt 06682
    Germany

    Active - Recruiting

  • Praxis Jessen/Grimm /ID# 275933

    Altenholz, Schleswig-Holstein 24161
    Germany

    Active - Recruiting

  • Praxis S. Tetzlaff /ID# 275882

    Büdelsdorf, Schleswig-Holstein 24782
    Germany

    Site Not Available

  • Praxis Dr. Guenther-Tritsch /ID# 275886

    Geesthacht, Schleswig-Holstein 21502
    Germany

    Active - Recruiting

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

    Kiel, Schleswig-Holstein 24105
    Germany

    Active - Recruiting

  • Praxis fuer Gastroenterologie /ID# 275903

    Lübeck, Schleswig-Holstein 23560
    Germany

    Active - Recruiting

  • Dr. Jack Peter-Stein /ID# 276815

    Jena, Thueringen 07743
    Germany

    Active - Recruiting

  • Praxis Heil & Mueller /ID# 275927

    Andernach, 56626
    Germany

    Active - Recruiting

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 275884

    Berlin, 10117
    Germany

    Active - Recruiting

  • Dres. Schick/Wesenberg /ID# 275878

    Berlin, 10437
    Germany

    Active - Recruiting

  • Drk Kliniken Berlin - Köpenick /ID# 276277

    Berlin, 12559
    Germany

    Active - Recruiting

  • Gastro Studien GbR /ID# 275920

    Berlin, 10825
    Germany

    Active - Recruiting

  • Gastroenterologie im Mühlenbergviertel /ID# 275883

    Berlin, 10409
    Germany

    Site Not Available

  • Krankenhaus Waldfriede /ID# 275913

    Berlin, 14163
    Germany

    Active - Recruiting

  • Praxis Dr. Soellenboehmer /ID# 276183

    Berlin, 14052
    Germany

    Active - Recruiting

  • Praxis Dr. Spitz /ID# 275912

    Berlin, 14163
    Germany

    Active - Recruiting

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

    Berlin, 12683
    Germany

    Active - Recruiting

  • Dr. Janschek /ID# 275877

    Dresden, 01309
    Germany

    Active - Recruiting

  • Gastroenterologie Rahlstedt /ID# 276408

    Hamburg, 22143
    Germany

    Active - Recruiting

  • Private Practice - Dr. Matthias Eichler /ID# 275875

    Hamburg, 22041
    Germany

    Active - Recruiting

  • GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 275874

    Herne, 44623
    Germany

    Active - Recruiting

  • Dres. Breitschwerdt/Glas/Gurtler /ID# 276057

    Leipzig, 04107
    Germany

    Active - Recruiting

  • MVZ Gastroenterologie Leverkusen /ID# 275901

    Leverkusen, 51375
    Germany

    Active - Recruiting

  • Gastropraxis Magdeburg /ID# 275885

    Magdeburg, 39104
    Germany

    Active - Recruiting

  • Pc Docs /Id# 275876

    Pirmasens, 66953
    Germany

    Active - Recruiting

  • Praxis fuer Gastroenterologie /ID# 275946

    Schwerin, 19057
    Germany

    Active - Recruiting

  • Dres. Rehbehn/Skusa /ID# 276090

    Solingen, 42651
    Germany

    Active - Recruiting

  • Praxis Dr. Kempelmann /ID# 275726

    Tostedt, 21255
    Germany

    Active - Recruiting

  • Private Practice - Dr. Markus Braunfels /ID# 277129

    Wesseling, 50389
    Germany

    Site Not Available

  • Dr. Schirin-Sokhan /ID# 276982

    Würselen, 52146
    Germany

    Active - Recruiting

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