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

NCT06764706 · tracked via the Priya Life Science Germany tracker

Sponsor

AbbVie

Phase

Observational

Started

2025-02-27

Last updated

2026-06-18

Condition(s) studied

Ulcerative Colitis

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 outcome measure(s)

Percentage of Participants Achieving Symptomatic Remission Responder Per Partial Adapted Mayo Score — Up to approximately 52 weeks
Symptomatic remission is defined as stool frequency (SFS) \<=1 and rectal bleeding subscore (RBS)=0

Trial sites (56)

Facility	City	Region	Status
Universitaetsklinikum Heidelberg /ID# 275906	Heidelberg	Baden-Wurttemberg	Recruiting
Klinikum Ernst Von Bergmann /ID# 278268	Potsdam	Brandenburg	Recruiting
Private Practice - Dr. Kempelmann /ID# 275726	Tostedt	Free and Hanseatic City of Hamburg	Recruiting
Gastroenterologische Schwerpunktpraxis - Hannover /ID# 276701	Hanover	Lower Saxony	Recruiting
Praxis fuer Gastroenterologie - Schwerin /ID# 275946	Schwerin	Mecklenburg-Vorpommern	Recruiting
Medizinisches Versorgungszentrum Ahaus /ID# 280966	Ahaus	North Rhine-Westphalia	Recruiting
Gastropraxis Bochum /ID# 281375	Bochum	North Rhine-Westphalia	Recruiting
Katholisches Klinikum Bochum gGmbH /ID# 279486	Bochum	North Rhine-Westphalia	Recruiting
Evangelisches Krankenhaus Kalk /ID# 276414	Cologne	North Rhine-Westphalia	Recruiting
Dres. Kamp & Partner /ID# 275904	Minden	North Rhine-Westphalia	Recruiting
Gemeinschaftspraxis Innere Medizin /ID# 280068	Witten	North Rhine-Westphalia	Recruiting
Gastroenterologische Gemeinschaftspraxis Im Loehr-Center Koblenz /ID# 275943	Koblenz	Rhineland-Palatinate	Recruiting
Gastroenterologische Schwerpunkt Praxis /ID# 279856	Ludwigshafen am Rhein	Rhineland-Palatinate	Recruiting
Private Practice - Dr. Johannes Janschek /ID# 275877	Dresden	Saxony	Recruiting
Universitaetsklinikum Leipzig /ID# 276779	Leipzig	Saxony	Recruiting
Gesellschaft für klinische Studien /ID# 275867	Leipzig	Saxony	Recruiting
Private Practice - Dr. Thomas Zeisler /ID# 277933	Halle	Saxony-Anhalt	Recruiting
Studiengesellschaft BSF Unternehmergesellschaft /ID# 275905	Halle	Saxony-Anhalt	Recruiting
Praxisgemeinschaft Jerichow Schulze /ID# 275911	Jerichow	Saxony-Anhalt	Recruiting
Private Practice - Dr. Jaqueline Schumann /ID# 276126	Teuchern	Saxony-Anhalt	Recruiting
Gemeinschaftspraxis im Medicum /ID# 275933	Altenholz	Schleswig-Holstein	Recruiting
Praxis S. Tetzlaff /ID# 275882	Buedelsdorf	Schleswig-Holstein	Recruiting
Praxis Dr. Guenther-Tritsch /ID# 275886	Geesthacht	Schleswig-Holstein	Recruiting
Diabetologie Dithmarschen /ID# 281104	Heide	Schleswig-Holstein	Recruiting
Private Practice - Dr. Thormann & Dr. Bethge /ID# 275931	Kiel	Schleswig-Holstein	Recruiting
Praxis fuer Gastroenterologie - Lubeck /ID# 275903	Lübeck	Schleswig-Holstein	Recruiting
Fek - Friedrich-Ebert-Krankenhaus Neumünster /ID# 276105	Neumünster	Schleswig-Holstein	Recruiting
Klinikum Altenburger Land /ID# 283912	Altenburg	Thuringia	Recruiting
Dr. Jack Peter-Stein /ID# 276815	Jena	Thuringia	Recruiting
Tumorzentrum Nordthuringen Medizinisches Versorgungszentrum /ID# 280072	Nordhausen	Thuringia	Recruiting
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

+ 16 more sites — see the full list on the official registry below.

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Other trials for the same condition

Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis Active, not recruiting

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis Recruiting

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis Recruiting

ABTECT - Maintenance Active, not recruiting

Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06764706 on ClinicalTrials.gov ↗ ← All trials in Germany