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NCT Number: NCT06764706

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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaetsklinikum Heidelberg /ID# 275906, Heidelberg, Baden-Wurttemberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Percentage of Participants Achieving Symptomatic Remission Responder Per Partial Adapted Mayo Score

    Time frame: Up to approximately 52 weeks

    Symptomatic remission is defined as stool frequency (SFS) <=1 and rectal bleeding subscore (RBS)=0

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Information Germany

CONTACT

[email protected]

49 611 1720 1520

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Prospective, Real-World Study EvalUating the EffectiveNess and Safety of RISankizumab in PatiEnts With Ulcerative Colitis (SUNRISE-UC)

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 8, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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