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NCT07695636Completed

Effectiveness and Safety of Mirikizumab in Patients With Moderate-to-severe Ulcerative Colitis: a Real-life Retrospective Multicenter Study

EFFECTIVENESS AND SAFETY OF MIRIKIZUMB IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS: A REAL-LIFE RETROSPECTIVE MULTICENTRE STUDY

Source: ClinicalTrials.gov · Last updated 10 Jul 2026

Brief summary (registry, in English)

This is a real-life, multicenter, retrospective observational study with the aim to evaluate effectiveness and safety of Mirikizumab in a real life setting from the baseline up to manteinance at 12, 24 and 52 weeks. Patients with UC who have started mirikizumab will be included. Patients \> 18 years, with no distinction based on age, demographic group, special population, or general health status will be included. Eligible patients will be identified at each participating center among those receiving mirikizumab as part of routine clinical practice.The primary objective of this study is to evaluate the effectiveness of treatment in achieving clinical remission at week 12, as well as endoscopic remission at weeks 24 and 52. The secondary objectives are to assess changes over time in clinical, biochemical, and imaging parameters. Specifically, the study will evaluate changes in bowel urgency as measured by the Urgency Numeric Rating Scale (NRS), as well as changes in fecal calprotectin and C-reactive protein (CRP) levels from baseline to weeks 12, 24, and 52.

Status (registry)
Completed
Study type
Observational
Enrollment
282 (actual)
First submitted
6 Jul 2026
Start date
1 Jan 2024
Primary completion date
1 Jan 2026
Lead sponsor
IRCCS San Raffaele
NCT number
NCT07695636

What you commit to

  • Study type: Observational
  • Participants enrolled: 282
  • From 1 Jan 2024 to the primary completion date, 1 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Diagnosis of undetermined IBD, CD or other gastrointestinal inflammatory conditions;

Age

  • Age \< 18 years-old;

Other

  • Acute severe IBD complications necessitating hospitalization at baseline;

Who the study is looking for

  • Established diagnosis of UC according to the current ECCO Guidelines;
  • Age ≥18 years old;
  • Patients must have received mirikizumab as UC treatment, as per clinical practice;
  • At least 12 weeks follow-up visits after baseline;

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS San Raffaele
Coordinator of this site? Confirm its status
MilanItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.