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Completed

NCT Number: NCT06626165

Association Between Effectiveness of Mirikizumab and UC Patients With High Neutrophilic Infiltration in Epithelium of the Colonic Mucosa

The goal of this study is to confirm that Mirikizumab therapy may provide clinical, endoscopic, and histopathologic improvements in patients with moderate to severe UC refractory to maintenance therapy when high neutrophilic infiltration in epithelium of the colonic mucosa (Geboes score Grade ≥3.2) on endoscopic biopsy is found.

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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

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Showa Inan General Hospital

Komagane, Nagano, 399-4117, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • They were endoscopically active ulcerative colitis patients.

Exclusion criteria

  • the presence of a long-term illness, colorectal cancer, or infectious colitis

Treatment and study plan

Mirikizumab

Drug

Mirikizmgab will be administered based on the result of Geboes score Grade ≥ 3.2.

Vedolizumab

Drug

Vedolizmab will be administered based on the result of Geboes score Grade 3.1.

Primary outcomes

  1. Changes in clinical activities before and after mirikizumab or vedolizumab treatment.

    Time frame: 2 weeks

    Clinical activity is graded using the clinical activity index (0, best - 15, worst).

Secondary outcomes

  1. Changes in endoscopic activities before and after mirikizumab or vedolizumab administration.

    Time frame: 2 months

    Mayo endoscopic subscore (0, best - 3, worst) and ulcerative colitis endoscopic index of severity (UCEIS) score are assessed at the site with the maximum endoscopic activity, (0, best - 8, worst).

  2. Changes in pathological activity

    Time frame: 2 months

    Pathological activity was graded using Geboes biopsy histology scores, which were classified on a scale from 0 to 5, with higher scores indicating more severe histologic inflammation.

Sponsors and collaborators

Lead sponsor

Showa Inan General Hospital

Other

Registry information

Official study title

Mirikizumab Therapy is Effective for Patients With Moderate to Severe Ulcerative Colitis Patients Whose Geboes Score Grade is ≥3.2) on Endoscopic Biopsy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2024
Registry last updated
Oct 20, 2025

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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