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

October 16, 2025 updated by: Akira Horiuchi, Showa Inan General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Nagano
      • Komagane, Nagano, Japan, 399-4117
        • Showa Inan General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • They were endoscopically active ulcerative colitis patients.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mirikizumab
When the patients were endoscopically active and pathologically high neutrophil infiltration in epithelium of the colonic mucosa (Geboes score Grade ≥3.2), using Geboes biopsy histology scores they will be administered by mirikizumab.
Drug: Mirikizumab
Mirikizmgab will be administered based on the result of Geboes score Grade ≥ 3.2.
Active Comparator: Vedolizumab
When the patients are endoscopically active and pathologically low neutrophil infiltration in epithelium of the colonic mucosa (Geboes score Grade 3.1), using Geboes biopsy histology scores, they will be administered by vedolizumab.
Drug: Vedolizumab
Vedolizmab will be administered based on the result of Geboes score Grade 3.1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Showa Inan General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2024

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

July 20, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Estimated)

October 20, 2025

Last Update Submitted That Met QC Criteria

October 16, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Geboes 3.2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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