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

NCT ID: NCT06626165

Last Updated: 2025-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-20

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Mirikizumab

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Vedolizumab

Intervention Type DRUG

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

Interventions

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Mirikizumab

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

Intervention Type DRUG

Vedolizumab

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* They were endoscopically active ulcerative colitis patients.

Exclusion Criteria

* the presence of a long-term illness, colorectal cancer, or infectious colitis
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Showa Inan General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Akira Horiuchi

Chief, Digestive Disease Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Showa Inan General Hospital

Komagane, Nagano, Japan

Site Status

Countries

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Japan

Other Identifiers

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Geboes 3.2

Identifier Type: -

Identifier Source: org_study_id

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