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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06626165

Enrollment

100

Registered

2024-10-03

Start date

2024-07-20

Completion date

2025-09-30

Last updated

2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

ulcerative colitis

Brief summary

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.

Interventions

DRUGMirikizumab

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

DRUGVedolizumab

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* They were endoscopically active ulcerative colitis patients.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Changes in clinical activities before and after mirikizumab or vedolizumab treatment.	2 weeks	Clinical activity is graded using the clinical activity index (0, best - 15, worst).

Secondary

Measure	Time frame	Description
Changes in endoscopic activities before and after mirikizumab or vedolizumab administration.	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).
Changes in pathological activity	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.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026