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

NCT06626165 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-10-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Mirikizumab

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

DRUG

Vedolizumab

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

Sponsors & Collaborators

  • Showa Inan General Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-20
Primary Completion
2025-09-30
Completion
2025-09-30
FDA Drug
Yes

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06626165 on ClinicalTrials.gov