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

Phase 4

Recruiting

• Conditions: Ulcerative Colitis
• Interventions: Drug: Mirikizumab; Drug: Vedolizumab

• Registration Number: NCT06626165
• Lead Sponsor: Showa Inan General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-20
• Study First Submitted: 2024-07-20
• Status Verified: 2024-09
• Study First Submitted QC: 2024-10-01
• Last Update Submitted: 2024-10-02
• Study First Posted: 2024-10-03
• Last Update Posted: 2024-10-04
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• They were endoscopically active ulcerative colitis patients.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirikizumab	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.
Vedolizumab	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Showa Inan General Hospital; 🇯🇵 Komagane, Nagano, Japan