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

NCT06626165 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: Geboes 3.2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• Changes in clinical activities before and after mirikizumab or vedolizumab treatment.

  Clinical activity is graded using the clinical activity index (0, best - 15, worst).

  2 weeks

Secondary Outcomes (2)

• Changes in endoscopic activities before and after mirikizumab or vedolizumab administration.

  2 months

• Changes in pathological activity

  2 months

Study Arms (2)

Mirikizumab

ACTIVE COMPARATOR

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

Vedolizumab

ACTIVE COMPARATOR

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

Interventions

Mirikizumab DRUG

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

Mirikizumab

Vedolizumab DRUG

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

Vedolizumab

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• They were endoscopically active ulcerative colitis patients.

You may not qualify if:

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

Sponsors & Collaborators

• Showa Inan General Hospital: lead

Study Sites (1)

Showa Inan General Hospital

Komagane, Nagano, 399-4117, Japan

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

mirikizumab; vedolizumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Digestive Disease Center

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: October 3, 2024
• Study Start: July 20, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 20, 2025

Record last verified: 2024-09

Locations

JP (1)