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

Showa Inan General Hospital

Status and phase: Completed; Phase 4

Conditions: Ulcerative Colitis

Treatments: Drug: Vedolizumab; Drug: Mirikizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06626165

Geboes 3.2

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Mirikizumab

Active Comparator group

Description:

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.

Treatment:

Drug: Mirikizumab

Vedolizumab

Active Comparator group

Description:

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.

Treatment:

Drug: Vedolizumab