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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirikizumab | Drug | Mirikizmgab will be administered based on the result of Geboes score Grade ≥ 3.2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in endoscopic activities before and after mirikizumab or vedolizumab administration. | 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). | 2 months |
| Changes in pathological activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Showa Inan General Hospital | Komagane | Nagano | 399-4117 | Japan |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000708407 | mirikizumab |
| C543529 | vedolizumab |
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| Vedolizumab | Drug | Vedolizmab will be administered based on the result of Geboes score Grade 3.1. |
|
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. |
| 2 months |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |