Mirikizumab Therapy is Effective for Patients with Moderate to Severe Ulcerative Colitis Patients Whose Geboes Score Grade is ≥3.2) on Endoscopic Biopsy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• They were endoscopically active ulcerative colitis patients.
Locations
Other Locations
Japan
Showa Inan General Hospital
RECRUITING
Komagane
Contact Information
Primary
Akira Horiuchi, MD
horiuchi.akira@sihp.jp
+81-265-82-2121
Time Frame
Start Date: 2024-07-20
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 100
Treatments
Active_comparator: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Showa Inan General Hospital