Evaluating Mirikizumab for Ulcerative Colitis Patients with High Neutrophil Levels
Mirikizumab Therapy is Effective for Patients with Moderate to Severe Ulcerative Colitis Patients Whose Geboes Score Grade is ≥3.2) on Endoscopic Biopsy
This study is testing if Mirikizumab can help people with moderate to severe ulcerative colitis who have high levels of certain white blood cells and haven't improved with other treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Showa Inan General Hospital Academic / other |
| Drugs / interventions | Mirikizumab |
| Locations | 1 site (Komagane, Nagano) |
| Trial ID | NCT06626165 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of Mirikizumab in patients with moderate to severe ulcerative colitis (UC) who have not responded to maintenance therapy. It focuses on patients exhibiting high neutrophilic infiltration in the colonic mucosa, as indicated by a Geboes score of 3.2 or higher on endoscopic biopsy. The study will evaluate clinical, endoscopic, and histopathologic improvements following treatment with Mirikizumab compared to Vedolizumab. The goal is to provide insights into targeted therapies for this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are patients with moderate to severe ulcerative colitis who show high neutrophilic infiltration in their colonic mucosa.
Not a fit: Patients with long-term illnesses, colorectal cancer, or infectious colitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with refractory ulcerative colitis.
How similar studies have performed: Other studies have shown promising results with similar targeted therapies for ulcerative colitis, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * They were endoscopically active ulcerative colitis patients. Exclusion Criteria: * the presence of a long-term illness, colorectal cancer, or infectious colitis
Where this trial is running
Komagane, Nagano
- Showa Inan General Hospital — Komagane, Nagano, Japan (Recruiting)
Study contacts
- Study coordinator: Akira Horiuchi, MD
- Email: horiuchi.akira@sihp.jp
- Phone: +81-265-82-2121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.