Status:
COMPLETED
Carotegrast Methyl in Ulcerative Colitis
Lead Sponsor:
Takayuki Yamamoto
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
Carotegrast methyl, an oral α4-integrin inhibitor, was recently approved in Japan for the treatment of active ulcerative colitis (UC). However, real-world data regarding its efficacy and safety remain...
Eligibility Criteria
Inclusion
- Patients diagnosed with UC based on endoscopic and histological findings
- Patients with clinically and endoscopically moderate UC who were eligible for outpatient treatment (however, patients in clinical remission or with mild clinical activity but endoscopically moderate UC were also considered eligible as an exception)
- Patients who exhibited an inadequate response to or intolerance of 5-ASA formulations (including topical agents) or budesonide formulations (including topical agents)
- Patients who provided informed consent for endoscopic examinations at the start of treatment and during the treatment period
- Patients who agreed to blood sampling and fecal biomarker tests
Exclusion
- Patients with severe disease on endoscopy (presumed ineffective due to the drug's characteristics)
- Patients currently using biologics, JAK inhibitors, thiopurines, or calcineurin inhibitors (tacrolimus or cyclosporine)
- Patients with a history of malignancy
- Patients with severe hepatic dysfunction
- Pregnant women or those planning pregnancy
- Patients with acute severe conditions, such as toxic megacolon, sepsis, peritonitis, or infectious colitis
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06897150
Start Date
June 1 2022
End Date
March 15 2025
Last Update
April 2 2025
Active Locations (1)
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1
Yokkaichi Hazu Medical Center
Yokkaichi, Mie-ken, Japan, 510-0016