Ulcerative Colitis
Conditions
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 scarce. This study aimed to assess the clinical effectiveness and safety profile of carotegrast methyl in patients with active UC.
Interventions
DRUGCarotegrast methyl
a dosage of 960 mg three times daily
Sponsors
Takayuki Yamamoto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission | Week 8 | A total clinical subscores in the Mayo score of 0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic remission | Week 8 | Endoscopic subscore in the Mayo score of 0 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement | Week 24 | Decreae of clinical score in the mayo score at least 1 |
Countries
Japan
Outcome results
None listed