Carotegrast Methyl in Ulcerative Colitis (CAR in UC)

Takayuki Yamamoto

Status and phase

Completed

Phase 4

Conditions

Ulcerative Colitis

Treatments

Drug: Carotegrast methyl

Study type

Interventional

Funder types

Other

Identifiers

NCT06897150

Yokkaichi Hazu 2024-11

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Volunteers

No Healthy Volunteers

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