Carotegrast Methyl in Ulcerative Colitis

Phase 4

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: Carotegrast methyl

• Registration Number: NCT06897150
• Lead Sponsor: Takayuki Yamamoto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Status Verified: 2025-03
• Primary Completion: 2025-03-15
• Study Completion: 2025-03-15
• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-19
• Study First Posted: 2025-03-26
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carotegrast methyl	Carotegrast methyl	Carotegrast methyl at a dosage of 960 mg three times daily

Primary Outcome Measures

Name	Time	Method
Clinical remission	Week 8	A total clinical subscores in the Mayo score of 0

Secondary Outcome Measures

Name	Time	Method
Endoscopic remission	Week 8	Endoscopic subscore in the Mayo score of 0

Trial Locations

Locations (1)

Yokkaichi Hazu Medical Center; 🇯🇵 Yokkaichi, Mie, Japan