Carotegrast Methyl in Ulcerative Colitis (CAR in UC)

Efficacy and Safety of Carotegrast Methyl in Active Ulcerative Colitis: a Real-World Prospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Carotegrast methyl

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Mie
    • Yokkaichi, Mie, Japan, 510-0016
      • Yokkaichi Hazu Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carotegrast methyl; Carotegrast methyl at a dosage of 960 mg three times daily	Drug: Carotegrast methyl; a dosage of 960 mg three times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical remission	A total clinical subscores in the Mayo score of 0	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic remission	Endoscopic subscore in the Mayo score of 0	Week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical improvement	Decreae of clinical score in the mayo score at least 1	Week 24

Collaborators and Investigators

• Sponsor: Takayuki Yamamoto
• Investigators: Study Chair: Takayuki Yamamoto, MD, PhD, Yokkaichi Hazu Medical Center; Study Director: Takayuki Yamamoto, MD, PhD, Yokkaichi Hazu Medical Center; Principal Investigator: Takayuki Yamamoto, MD, PhD, Yokkaichi Hazu Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): March 15, 2025
• Study Completion (Actual): March 15, 2025

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Ulcer
• Other Study ID Numbers: Yokkaichi Hazu 2024-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Within 6 months of the publication of study results Data will be available for access for 1 year
• IPD Sharing Access Criteria: The data will be available for use in further scientific research, such as additional analyses, validating clinical outcomes, or investigating new treatment options.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No