Carotegrast Methyl in Ulcerative Colitis

NCT06897150 | Completed Phase 4

• 1 other identifier: Yokkaichi Hazu 2024-11
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Clinical remission

  A total clinical subscores in the Mayo score of 0

  Week 8

Secondary Outcomes (1)

• Endoscopic remission

  Week 8

Other Outcomes (1)

• Clinical improvement

  Week 24

Study Arms (1)

Carotegrast methyl

EXPERIMENTAL

Carotegrast methyl at a dosage of 960 mg three times daily

Drug: Carotegrast methyl

Interventions

Carotegrast methyl DRUG

a dosage of 960 mg three times daily

Carotegrast methyl

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Takayuki Yamamoto: lead

Study Sites (1)

Yokkaichi Hazu Medical Center

Yokkaichi, Mie-ken, 510-0016, Japan

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

AJM300

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Takayuki Yamamoto, MD, PhD

  Yokkaichi Hazu Medical Center

  STUDY CHAIR

• Takayuki Yamamoto, MD, PhD

  Yokkaichi Hazu Medical Center

  STUDY DIRECTOR

• Takayuki Yamamoto, MD, PhD

  Yokkaichi Hazu Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The Director of the Hospital

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: June 1, 2022
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 6 months of the publication of study results Data will be available for access for 1 year
• 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.

Locations

JP (1)