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OpenTrials
Completed

NCT Number: NCT06897150

Carotegrast Methyl in Ulcerative Colitis

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yokkaichi Hazu Medical Center

Yokkaichi, Mie-ken, 510-0016, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carotegrast methyl

Drug

a dosage of 960 mg three times daily

Primary outcomes

  1. Clinical remission

    Time frame: Week 8

    A total clinical subscores in the Mayo score of 0

Secondary outcomes

  1. Endoscopic remission

    Time frame: Week 8

    Endoscopic subscore in the Mayo score of 0

Other outcomes

  1. Clinical improvement

    Time frame: Week 24

    Decreae of clinical score in the mayo score at least 1

Sponsors and collaborators

Lead sponsor

Takayuki Yamamoto

Other

Registry information

Official study title

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

Acronym: CAR in UC

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 26, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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