Carotegrast Methyl in Ulcerative Colitis

Last updated: March 26, 2025
Sponsor: Takayuki Yamamoto
Overall Status: Completed

Phase

4

Condition

Crohn's Disease

Ulcers

Ulcerative Colitis

Treatment

Carotegrast methyl

Clinical Study ID

NCT06897150
Yokkaichi Hazu 2024-11
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients diagnosed with UC based on endoscopic and histological findings

  • Patients with clinically and endoscopically moderate UC who were eligible foroutpatient treatment (however, patients in clinical remission or with mild clinicalactivity but endoscopically moderate UC were also considered eligible as anexception)

  • Patients who exhibited an inadequate response to or intolerance of 5-ASAformulations (including topical agents) or budesonide formulations (includingtopical agents)

  • Patients who provided informed consent for endoscopic examinations at the start oftreatment and during the treatment period

  • Patients who agreed to blood sampling and fecal biomarker tests

Exclusion

Exclusion Criteria:

  • Patients with severe disease on endoscopy (presumed ineffective due to the drug'scharacteristics)

  • Patients currently using biologics, JAK inhibitors, thiopurines, or calcineurininhibitors (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

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Carotegrast methyl
Phase: 4
Study Start date:
June 01, 2022
Estimated Completion Date:
March 15, 2025

Connect with a study center

  • Yokkaichi Hazu Medical Center

    Yokkaichi, Mie 510-0016
    Japan

    Site Not Available

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