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Recruiting

NCT Number: NCT07243639

Efficacy and Safety of Etrasimod in Elderly Patients With Ulcerative Colitis

Eligible patients will be identified in regular clinical practice. After providing thorough explanation and obtaining voluntary written informed consent, the clinical course, adverse events, endoscopic findings, and histopathological changes in biopsy specimens after Etrasimod administration will be prospectively collected and analyzed.

Recruiting

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Showa Inan General Hospital

Komagane, Nagano, 399-4117, Japan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with active ulcerative colitis

Exclusion criteria

  • the presence of acute or chronic renal failure, chronic heart disease, pulmonary infection, liver cirrhosis, colorectal cancer, autoimmune disease, and infectious disease

Treatment and study plan

Etrasimod administration

Drug

2 mg of Etrasimod is orally administered everyday.

Primary outcomes

  1. Primary endpoint: Clinical remission rate at 4 weeks (Clinical activity Index score <4) (max.29, min. 0)

    Time frame: 4 weeks

Secondary outcomes

  1. Secondary endpoints: Endoscopic improvement rate at 52 weeks (Mayo Endoscopic Subscore (MES) <1 or improved (Ulcerative colitis endoscopic of severity, UCEIS), and incidence of adverse events during the study

    Time frame: 52 weeks

    MES: Min. 0, Max 3, UCEIS: Min. 0, Max 8

Study contacts

Contact information is provided by the study sponsor or research team.

Norio Saegusa

CONTACT

[email protected]

81265822121 ext. 2090

Sponsors and collaborators

Lead sponsor

Showa Inan General Hospital

Other

Registry information

Official study title

A Prospective Study on the Efficacy and Safety of a Novel Oral Drug, Etrasimod, in Elderly Patients With Ulcerative Colitis

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 24, 2025
Registry last updated
Jul 21, 2026

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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