Efficacy and Safety of Etrasimod in Elderly Patients With Ulcerative Colitis

December 9, 2025 updated by: Akira Horiuchi, Showa Inan General Hospital

A Prospective Study on the Efficacy and Safety of a Novel Oral Drug, 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Nagano
      • Komagane, Nagano, Japan, 399-4117
        • Recruiting
        • Showa Inan General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: elderly patients (aged 65 years or older) with active ulcerative colitis
Drug: Etrasimod administration
2 mg of Etrasimod is orally administered everyday.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Showa Inan General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Estimated)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Etrasimod in elderly UC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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