NCT07243639

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Oct 2025Sep 2026

Study Start

First participant enrolled

October 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

November 14, 2025

Last Update Submit

December 9, 2025

Conditions

Ulcerative Colitis (Disorder)

Outcome Measures

Primary Outcomes (1)

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

    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

    52 weeks

Study Arms (1)

elderly patients (aged 65 years or older) with active ulcerative colitis

EXPERIMENTAL
Drug: Etrasimod administration

Interventions

Etrasimod administrationDRUG

2 mg of Etrasimod is orally administered everyday.

elderly patients (aged 65 years or older) with active ulcerative colitis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with active ulcerative colitis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Showa Inan General Hospital

Komagane, Nagano, 399-4117, Japan

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Central Study Contacts

Norio Saegusa

CONTACT

81265822121ikyoku.tosho@sihp.jp

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Digestive Disease Center

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 24, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

December 11, 2025

Record last verified: 2025-12

Locations

JP(1)