Etrasimod for ulcerative colitis in older adults
A Prospective Study on the Efficacy and Safety of a Novel Oral Drug, Etrasimod, in Elderly Patients With Ulcerative Colitis
This study will test whether etrasimod is safe and helps control active ulcerative colitis in older adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Sex | All |
| Sponsor | Showa Inan General Hospital Academic / other |
| Locations | 1 site (Komagane, Nagano) |
| Trial ID | NCT07243639 on ClinicalTrials.gov |
What this trial studies
This single-center interventional study will give etrasimod to elderly patients with active ulcerative colitis identified during routine clinical practice and prospectively collect clinical course, adverse events, endoscopic findings, and biopsy histopathology. Eligible patients provide written informed consent and are followed with standard clinical assessments and endoscopy as part of care. Patients with significant comorbidities such as renal failure, chronic heart disease, pulmonary infection, liver cirrhosis, colorectal cancer, autoimmune disease, or active infections are excluded. The open-label design aims to generate real-world safety and effectiveness data specific to an older patient population.
Who should consider this trial
Good fit: Ideal candidates are older adults with active ulcerative colitis who can give informed consent and do not have the listed exclusionary comorbidities.
Not a fit: Patients with acute or chronic renal failure, chronic heart disease, pulmonary infection, liver cirrhosis, colorectal cancer, autoimmune disease, active infections, or those unable to attend the study site are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could show that etrasimod safely controls inflammation in older adults with ulcerative colitis and support its use in this age group.
How similar studies have performed: Previous phase II and III trials of etrasimod in adult populations have shown efficacy for inducing and maintaining remission in ulcerative colitis, but data focused on elderly patients are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Komagane, Nagano
- Showa Inan General Hospital — Komagane, Nagano, Japan (Recruiting)
Study contacts
- Study coordinator: Norio Saegusa
- Email: ikyoku.tosho@sihp.jp
- Phone: 81265822121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.