RecruitingPhase 2NCT07486921

Etrasimod as Prevention of Pouchitis

Etrasimod as Primary and Secondary Prevention of Pouchitis (ESPIRIT)

Sponsor

Maia Kayal

Enrollment

40 participants

Start Date

Jun 12, 2026

Study Type

INTERVENTIONAL

Conditions

Pouchitis

Summary

The researchers propose conducting a multi-center, randomized, placebo-controlled study to investigate the potential role of etrasimod for the primary and secondary prevention of pouchitis among high-risk patients submitted to total proctocolectomy (TPC) with ileal-pouch anal anastomosis (IPAA) for medically refractory disease. The trial will be conducted in compliance with this protocol, Good Clinical Practice guidelines, and Institutional Review Board requirements.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called etrasimod for people with pouchitis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGetrasimod

2 mg once daily for 48 weeks

DRUGPlacebo

matching placebo for 48 weeks

Locations(1)

Icahn School Of Medicine at Mount Sinai

New York, New York, United States

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NCT07486921

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