NCT07486921

Etrasimod as Prevention of Pouchitis

Etrasimod as Primary and Secondary Prevention of Pouchitis (ESPIRIT)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Maia Kayal · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of etrasimod as primary and secondary prevention of pouchitis among high-risk ulcerative colitis (UC) patients who have undergone TPC + IPAA and have no evidence of pouchitis (i.e., are in remission) at time of enrollment. Eligible patients will be randomized (1:1 ratio) to receive either etrasimod (2 mg once daily) or placebo for 48 weeks. Randomization will be stratified by the presence of medical history of primary sclerosing cholangitis (yes or no) and by the presence of medical history of at least one prior episode of acute pouchitis (yes or no).

Conditions

• Pouchitis

Interventions

Type	Name	Description
DRUG	etrasimod	2 mg once daily for 48 weeks
DRUG	Placebo	matching placebo for 48 weeks

Timeline

• Start date: 2026-03-01
• Primary completion: 2030-02-06
• Completion: 2030-02-06
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study