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Etrasimod as Prevention of Pouchitis

NCT07486921 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-23

No results posted yet for this study

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.

Conditions

  • Pouchitis

Interventions

DRUG

etrasimod

2 mg once daily for 48 weeks

DRUG

Placebo

matching placebo for 48 weeks

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Maia Kayal

    lead OTHER

Principal Investigators

  • Maia Kayal, MD · Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2030-02-06
Completion
2030-02-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07486921 on ClinicalTrials.gov