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Etrasimod as Prevention of Pouchitis

Study acronym: ESPIRIT
StatusRecruiting
PhasePhase 2
SponsorMaia Kayal
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date changed from estimate of Jun 12, 2026 to Jul 1, 2026
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: details revised at 3 of 5 entries
  2. Recruitment opened
    • Start date: Mar 2026 to Jun 12, 2026
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Maia Kayal
2 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT07486921
Lead Sponsor Maia Kayal
Collaborators: Pfizer
Conditions
(from sponsor)		 Pouchitis
Related terms Pouchitis
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov