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NCT07486921 · ClinicalTrials.gov registry record · Phase 2
Etrasimod as Prevention of Pouchitis
A Phase 2 study, sponsored by Maia Kayal.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT07486921: Recruiting Phase 2 study, sponsored by Maia Kayal.
NCT07486921 is a Phase 2 study that is actively recruiting participants, run by Maia Kayal. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07486921, a Phase 2 study, is actively recruiting participants, sponsored by Maia Kayal.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
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.
Primary Outcome
The proportion of patients with at least 1 episode of acute pouchitis during the 48 weeks of treatment. Acute Pouchitis defined as: modified pouchitis disease activity index (mPDAI) score ≥ 5 points OR an increase of ≥ 2 points vs. baseline, AND Endoscopic component of the mPDAI Score \>= 2 points (within 7 days prior or post the collection date of the symptomatic component of the mPDAI score)
Interventions
- DRUG Placebo
- DRUG etrasimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-06-12 |
| Est. Completion | 2030-02-06 |
| Phase | Phase 2 |
What NCT07486921 shows while recruiting
NCT07486921 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07486921 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07486921 about?
NCT07486921 is a clinical study titled "Etrasimod as Prevention of Pouchitis". 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 ...
What is the current status of trial NCT07486921?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2026-06-12. Estimated completion is 2030-02-06.
What interventions are being tested in trial NCT07486921?
The interventions under investigation include: Placebo (DRUG), etrasimod (DRUG).
Who is sponsoring clinical trial NCT07486921?
This trial is sponsored by Maia Kayal, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07486921's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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