drugset / Trial / NCT07486921
Etrasimod as Prevention of Pouchitis
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2026-06-12
- Primary completion
- 2030-02-06
- Completion
- 2030-02-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Etrasimod | Small molecule | 2 mg | — |