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 medically refractory disease. The trial will be conducted in compliance with this protocol, Good Clinical Practice guidelines, and Institutional Review Board requirements.
Male or female aged ≥ 18 years (verified at screening) [+10]
Isolated cuffitis (verified at screening pouchoscopy) [+25]