Etrasimod as Primary and Secondary Prevention of Pouchitis (ESPIRIT)
Maia Kayal
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.
Description
This is a multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of etrasimod as primary and secondary prevention of pouchitis among high-risk ulcerative colitis (UC) patients who have undergone TPC + IPAA and have no evidence of pouchitis (i.e., are in remission) at time of enrollment. Eligible patients will be randomized (1:1 ratio) to receive either etrasimod (2 mg once daily) or placebo for 48 weeks. Randomization will be stratified by the presence of medical history of primary sclerosing cholangitis (yes or no) and by the presence of medical history o…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female aged ≥ 18 years (verified at screening) * Ability to provide written informed consent and to be compliant with protocol assessments (verified at screening) * Diagnosed with UC and underwent TPC with IPAA for medically refractory disease or dysplasia (verified at screening) * Screening may take place at any time from one month to two years after the final surgical stage * High-risk of developing acute pouchitis - defined as fulfilling at least one of the criteria defined in section 2 (verified at screening) * Patients with 1 prior episode of acute pouchitis…
Interventions
- Drugetrasimod
2 mg once daily for 48 weeks
- DrugPlacebo
matching placebo for 48 weeks
Location
- Icahn School Of Medicine at Mount SinaiNew York, New York