Etrasimod as Prevention of Pouchitis
ConditionPouchitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMaia Kayal
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Isolated cuffitis (verified at screening pouchoscopy)
Diagnosis of Crohn's disease (verified at screening)
Diagnosis of Crohn's disease-like pouch inflammation (verified at screening)
Diagnosis of chronic pouchitis (verified at screening)
Trial design
Treatments tested in this trial
- etrasimod
- Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov