Etrasimod as Prevention of Pouchitis (NCT07486921) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Etrasimod as Prevention of Pouchitis
United States40 participantsStarted 2026-03
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 can be enrolled - after a minimum period of 4 weeks after completion of a course of antibiotics and resolution of symptoms of pouchitis
* Symptomatic remission defined by a symptom mPDAI subscore ≤2 points at the baseline visit (verified at screening, baseline)
* Adequate hematological function defined by white blood cell count ≥ 3.5 × 109/L with absolute neutrophil count (ANC) ≥ 1.5 × 109/L, absolute lymphocyte count (ALC) ≥ 0.8 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 8 g/dL (verified at screening)
* Healthcare professional-confirmed history of varicella or a full course of vaccination against varicella zoster virus (VZV) or a positive antibody test to VZV (verified at screening)
* 12-lead electrocardiogram (ECG) that showed no clinically significant abnormalities as defined by the clinician's judgement (verified at screening)
* Females must be non-pregnant, as determin…
What they're measuring
1
Proportion of participants with at least 1 episode of acute pouchitis