Etrasimod as Prevention of Pouchitis

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Pouchitis

In brief

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.

Key facts

Study ID

NCT07486921

Run by

Maia Kayal

People needed

40

Starts

2026-06-12

Expected to finish

2030-02-06

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 determined by qualitative urine hCG testing, non-lactating, and if premenopausal, must agree to using a highly effective contraception method (that can achieve a failure rate of less than 1% per year when used consistently and correctly) during treatment and for one week after stopping treatment with etrasimod (verified at screening)

You may not qualify if…

• 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)
• o Crohn's disease-like pouch inflammation is defined as ulcerations of the pre-pouch ileum extending > 10 cm above the inlet, strictures in the pre-pouch ileum or pouch body outside of the anastomoses, and/or fistulae of the pre-pouch ileum, pouch body, or perineum
• Diagnosis of chronic pouchitis (verified at screening)
• o Chronic pouchitis is defined as persistent (> 4 weeks) or recurrent (> 4 episodes/year) symptoms of pouchitis
• Anastomotic stenosis or other mechanical complications of the pouch (verified at screening pouchoscopy)
• Treatment with probiotics ≤ 3 months prior to screening (verified at screening)
• Treatment with topical rectal 5-ASA, or steroids ≤ 2 weeks prior to or during screening (verified at screening)
• Any use of a biologic or small molecule approved for moderately to severely active UC or investigational, after TPC with IPAA (verified at screening)
• Any prior exposure to a S1P receptor modulator therapy, at any time (verified at screening)
• Any investigational or biologic agent within 30 days of screening pouchoscopy (verified at screening)
• Have the following cardiovascular history (verified at screening):
• In the last 6 months, have experienced a myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III or IV heart failure
• Have a history or presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker
• A history of symptomatic bradycardia, recurrent cardiogenic syncope, Mobitz type I second-degree AV block, or severe untreated sleep apnea
• Significant QT prolongation (QTcF interval ≥ 450 ms in male or ≥ 470 ms in females)
• Arrhythmias requiring treatment with Class Ia or Class III anti-arrhythmic drugs or QT prolonging drugs
• Clinically significant or serious active infection ≤ 28 days prior to baseline - including but not limited to (verified at screening):
• Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or
• positive test for Clostridioides difficile toxin at screening
• Active tuberculosis
• Acute or chronic hepatitis B or hepatitis C
• HIV infection
• Pregnancy, lactation, or a positive urine pregnancy test measured during screening

Where it is running

• Icahn School Of Medicine at Mount Sinai — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.