Etrasimod as Prevention of Pouchitis

NCT07486921 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY-25-01158
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pouchitis

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with at least 1 episode of acute pouchitis

  The proportion of patients with at least 1 episode of acute pouchitis during the 48 weeks of treatment. Acute Pouchitis defined as: modified pouchitis disease activity index (mPDAI) score ≥ 5 points OR an increase of ≥ 2 points vs. baseline, AND Endoscopic component of the mPDAI Score \>= 2 points (within 7 days prior or post the collection date of the symptomatic component of the mPDAI score)

  48 weeks

Secondary Outcomes (5)

• Time to first episode of acute pouchitis

  end of study at 48 weeks

• Proportion of patients with acute pouchitis

  Weeks 12, 24 and 36

• Number of participants with clinical remission

  end of study at 48 weeks

• Number of episodes of acute pouchitis

  end of study at 48 weeks

• Change in Inflammatory Bowel Disease (IBD) Disability Index

  Baseline and at Weeks 12, 24, 36 and 48

Study Arms (2)

etrasimod

ACTIVE COMPARATOR

study drug etrasimod 2 mg once daily for 48 weeks

Drug: etrasimod

Placebo

PLACEBO COMPARATOR

Placebo for 48 weeks

Drug: Placebo

Interventions

etrasimod DRUG

2 mg once daily for 48 weeks

etrasimod

Placebo DRUG

matching placebo for 48 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)
• 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

Sponsors & Collaborators

• Maia Kayal: lead
• Pfizer: collaborator

Study Sites (1)

Icahn School Of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Pouchitis

Interventions

etrasimod

Condition Hierarchy (Ancestors)

Ileitis; Enteritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ileal Diseases

Study Officials

• Maia Kayal, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maia Kayal, MD

CONTACT

212-241-8100; maia.kayal@mountsinai.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: June 12, 2026
• Primary Completion (Estimated): February 6, 2030
• Study Completion (Estimated): February 6, 2030
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)