[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630380":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":61,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":25,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":25,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"etrasimod","ACTIVE_COMPARATOR","study drug etrasimod 2 mg once daily for 48 weeks",[13],"Drug: etrasimod",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo for 48 weeks",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","2 mg once daily for 48 weeks",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"matching placebo for 48 weeks",[15],[30],{"name":31,"affiliation":32,"role":33},"Maia Kayal, MD","Principal Investigator","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","212-241-8100","maia.kayal@mountsinai.org",[40],{"facility":41,"status":42,"city":43,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Icahn School Of Medicine at Mount Sinai","RECRUITING","New York","10029","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-74.00597,40.71427,{"lat":51,"lon":50},[54,57,60],{"name":55,"role":36,"phone":37,"phoneExt":25,"email":56},"Maia Kayal","maia.kayal@mssm.edu",{"name":58,"role":36,"phone":37,"phoneExt":25,"email":59},"Sari Feldman","sari.feldman@mssm.edu",{"name":55,"role":33,"phone":25,"phoneExt":25,"email":25},{"type":62,"investigatorFullName":55,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Associate Professor",[65],{"name":66,"class":67},"Pfizer","INDUSTRY","100630380","phase-2-etrasimod-as-prevention-of-pouchitis-100630380",false,"NCT07486921","Etrasimod as Prevention of Pouchitis","Etrasimod as Primary and Secondary Prevention of Pouchitis (ESPIRIT)","ESPIRIT","Inclusion Criteria:\n\n* Male or female aged ≥ 18 years (verified at screening)\n* Ability to provide written informed consent and to be compliant with protocol assessments (verified at screening)\n* Diagnosed with UC and underwent TPC with IPAA for medically refractory disease or dysplasia (verified at screening)\n* Screening may take place at any time from one month to two years after the final surgical stage\n* High-risk of developing acute pouchitis - defined as fulfilling at least one of the criteria defined in section 2 (verified at screening)\n* 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\n* Symptomatic remission defined by a symptom mPDAI subscore ≤2 points at the baseline visit (verified at screening, baseline)\n* Adequate hematological function defined by white blood cell count ≥ 3.5 × 109\u002FL with absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, absolute lymphocyte count (ALC) ≥ 0.8 × 109\u002FL, platelet count ≥ 100 × 109\u002FL, and hemoglobin ≥ 8 g\u002FdL (verified at screening)\n* 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)\n* 12-lead electrocardiogram (ECG) that showed no clinically significant abnormalities as defined by the clinician's judgement (verified at screening)\n* 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)\n\nExclusion Criteria:\n\n* Isolated cuffitis (verified at screening pouchoscopy)\n* Diagnosis of Crohn's disease (verified at screening)\n* Diagnosis of Crohn's disease-like pouch inflammation (verified at screening)\n\n  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\u002For fistulae of the pre-pouch ileum, pouch body, or perineum\n* Diagnosis of chronic pouchitis (verified at screening)\n\n  o Chronic pouchitis is defined as persistent (\\> 4 weeks) or recurrent (\\> 4 episodes\u002Fyear) symptoms of pouchitis\n* Anastomotic stenosis or other mechanical complications of the pouch (verified at screening pouchoscopy)\n* Treatment with probiotics ≤ 3 months prior to screening (verified at screening)\n* Treatment with topical rectal 5-ASA, or steroids ≤ 2 weeks prior to or during screening (verified at screening)\n* Any use of a biologic or small molecule approved for moderately to severely active UC or investigational, after TPC with IPAA (verified at screening)\n* Any prior exposure to a S1P receptor modulator therapy, at any time (verified at screening)\n* Any investigational or biologic agent within 30 days of screening pouchoscopy (verified at screening)\n* Have the following cardiovascular history (verified at screening):\n\n  * 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\n  * 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\n  * A history of symptomatic bradycardia, recurrent cardiogenic syncope, Mobitz type I second-degree AV block, or severe untreated sleep apnea\n  * Significant QT prolongation (QTcF interval ≥ 450 ms in male or ≥ 470 ms in females)\n  * Arrhythmias requiring treatment with Class Ia or Class III anti-arrhythmic drugs or QT prolonging drugs\n* Clinically significant or serious active infection ≤ 28 days prior to baseline - including but not limited to (verified at screening):\n\n  * Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or\n  * positive test for Clostridioides difficile toxin at screening\n  * Active tuberculosis\n  * Acute or chronic hepatitis B or hepatitis C\n  * HIV infection\n* Pregnancy, lactation, or a positive urine pregnancy test measured during screening\n* Severe hepatic impairment (Child Pugh Class C) (verified at screening)\n* Have a known history of macular edema or retinopathy (verified at screening)\n* History of cancer within the last 5 years (excluding in situ squamous or basal cell carcinoma of the skin that has been excised and resolved) or current malignancy (verified at screening)\n* History of posterior reversible encephalopathy syndrome (PRES)\n* Have a history of any clinically significant medical condition that, in the investigator's opinion, precludes participation in the study (verified at screening)","ALL","18 Years","65 Years",{"count":80,"type":81},40,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","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.",[87],"Pouchitis","2026-06-08",{"date":90,"type":91},"2026-06-10","ACTUAL",{"date":93,"type":81},"2026-06-12",{"date":95,"type":81},"2030-02-06",{"name":55,"class":6},1]