[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646670":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":30,"locations":36,"responsibleParty":60,"collaborators":11,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":11,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":39,"whyStopped":11,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Vanda Pharmaceuticals","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ponesimod (VSP-128)","EXPERIMENTAL",null,[13],"Drug: Ponesimod",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Ponesimod","Ponesimod administered orally once daily. Participants are randomized 2:1 to Ponesimod or placebo during a 16-week double-blind period. A 14-day titration is followed by a stable dose daily from Day 15 through end of treatment. Participants may enter a 36-week open-label extension receiving Ponesimod.",[9],[26],"VSP-128",{"type":21,"name":15,"description":28,"armGroupLabels":29,"otherNames":11},"Matching placebo administered orally once daily during a 16-week double-blind period (2:1 randomization). A mock 14-day titration is used to maintain blinding. Participants may enter a 36-week open-label extension receiving Ponesimod.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":11,"email":35},"Vanda Pharmaceuticals Inc.","CONTACT","202-734-3400","clinicaltrials@vandapharma.com",[37,51],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":11},"Vanda Investigational Site","RECRUITING","Chula Vista","California","91910","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-117.0842,32.64005,{"lat":49,"lon":48},{"facility":38,"status":39,"city":52,"state":53,"zip":54,"country":43,"countryCode":44,"cosmosGeoPoint":55,"geoPoint":59,"contacts":11},"Nashville","Tennessee","37211",{"type":46,"coordinates":56},[57,58],-86.78444,36.16589,{"lat":58,"lon":57},{"type":61,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100646670","phase-3-study-to-evaluate-the-efficacy-and-safety-of-ponesimod-vsp-128-in-patients-with-moderately-to-severely-active-ulcerative-colitis-100646670",false,"NCT07686081","Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ponesimod in Patients With Moderately to Severely Active Ulcerative Colitis","Inclusion Criteria:\n\n* Male and female subjects aged 18-75 years\n* Able to provide written informed consent\n* Diagnosis of ulcerative colitis for ≥90 days prior to screening\n* Three-component Mayo score of 5-9 with endoscopy subscore ≥2 and rectal bleeding subscore ≥1\n* History of inadequate response, loss of response, or intolerance to at least one approved UC therapy\n\nExclusion Criteria:\n\n* Severe or fulminant UC likely to require hospitalization or surgery\n* Diagnosis of Crohn's disease or other non-UC colitis\n* Prior exposure to S1P receptor modulators\n* Active or chronic infections\n* Clinically significant cardiovascular, hepatic, or other uncontrolled systemic disease\n* History of an allergic reaction or significant sensitivity to constituents of study drug","ALL","18 Years","75 Years",{"count":73,"type":74},150,"ESTIMATED","INTERVENTIONAL",[77],"PHASE3","A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Ponesimod (VSP-128) in patients with moderately to severely active ulcerative colitis",[80],"Ulcerative Colitis (UC)",[82,83],"ulcerative colitis","moderately to severely active ulcerative colitis","2026-08-14",{"date":86,"type":87},"2026-08-18","ACTUAL",{"date":89,"type":74},"2026-09",{"date":91,"type":74},"2029-08",{"name":5,"class":6},2]