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Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis

NCT07686081 · Vanda Pharmaceuticals
In plain English

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Official title
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
About this study
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
Eligibility criteria
Inclusion Criteria: * Male and female subjects aged 18-75 years * Able to provide written informed consent * Diagnosis of ulcerative colitis for ≥90 days prior to screening * Three-component Mayo score of 5-9 with endoscopy subscore ≥2 and rectal bleeding subscore ≥1 * History of inadequate response, loss of response, or intolerance to at least one approved UC therapy Exclusion Criteria: * Severe or fulminant UC likely to require hospitalization or surgery * Diagnosis of Crohn's disease or other non-UC colitis * Prior exposure to S1P receptor modulators * Active or chronic infections * Clinically significant cardiovascular, hepatic, or other uncontrolled systemic disease * History of an allergic reaction or significant sensitivity to constituents of study drug
Study design
Enrollment target: 150 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-09
Estimated completion: 2029-08
Last updated: 2026-08-18
Interventions
Drug: PonesimodDrug: Placebo
Primary outcomes
  • Clinical Remission at Week 16 (Week 16)
Sponsor
Vanda Pharmaceuticals · industry
Contacts & investigators
ContactVanda Pharmaceuticals Inc. · contact · clinicaltrials@vandapharma.com · 202-734-3400
All locations (2)
Vanda Investigational SiteRecruiting
Chula Vista, California, United States
Vanda Investigational SiteRecruiting
Nashville, Tennessee, United States
Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis · TrialPath