Vanda Pharmaceuticals
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
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 * Clin…
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.
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.
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