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

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
• Clinically significant cardiovascular, hepatic, or other uncontrolled systemic disease
• History of an allergic reaction or significant sensitivity to constituents of study drug