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NCT07686081PHASE3Recruiting

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

Vanda Pharmaceuticals

Start Date

9/1/2026

Completion Date

8/1/2029

Summary

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

Age Range: 18 years to 75 years

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

Interventions

DRUG

Ponesimod

DRUG

Placebo

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Conditions

Ulcerative Colitis (UC)

Locations

Vanda Investigational Site

Chula Vista, California 91910

United States

Vanda Investigational Site

Nashville, Tennessee 37211

United States