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
Conditions
Ulcerative Colitis (UC)
Locations
Vanda Investigational Site
Chula Vista, California 91910
United States
Vanda Investigational Site
Nashville, Tennessee 37211
United States