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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

RecruitingPhase 3

Sponsor: Vanda Pharmaceuticals

Conditions: Ulcerative Colitis (UC)

Interventions: Ponesimod, Placebo

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (2)

Chula Vista, California, United States
Nashville, Tennessee, United States