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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

Who can join

Ages 18 to 75 · All sexes

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

About the study

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

What is being tested

• Ponesimod (drug)
• Placebo (drug)

Sponsor: Vanda Pharmaceuticals · Participants: 150 · Started: 2026-09

Contact the study team

• Vanda Pharmaceuticals Inc. · Phone: 202-734-3400

Official record on ClinicalTrials.gov — NCT07686081

Locations in the U.S.

Conditions

• Ulcerative Colitis

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.