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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVanda Pharmaceuticals

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ponesimod
  • Placebo

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators