Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis
Recruiting · NCT07686081 · Interventional (participants receive a specific treatment) · Lead sponsor: Vanda Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboPonesimod
What this trial is about
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
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed across 2 US states.
- Vanda Investigational Site - Chula Vista, California, United States
- Vanda Investigational Site - Nashville, Tennessee, United States