Ponesimod for moderately to severely active ulcerative colitis: a treatment study
Official title: 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
Run by Vanda Pharmaceuticals · NCT07686081 · Data updated 2026-11-12
This study tests whether ponesimod can help people with moderately to severely active ulcerative colitis who have not responded well to other treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Vanda Pharmaceuticals Industry-sponsored |
| Locations | 2 sites (Chula Vista, California and 1 other locations) |
| Status | Recruiting |
| Started | September 2026 |
| Main results expected | April 2029 |
| Study ends | August 2029 |
| Registry record updated | August 18, 2026 |
| Trial ID | NCT07686081 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-75 with moderately to severely active UC, previous nonresponse or intolerance to at least one approved UC therapy, and specific Mayo score criteria.
✕Probably not a fit
Participants with severe or fulminant UC, Crohn's disease, active infections, or contraindications to the study drug may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, randomized, double-blind, placebo-controlled phase 3 trial evaluating the safety and effectiveness of ponesimod (VSP-128) in adults with ulcerative colitis. Eligible participants have a history of inadequate response or intolerance to prior UC therapies and meet specific Mayo score criteria. Participants are assigned to receive either ponesimod or placebo, with ongoing monitoring for adverse events and disease activity. The trial is conducted at two Vanda investigational sites in California and Tennessee, led by Vanda Pharmaceuticals. The study aims to determine if ponesimod can provide meaningful improvement in UC symptoms and quality of life.
Why it matters
Potential benefit: If successful, participants may experience reduced disease activity and improved symptoms related to ulcerative colitis.
How similar studies have gone: Ponesimod and other S1P receptor modulators have shown potential in related inflammatory conditions, but results for UC are still being established and this trial investigates efficacy in this indication.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Vanda Investigational Site
Chula Vista, California, United States Recruiting -
Vanda Investigational Site
Nashville, Tennessee, United States Recruiting
Study contacts
- Study coordinator: Vanda Pharmaceuticals Inc.
- Email: clinicaltrials@vandapharma.com
- Phone: 202-734-3400
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.