Ponesimod for Adults With Moderately to Severely Active Ulcerative Colitis
Tests ponesimod against a placebo in adults with active ulcerative colitis.
Key facts
- Who runs it
- Vanda Pharmaceuticals
- Where
- Slaný, CzechiaSee the siteAlso in 2 other countries, 5 sites
- Trial code
- Registry title
- Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 150 people, planned
- Started
- Sept 2026
- Expected to end
- Aug 2029
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Ponesimod
- Placebo
- Record updated
- 18 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with ulcerative colitis that is moderately to severely active and who did not do well on at least one approved UC treatment.
- Age
- 18 to 75 years
- Sex
- Men and women can join
- Disease stage
- Ulcerative colitis diagnosed at least 90 days before screening, with a three-component Mayo score of 5-9, endoscopy subscore of 2 or more and rectal bleeding subscore of 1 or more
- Earlier treatment
- Must have had an inadequate response, loss of response, or intolerance to at least one approved UC therapy. Must not have had S1P receptor modulators before.
Main reasons for not taking part
- Severe or fulminant UC likely to need hospital stay or surgery
- Crohn's disease or other colitis that is not UC
- Earlier treatment with S1P receptor modulators
- Active or chronic infections
- Serious uncontrolled heart, liver or other body-wide disease
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- Severe or fulminant UC likely to require hospitalization or surgery
- Prior exposure to S1P receptor modulators
- Diagnosis of Crohn's disease or other non-UC colitis
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in Czechia
Also in 2 other countries, 5 sites
- Nemocnice SlanySlaný, CzechiaNot yet recruiting
About the trial
What the trial wants to find out
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
The 2 groups in the trial
- Ponesimod (VSP-128)Treatment being tested
Treatment: Ponesimod
- PlaceboPlacebo, for comparison
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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
- Plain-language title
- Ponesimod for Adults With Moderately to Severely Active Ulcerative ColitisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07686081, who can take part
- Record updated
- 18 August 2026