Ponesimod for Adults With Moderately to Severely Active Ulcerative Colitis
Tests ponesimod against a placebo in adults with active ulcerative colitis.
Plain-language title generated from the registry record
Registry title: Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis
Key facts
- Where
- Liepaja and Riga, LatviaSee the 3 sites
- Phase
- Phase 3
Could this be for you?
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?
Source: NCT07686081, who can take part
Where in Latvia
- Liepajas Regionala Slimnica SIALiepaja, LatviaNot yet recruiting
- Pauls Stradins Clinical University HospitalRiga, LatviaNot yet recruiting
- Veselibas Centrs 4 SIARiga, LatviaNot yet recruiting
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?
Trial details
- Who runs it
- Vanda Pharmaceuticals
- Trial code
- NCT07686081EU 2025-524520-22-00
- Record updated
- 18 August 2026
- Original description
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 colitisRead full original descriptionShow less
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
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
Inclusion: 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: 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.