NCT07686081RecruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) 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 in Patients With Moderately to Severely Active Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 30 Jun 2026
- Start date
- Sept 2026
- Primary completion date
- Apr 2029
- Lead sponsor
- Vanda Pharmaceuticals
- Diseases
- Ulcerative colitis
- NCT number
- NCT07686081
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 150
- From Sept 2026 to the primary completion date, Apr 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe or fulminant UC likely to require hospitalization or surgery
- Prior exposure to S1P receptor modulators
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Chula Vista | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.