NCT07686081 Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis
| NCT ID | NCT07686081 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Vanda Pharmaceuticals |
| Condition | Ulcerative Colitis (UC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-09 |
| Primary Completion | 2029-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 150 participants in total. It began in 2026-09 with a primary completion date of 2029-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07686081 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Ulcerative Colitis (UC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07686081 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 150 participants.
Is NCT07686081 currently recruiting?
Yes, NCT07686081 is actively recruiting participants. Contact the research team at clinicaltrials@vandapharma.com for enrollment information.
Where is the NCT07686081 trial being conducted?
This trial is being conducted at Chula Vista, United States, Nashville, United States.
Who is sponsoring the NCT07686081 clinical trial?
NCT07686081 is sponsored by Vanda Pharmaceuticals. The trial plans to enroll 150 participants.
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