A Phase 3 interventional study of Ponesimod and Placebo in Ulcerative Colitis (UC), sponsored by Vanda Pharmaceuticals. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Vanda Pharmaceuticals · Phase 3, Interventional, and Treatment
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
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 150 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Vanda Pharmaceuticals is the lead sponsor of 82 studies on the registry; 17 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 22 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Ponesimod
Drug: Placebo
Ponesimod administered orally once daily. Participants are randomized 2:1 to Ponesimod or placebo during a 16-week double-blind period. A 14-day titration is followed by a stable dose daily from Day 15 through end of treatment. Participants may enter a 36-week open-label extension receiving Ponesimod.
Also known as: VSP-128
Matching placebo administered orally once daily during a 16-week double-blind period (2:1 randomization). A mock 14-day titration is used to maintain blinding. Participants may enter a 36-week open-label extension receiving Ponesimod.
Clinical Remission at Week 16
Proportion of participants achieving clinical remission at Week 16.
Time frame: Week 16
Clinical Response at Week 16
Proportion of participants achieving clinical response at Week 16.
Time frame: Week 16
Change From Baseline in Mayo Score at Week 16
Change from baseline in the three-component Mayo Score at Week 16. The overall score value ranges from 0 to 9, with higher scores indicating more severe ulcerative colitis disease activity.
Time frame: Baseline to Week 16.
Endoscopic Improvement at Week 16
Proportion of participants achieving endoscopic improvement at Week 16.
Time frame: Week 16
Symptomatic Remission at Week 16
Proportion of participants achieving symptomatic remission at Week 16.
Time frame: Week 16
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Apr 2029, 31 months later.
Of 87 industry-sponsored phase 3 interventional studies under Colitis, Ulcerative, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 70. This study's planned 31 months is below that.
Counting every sponsor, half of 101 studies reached it within 48 months; a quarter within 31 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ponesimod