Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ponesimod · 2 trials · 2 indications
Proportion of participants achieving clinical remission at Week 16.
Safety will be assessed based on frequency of treatment-emergent adverse events and serious adverse events, and frequency of clinically notable abnormal vital signs, blood chemistry, hematology, urology, and ECGs
| Arm | Type | Description |
|---|---|---|
| Ponesimod (VSP-128) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Ponesimod | EXPERIMENTAL | Ponesimod |
| Name | Type | Description |
|---|---|---|
| Ponesimod | DRUG | 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. |
| Placebo | DRUG | 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. |
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 respons...