Phase 2
Completed N=353
Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis
Source: ClinicalTrials.gov NCT01093326 ↗Enrolled (actual)
353
Serious AEs
21.2%
Results posted
Oct 2024
Primary outcomePrimary: Annualized Relapse Rate (ARR) of Confirmed Relapses — 0.205; 0.142; 0.150 Confirmed relapses per year
Summary
This study is an extension to the study AC-058B201 and will investigate the long-term safety, tolerability and efficacy of ponesimod in patients with relapsing-remitting multiple sclerosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Relapse Rate (ARR) of Confirmed Relapses |
0.205; 0.142; 0.150 | — |
| PRIMARY Time to First Confirmed Relapse |
272.3; 656.7; 431.7 | — |
| PRIMARY Time to 24 Weeks Confirmed Disability Progression |
NA; NA; NA | — |
Eligibility Criteria
Inclusion Criteria
- Patients who completed study treatment at their regular Week 24 (End of treatment) visit within the core study AC-058B201.
- Signed informed consent for participating in the extension study.
Exclusion Criteria
- Any clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the patient at risk by participating in the extension study.
Data sourced from ClinicalTrials.gov (NCT01093326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.