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Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis

Multicenter, Randomized, Double-blind, Parallel-group Extension to Study AC-058B201 to Investigate the Long-term Safety, Tolerability, and Efficacy of Three Doses of Ponesimod, an Oral S1P1 Receptor Agonist, in Patients With Relapsing-remitting Multiple Sclerosis
CompletedPhase 2Relapsing MSNCT010933262009-011470-15

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Ponesimod

    Sphingosine 1-phosphate receptor Edg-1 agonist

Results by group

Annualized Relapse Rate (ARR) of Confirmed Relapses

From ponesimod start date up to the end of Analysis Period (AP) 3. The actual time varied for each participant and could be up to 13.3 years

GroupValueIntervalNumber analysed
Ponesimod 10 Milligrams (mg)0.205 Confirmed relapses per year0.15–0.282139
Ponesimod 20 Milligrams (mg)0.142 Confirmed relapses per year0.102–0.198145
Ponesimod 40 Milligrams (mg)0.150 Confirmed relapses per year0.105–0.215151

Ponesimod 10 Milligrams (mg)

0.205

Ponesimod 20 Milligrams (mg)

0.142

Ponesimod 40 Milligrams (mg)

0.15

Time to First Confirmed Relapse

From ponesimod start date up to the end of Analysis Period (AP) 3. The actual time varied for each participant and could be up to 13.3 years

GroupValueIntervalNumber analysed
Ponesimod 10 Milligrams (mg)272.3 Weeks139
Ponesimod 20 Milligrams (mg)656.7 Weeks145
Ponesimod 40 Milligrams (mg)431.7 Weeks151

Ponesimod 10 Milligrams (mg)

272.3

Ponesimod 20 Milligrams (mg)

656.7

Ponesimod 40 Milligrams (mg)

431.7

Time to 24 Weeks Confirmed Disability Progression

From ponesimod baseline up to the end of Analysis Period (AP) 3. The actual time varied for each participant and could be up to 13.3 years

GroupValueIntervalNumber analysed
Ponesimod 10 Milligrams (mg)Not reached139
Ponesimod 20 Milligrams (mg)Not reached145
Ponesimod 40 Milligrams (mg)Not reached151

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Ponesimod 10 Milligrams (mg)13932 (23.0%)0
Ponesimod 20 Milligrams (mg)14535 (24.1%)1
Ponesimod 40 Milligrams (mg)15125 (16.6%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Annualized Relapse Rate (ARR) of Confirmed Relapses

    From ponesimod start date up to the end of Analysis Period (AP) 3. The actual time varied for each participant and could be up to 13.3 years

    Disability progressionRelapsesBladder, bowel and sexual function

  • Time to First Confirmed Relapse

    From ponesimod start date up to the end of Analysis Period (AP) 3. The actual time varied for each participant and could be up to 13.3 years

    Disability progressionRelapsesBladder, bowel and sexual function

  • Time to 24 Weeks Confirmed Disability Progression

    From ponesimod baseline up to the end of Analysis Period (AP) 3. The actual time varied for each participant and could be up to 13.3 years

    Disability progressionRelapses

  • Only exploratory efficacy endpoints will be investigated.

Other measures (1)

  • Not applicable

Who could take part

Relapsing MS · 18 to 55

Inclusion Criteria: 1. Patients who completed study treatment at their regular Week 24 (End of treatment) visit within the core study AC-058B201. 2. Signed informed consent for participating in the extension study. Exclusion Criteria: 1. 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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Related trials

History

    1. Started

      May 2010

    2. Main results due

      Sept 2023

    3. Finished

      Sept 2023

    4. Results posted

      Oct 2024

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