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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Ponesimod 10 mg
* Drug: Ponesimod 20 mg
* Drug: Ponesimod 40 mg


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ponesimod 10 mg<br>Ponesimod 10 mg oral use | Drug: Ponesimod 10 mg<br>* Ponesimod 10 mg oral use<br>|
| Experimental: Ponesimod 20 mg<br>Ponesimod 20 mg oral use | Drug: Ponesimod 20 mg<br>* Ponesimod 20 mg oral use<br>|
| Experimental: Ponesimod 40 mg<br>Ponesimod 40 mg oral use | Drug: Ponesimod 40 mg<br>* Ponesimod 40 mg oral use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized confirmed relapse rate | IMPORTANT NOTE: Only exploratory analyses will be performed. | Up to 660 weeks (core plus extension) | 
| Time to first confirmed relapse | IMPORTANT NOTE: Only exploratory analyses will be performed. | Up to 660 weeks (core plus extension) | 
| Time to 24 Weeks Confirmed Disability Progression up to end of the study | IMPORTANT NOTE: Only exploratory analyses will be performed. Disability progression is defined as an increase of at least one full point in the EDSS score (or 1.5 points if the baseline EDSS was 0, or 0.5 points if the baseline EDSS was equal or greater than 5.5) with or without relapse, confirmed at the next scheduled EDSS assessment at least 24 weeks later (or if missing, at the next available scheduled EDSS assessment). The time to event is defined as the time from initiation of study treatment until the first EDSS assessment meeting the criteria for disability progression. | Up to 660 weeks (core plus extension) |