Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT01093326 |
Recruitment Status :
Active, not recruiting
First Posted : March 25, 2010
Last Update Posted : June 1, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis | Drug: Ponesimod 10 mg Drug: Ponesimod 20 mg Drug: Ponesimod 40 mg | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 353 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | May 12, 2010 |
Estimated Primary Completion Date : | September 6, 2023 |
Estimated Study Completion Date : | September 6, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Ponesimod 10 mg
Ponesimod 10 mg oral use
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Drug: Ponesimod 10 mg
Ponesimod 10 mg oral use |
Experimental: Ponesimod 20 mg
Ponesimod 20 mg oral use
|
Drug: Ponesimod 20 mg
Ponesimod 20 mg oral use |
Experimental: Ponesimod 40 mg
Ponesimod 40 mg oral use
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Drug: Ponesimod 40 mg
Ponesimod 40 mg oral use |
- Annualized confirmed relapse rate [ Time Frame: Up to 660 weeks (core plus extension) ]IMPORTANT NOTE: Only exploratory analyses will be performed.
- Time to first confirmed relapse [ Time Frame: Up to 660 weeks (core plus extension) ]IMPORTANT NOTE: Only exploratory analyses will be performed.
- Time to 24 Weeks Confirmed Disability Progression up to end of the study [ Time Frame: Up to 660 weeks (core plus extension) ]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.
- (Serious) Adverse Events [ Time Frame: Up to 660 weeks (core plus extension) ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093326

Responsible Party: | Actelion |
ClinicalTrials.gov Identifier: | NCT01093326 |
Other Study ID Numbers: |
AC-058B202 2009-011470-15 ( EudraCT Number ) |
First Posted: | March 25, 2010 Key Record Dates |
Last Update Posted: | June 1, 2023 |
Last Verified: | May 2023 |
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases |
Autoimmune Diseases Immune System Diseases Ponesimod Sphingosine 1 Phosphate Receptor Modulators Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |