Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis

Primary outcome measures

• Annualized Confirmed Relapse Rate (ARR)
• Time From Core Study Randomization to First Confirmed Relapse
• Time to First 12-week Confirmed Disability Accumulation (CDA)
• Time to First 24-week Confirmed Disability Accumulation (CDA)
• Percentage of Participants With Absence of Relapses
• Change From Baseline in Expanded Disability Status Scale (EDSS)
• Percentage of Participants With No Evidence of Disease Activity (NEDA) Status According to NEDA With Three Components (NEDA-3) at Extension End of Study
• Percentage of Participants With No Evidence of Disease Activity (NEDA) Status According to NEDA With Four Components (NEDA-4) at Extension End of Study
• Percent Change From Baseline in Brain Volume (PCBV) Measured by Magnetic Resonance Imaging (MRI)
• Cumulative Number of Combined Unique Active Lesions (CUAL) Measured by MRI
• Number of Gadolinium-enhancing (Gd+) T1 Lesions Measured by MRI
• Cumulative Number of New or Enlarging T2 Lesions Measured by MRI
• Change From Baseline in Volume of MRI Lesions (T2 Lesions and T1 Hypointense Lesions)
• Number of Participants With Absence of MRI Lesions (Gd+ T1 Lesions, New or Enlarging T2 Lesions)
• Percentage of Gd+ Lesions at Baseline Evolving to Persistent Black Holes (PBHs)
• Number of Participants With Treatment-emergent Adverse Events (TEAEs)
• Number of Participants With Treatment-emergent New Morphological Electrocardiogram (ECG) Abnormalities
• Actual Values of 12-lead ECG Measurements up to End of Study Treatment: Heart Rate
• Actual Values of 12-lead ECG Measurements up to End of Study Treatment: PR, QRS, QT, QTcB, QTcF
• Change in Heart Rate (HR) From Baseline up to End of Study Treatment
• Change in PR, QRS, QT, QTcB, QTcF From Baseline up to End of Study Treatment
• Absolute Values in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) Values
• Percent Change in (FEV1) and Forced Vital Capacity (FVC) From Baseline (%)
• Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
• Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs)
• Number of Participants With AE Leading to Premature Discontinuation of Study Treatment
• Number of Participants With Treatment-emergent Decrease From Baseline >20% and >30% in FEV1 or FVC
• Number of Participants With Treatment-emergent Decrease of >20% Points in Percent Predicted FEV1 and FVC From Baseline
• Number of Participants With a Decrease of >=200 mL or >=12% in FEV1 or FVC From Baseline to EOT
• Change in FEV1 and FVC (% Predicted) From Baseline to End of Treatment (EOT)
• Change in FEV1 and FVC (% Predicted) From Baseline to End of Study (EOS)
• Absolute Change in Lung Diffusion Capacity as Assessed by Diffusing Capacity for the Lungs Measured Using Carbon Monoxide (DL[CO]) From Baseline
• Change in DL[CO] (% Predicted) From Baseline to EOT
• Change in DL[CO] (% Predicted) From Baseline to EOS