OPTIMUM-LT
What it found
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 Confirmed Relapse Rate (ARR)
From randomization in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 0.143 relapses per patient-year | 0.123–0.167 | 439 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 0.184 relapses per patient-year | 0.158–0.213 | 438 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Treatment Effect (Rate Ratio) 0.779 (95% CI 0.629–0.965)
Time From Core Study Randomization to First Confirmed Relapse
From randomization in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 402.71 Weeks | 439 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | Not reached | 438 |
Time to First 12-week Confirmed Disability Accumulation (CDA)
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | Not reached | 439 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | Not reached | 438 |
Time to First 24-week Confirmed Disability Accumulation (CDA)
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | Not reached | 439 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | Not reached | 438 |
Percentage of Participants With Absence of Relapses
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 56.7 Percentage of Participants | 439 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 51.6 Percentage of Participants | 438 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Change From Baseline in Expanded Disability Status Scale (EDSS)
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 0.16 Score on a scale | 1.008 (Standard Deviation) | 346 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 0.34 Score on a scale | 1.105 (Standard Deviation) | 364 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Percentage of Participants With No Evidence of Disease Activity (NEDA) Status According to NEDA With Three Components (NEDA-3) at Extension End of Study
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 17.5 Percentage of Participants | 439 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 7.5 Percentage of Participants | 436 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Percentage of Participants With No Evidence of Disease Activity (NEDA) Status According to NEDA With Four Components (NEDA-4) at Extension End of Study
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 5.2 Percentage of Participants | 437 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 2.3 Percentage of Participants | 435 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Percent Change From Baseline in Brain Volume (PCBV) Measured by Magnetic Resonance Imaging (MRI)
From baseline in the core study up to the end of treatment (EOT) in the extension study. The actual time varied for each participant and could be up to 94.8 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | -2.52 Percent Change | 2.179 (Standard Deviation) | 196 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | -2.72 Percent Change | 2.024 (Standard Deviation) | 193 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Cumulative Number of Combined Unique Active Lesions (CUAL) Measured by MRI
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 1.352 CUAL per patient-year | 1.153–1.586 | 438 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 1.954 CUAL per patient-year | 1.667–2.291 | 435 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Number of Gadolinium-enhancing (Gd+) T1 Lesions Measured by MRI
From baseline in the core study up to the end of treatment (EOT) in the extension study. The actual time varied for each participant and could be up to 94.8 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 0.211 Gd+ T1 lesions | 0.131–0.341 | 350 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 0.395 Gd+ T1 lesions | 0.25–0.622 | 347 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Cumulative Number of New or Enlarging T2 Lesions Measured by MRI
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 1.352 Lesions per year | 1.152–1.586 | 438 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 1.951 Lesions per year | 1.664–2.287 | 435 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Change From Baseline in Volume of MRI Lesions (T2 Lesions and T1 Hypointense Lesions)
From baseline in the core study up to the end of treatment (EOT) in the extension study. The actual time varied for each participant and could be up to 94.8 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | -435.7 cubic millimeters (mm^3) | 2822.71 (Standard Deviation) | 347 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 91.5 cubic millimeters (mm^3) | 3647.08 (Standard Deviation) | 348 |
| Ponesimod 20 mg (Core and Extension Study) | 165.6 cubic millimeters (mm^3) | 1427.3 (Standard Deviation) | 347 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 309.4 cubic millimeters (mm^3) | 1712.36 (Standard Deviation) | 348 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Number of Participants With Absence of MRI Lesions (Gd+ T1 Lesions, New or Enlarging T2 Lesions)
From baseline in the core study up to the end of treatment (EOT) in the extension study. The actual time varied for each participant and could be up to 94.8 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 293 Participants | 439 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 236 Participants | 435 | |
| Ponesimod 20 mg (Core and Extension Study) | 152 Participants | 439 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 101 Participants | 435 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Percentage of Gd+ Lesions at Baseline Evolving to Persistent Black Holes (PBHs)
From baseline in the core study up to the end of treatment (EOT) in the extension study. The actual time varied for each participant and could be up to 94.8 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 22.3 Percentage of lesions | 350 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 25.1 Percentage of lesions | 346 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months +
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 411 Participants | 439 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 410 Participants | 438 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Number of Participants With Treatment-emergent New Morphological Electrocardiogram (ECG) Abnormalities
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months +
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 153 Participants | 439 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 140 Participants | 438 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Actual Values of 12-lead ECG Measurements up to End of Study Treatment: Heart Rate
From the start of study treatment in the extension study up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 67.4 Beats per minute (bpm) | 9.64 (Standard Deviation) | 361 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 67.6 Beats per minute (bpm) | 9.33 (Standard Deviation) | 361 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Actual Values of 12-lead ECG Measurements up to End of Study Treatment: PR, QRS, QT, QTcB, QTcF
From the start of study treatment in the extension study up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 150.0 millisecond (ms) | 20.41 (Standard Deviation) | 361 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 153.3 millisecond (ms) | 20.27 (Standard Deviation) | 361 |
| Ponesimod 20 mg (Core and Extension Study) | 92.1 millisecond (ms) | 9.22 (Standard Deviation) | 361 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 93.3 millisecond (ms) | 10.63 (Standard Deviation) | 361 |
| Ponesimod 20 mg (Core and Extension Study) | 392.5 millisecond (ms) | 27.26 (Standard Deviation) | 361 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 391.0 millisecond (ms) | 25.67 (Standard Deviation) | 361 |
| Ponesimod 20 mg (Core and Extension Study) | 414.8 millisecond (ms) | 19.2 (Standard Deviation) | 361 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 413.8 millisecond (ms) | 19.66 (Standard Deviation) | 361 |
| Ponesimod 20 mg (Core and Extension Study) | 406.9 millisecond (ms) | 17.78 (Standard Deviation) | 361 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 405.7 millisecond (ms) | 17.78 (Standard Deviation) | 361 |
Change in Heart Rate (HR) From Baseline up to End of Study Treatment
From the start of study treatment in the extension study up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | -1.7 beats per minute (bpm) | 10 (Standard Deviation) | 361 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | -1.5 beats per minute (bpm) | 9.17 (Standard Deviation) | 361 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Change in PR, QRS, QT, QTcB, QTcF From Baseline up to End of Study Treatment
From the start of study treatment in the extension study up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 0.5 millisecond (ms) | 14.09 (Standard Deviation) | 361 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 2.0 millisecond (ms) | 14.37 (Standard Deviation) | 361 |
| Ponesimod 20 mg (Core and Extension Study) | -0.4 millisecond (ms) | 6.79 (Standard Deviation) | 361 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 2.9 millisecond (ms) | 6.88 (Standard Deviation) | 361 |
| Ponesimod 20 mg (Core and Extension Study) | 7.8 millisecond (ms) | 25.68 (Standard Deviation) | 361 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 8.9 millisecond (ms) | 21.66 (Standard Deviation) | 361 |
| Ponesimod 20 mg (Core and Extension Study) | 2.9 millisecond (ms) | 16.75 (Standard Deviation) | 361 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 5.2 millisecond (ms) | 17.07 (Standard Deviation) | 361 |
| Ponesimod 20 mg (Core and Extension Study) | 4.6 millisecond (ms) | 15.28 (Standard Deviation) | 361 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 6.5 millisecond (ms) | 14.18 (Standard Deviation) | 361 |
Absolute Values in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) Values
From extension study baseline up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 3.01 Liters (L) | 0.768 (Standard Deviation) | 315 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 3.08 Liters (L) | 0.797 (Standard Deviation) | 327 |
| Ponesimod 20 mg (Core and Extension Study) | -3.96 Liters (L) | 0.965 (Standard Deviation) | 315 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 4.04 Liters (L) | 1.031 (Standard Deviation) | 327 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Percent Change in (FEV1) and Forced Vital Capacity (FVC) From Baseline (%)
From extension study baseline up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | -7.96 Percent change | 13.356 (Standard Deviation) | 315 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | -6.75 Percent change | 12.323 (Standard Deviation) | 327 |
| Ponesimod 20 mg (Core and Extension Study) | -5.09 Percent change | 11.793 (Standard Deviation) | 315 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | -3.93 Percent change | 12.141 (Standard Deviation) | 327 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months +
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 56 Participants | 439 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 57 Participants | 438 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs)
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months +
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 11 Participants | 439 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 13 Participants | 438 | |
| Ponesimod 20 mg (Core and Extension Study) | 5 Participants | 439 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 5 Participants | 438 | |
| Ponesimod 20 mg (Core and Extension Study) | 31 Participants | 439 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 25 Participants | 438 | |
| Ponesimod 20 mg (Core and Extension Study) | 4 Participants | 439 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 6 Participants | 438 | |
| Ponesimod 20 mg (Core and Extension Study) | 2 Participants | 439 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 1 Participants | 438 | |
| Ponesimod 20 mg (Core and Extension Study) | 4 Participants | 439 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 3 Participants | 438 | |
| Ponesimod 20 mg (Core and Extension Study) | 4 Participants | 439 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 3 Participants | 438 | |
| Ponesimod 20 mg (Core and Extension Study) | 1 Participants | 439 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 2 Participants | 438 | |
| Ponesimod 20 mg (Core and Extension Study) | 2 Participants | 439 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 3 Participants | 438 |
Number of Participants With AE Leading to Premature Discontinuation of Study Treatment
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months +
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 34 Participants | 439 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 41 Participants | 438 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Number of Participants With Treatment-emergent Decrease From Baseline >20% and >30% in FEV1 or FVC
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months +
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 80 Participants | 424 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 82 Participants | 423 | |
| Ponesimod 20 mg (Core and Extension Study) | 18 Participants | 424 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 21 Participants | 423 | |
| Ponesimod 20 mg (Core and Extension Study) | 54 Participants | 424 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 60 Participants | 423 | |
| Ponesimod 20 mg (Core and Extension Study) | 19 Participants | 424 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 15 Participants | 423 |
Number of Participants With Treatment-emergent Decrease of >20% Points in Percent Predicted FEV1 and FVC From Baseline
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months +
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 70 Participants | 423 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 68 Participants | 423 | |
| Ponesimod 20 mg (Core and Extension Study) | 59 Participants | 423 | |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 57 Participants | 423 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Change in FEV1 and FVC (% Predicted) From Baseline to End of Treatment (EOT)
From extension study baseline up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | -7.14 Percentage predicted change | 13.315 (Standard Deviation) | 315 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | -5.43 Percentage predicted change | 11.839 (Standard Deviation) | 327 |
| Ponesimod 20 mg (Core and Extension Study) | -4.70 Percentage predicted change | 13.129 (Standard Deviation) | 315 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | -3.19 Percentage predicted change | 13.081 (Standard Deviation) | 327 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Change in FEV1 and FVC (% Predicted) From Baseline to End of Study (EOS)
From extension study baseline up to the end of study in the extension study. The actual time varied for each participant and could be up to 73.2 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | -5.95 Percentage predicted change | 12.854 (Standard Deviation) | 288 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | -4.08 Percentage predicted change | 14.365 (Standard Deviation) | 299 |
| Ponesimod 20 mg (Core and Extension Study) | -4.48 Percentage predicted change | 13.727 (Standard Deviation) | 288 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | -1.98 Percentage predicted change | 15.747 (Standard Deviation) | 299 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Absolute Change in Lung Diffusion Capacity as Assessed by Diffusing Capacity for the Lungs Measured Using Carbon Monoxide (DL[CO]) From Baseline
From extension study baseline up to the end of study in the extension study. The actual time varied for each participant and could be up to 73.2 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 0.7 Millimoles/minute/kilopascal | 3.44 (Standard Deviation) | 65 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 0.1 Millimoles/minute/kilopascal | 4.17 (Standard Deviation) | 53 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Change in DL[CO] (% Predicted) From Baseline to EOT
From extension study baseline up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 5.7 Percentage predicted DL[CO] | 32.2 (Standard Deviation) | 50 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | -9.4 Percentage predicted DL[CO] | 7.82 (Standard Deviation) | 41 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Change in DL[CO] (% Predicted) From Baseline to EOS
From extension study baseline up to the end of study in the extension study. The actual time varied for each participant and could be up to 73.2 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 9.3 Percentage predicted DL[CO] | 39.38 (Standard Deviation) | 39 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 2.2 Percentage predicted DL[CO] | 49.5 (Standard Deviation) | 35 |
Ponesimod 20 mg (Core and Extension Study)
Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Ponesimod 20 mg (Core and Extension Study) | 439 | 56 (12.8%) | 1 |
| Teriflunomide 14 mg (Core) Then Ponesimod 20 mg (Extension) | 438 | 57 (13.0%) | 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 Confirmed Relapse Rate (ARR)
From randomization in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Disability progressionRelapsesWalking and mobilityBladder, bowel and sexual functionTime From Core Study Randomization to First Confirmed Relapse
From randomization in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Disability progressionRelapsesWalking and mobilityBladder, bowel and sexual functionTime to First 12-week Confirmed Disability Accumulation (CDA)
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Disability progressionTime to First 24-week Confirmed Disability Accumulation (CDA)
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Disability progressionPercentage of Participants With Absence of Relapses
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Disability progressionRelapsesWalking and mobilityBladder, bowel and sexual functionChange From Baseline in Expanded Disability Status Scale (EDSS)
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Disability progressionWalking and mobilityBladder, bowel and sexual functionPercentage of Participants With No Evidence of Disease Activity (NEDA) Status According to NEDA With Three Components (NEDA-3) at Extension End of Study
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Disability progressionRelapsesMRI lesionsWalking and mobilityPercentage of Participants With No Evidence of Disease Activity (NEDA) Status According to NEDA With Four Components (NEDA-4) at Extension End of Study
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
Disability progressionRelapsesMRI lesionsBrain volume lossWalking and mobilityPercent Change From Baseline in Brain Volume (PCBV) Measured by Magnetic Resonance Imaging (MRI)
From baseline in the core study up to the end of treatment (EOT) in the extension study. The actual time varied for each participant and could be up to 94.8 months
MRI lesionsBrain volume lossCumulative Number of Combined Unique Active Lesions (CUAL) Measured by MRI
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
MRI lesionsNumber of Gadolinium-enhancing (Gd+) T1 Lesions Measured by MRI
From baseline in the core study up to the end of treatment (EOT) in the extension study. The actual time varied for each participant and could be up to 94.8 months
MRI lesionsCumulative Number of New or Enlarging T2 Lesions Measured by MRI
From baseline in the core study up to the end of study (EOS) in the extension study. The actual time varied for each participant and could be up to 98.5 months
MRI lesionsChange From Baseline in Volume of MRI Lesions (T2 Lesions and T1 Hypointense Lesions)
From baseline in the core study up to the end of treatment (EOT) in the extension study. The actual time varied for each participant and could be up to 94.8 months
MRI lesionsNumber of Participants With Absence of MRI Lesions (Gd+ T1 Lesions, New or Enlarging T2 Lesions)
From baseline in the core study up to the end of treatment (EOT) in the extension study. The actual time varied for each participant and could be up to 94.8 months
MRI lesionsPercentage of Gd+ Lesions at Baseline Evolving to Persistent Black Holes (PBHs)
From baseline in the core study up to the end of treatment (EOT) in the extension study. The actual time varied for each participant and could be up to 94.8 months
MRI lesionsNumber of Participants With Treatment-emergent Adverse Events (TEAEs)
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months +
SafetyNumber of Participants With Treatment-emergent New Morphological Electrocardiogram (ECG) Abnormalities
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months +
Actual Values of 12-lead ECG Measurements up to End of Study Treatment: Heart Rate
From the start of study treatment in the extension study up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Actual Values of 12-lead ECG Measurements up to End of Study Treatment: PR, QRS, QT, QTcB, QTcF
From the start of study treatment in the extension study up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Change in Heart Rate (HR) From Baseline up to End of Study Treatment
From the start of study treatment in the extension study up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Change in PR, QRS, QT, QTcB, QTcF From Baseline up to End of Study Treatment
From the start of study treatment in the extension study up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
Absolute Values in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) Values
From extension study baseline up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
SafetyPercent Change in (FEV1) and Forced Vital Capacity (FVC) From Baseline (%)
From extension study baseline up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
SafetyNumber of Participants With Treatment-emergent Serious Adverse Events (SAEs)
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months +
SafetyNumber of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs)
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months +
RelapsesSafetyNumber of Participants With AE Leading to Premature Discontinuation of Study Treatment
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months +
SafetyNumber of Participants With Treatment-emergent Decrease From Baseline >20% and >30% in FEV1 or FVC
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months +
Number of Participants With Treatment-emergent Decrease of >20% Points in Percent Predicted FEV1 and FVC From Baseline
From the start of study treatment in the extension study up to the end of study treatment + 15 days in the extension study. The actual time varied for each participant and could be up to 71.8 months +
Number of Participants With a Decrease of >=200 mL or >=12% in FEV1 or FVC From Baseline to EOT
From extension study baseline up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
SafetyChange in FEV1 and FVC (% Predicted) From Baseline to End of Treatment (EOT)
From extension study baseline up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
SafetyChange in FEV1 and FVC (% Predicted) From Baseline to End of Study (EOS)
From extension study baseline up to the end of study in the extension study. The actual time varied for each participant and could be up to 73.2 months
SafetyAbsolute Change in Lung Diffusion Capacity as Assessed by Diffusing Capacity for the Lungs Measured Using Carbon Monoxide (DL[CO]) From Baseline
From extension study baseline up to the end of study in the extension study. The actual time varied for each participant and could be up to 73.2 months
MRI lesionsSafetyChange in DL[CO] (% Predicted) From Baseline to EOT
From extension study baseline up to the end of study treatment in the extension study. The actual time varied for each participant and could be up to 71.8 months
SafetyChange in DL[CO] (% Predicted) From Baseline to EOS
From extension study baseline up to the end of study in the extension study. The actual time varied for each participant and could be up to 73.2 months
SafetyThe main clinical and MRI-based endpoints are:
MRI lesions
Other measures (1)
NA
Who could take part
Relapsing and progressive · 18 to 65
Inclusion Criteria: 1. Signed informed consent 2. Subjects with MS having completed the double-blind treatment in the core study as scheduled 3. Compliance with teriflunomide elimination procedure 4. Women of childbearing potential (WOCBP) must have a negative pre-treatment urine pregnancy test, must agree to undertake 4-weekly urine pregnancy tests, and must have been using reliable methods of contraception. Fertile male subjects participating in the study must agree to use a condom. Exclusion Criteria: 1. Any of the following cardiovascular conditions on Day 1 pre-dose: 1. Resting heart rate (HR) \< 50 bpm; 2. Presence of second degree atrioventricular (AV) block or third degree AV block or a QTcF interval > 470 ms (females), > 450 ms (males); 2. Any of the following alerts from central laboratory at Visit 14 of the core study (EOT) which was confirmed as an alert at repeated testing or not repeated prior to FU1 of the core study: 1. Lymphocyte count: \< 0.2 x 109/L; 2. Neutrophil count \<1.0 × 109/L; 3. Platelet count \< 50 × 109/L; 4. Creatinine clearance \< 30 mL/min 3. At Visit 14 of the core study (EOT) >30% decrease from core study baseline FEV1 and/or FVC; 4. Clinically significant, persistent respiratory AEs (e.g., dyspnea) not resolved prior to first dosing in the extension study. 5. Macular edema at any time between Visit 1 (Screening) in the core study and Day 1 of the extension study. 6. Presence of the following at core study Visit 14 (EOT, Week 108), FU1, or abbreviated visit FU2, or on Day 1 of the extension study pre-dose: 1. Suspected opportunistic infection of the CNS or any other infection which, in the opinion of the investigator, contraindicates re-start of the study drug; 2. Stevens-Johnson syndrome or toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms. 7. Need for and intention to administer forbidden study treatment-concomitant therapy 8. Women who are pregnant or lactating. 9. Male subjects wishing to parent a child; 10. Treatment with any MS Disease Modifying Therapies; 11. Any other clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the subject at risk by participating in the study; 12. Subjects unlikely to comply with the extension study protocol based on investigator best judgment
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS). The AC-058B303 study is the long-term extension for the core study AC-058B301. The purpose of this long term extension of the core study AC-058B301 is to characterize the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with RMS.
Papers
Loading reviews and guidelines…
Linked trials
Extension of
OPTIMUMPhase 3 · Completed
Links found where a registry record names another trial's registry number.
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History
Started
Jul 2017
Main results due
Jan 2024
Finished
Jan 2024
Results posted
Feb 2025
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