Phase 3
Completed N=1,651
Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)
Source: ClinicalTrials.gov NCT01665144 ↗Enrolled (actual)
1,651
Serious AEs
28.1%
Results posted
Oct 2018
Primary outcomePrimary: Percentage of Participants With 3-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS) — 26.3; 31.7 Percentage of participants — p=0.0134
◆ Published Evidence
Established
51citations · ~13 / year
Blood Neurofilament Light in Progressive Multiple Sclerosis: Post Hoc Analysis of 2 Randomized Controlled Trials.
Summary
Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (Core Part) followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability and efficacy (Extension Part).
Linked Publications (5)
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Blood Neurofilament Light in Progressive Multiple Sclerosis: Post Hoc Analysis of 2 Randomized Controlled Trials.
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Long-term efficacy and safety of siponimod in patients with secondary progressive multiple sclerosis: Analysis of EXPAND core and extension data up to >5 years.
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Effect of siponimod on magnetic resonance imaging measures of neurodegeneration and myelination in secondary progressive multiple sclerosis: Gray matter atrophy and magnetization transfer ratio analyses from the EXPAND phase 3 trial.
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Siponimod vs placebo in active secondary progressive multiple sclerosis: a post hoc analysis from the phase 3 EXPAND study.
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Cost Effectiveness and Budget Impact of Siponimod Compared to Interferon Beta-1a in the Treatment of Adult Patients with Secondary Progressive Multiple Sclerosis with Active Disease in Switzerland.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With 3-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS) |
26.3; 31.7 | 0.0134 sig |
| SECONDARY Percentage of Participants With 3-month Confirmed Worsening in T25W of at Least 20% From Baseline |
39.7; 41.4 | 0.4398 |
| SECONDARY Change From Baseline in T2 Lesion Volume |
204.9; 818.0; 162.9; 940.4; 183.9; 879.2 | <0.0001 sig |
| SECONDARY Percentage of Participants With 6-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS) |
19.9; 25.5 | 0.0058 sig |
| SECONDARY Annualized Relapse Rate (ARR) for Confirmed Relapses |
0.071; 0.160 | <0.0001 sig |
| SECONDARY Percentage of Participants With First Relapse Events as Measured by Time to First Confirmed Relapse |
10.7; 18.9 | <0.0001 sig |
| SECONDARY Percentage of Patients With Relapse (Confirmed Relapse and Any Relapse) |
16.7; 26.0; 10.3; 18.7 | — |
| SECONDARY Change From Baseline in MSWS-12 Converted Score |
1.53; 3.36; 4.16; 5.38 | 0.0764 |
| SECONDARY Number of T1 Gd-enhancing Lesions Per Patient Per Scan |
0.080; 0.640; 0.074; 0.418 | <0.0001 sig |
| SECONDARY Number of New or Enlarging T2 Lesions Per Patient Per Year |
1.003; 3.776; 0.489; 3.437 | <0.0001 sig |
| SECONDARY Percent Brain Volume Change (PBVC) Relative to Baseline |
-0.283; -0.458; -0.711; -0.839 | <0.0001 sig |
| SECONDARY Number of Participants With 3-month CDP Events as Measured by EDSS in the Subgroup of SPMS Patients With/Without Superimposed Relapses |
190; 101; 98; 72; 237; 122 | — |
| SECONDARY Number of Participants With 3-month CDP Events as Measured by EDSS in the Subgroup of Rapidly and Not Rapidly Evolving Patients |
82; 60; 206; 113 | — |
| SECONDARY Number of Participants With 3-month CDP Events as Measured by EDSS in the Subgroup of Patients With and Without Moderate/Severe Disease Course |
232; 141; 56; 32 | — |
Eligibility Criteria
Inclusion Criteria
- Prior history of relapsing remitting MS
- SPMS defined as progressive increase of disability over at least 6 months
- EDSS score of 3.0 to 6.5
- No relapse of corticosteroid treatment within 3 months
Exclusion Criteria
- Women of child bearing potential must use reliable forms of contraception.
- Diagnosis of Macular edema during screening period
- Any medically unstable condition determined by investigator.
- Unable to undergo MRI scans
- Hypersensitivity to any study drugs or drugs of similar class
Data sourced from ClinicalTrials.gov (NCT01665144) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.