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Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis Followed by Extended Treatment With Open-label BAF312.
CompletedPhase 3Relapsing and progressiveNCT016651442012-003056-36

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Percentage of Participants With 3-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS)Hazard Ratio (HR) 0.790.65–0.950.0134

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

  • Siponimod

    Sphingosine 1-phosphate receptor Edg-1 agonist

Placebo or sham

  • Placebo

Results by group

Percentage of Participants With 3-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS)

Baseline, every 3 month up to the maximum of approximately 3 years

GroupValueIntervalNumber analysed
Siponimod (BAF312)26.3 Percentage of participants1096
Placebo31.7 Percentage of participants545

Siponimod (BAF312)

26.3

Placebo

31.7

p = 0.0134; Hazard Ratio (HR) 0.79 (95% CI 0.65–0.95)

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Core-BAF3121099196 (17.8%)4
Core-Placebo54683 (15.2%)4
All BAF3121517610 (40.2%)33

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

  • Percentage of Participants With 3-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS)

    Baseline, every 3 month up to the maximum of approximately 3 years

    Disability progressionBladder, bowel and sexual function

  • The delay in time to 3-month confirmed disability progression by Siponimod (BAF312) relative to placebo as measured by expanded disability status scale (EDSS)

    Disability progression

Other measures (14)

  • Percentage of Participants With 3-month Confirmed Worsening in T25W of at Least 20% From Baseline

    Baseline, every 3 months up to the maximum of approximately 3 years

    Disability progressionWalking and mobility

  • Change From Baseline in T2 Lesion Volume

    Baseline, Month 12 and Month 24

    MRI lesions

  • Percentage of Participants With 6-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS)

    Baseline, every 3 months up to the maximum of approximately 3 years

    Disability progressionBladder, bowel and sexual function

  • Annualized Relapse Rate (ARR) for Confirmed Relapses

    Up to maximum approximately 3 years

    Disability progressionRelapses

  • Percentage of Participants With First Relapse Events as Measured by Time to First Confirmed Relapse

    Up to maximum approximately 3 years

    Disability progressionRelapses

  • Percentage of Patients With Relapse (Confirmed Relapse and Any Relapse)

    Up to maximum approximately 3 years

    Disability progressionRelapses

  • Change From Baseline in MSWS-12 Converted Score

    Baseline, Month 12 and Month 24

    Walking and mobility

  • Number of T1 Gd-enhancing Lesions Per Patient Per Scan

    Baseline, Month 12 and Month 24

    MRI lesions

  • Number of New or Enlarging T2 Lesions Per Patient Per Year

    Baseline, Month 12 and Month 24

    MRI lesions

  • Percent Brain Volume Change (PBVC) Relative to Baseline

    Baseline, Month 12 and Month 24

    MRI lesionsBrain volume loss

Who could take part

Relapsing and progressive · 18 to 60

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

Papers

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Linked trials

Links found where a registry record names another trial's registry number.

Related trials

History

    1. Started

      Dec 2012

    2. Main results due

      Apr 2016

    3. Finished

      Mar 2023

    4. Results posted

      Oct 2018

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