Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003056-36-HU

Enrollment

1530

Registered

2012-09-03

Start date

2012-10-31

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary progressive multiple sclerosis MedDRA version: 21.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: Siponimod 2 mg tablet Product Code: BAF312A Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Siponimod CAS Number: 1234627-85-0 Current Sponsor code: BAF312 Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Prior history of relapsing remitting MS Secondary progressive multiple sclerosis (SPMS) defined as progressive increase of disability in at least 6 months EDSS score of 3.0 to 6.5 No relapse or corticosteroid treatment within 3 months Other protocol-defined inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1530 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 Other protocol-defined exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective: To demonstrate the efficacy of Siponimod (BAF312) relative to placebo in delaying the time to 3-month confirmed disability progression in patients with secondary progressive multiple sclerosis (SPMS) as measured by expanded disability status scale (EDSS) ;Secondary Objective: First key secondary objective: To demonstrate the efficacy of Siponimod relative to placebo in delaying the time to 3-month confirmed worsening of at least 20% from Baseline in the timed 25-foot walk test (T25W) Second key secondary objective: To demonstrate the efficacy of Siponimod relative to placebo in reducing the increase in T2 lesion volume from Baseline to the end of the study For further secondary objectives please see protocol ;Primary end point(s): The delay in time to 3-month confirmed disability progression by Siponimod (BAF312) relative to placebo as measured by expanded disability status scale (EDSS) Confirmed disability is defined as an increase of score of 1 point in patients with baseline score of 3.0-5.0 and 0.5 point increase with baseline score of 5.5 to 6.5.;Timepoint(s) of evaluation of this end point: baseline, every three months	—

Measure

Time frame

Main Objective: Primary objective: To demonstrate the efficacy of Siponimod (BAF312) relative to placebo in delaying the time to 3-month confirmed disability progression in patients with secondary progressive multiple sclerosis (SPMS) as measured by expanded disability status scale (EDSS) ;Secondary Objective: First key secondary objective: To demonstrate the efficacy of Siponimod relative to placebo in delaying the time to 3-month confirmed worsening of at least 20% from Baseline in the timed 25-foot walk test (T25W) Second key secondary objective: To demonstrate the efficacy of Siponimod relative to placebo in reducing the increase in T2 lesion volume from Baseline to the end of the study For further secondary objectives please see protocol ;Primary end point(s): The delay in time to 3-month confirmed disability progression by Siponimod (BAF312) relative to placebo as measured by expanded disability status scale (EDSS) Confirmed disability is defined as an increase of score of 1 point in patients with baseline score of 3.0-5.0 and 0.5 point increase with baseline score of 5.5 to 6.5.;Timepoint(s) of evaluation of this end point: baseline, every three months

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Secondary

Measure	Time frame
Secondary end point(s): The first key secondary endpoint is the delay in time to 3-month confirmed worsening of at least 20% from Baseline in the timed 25-foot walk test (T25W) by Siponimod (BAF312) compared to placebo. The second key secondary endpoint is the efficacy of Siponimod (BAF312) relative to placebo in reducing the increase in T2 lesion volume from Baseline to the end of the study.;Timepoint(s) of evaluation of this end point: 1.) baseline, every three months 2.) baseline, every year	—

Measure

Time frame

Secondary end point(s): The first key secondary endpoint is the delay in time to 3-month confirmed worsening of at least 20% from Baseline in the timed 25-foot walk test (T25W) by Siponimod (BAF312) compared to placebo. The second key secondary endpoint is the efficacy of Siponimod (BAF312) relative to placebo in reducing the increase in T2 lesion volume from Baseline to the end of the study.;Timepoint(s) of evaluation of this end point: 1.) baseline, every three months 2.) baseline, every year

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Countries

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States

Contacts

Public ContactPublic Information Desk

Novartis Hungary Kft. Pharma

infoph.hungary@novartis.com+361457-6500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026