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

INTERVENTION: 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 name: BAF312 hemifumarate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: Siponimod 1 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 name: BAF312 hemifumarate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: Siponimod 0.5 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 name: BAF312 hemifumarate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: Siponimod 0.25 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 name: BAF312 hemifumarate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Secondary progressive multiple sclerosis ; MedDRA version: 20.0 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 ‐ Nervous system disorders Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: 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); ; 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. 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 ; ; For further secondary objectives please see protocol; ; Extension part: To evaluate the long‐term safety and tolerability of BAF312; ; ; Timepoint(s) of evaluation of this end point: baseline, every three months ; ; 2.) baseline, every year 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 SECONDARY OUTCOME: 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. Timepoint(s) of evaluation of this end point: 1.) baseline, every three months 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