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

• Register: EUCTR
• Last refreshed on: 26 October 2020
• Main ID: EUCTR2012-003056-36-AT
• Date of registration: 08/10/2012
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: 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
• Scientific title: 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 - EXPAND
• Date of first enrolment: 28/11/2012
• Target sample size: 1530
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003056-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

• Name: Drug Regulatory Affairs
• Affiliation: Novartis Pharma GmbH

• Name: Drug Regulatory Affairs
• Affiliation: Novartis Pharma GmbH

Key inclusion & exclusion 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:
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

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

Primary Outcome(s)

Secondary Objective: First key secondary objective (Core part): 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 (Core Part): 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, tolerability and efficacy of BAF312

Timepoint(s) of evaluation of this end point: baseline, every three months up the maximum of 3 years

Main Objective: Primary objective (Core part): 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): Core part: 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 Outcome(s)

Timepoint(s) of evaluation of this end point: 1.) baseline, every three months up to the maximum of 3 years
2.) baseline, every year up to the maximum of 3 years

Secondary end point(s): Core part: 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

For further secondary endpoints please see protocol.

Secondary ID(s)

CBAF312A2304

NCT01665144

2012-003056-36-HU

Source(s) of Monetary Support

Novartis Pharma AG

Ethics review

Status: Approved
Approval date: 06/11/2012
Contact: