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EUCTR2012-003056-36
Alternative entry with additional local information: NCT01665144

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

Data source: WHO (Imported from 29.11.2020)
Changed: 29.11.2020
Disease category:

Health conditions (Data source: WHO)

Secondary progressive multiple sclerosis
MedDRA version: 21.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Interventions (Data source: WHO)


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

Inclusion/Exclusion Criteria (Data source: WHO)

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

Further information on the trial in WHO primary registry

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003056-36

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2012-003056-36-LT

Further information on trial

Date trial registered

29.10.2012

Incorporation of the first participant

21.12.2012

Recruitment status

Authorised-recruitment may be ongoing or finished

Academic title (Data source: WHO)

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

Type of trial (Data source: WHO)

Interventional clinical trial of medicinal product

Design of the trial (Data source: WHO)

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 (Data source: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no

Primary end point (Data source: WHO)

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)

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

Secundary end point (Data source: WHO)

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.;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

Contact information (Data source: WHO)

Novartis Pharma Services AG

Trial results (Data source: WHO)

Results summary

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

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Countries (Data source: WHO)

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Czechia, 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

Contact for further information on the trial

Contact for general information (Data source: WHO)

Clinical Trial Information Desk
Upes str. 19
Novartis Pharma Services Inc. Representative Office
+3705269 1650
DRA.Lithuania@novartis.com

Contact for scientific information (Data source: WHO)

Clinical Trial Information Desk
Upes str. 19
Novartis Pharma Services Inc. Representative Office
+3705269 1650
DRA.Lithuania@novartis.com

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Novartis Pharma Services AG

Further trial identification numbers

Secondary ID (Data source: WHO)

CBAF312A2304
NCT01665144
2012-003056-36-HU