Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple Sclerosis

Novartis

Status and phase: Completed; Phase 2

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: BAF312

Study type: Interventional

Funder types: Industry

Identifiers

NCT01185821

CBAF312A2201E1

2009-014392-51 (EudraCT Number)

Details and patient eligibility

About

This study consisted of a two year dose blinded phase during which patients received one of five doses of siponimod (10, 2, 1.25, 0.5 or 0.25mg) following which patients were switched to open label treatment with siponimod 2mg for approximately a further 3 years. It will provide data on long term safety, tolerability and efficacy of siponimod in the RRMS patient population

Full description

This study was prematurely discontinued after approximately 5 years. The decision to prematurely discontinue the study was not taken due to safety-related concerns, rather due to a decision to focus the development of siponimod in MS on a different population.

Enrollment: 185 patients

Sex: All

Ages: 18 to 56 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients completed the core study BAF312A2201
• Written informed consent provided before any assessment of the extension study
• Female patients at risk of becoming pregnant must have a negative pregnancy test and use simultaneously two forms of effective contraception

Exclusion criteria

• Newly diagnosed systemic disease other than MS (which may require immunosuppressive treatment)
• Malignancies, diabetes, significant cardiovascular and pulmonary diseases and conditions
• Active infections

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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185 participants in 5 patient groups

BAF312 10 mg/2 mg

Experimental group

Description:

10 mg dose in Double Blind Phase and 2 mg in Open Label Phase

Treatment:

Drug: BAF312

BAF312 2 mg/2 mg

Experimental group

Description:

2 mg dose in Double Blind Phase and 2 mg in Open Label Phase

Treatment:

Drug: BAF312

BAF312 1.25 mg/2 mg

Experimental group

Description:

1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase

Treatment:

Drug: BAF312

BAF312 .5 mg/2 mg

Experimental group

Description:

.5 mg dose in Double Blind Phase and 2 mg in Open Label Phase

Treatment:

Drug: BAF312

BAF312 .25 mg/2 mg

Experimental group

Description:

.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase

Treatment:

Drug: BAF312