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

Status:	Completed
Conditions:	Infectious Disease, Neurology, Neurology, Neurology
Therapuetic Areas:	Immunology / Infectious Diseases, Neurology
Healthy:	No
Age Range:	18 - 56
Updated:	4/17/2018
Start Date:	August 30, 2010
End Date:	October 10, 2016

A Dose Blinded Extension Study to the CBAF312A2201 Study to Evaluate Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally Once Daily in Patients With Relapsing-remitting Multiple Sclerosis

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

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.

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

We found this trial at

sites

Novartis Investigative Site

Greenville, South Carolina 29605

from

Greenville, SC