An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
This is a multicenter study conducted in 2 parts:

 The primary objective in Part I of this study is to determine the efficacy of BG00012
 (dimethyl fumarate, DMF) on inflammatory brain magnetic resonance imaging (MRI) lesion
 activity (Gadolinium-enhancing lesions) when compared with placebo from 4 scans performed at
 Weeks 12, 16, 20, and 24 in participants with Relapsing Remitting Multiple Sclerosis (RRMS)
 including participants from the Asia-Pacific region.

 The secondary objectives in Part I of this study in this study population are to determine
 whether BG00012, when compared with placebo over 24 weeks, is effective in reducing the
 cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24; reducing the
 number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Week 24
 compared with Baseline.

 The primary objective in Part II (open label) of this study is to evaluate the long-term
 safety profile of BG00012 in eligible participants from Part I.
Key Inclusion Criteria:

 -  Inclusion Criteria for Part I:

 -  Must have a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS).

 -  Must have a baseline Expanded Disability Status Scale (EDSS) score between 0.0
 and 5.0, inclusive.

 Key Inclusion Criteria for Part II:

 • Subjects who participated in and completed Part I per protocol.

 Key Exclusion Criteria:

 -  Other chronic disease of the immune system, malignancies, acute urologic, pulmonary,
 gastrointestinal disease.

 -  Pregnant or nursing women.

 NOTE: Other protocol-defined inclusion/exclusion criteria may apply.