Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)

Key Inclusion Criteria:

• Informed consent and assent as appropriate
• Must have a body weight of ≥30 kg
• Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric multiple sclerosis (MS)
• Must be ambulatory with a converted Krutzke Baseline Expanded Disability Status Scale (EDSS) score between 0 and 5.0, inclusive

Key Exclusion Criteria:

• Primary progressive, secondary progressive, or progressive relapsing MS.
• History of disorders mimicking MS, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis), systemic autoimmune disorders (e.g., Sjögren disease and lupus erythematosus), metabolic disorders (e.g., dystrophies), and infectious disorders.
• History of severe allergic or anaphylactic reactions, or known drug hypersensitivity to dimethyl fumarate (DMF) or fumaric acid esters.
• Prior treatment with any of the following medications within 12 months prior to randomization: mitoxantrone, cyclophosphamide, rituximab.
• Prior treatment with any of the following medications or procedures within 6 months prior to randomization: fingolimod, teriflunomide, natalizumab, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, laquinimod, intravenous (IV) immunoglobulin, plasmapheresis or cytapheresis.

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