Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).

An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis

The primary objective of the study is to evaluate the effect of BG00012 on lymphocyte subset counts during the first year of treatment in subjects with relapsing-remitting multiple sclerosis (RRMS). A secondary objective is to evaluate the pharmacodynamic effect on absolute lymphocyte counts (ALCs) and immunoglobulins (Igs) during the first year of treatment.

Key Inclusion Criteria:

• Subjects of childbearing potential (including female subjects who are post-menopausal for less than 1 year) must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
• Must have a confirmed diagnosis of RRMS according to the revised McDonald criteria (2010) [Polman 2011]

Key Exclusion Criteria:

• History of or positive test result at Screening for:
• human immunodeficiency virus
• hepatitis C virus antibody
• hepatitis B infection
• Drug or alcohol abuse within 1 year prior to Screening.
• Prior treatment with any of the following:
• cladribine
• mitoxantrone
• total lymphoid irradiation
• alemtuzumab
• T-cell or T-cell receptor vaccination
• any therapeutic monoclonal antibody, with the exception of natalizumab or daclizumab
• Treatment with any of the following medications or procedures within 6 months prior to Baseline (Day 1):
• DMF (given as Fumaderm®) or BG00012; enrollment will be limited to no more than 40 subjects (out of 200) with prior DMF exposure
• cyclosporine
• azathioprine
• methotrexate
• mycophenolate mofetil
• intravenous (IV) Ig
• plasmapheresis or cytapheresis

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply