Efficacy and Safety of BG00012 in MS

The study will be divided into two parts: Part 1 will be a 24-week, blinded, placebo-controlled treatment phase followed by Part 2, a 24-week blinded, safety extension phase in which all subjects will receive BG00012.

Inclusion criteria

• Must be 18 to 55 years old, inclusive, at the time of informed consent.
• Must have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 (McDonald et al, 2001; Appendix 2).
• Must have a baseline EDSS between 0.0 and 5.0, inclusive.
• Must have experienced at least one relapse within the 12 months prior to randomization, with a prior cranial MRI demonstrating lesion(s) consistent with MS OR show evidence of Gd-enhancing lesions of the brain on an MRI performed within the 6 weeks.
• Male and female subjects must be willing to take appropriate measures to prevent pregnancy.

Exclusion criteria

• Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 1996 [Appendix 3]).
• History of malignancy.
• History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
• History of abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurologic (other than MS), and/or other major disease.
• History of human immunodeficiency virus (HIV).
• History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization.
• An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization.
• Body weight >100 kg.
• Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
• Any of the following abnormal blood tests at screening.
• Any previous treatment with FUMADERM®, FAG-201, or BG00012.
• A medication history that precludes entry into the study.
• Female subjects who are currently pregnant or breast-feeding.