Efficacy and Safety of BG00012 in MS

Study Overview
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Brief Summary
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Determine the efficacy, safety, and tolerability of BG00012 in MS patients.

Detailed Description
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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.

Official Title
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Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: BG00012


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: BG00012|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24. |  | Weeks 12, 16, 20, and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary endpoints will include measuring the changes in MRIs from baseline until Week 24, changes in other MS measurements q12 weeks, and the annualized relapse rate and proportion of changes at Weeks 24 and 48. |  | Weeks 24 and 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, MRI