Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis

Study Overview
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Brief Summary
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The primary objective of the study is to assess the early efficacy of treatment with BG00012 (dimethyl fumarate) 240 mg twice daily (BID) in the brain of newly diagnosed and naive-to-treatment patients with relapsing-remitting multiple sclerosis (RRMS). The Secondary objectives are to establish the time course of the beneficial effect of BG00012 240 mg BID over 24 weeks and to evaluate the safety of BG00012.

Official Title
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Phase IV, Interventional, multicenteR, Double-blind, Randomized, Placebo-controlled Study tO Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With relapsingremitTing Multiple Sclerosis

Conditions
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Relapsing Remitting Multiple Sclerosis

Intervention / Treatment
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* Drug: dimethyl fumarate
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Participants with RRMS (McDonald criteria, 2010) who do not accept current injectable firstline DMTs. Multiple sclerosis (MS) onset within one year before enrolment ≥ 1 Gd+ lesions at a brain MRI scan performed within three months beforeenrolment. No previous disease modifying and/or immunosuppressive treatments for MS. Must have a baseline EDSS between 0.0 and 5.0, inclusive. · Women of childbearing potential (i.e. who are not post-menopausal for at least 1 year) and men must practice effective contraception (as defined by the Investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. Exclusion Criteria: Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996) Previous disease modifying and/or immunosuppressive treatments for MS, including Tcell or T-cell receptor vaccination, any therapeutic monoclonal antibody, Mitoxantrone, Cyclophosphamide Previous treatment with Fumaderm®, dimethyl fumarate or other fumarates History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment) History of severe allergic or anaphylactic reactions or known drug hypersensitivity.Known allergy/hypersensitivity to Gadolinium. History of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or other major disease that in the opinion of the Investigator would preclude participation in a clinical trial. History of or positive test result at screening for human immunodeficiency virus (HIV).Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to inclusion. An MS relapse that has occurred within the 30 days prior to inclusion (screening) AND/OR the subject has not stabilized from a previous relapse prior to inclusion. NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BG00012<br>120 mg capsule oral twice daily (BID) during the first week and 240 mg BID thereafter. | Drug: dimethyl fumarate<br>* dimethyl fumarate 120 mg capsules<br>* Other names: BG00012;|
| Placebo Comparator: Placebo<br>Placebo capsules orally twice a day. | Other: Placebo<br>* Placebo for BG00012<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of cumulative combined unique active (CUA) lesions (registered from week 4 to 24) |  | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of CUA |  | at 4, 8, 12, 16, 20 and 24 weeks | 
| Mean number of hypointense T1 lesions |  | at 24 weeks | 
| New Gd+ lesions |  | at 4, 8, 12, 16, 20 and 24 weeks | 
| New/enlarging T2 lesions |  | at 4, 8, 12, 16, 20 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapsing remitting Multiple Sclerosis