An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

Study Overview
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Brief Summary
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This is a multicenter study conducted in 2 parts: The primary objective in Part I of this study is to determine the efficacy of BG00012 (dimethyl fumarate, DMF) on inflammatory brain magnetic resonance imaging (MRI) lesion activity (Gadolinium-enhancing lesions) when compared with placebo from 4 scans performed at Weeks 12, 16, 20, and 24 in participants with Relapsing Remitting Multiple Sclerosis (RRMS) including participants from the Asia-Pacific region. The secondary objectives in Part I of this study in this study population are to determine whether BG00012, when compared with placebo over 24 weeks, is effective in reducing the cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24; reducing the number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Week 24 compared with Baseline. The primary objective in Part II (open label) of this study is to evaluate the long-term safety profile of BG00012 in eligible participants from Part I.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of BG00012 in Subjects From the Asia-Pacific Region and Other Countries With Relapsing-Remitting Multiple Sclerosis

Conditions
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Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis

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


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Inclusion Criteria for Part I: Must have a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS). Must have a baseline Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0, inclusive. Key Inclusion Criteria for Part II: • Subjects who participated in and completed Part I per protocol. Key Exclusion Criteria: Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease. Pregnant or nursing women. NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Part I Placebo<br>Placebo orally twice a day. In Part I: participants will be randomized into one of 2 groups: BG00012, 240 mg twice daily (BID) or matching placebo BID Participants will begin the study by taking 1 capsule orally BID for first 7 days and escalate their dosing from day 8 to 2 matching capsules orally BID. | Drug: Placebo<br>* Two placebo capsules orally BID<br>|
| Experimental: Part I BG00012<br>BG00012 240 mg orally twice a day (participants will begin dosing at 120 mg BG00012 twice daily (BID) for the first 7 days and 240 mg BG00012 BID thereafter.) In Part I: participants will be randomized into one of 2 groups: BG00012, 240 mg twice daily (BID) or matching placebo BID | Drug: dimethyl fumarate<br>* Two dimethyl fumarate 120mg capsules orally BID<br>* Other names: DMF;|
| Experimental: Part II BG00012<br>Part II: All participants will receive BG00012 240 mg orally twice a day (participants will begin dosing at 120 mg (1 capsule) BG00012 twice daily (BID) for the first 7 days and 240 mg (2 capsules) BG00012 BID thereafter. | Drug: dimethyl fumarate<br>* Two dimethyl fumarate 120mg capsules orally BID<br>* Other names: DMF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of new Gadolinium-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24. |  | Part I (Week 24) | 
| Incidence of treatment-emergent adverse events and serious adverse events |  | Part II (Up to 4.5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24 |  | Part I (Week 24) | 
| Number of new or newly enlarging T2 hyperintense lesions at Week 24 compared with Baseline |  | Part I (Week 24) |