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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Biogen
- Enrollment
- 225
- Locations
- 54
- Primary Endpoint
- Total number of new Gadolinium-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Arms & Interventions
Part I Placebo
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.
Intervention: Placebo (Drug)
Part I BG00012
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
Intervention: dimethyl fumarate (Drug)
Part II BG00012
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.
Intervention: dimethyl fumarate (Drug)
Outcomes
Primary Outcomes
Total number of new Gadolinium-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24.
Time Frame: Part I (Week 24)
Incidence of treatment-emergent adverse events and serious adverse events
Time Frame: Part II (Up to 4.5 years)
Secondary Outcomes
- 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))