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

Biogen

Status and phase: Completed; Phase 3

Conditions: Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis

Treatments: Drug: dimethyl fumarate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01838668

2013-004533-32 (EudraCT Number)

109MS305

Details and patient eligibility

About

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.

Enrollment: 225 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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225 participants in 3 patient groups, including a placebo group

Part I Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Part I BG00012

Experimental group

Description:

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

Treatment:

Drug: dimethyl fumarate

Part II BG00012

Experimental group

Description:

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.

Treatment:

Drug: dimethyl fumarate