Overview

This trial is active, not recruiting.

Conditions relapsing-remitting multiple sclerosis, multiple sclerosis
Treatments placebo, dimethyl fumarate
Phase phase 3
Sponsor Biogen
Start date March 2013
End date June 2015
Trial size 225 participants
Trial identifier NCT01838668, 109MS305, 2013-004533-32

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
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.
placebo
Two placebo capsules orally BID
(Experimental)
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
dimethyl fumarate BG00012
Two dimethyl fumarate 120mg capsules orally BID
(Experimental)
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.
dimethyl fumarate BG00012
Two dimethyl fumarate 120mg capsules orally BID

Primary Outcomes

Measure
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

Measure
Cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24
time frame: Part I (Week 24)
Number of new or newly enlarging T2 hyperintense lesions at Week 24 compared with Baseline
time frame: Part I (Week 24)

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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.

Additional Information

Official title 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 information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Biogen.