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

Conditions

Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis

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.

Takayuki Kondo, Izumi Kawachi, Y. Onizuka, Katsutoshi Hiramatsu, Masakazu Hase et al. (8 authors)

Multiple Sclerosis Journal - Experimental Translational and Clinical2019-07-015 citations

10.1177/2055217319864974

A randomized placebo-controlled trial of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis from East Asia and other countries.

Saida T, Yamamura T, Kondo T, Yun J, Yang M, Li J, Mahadavan L, Zhu B, Sheikh SI.

2019-01-0722 citations

10.1186/s12883-018-1220-3

72-Week Safety and Tolerability of Dimethyl Fumarate in Japanese Patients with Relapsing-remitting Multiple Sclerosis: Analysis of the Randomised, Double Blind, Placebo-Controlled, Phase III APEX Study and its Open-Label Extension.

Ochi H, Niino M, Onizuka Y, Hiramatsu K, Hase M, Yun J, Matta A, Torii S.

2018-09-1120 citations

10.1007/s12325-018-0788-8

Safety and Efficacy of Delayed-release Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis from Asia-Pacific and Other Countries: Interim Analysis of the APEX Extension Study (P5.363)

Takahiko Saida, Takashi Yamamura, Takayuki Kondo, Jang Yun, Jie Li et al. (8 authors)

Neurology2017-04-181 citations

10.1212/wnl.88.16_supplement.p5.363

Interventions

DRUGPlacebo

Two placebo capsules orally BID

DRUGdimethyl fumarate

Two dimethyl fumarate 120mg capsules orally BID

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

No

Inclusion 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/

Design outcomes

Primary

Measure	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

Measure	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)

Countries

Czechia, Japan, Poland, South Korea, Taiwan

Outcome results

None listed