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

Phase 3

Completed

• Conditions: Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis
• Interventions: Drug: Placebo; Drug: dimethyl fumarate

• Registration Number: NCT01838668
• Lead Sponsor: Biogen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-28
• Study First Submitted: 2013-04-20
• Study First Submitted QC: 2013-04-20
• Study First Posted: 2013-04-24
• Primary Completion: 2015-06-16
• Study Completion: 2018-09-04
• Status Verified: 2018-10
• Last Update Submitted: 2018-11-19
• Last Update Posted: 2018-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part I Placebo	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.
Part I BG00012	dimethyl fumarate	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
Part II BG00012	dimethyl fumarate	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (54)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Miedzyleski Szpital Specjalistyczny; 🇵🇱 Warszawa, Poland

Nzoz Novo-Med; 🇵🇱 Katowice, Poland

Neuro-Care Gabriela Klodowska; 🇵🇱 Katowice, Poland

National Cancer Center; 🇰🇷 Gyeonggi-do, Korea, Republic of

Irino Clinic, Inc.; 🇯🇵 Osaka-shi, Japan

Kyoto University Hospital; 🇯🇵 Kyoto-shi, Japan

Kindai University Hospital; 🇯🇵 Osakasayama-shi, Japan

Fakultni poliklinika VFN; 🇨🇿 Praha 2, Czechia

Nemocnice Jihlava; 🇨🇿 Jihlava, Czechia

Fakultni nemocnice Olomouc; 🇨🇿 Olomouc, Czechia

NHO Asahikawa Medical Center; 🇯🇵 Asahikawa-shi, Japan

Neurospol, s.r.o.; 🇨🇿 Havirov, Czechia

Privatni ordinace - neurologie; 🇨🇿 Hradec Kralove, Czechia

Kyushu University Hospital; 🇯🇵 Fukuoka-shi, Japan

M.A. - LEK A.M.Maciejowscy SC.; 🇵🇱 Katowice, Poland

MCD Medical; 🇵🇱 Krakow, Poland

Centrum Neurologii K. Selmaj; 🇵🇱 Lodz, Poland

Niigata University Medical & Dental Hospital; 🇯🇵 Niigata-shi, Japan

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Keio University Hospital; 🇯🇵 Shinjuku-ku, Japan

Juntendo University Hospital; 🇯🇵 Bunkyo-ku, Japan

National Defense Medical College Hospital; 🇯🇵 Tokorozawa-shi, Japan

Neurologiczny NZOZ Centrum Leczenia SM; 🇵🇱 Plewiska, Poland

Tsukuba University Hospital; 🇯🇵 Tsukuba-shi, Japan

Copernicus Podmiot Leczniczy Sp. z o.o.; 🇵🇱 Gdansk, Poland

Department of Neurosurgery, Tokyo Women's Medical University; 🇯🇵 Shinjuku-ku, Japan

Tohoku University Hospital; 🇯🇵 Sendai-shi, Japan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Saitama Medical Center; 🇯🇵 Kawagoe-shi, Japan

National Center Hospital, NCNP; 🇯🇵 Kodaira-shi, Japan

NHO Hokkaido Medical Center; 🇯🇵 Sapporo-shi, Japan

CEReS Sapporo Neurology Clinic; 🇯🇵 Sapporo-shi, Japan

Ehime University Hospital; 🇯🇵 Toon-shi, Japan

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Fakultni nemocnice u sv. Anny v Brne; 🇨🇿 Brno, Czechia

Fakultni nemocnice Hradec Kralove; 🇨🇿 Hradec Kralove, Czechia

Fakultni nemocnice v Motole; 🇨🇿 Praha 5, Czechia

Krajska zdravotni, a.s. - Nemocnice Teplice, o.z.; 🇨🇿 Teplice, Czechia

Chiba University Hospital; 🇯🇵 Chiba-shi, Japan

Kanazawa Medical University Hospital; 🇯🇵 Kahoku-gun, Japan

Kobe University Hospital; 🇯🇵 Kobe-shi, Japan

NHO Utano Hospital; 🇯🇵 Kyoto-shi, Japan

Yamaguchi University Hospital; 🇯🇵 Ube-shi, Japan

Iwate Medical University Hospital; 🇯🇵 Morioka-shi, Japan

Osaka University Hospital; 🇯🇵 Suita-shi, Japan

Tokyotohokeniryokosya Ebara Hospital; 🇯🇵 Ota-ku, Japan

Yeungnam University Hospital; 🇰🇷 Daegu, Korea, Republic of

Tokyo Womens Medical University Yachiyo Medical Center; 🇯🇵 Yachiyo-shi, Japan

Yokohama City University Hospital; 🇯🇵 Yokohama-shi, Japan

NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.; 🇵🇱 Poznan, Poland

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan