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

NCT01838668 | Completed Phase 3

• 2 other identifiers: 109MS3052013-004533-32
• Study Type: interventional
• Target: 225
• Locations: 5 countries
• Sites: 54

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.

Conditions

Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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)

Study Arms (3)

Part I Placebo

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.

Drug: Placebo

Part I BG00012

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

Drug: dimethyl fumarate

Part II BG00012

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.

Drug: dimethyl fumarate

Interventions

Placebo DRUG

Two placebo capsules orally BID

Part I Placebo

dimethyl fumarate DRUG

Two dimethyl fumarate 120mg capsules orally BID

Also known as: BG00012, Tecfidera, DMF

Part I BG00012; Part II BG00012

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Subjects who participated in and completed Part I per protocol.

You may not qualify if:

• Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
• Pregnant or nursing women.

Sponsors & Collaborators

• Biogen: lead

Study Sites (54)

Fakultni nemocnice u sv. Anny v Brne

Brno, 656 91, Czechia

Location

Neurospol, s.r.o.

Havířov, 736 00, Czechia

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Privatni ordinace - neurologie

Hradec Králové, 50003, Czechia

Location

Nemocnice Jihlava

Jihlava, 58633, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

Fakultni poliklinika VFN

Prague, 128 08, Czechia

Location

Fakultni nemocnice v Motole

Prague, 150 06, Czechia

Location

Krajska zdravotni, a.s. - Nemocnice Teplice, o.z.

Teplice, 41529, Czechia

Location

NHO Asahikawa Medical Center

Asahikawa-shi, 070-8644, Japan

Location

Juntendo University Hospital

Bunkyō City, 113-8431, Japan

Location

Chiba University Hospital

Chiba, 260-8677, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Kanazawa Medical University Hospital

Kahoku-gun, 920-0293, Japan

Location

Saitama Medical Center

Kawagoe-shi, 350-8550, Japan

Location

Kobe University Hospital

Kobe, 650-0017, Japan

Location

National Center Hospital, NCNP

Kodaira-shi, 187-8551, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

NHO Utano Hospital

Kyoto, 616-8255, Japan

Location

Iwate Medical University Hospital

Morioka, 020-8505, Japan

Location

Niigata University Medical & Dental Hospital

Niigata, 951-8520, Japan

Location

Irino Clinic, Inc.

Osaka, 556-0016, Japan

Location

Kindai University Hospital

Osakasayama-shi, 589-8511, Japan

Location

Tokyotohokeniryokosya Ebara Hospital

Ōta-ku, 145-0065, Japan

Location

NHO Hokkaido Medical Center

Sapporo, 063-0005, Japan

Location

CEReS Sapporo Neurology Clinic

Sapporo, 065-0021, Japan

Location

Tohoku University Hospital

Sendai, 980-8574, Japan

Location

Keio University Hospital

Shinjuku-ku, 160-8582, Japan

Location

Department of Neurosurgery, Tokyo Women's Medical University

Shinjuku-ku, 162-8666, Japan

Location

Osaka University Hospital

Suita-shi, 565-0871, Japan

Location

National Defense Medical College Hospital

Tokorozawa-shi, 359-8513, Japan

Location

Ehime University Hospital

Toon-shi, 791-0295, Japan

Location

Tsukuba University Hospital

Tsukuba, 305-8576, Japan

Location

Yamaguchi University Hospital

Ube-shi, 755-8505, Japan

Location

Tokyo Womens Medical University Yachiyo Medical Center

Yachiyo-shi, 276-8524, Japan

Location

Yokohama City University Hospital

Yokohama, 236-0004, Japan

Location

Copernicus Podmiot Leczniczy Sp. z o.o.

Gdansk, 80-803, Poland

Location

M.A. - LEK A.M.Maciejowscy SC.

Katowice, 40-571, Poland

Location

Nzoz Novo-Med

Katowice, 40-650, Poland

Location

Neuro-Care Gabriela Klodowska

Katowice, 40-749, Poland

Location

MCD Medical

Krakow, 31-637, Poland

Location

Centrum Neurologii K. Selmaj

Lodz, 90-324, Poland

Location

Neurologiczny NZOZ Centrum Leczenia SM

Plewiska, 62-064, Poland

Location

NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.

Poznan, 61-853, Poland

Location

Miedzyleski Szpital Specjalistyczny

Warsaw, 04-749, Poland

Location

Yeungnam University Hospital

Daegu, 42415, South Korea

Location

National Cancer Center

Gyeonggi-do, 10408, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Related Publications (3)

• Kondo T, Kawachi I, Onizuka Y, Hiramatsu K, Hase M, Yun J, Matta A, Torii S. Efficacy of dimethyl fumarate in Japanese multiple sclerosis patients: interim analysis of randomized, double-blind APEX study and its open-label extension. Mult Scler J Exp Transl Clin. 2019 Jul 31;5(3):2055217319864974. doi: 10.1177/2055217319864974. eCollection 2019 Jul-Sep.

  PMID: 31391949 DERIVED

• Saida T, Yamamura T, Kondo T, Yun J, Yang M, Li J, Mahadavan L, Zhu B, Sheikh SI. A randomized placebo-controlled trial of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis from East Asia and other countries. BMC Neurol. 2019 Jan 7;19(1):5. doi: 10.1186/s12883-018-1220-3.

  PMID: 30616596 DERIVED

• Ochi H, Niino M, Onizuka Y, Hiramatsu K, Hase M, Yun J, Matta A, Torii S. 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. Adv Ther. 2018 Oct;35(10):1598-1611. doi: 10.1007/s12325-018-0788-8. Epub 2018 Sep 11.

  PMID: 30206820 DERIVED

Related Links

• EudraCT Tabulated Result

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2013
• First Posted: April 24, 2013
• Study Start: March 28, 2013
• Primary Completion: June 16, 2015
• Study Completion: September 4, 2018
• Last Updated: November 20, 2018

Record last verified: 2018-10

Locations

KR (6); TW (3); PL (9); JP (27); CZ (9)