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

Primary Purpose

Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
dimethyl fumarate
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fakultni nemocnice u sv. Anny v Brne
  • Neurospol, s.r.o.
  • Fakultni nemocnice Hradec Kralove
  • Privatni ordinace - neurologie
  • Nemocnice Jihlava
  • Fakultni nemocnice Olomouc
  • Fakultni poliklinika VFN
  • Fakultni nemocnice v Motole
  • Krajska zdravotni, a.s. - Nemocnice Teplice, o.z.
  • NHO Asahikawa Medical Center
  • Juntendo University Hospital
  • Chiba University Hospital
  • Kyushu University Hospital
  • Kanazawa Medical University Hospital
  • Saitama Medical Center
  • Kobe University Hospital
  • National Center Hospital, NCNP
  • Kyoto University Hospital
  • NHO Utano Hospital
  • Iwate Medical University Hospital
  • Niigata University Medical & Dental Hospital
  • Irino Clinic, Inc.
  • Kindai University Hospital
  • Tokyotohokeniryokosya Ebara Hospital
  • NHO Hokkaido Medical Center
  • CEReS Sapporo Neurology Clinic
  • Tohoku University Hospital
  • Keio University Hospital
  • Department of Neurosurgery, Tokyo Women's Medical University
  • Osaka University Hospital
  • National Defense Medical College Hospital
  • Ehime University Hospital
  • Tsukuba University Hospital
  • Yamaguchi University Hospital
  • Tokyo Womens Medical University Yachiyo Medical Center
  • Yokohama City University Hospital
  • Yeungnam University Hospital
  • National Cancer Center
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Copernicus Podmiot Leczniczy Sp. z o.o.
  • M.A. - LEK A.M.Maciejowscy SC.
  • Nzoz Novo-Med
  • Neuro-Care Gabriela Klodowska
  • MCD Medical
  • Centrum Neurologii K. Selmaj
  • Neurologiczny NZOZ Centrum Leczenia SM
  • NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.
  • Miedzyleski Szpital Specjalistyczny
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Part I Placebo

Part I BG00012

Part II BG00012

Arm 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.

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: 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.

Outcomes

Primary Outcome Measures

Total number of new Gadolinium-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24.
Incidence of treatment-emergent adverse events and serious adverse events

Secondary Outcome Measures

Cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24
Number of new or newly enlarging T2 hyperintense lesions at Week 24 compared with Baseline

Full Information

First Posted
April 20, 2013
Last Updated
November 19, 2018
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT01838668
Brief Title
An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 28, 2013 (Actual)
Primary Completion Date
June 16, 2015 (Actual)
Study Completion Date
September 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part I Placebo
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Part I BG00012
Arm Type
Experimental
Arm 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
Arm Title
Part II BG00012
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two placebo capsules orally BID
Intervention Type
Drug
Intervention Name(s)
dimethyl fumarate
Other Intervention Name(s)
BG00012, Tecfidera, DMF
Intervention Description
Two dimethyl fumarate 120mg capsules orally BID
Primary Outcome Measure Information:
Title
Total number of new Gadolinium-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24.
Time Frame
Part I (Week 24)
Title
Incidence of treatment-emergent adverse events and serious adverse events
Time Frame
Part II (Up to 4.5 years)
Secondary Outcome Measure Information:
Title
Cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24
Time Frame
Part I (Week 24)
Title
Number of new or newly enlarging T2 hyperintense lesions at Week 24 compared with Baseline
Time Frame
Part I (Week 24)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Fakultni nemocnice u sv. Anny v Brne
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Neurospol, s.r.o.
City
Havirov
ZIP/Postal Code
736 00
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Privatni ordinace - neurologie
City
Hradec Kralove
ZIP/Postal Code
50003
Country
Czechia
Facility Name
Nemocnice Jihlava
City
Jihlava
ZIP/Postal Code
58633
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Fakultni poliklinika VFN
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Krajska zdravotni, a.s. - Nemocnice Teplice, o.z.
City
Teplice
ZIP/Postal Code
41529
Country
Czechia
Facility Name
NHO Asahikawa Medical Center
City
Asahikawa-shi
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyo-ku
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Chiba University Hospital
City
Chiba-shi
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka-shi
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Kanazawa Medical University Hospital
City
Kahoku-gun
ZIP/Postal Code
920-0293
Country
Japan
Facility Name
Saitama Medical Center
City
Kawagoe-shi
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe-shi
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
National Center Hospital, NCNP
City
Kodaira-shi
ZIP/Postal Code
187-8551
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto-shi
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
NHO Utano Hospital
City
Kyoto-shi
ZIP/Postal Code
616-8255
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka-shi
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata-shi
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Irino Clinic, Inc.
City
Osaka-shi
ZIP/Postal Code
556-0016
Country
Japan
Facility Name
Kindai University Hospital
City
Osakasayama-shi
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Tokyotohokeniryokosya Ebara Hospital
City
Ota-ku
ZIP/Postal Code
145-0065
Country
Japan
Facility Name
NHO Hokkaido Medical Center
City
Sapporo-shi
ZIP/Postal Code
063-0005
Country
Japan
Facility Name
CEReS Sapporo Neurology Clinic
City
Sapporo-shi
ZIP/Postal Code
065-0021
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Department of Neurosurgery, Tokyo Women's Medical University
City
Shinjuku-ku
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Osaka University Hospital
City
Suita-shi
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
National Defense Medical College Hospital
City
Tokorozawa-shi
ZIP/Postal Code
359-8513
Country
Japan
Facility Name
Ehime University Hospital
City
Toon-shi
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Tsukuba University Hospital
City
Tsukuba-shi
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
Yamaguchi University Hospital
City
Ube-shi
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
Tokyo Womens Medical University Yachiyo Medical Center
City
Yachiyo-shi
ZIP/Postal Code
276-8524
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama-shi
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Copernicus Podmiot Leczniczy Sp. z o.o.
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
M.A. - LEK A.M.Maciejowscy SC.
City
Katowice
ZIP/Postal Code
40-571
Country
Poland
Facility Name
Nzoz Novo-Med
City
Katowice
ZIP/Postal Code
40-650
Country
Poland
Facility Name
Neuro-Care Gabriela Klodowska
City
Katowice
ZIP/Postal Code
40-749
Country
Poland
Facility Name
MCD Medical
City
Krakow
ZIP/Postal Code
31-637
Country
Poland
Facility Name
Centrum Neurologii K. Selmaj
City
Lodz
ZIP/Postal Code
90-324
Country
Poland
Facility Name
Neurologiczny NZOZ Centrum Leczenia SM
City
Plewiska
ZIP/Postal Code
62-064
Country
Poland
Facility Name
NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.
City
Poznan
ZIP/Postal Code
61-853
Country
Poland
Facility Name
Miedzyleski Szpital Specjalistyczny
City
Warszawa
ZIP/Postal Code
04-749
Country
Poland
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
31391949
Citation
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.
Results Reference
derived
PubMed Identifier
30616596
Citation
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.
Results Reference
derived
PubMed Identifier
30206820
Citation
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.
Results Reference
derived
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004533-32/results
Description
EudraCT Tabulated Result

Learn more about this trial

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

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