Relapsing-Remitting Multiple SclerosisPhase 3NCT01838668
An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
A Phase 3 study testing dimethyl fumarate in people with Relapsing-Remitting Multiple Sclerosis and Multiple Sclerosis, run by Biogen at 54 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis
- What is being tested?
- dimethyl fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 54 sitesin 5 countries
- Study dates
- 28 Mar 2013to 4 Sep 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
54 sites in 5 countries.
54 sites in 5 countries
Japan27 sites
NHO Asahikawa Medical Center
Asahikawa-shi, 070-8644
Juntendo University Hospital
Bunkyō City, 113-8431
Chiba University Hospital
Chiba, 260-8677
Kyushu University Hospital
Fukuoka, 812-8582
Kanazawa Medical University Hospital
Kahoku-gun, 920-0293
Saitama Medical Center
Kawagoe-shi, 350-8550
Kobe University Hospital
Kobe, 650-0017
National Center Hospital, NCNP
Kodaira-shi, 187-8551
Kyoto University Hospital
Kyoto, 606-8507
NHO Utano Hospital
Kyoto, 616-8255
Iwate Medical University Hospital
Morioka, 020-8505
Niigata University Medical & Dental Hospital
Niigata, 951-8520
Irino Clinic, Inc.
Osaka, 556-0016
Kindai University Hospital
Osakasayama-shi, 589-8511
Tokyotohokeniryokosya Ebara Hospital
Ōta-ku, 145-0065
NHO Hokkaido Medical Center
Sapporo, 063-0005
CEReS Sapporo Neurology Clinic
Sapporo, 065-0021
Tohoku University Hospital
Sendai, 980-8574
Keio University Hospital
Shinjuku-ku, 160-8582
Department of Neurosurgery, Tokyo Women's Medical University
Shinjuku-ku, 162-8666
Osaka University Hospital
Suita-shi, 565-0871
National Defense Medical College Hospital
Tokorozawa-shi, 359-8513
Ehime University Hospital
Toon-shi, 791-0295
Tsukuba University Hospital
Tsukuba, 305-8576
Yamaguchi University Hospital
Ube-shi, 755-8505
Tokyo Womens Medical University Yachiyo Medical Center
Yachiyo-shi, 276-8524
Yokohama City University Hospital
Yokohama, 236-0004
Czechia9 sites
Fakultni nemocnice u sv. Anny v Brne
Brno, 656 91
Neurospol, s.r.o.
Havířov, 736 00
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Privatni ordinace - neurologie
Hradec Králové, 50003
Nemocnice Jihlava
Jihlava, 58633
Fakultni nemocnice Olomouc
Olomouc, 775 20
Fakultni poliklinika VFN
Prague, 128 08
Fakultni nemocnice v Motole
Prague, 150 06
Krajska zdravotni, a.s. - Nemocnice Teplice, o.z.
Teplice, 41529
Poland9 sites
Copernicus Podmiot Leczniczy Sp. z o.o.
Gdansk, 80-803
M.A. - LEK A.M.Maciejowscy SC.
Katowice, 40-571
Nzoz Novo-Med
Katowice, 40-650
Neuro-Care Gabriela Klodowska
Katowice, 40-749
MCD Medical
Krakow, 31-637
Centrum Neurologii K. Selmaj
Lodz, 90-324
Neurologiczny NZOZ Centrum Leczenia SM
Plewiska, 62-064
NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.
Poznan, 61-853
Miedzyleski Szpital Specjalistyczny
Warsaw, 04-749
South Korea6 sites
Yeungnam University Hospital
Daegu, 42415
National Cancer Center
Gyeonggi-do, 10408
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Taiwan3 sites
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 100
Taipei Veterans General Hospital
Taipei, 11217
About this study
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
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.
Read more
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.
- Being tested
- Placebo, dimethyl fumarate
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Two placebo capsules orally BID
dimethyl fumarateDrug
Also called BG00012, Tecfidera, DMF
Two dimethyl fumarate 120mg capsules orally BID
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Drug: dimethyl fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of new Gadolinium-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24.
Measured: Part I (Week 24)
Incidence of treatment-emergent adverse events and serious adverse events
Measured: Part II (Up to 4.5 years)
Secondary outcomes (2)
Cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24
Measured: Part I (Week 24)
Number of new or newly enlarging T2 hyperintense lesions at Week 24 compared with Baseline
Measured: Part I (Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study start28 Mar 2013
- Primary completion16 Jun 2015
- Study completion4 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838668
- Sponsor's protocol ID
- 109MS305
- Other IDs
- 2013-004533-32
- Status last verified
- Oct 2018
- First submitted
- 20 Apr 2013
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31391949Saida 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.
PubMed 30616596Ochi 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.
PubMed 30206820
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01838668
- Acronym / sponsor ID
- 109MS305
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2013 (actual)
- Primary completion
- 16 Jun 2015 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part I Placebo | Placebo comparator | Drug: PlaceboPlacebo 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 | Experimental | Drug: dimethyl fumarateBG00012 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 | Experimental | Drug: dimethyl fumaratePart 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects who participated in and completed Part I per protocol.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboTwo placebo capsules orally BID | Drug | Part I Placebo |
| dimethyl fumarateAlso: BG00012, Tecfidera, DMFTwo dimethyl fumarate 120mg capsules orally BID | Drug | Part I BG00012, Part II BG00012 |
Primary outcome
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)
2 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Derived from this study: PubMed 31391949Kondo 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.
- Derived from this study: PubMed 30616596Saida 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.
- Derived from this study: PubMed 30206820Ochi 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.
- EudraCT Tabulated ResultLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
54 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dimethyl fumarate in people with Relapsing-Remitting Multiple Sclerosis and Multiple Sclerosis, run by Biogen at 54 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Japan, Czechia, Poland, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of new Gadolinium-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24. (time frame: Part I (Week 24)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01838668, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.