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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41232   clinical trials with a EudraCT protocol, of which   6757   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2013-004533-32
    Sponsor's Protocol Code Number:109MS305
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-05-05
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2013-004533-32
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study that evaluates the efficacy and safety of BG00012 in patients with RRMS
    A.4.1Sponsor's protocol code number109MS305
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01838668
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBiogen Idec Research Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointClinical Trials - Neurology
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBG00012
    D.3.2Product code BG00012
    D.3.4Pharmaceutical form Gastro-resistant capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 624-49-7
    D.3.9.2Current sponsor codeBG00012
    D.3.9.3Other descriptive nameDIMETHYL FUMARATE
    D.3.9.4EV Substance CodeSUB13608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGastro-resistant capsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing-Remitting Multiple Sclerosis
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of Part I of the study is to determine the efficacy of BG00012 on inflammatory brain MRI lesion activity (Gd-enhancing lesions) when compared with placebo from 4 scans performed at Weeks 12, 16, 20, and 24 in subjects with RRMS including subjects from the Asia-Pacific region.

    The primary objective of part II of this study is to evaluate the long-term safety profile of BG00012 in eligible subjects from part 1.

    E.2.2Secondary objectives of the trial
    The secondary objectives of Part I of this study in this study population are to determine whether BG00012, when compared with placebo over 24 weeks, is effective in:

    1. Reducing the cumulative number of new Gd-enhancing lesions from Baseline (Day 1) to Week 24

    2. Reducing the number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Week 24 compared with Baseline (Day 1)

    There are no secondary objectives for part II of the study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part I:
    1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.

    2. Men and women from the Asia-Pacific region (with ethnic origin from those respective countries) or from other countries, aged 18 to 55 years old, inclusive, at the time of informed consent.

    3. Must have a diagnosis of RRMS, as defined by the revised McDonald criteria 1 through 4 [Polman 2005]. All other possible neurologic diagnoses must have been reasonably excluded.

    4. Must have a brain MRI performed at any time prior to randomization that demonstrates lesion(s) consistent with MS.

    5. Must have an EDSS score between 0.0 and 5.0, inclusive.

    6. Must have experienced disease activity within the 12 months prior to randomization as evidenced by at least 1 relapse or Gd-enhancing lesion of the brain on an MRI performed within the 6 weeks prior to randomization.

    7. Female subjects of childbearing potential and male subjects who are not surgically sterile must practice effective contraception during their participation in the study and be willing and able to continue contraception for 12 weeks after their last dose of study treatment.

    Part II:
    1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use PHI in accordance with national and local subject privacy regulations.

    2. Subjects who participated in and completed Part I per protocol including those subjects who prematurely discontinued study treatment but completed the visit schedule.

    3. Female subjects of childbearing potential and male subjects who are not surgically sterile must practice effective contraception during their participation in the study and be willing and able to continue contraception for 12 weeks after their last dose of study treatment.
    E.4Principal exclusion criteria
    Part I:

    Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold [1996]), with continuous clinical disease worsening over a period of at least 3 months. Subjects may also have superimposed relapses, but are distinguished from RRMS subjects by the lack of clinically stable periods or clinical improvement.

    Diagnosis or history of NMO, eg, a long spinal lesion extending over ≥3 vertebral bodies was detected, or the subject has a history of positive tests for anti-AQP4 antibodies. Subjects whose anti-AQP4 antibody test result from Screening is positive and available prior to enrollment will be excluded from study participation.

    A relapse that has occurred within the 50 days prior to randomization and/or the subject has not stabilized from a previous relapse prior to randomization.
    History of:
    • Malignancy, except subjects with basal cell carcinoma that has been completely excised prior to Screening will remain eligible.
    • Severe allergic or anaphylactic reactions or known drug hypersensitivity.
    • Clinically significant cardiovascular, pulmonary, GI, dermatologic, psychiatric, neurologic (other than MS), and/or other major disease that would preclude participation in a clinical study.
    • Abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or other major disease that would preclude participation in a clinical study.
    • HIV.
    • Hepatitis C virus antibody or hepatitis B virus, or positive test result at Screening.
    • Drug or alcohol abuse (as defined by the Investigator) within 2 yrs prior to randomization.

    Any of the following abnormal blood tests at Screening:
    • ALT/ SGPT, or aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase (GGT) ≥2 times the upper limit of normal (ULN)
    • Leukocytes <3500/mm3
    • Eosinophils >0.7 × 103/L or >0.7 GI/L

    Any of the following abnormal urine tests at Screening confirmed by a second urinalysis approx. 2 weeks later:
    • Proteinuria (1+ or greater)
    • Hematuria, without known etiology
    • Glycosuria, without known etiology
    • Note: If a subject has a positive test at Screening and the etiology is known (eg, due to menses or urinary tract infection in the case of hematuria, or due to recent steroid use or elevated serum glucose in the case of glycosuria), a repeat test is not required.

    Prior treatment or procedures with any of the following:
    • BG00012 or fumaric acid esters.
    • Total lymphoid irradiation, Cladribine, T-cell or T-cell receptor vaccination, any therapeutic monoclonal antibody, with the exception of natalizumab.
    • Mitoxantrone or cyclophosphamide within 1 year prior to randomization.
    • Cyclosporine, Azathioprine, Methotrexate, Natalizumab, Fingolimod, Mycophenolate mofetil, Laquinimod, IV immunoglobulin, Plasmapheresis or cytapheresis within the 6 months prior to randomization.
    • IFN-α, IFN-β, Glatiramer acetate within the 3 months prior to randomization.
    • IV steroids or oral corticosteroid treatment, including agents that may act through the corticosteroid pathway; new or changed dosing of 4-aminopyridine or related products within the 50 days prior to randomization
    • Other investigational drugs or approved therapy for investigational use within the 6 months prior to randomization.
    • Use at the time of randomization or anticipated ongoing use of Traditional or Unlicensed Medicines or Traditional Therapies or herbal preparations.

    Female subjects considering becoming pregnant or breast feeding while in the study or who are currently pregnant or breast feeding.

    Current enrollment in any other investigational drug study or participation in any other investigational study within 6 months prior to randomization.

    Unwillingness or inability to comply with the requirements of the protocol, or presence of any condition that is likely to affect the subject’s ability to comply with the protocol.

    Additionally for Part II (at baseline visit):
    • Any significant change in medical history including laboratory tests, cardiovascular risk factors, • or current clinically significant condition that in the opinion of the Investigator would have excluded the subject’s participation in Part I of the study.
    • Subjects from Part I who discontinued study treatment due to an AE or due to reasons other than protocol defined relapse or disability progression.
    • History of malignancy, except subjects with basal cell carcinoma that has been completely excised prior to entry into the Part II Extension Period will remain eligible.
    • ALT/SGPT, AST/SGOT, or GGT >3 × ULN.
    • Previous participation in Part II of this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in Part I is the total number of new Gd-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24, calculated as the sum of these 4 MRI scans.

    The primary endpoints in Part II are as follows:
    - incidence of treatment emergent AEs
    - incidence of treatment-emergent SAEs
    - clinical laboratory reported values
    - clinically significant changes in vital sign measurements
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part I: Weeks 12, 16, 20, and 24, calculated as the sum of these 4 MRI scans.

    Not defined for Part II.
    E.5.2Secondary end point(s)
    Part I: the following brain MRI Parameters:
    1. the cumulative number of new Gd-enhancing lesions
    2. the number of new or newly enlarging T2 hyperintense lesions

    Part II: No secondary endpoints defined.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part I:
    1. Baseline (Day 1) to Week 24
    2. at Week 24 compared with Baseline (Day 1)

    Part II: not applicable.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    Part I of the trial is controlled, randomised, double-blind; part II is open-label, uncontrolled.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    Korea, Republic of
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS: The end of study is last subject, last visit for final collection of data for the primary outcome (i.e. the safety follow-up visit).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 202
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 73
    F.4.2.2In the whole clinical trial 202
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    As BG00012 is approved in Poland and is available for use outside of this study, subjects will be required to complete the “end of Treatment” visit” within 8 weeks of implementation of protocol amendment 4.3. Patients will come off the study and the investigator will discuss their future treatment with them. DMF will not be made available by the sponsor to subjects after the end of the study under this protocol.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-04
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