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    Summary
    EudraCT Number:2008-004753-14
    Sponsor's Protocol Code Number:109MS303
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-02-03
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2008-004753-14
    A.3Full title of the trial
    A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-Term Safety and Efficacy Study of Oral BG00012 Monotherapy in Relapsing-Remitting Multiple Sclerosis
    A.3.2Name or abbreviated title of the trial where available
    ENDORSE
    A.4.1Sponsor's protocol code number109MS303
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00835770
    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 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 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 Limited
    B.5.2Functional name of contact pointNot Available
    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
    B.5.6E-mailclinicaltrials@biogen.com
    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 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.3.8INN - Proposed INNDimethyl Fumarate
    D.3.9.1CAS number 624497
    D.3.9.2Current sponsor codeBG00012
    D.3.9.3Other descriptive nameDIMETHYL FUMARATE
    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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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
    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 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
    To evaluate the long-term safety profile of BG00012.
    E.2.2Secondary objectives of the trial
    To evaluate the long-term efficacy of BG00012 using clinical endpoints (including relapse and ARR) and disability progression (Expanded Disability Status Scale).

    To evaluate further the long-term effects of BG00012 on MS brain lesions on MRI scans in subjects who had MRI scans as part of Studies 109MS301 and 109MS302 and in 109MS303 up through and including Amendment 6. The following MRI endpoints will be evaluated in the subset of subjects who participated in the MRI scans: number and volume of Gd-enhancing lesions, number of new or newly-enlarging T2 lesions and volume of total T2 lesions, number of new T1 hypointense lesions and volume of T1 hypointense lesions, brain atrophy, and magnetization transfer ratio (MTR).

    To evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. The endpoints are the Short-from 36 Health Survey and the Euroqol EQ-5D Health Survey quality of life questionnaire, and the visual function test scores.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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. Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 or 109MS302, including those subjects who received an open-label, approved MS therapy and completed the modified visit schedule.

    3. All male subjects and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of BG00012.
    E.4Principal exclusion criteria
    1. Any significant change in medical history in subjects from 109MS301 or 109MS302, including laboratory tests, or current clinically significant condition that in the opinion of the Investigator would have excluded the subjects' participation from their previous study. The Investigator must re-review the subject's medical fitness for participation and consider any diseases that would preclude treatment.

    2. Subjects from 109MS301 or 109MS302 who discontinued BG00012 due to an AE or due to reasons other than protocol-defined relapse/disability progression.

    3. Subjects from 109MS301 or 109MS302 who discontinued BG00012 due to disability progression or relapses and did not follow the modified visit schedule up to Week 96.

    4. History of malignancy.

    5. History of severe allergic or anaphylactic reactions.

    6. Alanine transaminase (ALT), aspartate transaminase (AST), or gamma-glutamyltransferase (GGT) >3 times the upper limit of normal (ULN).

    7. Female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding.

    8. Previous participation in this study (109MS303).

    9. Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.

    10. Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective and endpoint is to evaluate the long-term safety profile of BG00012.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The safety analysis will focus on the 8-year safety data in the extension study. For subjects who were dosed with BG00012 in the previous study, long-term safety data (extension study+ 2 years) may also be summarized.
    E.5.2Secondary end point(s)
    • To evaluate the long-term efficacy of BG00012 using clinical endpoints (including relapse and ARR) and disability progression (EDSS).

    • To evaluate further the long-term effects of BG00012 on MS brain lesions on MRI scans in subjects who had MRI scans as part of Studies 109MS301 and 109MS302 and in 109MS303 up through and including Amendment 6. The following MRI endpoints will be evaluated in the subset of subjects who participated in the MRI scans: number and volume of Gd-enhancing lesions, number of new or newly-enlarging T2 lesions and volume of total T2 lesions, number of new T1 hypointense lesions and volume of T1 hypointense lesions, brain atrophy, and MTR.

    • To evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. The endpoints are the SF-36 and EQ-5D quality of life questionnaire, and the visual function test scores.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end points will be evaluated for the 8 years in the extension phase and for some the extension study + 2years starting from the original baseline of the Phase 3 studies (109MS301 and 109MS302).
    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 Yes
    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.7.1.3.1Other 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA134
    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
    Australia
    Austria
    Belarus
    Belgium
    Bosnia and Herzegovina
    Bulgaria
    Canada
    Croatia
    Czech Republic
    Estonia
    France
    Germany
    Greece
    Guatemala
    India
    Ireland
    Israel
    Italy
    Latvia
    Macedonia, the former Yugoslav Republic of
    Mexico
    Moldova, Republic of
    Netherlands
    New Zealand
    Poland
    Romania
    Serbia
    Slovakia
    South Africa
    Spain
    Switzerland
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    The end of study is Last Patient, Last Visit (LPLV) for final collection of data for the primary outcome
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months0
    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: 1738
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 884
    F.4.2.2In the whole clinical trial 1738
    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)
    Not applicable
    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 Decision2009-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-08
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