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    Summary
    EudraCT Number:2016-000283-41
    Sponsor's Protocol Code Number:FUMAPMS2016
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-29
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2016-000283-41
    A.3Full title of the trial
    Dimethyl fumarate treatment of primary progressive multiple sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with dimethyl fumarate in patients with primary progressive multiple sclerosis
    A.3.2Name or abbreviated title of the trial where available
    FUMAPMS
    A.4.1Sponsor's protocol code numberFUMAPMS2016
    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 SponsorFinn Sellebjerg
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBiogen
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelene Højsgaard Jensen
    B.5.2Functional name of contact pointRigshospitalet
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.6E-mailhelene.hoejsgaard.jensen@regionh.dk
    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 Yes
    D.2.1.1.1Trade name Tecfidera
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namedimethyl fumarate
    D.3.2Product code dimethyl fumarate
    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 624-49-7
    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.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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, 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
    Primary progressive multiple sclerosis (PPMS)
    E.1.1.1Medical condition in easily understood language
    Primary progressive multiple sclerosis (PPMS) is a chronic neurological disease in which neurological handicap progress over time. There is no registrered treatment for PPMS.
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10063401
    E.1.2Term Primary progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The trial investigates the use of dimethyl fumarate treatment in patients with primary progressive multiple sclerosis (PPMS).
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 18 to 60 years
    • PPMS according to the McDonald (2010) and Lublin (2014) criteria
    • Disease duration at least one year
    • Expanded Disability Status Scale (EDSS) under or equal to 6.5
    • Written informed consent to study participation
    • No other signs of significant disease judged by the investigator
    • Eligible for randomization to active treatment or placebo as assessed by cerebrospinal fluid (CSF) Neurofilament light chain (NFL) levels above
    380ng/L
    • Not eligible for randomization as assessed by CSF biomarker studies but accepts follow-up and open-label treatment per protocol
    • Patients not eligible for randomization due to low NFL concentrations in CSF at screening can be followed up after 48 weeks, and are eligible for open-label treatment if they fulfil one of the following clinical criteria of disease progression:
    • 1 point increase in EDSS score from screening to week 48 if screening EDSS less than 6
    • 0.5 point increase in EDSS score from screening to week 48 if screening EDSS is more than 5.5
    • 2 point increase in a physical functional system
    • Worsening in Symbol Digit Modalities Test, 9 hole peg test or timed 25 foot walk test more than 20% from screening to week 48
    E.4Principal exclusion criteria
    • Pregnancy or breast feeding
    • Lack of effective contraception for women of child-bearing potential
    • Relapse within 6 months of inclusion
    • Methylprednisolone treatment within 3 months of inclusion
    • Treatment with interferon-beta, glatiramer acetate, immunoglobulin G or other immunomodulatory treatment within 6 months of inclusion
    • Treatment with mitoxantrone, cyclophosphamide, azathioprine or other immunosuppressive treatment within 6 months of inclusion
    • Findings on the screening MRI judged to preclude participation by the treating physician
    • Other diseases associated with immunodeficiency
    • Other diseases judged to be relevant by the treating physician
    • Anticoagulant therapy other than platelet inhibitors
    • Active malignant disease in the previous 5 years
    • Renal insuffiency or blood creatinine more than 150 μmol/l
    • Present or chronic infection with hepatitis B virus, hepatitis C virus, HIV (tested in the screening blood samples) or other infections found to be relevant by the treating physician.
    • Psychiatric disorders or other disorders impairing the patient’s ability to participate in the trial
    • Contraindication to MRI
    • Known allergy or hypersensitivity to dimethyl fumarate
    E.5 End points
    E.5.1Primary end point(s)
    The primary aim of the study is to assess whether 48 weeks of treatment with dimethyl fumarate can decrease neuroaxonal damage in PPMS as assessed by:
    • Difference in change in the CSF concentration of NFL from screening to week 48 in PPMS patients treated with dimethyl fumarate or placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of the primary endpoint is done after 48 weeks of treatment with either dimethyl fumarate or placebo
    E.5.2Secondary end point(s)
    • Clinical endpoints: comparison of change from screening to week 48 in patients treated with dimethyl fumarate and placebo for the following variables:
     Expanded Disability Status Scale (EDSS)
     Timed 25-Foot Walk (T25FW)
     Nine-Hole Peg Test (9HPT)
     Brief International Cognitive Assessment for MS (BICAMS)
     Symbol Digit Modalities Test (SDMT)

    • CSF endpoints: comparison of change from screening to week 48 in patients treated with dimethyl fumarate and placebo for the following variables:
     IgG-index
     CSF-serum albumin quotient
     Concentrations of: chitinase-3-like-1, sCD14, sCD27, BCMA (TNFRSF17) and myelin basic protein (MBP)
    • Magnetic resonance imaging (MRI) endpoints: comparison of change from screening to week 48 in patients treated with dimethyl fumarate and placebo for the following variables:
     Number of new or enlarged T2 lesions
     Fractional anisotropy (FA) in Normal Appearing White Matter (NAWM)
     Lesion volume
     Magnetization Transfer Ratio (MTR) in lesions
     Thalamic volume
     Percentage brain volume change (PBVC)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation of the secondary endpoints are done after 48 weeks of treatment with either dimethyl fumarate or placebo
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned 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: 54
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state54
    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)
    None
    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 Decision2016-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-09
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