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    Summary
    EudraCT Number:2014-005624-98
    Sponsor's Protocol Code Number:109MS309
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-02-23
    Trial 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-005624-98
    A.3Full title of the trial
    A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of
    BG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis
    Studio randomizzato, controllato con placebo, a gruppi paralleli in soggetti pediatrici di età compresa fra 10 e 17 anni per valutare l’efficacia e la sicurezza di BG00012 per il trattamento delle forme recidivanti-remittenti di sclerosi multipla
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A safety and efficacy study of BG00012 in slowing the progression of disability in Pediatric patients with Relapsing -Remitting Multiple Sclerosis.
    Studio di sicurezza ed efficacia di BG00012 nel rallentare la progressione della disabilità nel pazienti Pediatrici con forme recidivanti-remittenti di sclerosi multipla
    A.3.2Name or abbreviated title of the trial where available
    IMAGINE
    IMAGINE
    A.4.1Sponsor's protocol code number109MS309
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02428218
    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 pointNA
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0
    B.5.5Fax number0
    B.5.6E-mailcta.submissions@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 Gastro-resistant capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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.3.9.2Current 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.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    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, Relapsing Forms of Multiple Sclerosis
    sclerosi multipla recidivante-remittente, forme recidivanti di sclerosi multipla
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    Sclerosi Multipla
    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 the study is to assess the efficacy of BID oral BG00012 as compared with placebo in pediatric subjects with RRMS.
    L’obiettivo primario dello studio è valutare l’efficacia di BG00012 orale due volte al giorno (BID) rispetto al placebo in soggetti pediatrici affetti da SMRR.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are as follows:
    -To evaluate the safety and tolerability of BG00012.
    -To compare the effect of BG00012 with placebo on additional clinical and radiological measures of disease activity.
    Gli obiettivi secondari di questo studio sono i seguenti:
     Valutare la sicurezza e la tollerabilità di BG00012.
     Confrontare l’effetto di BG00012 rispetto al placebo su altre misure cliniche e radiologiche dell’attività di malattia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    - Informed consent and assent as appropriate
    - Must have a body weight of ≥30 kg
    - Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric multiple sclerosis (MS)
    - Must be ambulatory with a converted Krutzke Baseline Expanded Disability Status Scale (EDSS) score between 0 and 5.0, inclusive
    NOTE: Other protocol defined inclusion/exclusion criteria may apply.
    Criteri di enclusione principali:
    - Consenso informato e assenso, a seconda del caso
    - Peso corporeo ≥30 kg
    - Diagnosi di SMRR in base alla definizione concordata modificata per la sclerosi multipla pediatrica (SM)
    - Essere deambulanti, con un punteggio della Scala di invalidità espansa (Expanded Disability Status Scale, EDSS) di Krutzke convertito al basale compreso tra 0 e 5,0, incluso
    NOTA: Possono applicarsi altri criteri di inclusione/esclusione definiti dal protocollo.
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    - Primary progressive, secondary progressive, or progressive relapsing MS.
    - History of disorders mimicking MS, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis), systemic autoimmune disorders (e.g., Sjögren disease and lupus erythematosus), metabolic disorders (e.g., dystrophies), and infectious disorders.
    - History of severe allergic or anaphylactic reactions, or known drug hypersensitivity to dimethyl fumarate (DMF) or fumaric acid esters.
    - Prior treatment with any of the following medications within 12 months prior to randomization: mitoxantrone, cyclophosphamide, rituximab.
    - Prior treatment with any of the following medications or procedures within 6 months prior to randomization: fingolimod, teriflunomide,
    natalizumab, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, laquinimod, intravenous (IV) immunoglobulin, plasmapheresis
    or cytapheresis.
    NOTE: Other protocol defined inclusion/exclusion criteria may apply.
    Criteri di esclusione principali:
    - SM primaria progressiva, secondaria progressiva o recidivante progressiva.
    - Anamnesi di patologie con caratteristiche simili a quelle della SM, come altri disturbi demielinizzanti (ad es., encefalomielite acuta disseminata), malattie sistemiche autoimmuni (ad es., morbo di Sjögren e lupus eritematoso), disturbi metabolici (ad es., distrofie) e malattie infettive.
    - Anamnesi di gravi reazioni allergiche o anafilattiche oppure ipersensibilità farmacologica nota a dimetilfumarato (DMF) o agli esteri dell’acido fumarico.
    - Precedente trattamento con uno qualsiasi dei seguenti farmaci nei 12 mesi precedenti la randomizzazione: mitoxantrone, ciclofosfamide, rituximab.
    - Precedente trattamento con uno qualsiasi dei farmaci o delle procedure seguenti nei 6 mesi precedenti la randomizzazione: fingolimod, teriflunomide, natalizumab, ciclosporina, azatioprina, metotrexato, micofenolato mofetile, laquinimod, immunoglobuline per via endovenosa (EV), plasmaferesi o citoaferesi.
    NOTA: Possono applicarsi altri criteri di inclusione/esclusione definiti dal protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first multiple sclerosis (MS) relapse
    -Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and
    accompanied by new objective neurological findings upon examination by the Examining Neurologist.
    Tempo alla prima recidiva della sclerosi multipla (SM)
    - Le recidive vengono definite come sintomi neurologici nuovi o ricorrenti non associati a febbre o infezione, della durata di almeno 24 ore, e accompagnati da nuovi riscontri neurologici obiettivi rilevati con esame neurologico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to first multiple sclerosis (MS) relapse
    up to week 104.
    Tempo alla prima recidiva della sclerosi multipla (SM) fino alla settimana 104.
    E.5.2Secondary end point(s)
    1. Number of participants that experience adverse events (AEs) and
    serious adverse events (SAEs)
    2. Number of new or newly enlarging T2 Hyperintense Lesions on Brain
    magnetic resonance imaging (MRI) scans
    3. Number of gadolinium-enhancing Lesions
    4. Annualized MS relapse rate
    1. Numero di partecipanti che manifestano eventi avversi (EA) ed eventi avversi seri (Serious Adverse Event, SAE)
    2. Numero di lesioni iperintense in T2 nuove o ingranditesi di recente evidenziate dalla risonanza magnetica per immagini (RMI) cerebrale
    3. Numero di lesioni captanti il gadolinio
    4. Tasso annualizzato di recidive nella SM
    E.5.2.1Timepoint(s) of evaluation of this end point
    For secondary endpoints 1,2 ,3 and 4 above timepoints are as follows:
    1.up to week 104
    2.Weeks 24, 48, 72 and 96
    3.Baseline, and weeks 24, 48, 72 and 96
    4.weeks 48 and 96
    Per i suddetti endpoint secondari 1, 2, 3 e 4 i punti temporali sono i seguenti:
    1. fino alla settimana 104
    2. Settimane 24, 48, 72 e 96
    3. Basale e settimane 24, 48, 72 e 96
    4. settimane 48 e 96
    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 No
    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) 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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Austria
    Bosnia and Herzegovina
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Croatia
    Czech Republic
    Estonia
    France
    Germany
    Hungary
    Israel
    Italy
    Kuwait
    Lebanon
    Mexico
    Netherlands
    Peru
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    Slovenia
    South Africa
    Spain
    Switzerland
    Turkey
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years11
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years11
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 1
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 26
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 146
    F.1.2Adults (18-64 years) No
    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 Yes
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 172
    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)
    Subjects who complete the 96 week treatment period including those who choose an alternative therapy and remain within the study may be eligible to enroll in an open label extension study where all patients will receive BG00012.
    I soggetti che completeranno il periodo di trattamento di 96 settimane, inclusi quelli che sceglieranno una terapia alternativa e rimarranno nello studio, potranno essere idonei all’arruolamento in uno studio di estensione in aperto dove tutti i pazienti riceveranno BG00012.
    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 Decision2015-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-01-25
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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