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    Summary
    EudraCT Number:2012-002470-31
    Sponsor's Protocol Code Number:MT-1303-E04
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-13
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-002470-31
    A.3Full title of the trial
    A phase II, multicentre, randomised, double-blind, parallel group, placebocontrolled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis
    Sperimentazione multicentrica di fase II, randomizzata, in doppio cieco, a gruppi paralleli, controllata con placebo, per la valutazione del dosaggio, sulla valutazione della sicurezza e dell'efficacia di tre diversi dosaggi orali di MT-1303, somministrati per un periodo di 24 settimane in soggetti affetti da sclerosi multipla recidivante-remittente.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengths
    Uno studio per valutare la sicurezza e l'efficacia del farmaco MT-1303 a differenti dosaggi
    A.4.1Sponsor's protocol code numberMT-1303-E04
    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 SponsorMITSUBISHI PHARMA CORPORATION
    B.1.3.4CountryJapan
    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 supportMitsubishi Tanabe Pharma Corporation (MTPC)
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMitsubishi Pharma Europe Ltd (MPE)
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressDashwood House, 69 Old Broad Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeEC2M 1QS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0044 2070 655 000
    B.5.5Fax number0044 2070 655 050
    B.5.6E-mailKGreenough@m-pharma.co.uk
    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 nameMT-1303
    D.3.2Product code MT-1303
    D.3.4Pharmaceutical form Capsule
    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.3.9.2Current sponsor codeMT-1303
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    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 nameMT-1303
    D.3.2Product code MT-1303
    D.3.4Pharmaceutical form Capsule
    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.3.9.2Current sponsor codeMT-1303
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 3
    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 nameMT-1303
    D.3.2Product code MT-1303
    D.3.4Pharmaceutical form Capsule
    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.3.9.2Current sponsor codeMT-1303
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    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
    Sclerosi Multipla Recidivante Remittente
    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 14.1
    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 safety, tolerability and effects of three oral doses of MT- 1303 compared to placebo given for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on MRI parameters.
    valutare la sicurezza, la tollerabilità e gli effetti di tre dosi orali di MT-1303 rispetto a placebo, somministrate per un periodo di 24 settimane a soggetti affetti da RRMS in base ai parametri della MRI.
    E.2.2Secondary objectives of the trial
    To evaluate the effects of MT-1303 compared to placebo on clinical outcomes, To explore the dose-response relationship of three dose levels of MT- 1303 in subjects with RRMS, To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of MT-1303 and its phosphorylated metabolite (MT-1303-P) in subjects with RRMS, To evaluate the effects of MT-1303 compared to placebo on quality of life as measured by the Multiple Sclerosis Quality of Life-54 (MSQOL-54), To obtain deoxyribonucleic acid (DNA) for exploratory purposes (optional).
    valutare gli effetti di MT-1303 rispetto al placebo sugli esiti clinici; esplorare la relazione dose-risposta di tre livelli di dosaggio di MT-1303 in soggetti affetti da RRMS; valutare la farmacocinetica (PK) e la farmacodinamica (PD) di MT-1303 e del suo metabolita fosforilato (MT-1303-P) in soggetti affetti da RRMS; valutare gli effetti di MT-1303 rispetto al placebo sulla qualità della vita misurata mediante la scala di valutazione della qualità della vita MSQOL-54 (Multiple Sclerosis Quality of Life-54); ottenere acido desossiribonucleico (DNA) a scopi esplorativi (opzionale).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. RRMS as defined by the revised McDonald criteria 2. Evidence of recent MS activity defined as either: at least one documented relapse in the previous 12 months, OR a positive gadolinium (Gd)-enhanced MRI scan within 3 months prior to screening, OR at least two documented relapses in the previous 24 months with a positive Gd-enhanced MRI scan within the previous 12 months 3. Expanded Disability Status Score (EDSS) score ≥0.0 and ≤5.5 points.
    1. Sclerosi multipla remittente recidivante come definita nella revisione ai criteri McDonald. 2. Evidenza di recente attività di SM definita come: almeno una recidiva documentata nei 12 mesi precedenti, O una RMI gadolinio (Gd)-captante positiva effettuata nei 3 mesi precedenti lo screening, O almeno due recidive documentate nei 24 mesi precedenti con una RMI Gd-captante positiva effettuata nei 12 mesi precedenti. 3. Punteggio sulla scala EDSS (Expanded Disability Status Score) ≥0,0 e ≤5,5 punti.
    E.4Principal exclusion criteria
    1. Primary progressive, secondary progressive or progressive relapsing MS at screening 2. Disease duration >15 years combined with an EDSS score ≤2.0 3. Relapse of MS during the Screening Period 4. History or known presence of other neurological disorders likely to render the subject unsuitable for the study 5. History of any of a list of pre-defined cardiovascular diseases 6. History or known presence of any significant central nervous system, infectious, metabolic, oncological, ophthalmological or respiratory system disease or illness likely to render the subject unsuitable for the study 7. Previous exposure to any sphingosine 1-phosphate receptor modulator 8. Receipt of a live vaccine or systemic corticosteroid use within 28 days prior to randomisation 9. Previous treatment with beta-interferons or glatiramer acetate within 14 days prior to randomisation 10. Previous treatment with intravenous immunoglobulin, plasmapheresis, certain immunosuppressants, lymphocyte-depleting therapy, total body irradiation or bone marrow transplantation 11. Need, or likely need for, treatment with Class I or III anti-arrhythmic drugs or with heart-rate-lowering beta-blockers or calcium-channel blockers, or with any other drugs which can reduce the heart rate 12. Evidence of significant anaemia, thrombocytopenia, leucopoenia or lymphocytopenia, renal or hepatic impairment 13. Clinically significant electrocardiogram (ECG) findings.
    1. SM primaria progressiva, secondaria progressiva o recidivante progressiva allo screening. 2. Durata della malattia &gt;15 anni con un punteggio EDSS ≤2,0. 3. Recidiva di SM durante il periodo di screening. 4. Anamnesi o presenza nota di altri disturbi neurologici, tale da rendere il soggetto inadatto allo studio. 5. Anamnesi di una qualsiasi malattia cardiovascolare predefinita in elenco. 6. Anamnesi o presenza nota di eventuale patologia o malattia significativa del sistema nervoso, infettiva, metabolica, oncologica, oftalmologica o del sistema respiratorio, tale da rendere il soggetto inadatto allo studio. 7. Precedente esposizione a qualsiasi modulatore del recettore della sfingosina-1-fosfato. 8. Ricezione di un vaccino vivo o uso di corticosteroide sistemico nei 28 giorni precedenti la randomizzazione. 9. Precedente trattamento con interferone beta o glatiramer acetato nei 14 giorni precedenti la randomizzazione. 10. Precedente trattamento con immunoglobulina per via endovenosa, plasmaferesi, alcuni immunosoppressivi, terapia di deplezione dei linfociti, irradiazione corporea totale o trapianto di midollo osseo. 11. Necessità, o probabile necessità, di trattamento con farmaci antiaritmici di Classe I o III o con beta bloccanti o calcio antagonisti che abbassano la frequenza del battito cardiaco oppure con qualsiasi altro farmaco che possa ridurre il battito cardiaco. 12. Evidenza di anemia, trombocitopenia, leucopenia o linfocitopenia, disfunzione renale o epatica significative. 13. Rilievi clinicamente significativi sull’elettrocardiogramma (ECG).
    E.5 End points
    E.5.1Primary end point(s)
    Total number of monthly MRI Gd-enhanced T1-weighted lesions observed across post-baseline visits (Weeks 8-24)
    numero totale di lesioni mensili evidenziate da RMI T1-pesata Gd-captante e osservate nel corso delle visite post-basale (Settimane 8-24).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Various timepoints throughout the study - please refer to the detailed Time and Events Schedule in the protocol for full details
    Vari momenti durante lo studio. Si prega di voler fare riferimento alla Scheda Ore ed Eventi nel protocollo per maggiori dettagli.
    E.5.2Secondary end point(s)
    Total number of monthly MRI Gd-enhanced T1-weighted lesions observed across all scheduled post-baseline visits (Weeks 4-24) Total number of and volume of new or enlarged T2-weighted lesions observed across all scheduled post-baseline visits (Weeks 4-24) Change from baseline in brain volume at Week 24 Exploratory Magnetisation Transfer Ratio (MTR) endpoints detailed in Statistical Analysis Plan (SAP) (selected centres only) Clinical endpoints o Annualised Relapse Rate (ARR) at Week 24 o Change from baseline in total EDSS score and total Multiple Sclerosis Functional Composite (MSFC) score at Week 24 Pharmacodynamic endpoints: Lymphocyte counts Lymphocyte subsets (selected centres only) Safety Endpoints: Adverse events (AEs), Vital signs, 12-lead ECG, 3-lead Holter ECG, monitoring , Routine safety laboratory assessments , Physical examination , Optical coherence tomography (OCT) Pharmacokinetic Endpoint: MT-1303 and MT-1303-P concentrations Subject-reported Outcome: Change from baseline in MSQOL-54 at Week 24.
    numero totale di lesioni mensili evidenziate da RMI T1-pesata Gd-captante e osservate nel corso di tutte le visite programmate post-basale (Settimane 4-24); numero totale e volume di nuove o ingrandite lesioni T2-pesate, osservate nel corso di tutte le visite post-basale programmate (Settimane 4-24); variazione rispetto al basale nel volume cerebrale alla Settimana 24; endpoint esplorativi sul rapporto del trasferimento di magnetizzazione (Magnetisation Transfer Ratio, MTR) descritti nel Piano di analisi statistica (SAP) (solo presso i centri selezionati); endpoint clinici o Tasso di recidive annualizzato (Annualised relapse rate, ARR) alla Settimana 24. Variazione rispetto al basale del punteggio EDSS totale e del punteggio totale sulla scala Multiple Sclerosis Functional Composite (MSFCS) alla Settimana 24. Endpoint farmacodinamici: conte linfocitarie; sottopopolazioni linfocitarie (solo presso i centri selezionati). Endpoint di sicurezza: eventi avversi (EA); segni vitali; ECG a 12 derivazioni; monitoraggio ECG a 3 derivazioni secondo Holter; esami standard di laboratorio sulla sicurezza; esame obiettivo; tomografia a coerenza ottica (OCT). Endpoint farmacocinetico:concentrazioni MT-1303 e MT-1303-P. Esito riferito dal paziente: variazione rispetto al basale in MSQOL-54 alla Settimana 24.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various timepoints throughout the study - please refer to the detailed Time and Events Schedule in the protocol for full details
    Vari momenti durante lo studio. Si prega di voler fare riferimento alla Scheda Ore ed Eventi nel protocollo per maggiori dettagli.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolleranza
    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 Yes
    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 trial4
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA63
    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
    Bosnia and Herzegovina
    Canada
    Croatia
    Russian Federation
    Switzerland
    Turkey
    Ukraine
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months21
    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 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.1.1Number of subjects for this age range: 0
    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: 400
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 400
    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
    Nessuno
    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 Decision2013-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-23
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