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    Summary
    EudraCT Number:2012-003647-30
    Sponsor's Protocol Code Number:LAQ-MS-305
    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:2013-01-11
    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 number2012-003647-30
    A.3Full title of the trial
    A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS)
    Studio multinazionale, multicentrico, randomizzato, in doppio cieco, a gruppi paralleli, controllato con placebo seguito da un periodo di trattamento attivo, per valutare l'efficacia, la sicurezza e la tollerabilita' di due dosaggi di somministrazione orale di laquinimod (0,6 mg/die o 1,2 mg/die) in soggetti affetti da sclerosi multipla recidivante remittente (relapsing remitting multiple sclerosis, RRMS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS)
    Studio multinazionale, multicentrico, randomizzato, in doppio cieco, a gruppi paralleli, controllato con placebo seguito da un periodo di trattamento attivo, per valutare l’efficacia, la sicurezza e la tollerabilità di due dosaggi di somministrazione orale di laquinimod (0,6 mg/die o 1,2 mg/die) in soggetti affetti da sclerosi multipla recidivante remittente (relapsing remitting multiple sclerosis, RRMS)
    A.3.2Name or abbreviated title of the trial where available
    Concerto
    Concerto
    A.4.1Sponsor's protocol code numberLAQ-MS-305
    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 SponsorTEVA PHARMACEUTICALS INDUSTRIES LTD
    B.1.3.4CountryIsrael
    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 supportTeva Pharmaceutical Industries Ltd
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Pharma GmbH
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressWaldeckerstrasse 7
    B.5.3.2Town/ cityMoerfelden-Walldorf
    B.5.3.3Post code64546
    B.5.3.4CountryGermany
    B.5.4Telephone number000 000 000 000
    B.5.5Fax number000 000 000 000
    B.5.6E-mailInfo-era-clinical@teva.de
    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 nameLaquinimod capsules 0.6 mg
    D.3.2Product code TV-5600
    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.3.9.1CAS number 248282-07-7
    D.3.9.2Current sponsor codeTV-5600
    D.3.9.3Other descriptive nameLaquinimod Sodium (USAN)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number.6
    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
    Relapsing remitting multiple sclerosis (RRMS).
    Sclerosi Multipla Recidivante Remittente (RRMS).
    E.1.1.1Medical condition in easily understood language
    Relapsing-remitting multiple sclerosis, is a chronic inflammatory disease that affects the central nervous system.
    La Sclerosi Multipla Recidivante Remittente, è una malattia infiammatoria cronica che colpisce il sistema nervoso centrale.
    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
    The study aims to assess the efficacy, safety and tolerability of a daily dose of 0.6 mg and 1.2 mg of laquinimod as compared to placebo in subjects with relapsing remitting multiple sclerosis (RRMS).
    Lo studio intende valutare l'efficacia, la sicurezza e la tollerabilità di laquinimod somministrato alla dose giornaliera da 0,6 mg e 1,2 mg rispetto a placebo in soggetti con Sclerosi Multipla Recidivante Remittente (RRMS).
    E.2.2Secondary objectives of the trial
    Not applicable.
    Non applicabile.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENETIC:
    Vers:Final
    Date:2012/08/15
    Title:GENETIC MARKERS SUB-STUDY
    Objectives:To investigate possible associations between genetic polymorphisms and response to laquinimod.

    OTHER SUBSTUDIES:
    Ancillary-studies (sub-studies) are included in the main study protocol LAQ-MS-305, dated 15 August 2012 (final version): IMMUNOLOGICAL SUB-STUDY, MTR MRI SUB-STUDY, CERVICAL CORD MRI SUB-STUDY
    FARMACOGENETICA:
    Vers:Final
    Data:2012/08/15
    Titolo:SOTTOSTUDIO SUI MARCATORI GENETICI
    Obiettivi:Indagare le possibili associazioni tra poliformismi genetici e la risposta al laquinimod.

    ALTRI SOTTOSTUDI:
    Studi ausiliari (sottostudi) sono inclusi nel protocollo di studio principale LAQ-MS-305,datato 15 Agosto 2012 (versione finale):SOTTOSTUDIO IMMUNOLOGICO,SULLA RMI MTR,SULLA RMI DEL MIDOLLO CERVICALE
    E.3Principal inclusion criteria
    1. Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course. 2. Subjects must be ambulatory with Kurtzke EDSS score of 0-5.5 in both screening and randomization visits. 3.Subjects must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)] or adrenocorticotrophic hormone (ACTH), 60 days prior to randomization. 4. Subjects must have experienced at least one documented relapse in the 12 months prior to randomization. 5. Subjects must be between 18 and 55 years of age at screening,inclusive. 6. Subjects must have disease duration of at least 6 months, but not more than 12 years (from the first symptom) prior to randomization. 7. Women of child-bearing potential must practice an acceptable method of birth control until 30 days after the last dose of treatment was administered. 8. Subjects must be able to sign and date a written informed consent prior to entering the study. 9. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
    1. Soggetti con diagnosi di sclerosi multipla confermata e documentata in base ai criteri McDonald Modificatia con malattia recidiva o decorso recidivante remittente. 2. Soggetti in grado di camminare con un punteggio al questionario EDSS Kurtzke di 0-5,5 sia alla visita di screening che alla randomizzazione. 3. Soggetti le cui condizioni neurologiche sono stabili, in assenza di recidiva e che non siano stati in trattamento con corticosteroidi [per via endovenosa (EV), intramuscolare (IM) e/o per os (PO)] oppure con ormone adrenocorticotrofico (ACTH) nei 60 giorni precedenti la randomizzazione. 4. Soggetti che abbiano manifestato almeno una recidiva documentata nei 12 mesi precedenti la randomizzazione. 5. Soggetti di età compresa fra 18 e 55 anni di età, compresi, allo screening. 6. Soggetti la cui malattia dura da non meno di 6 mesi e da non più di 12 anni (dall’esordio del primo sintomo) prima della randomizzazione. 7. Le pazienti in età fertile devono usare un metodo contraccettivo considerato efficace/accettabile fino a 30 giorni dopo l’assunzione dell'ultima dose del trattamento [nell'ambito di questo studio, sono considerati accettabili/efficaci i seguenti metodi contraccettivi: sterilizzazione chirurgica, dispositivi intrauterini, contraccettivi orali, cerotto contraccettivo, contraccettivo iniettabile a lunga durata d'azione oppure metodo doppio di barriera (preservativo o diaframma con spermicida)]. 8. Soggetti in grado di firmare e datare il consenso informato scritto prima di entrare nello studio. 9. Soggetti che siano disposti e in grado di attenersi ai requisiti del protocollo per l'intera durata dello studio.
    E.4Principal exclusion criteria
    1. Subjects with progressive forms of MS. 2. Subjects with Neuromyelitis Optica (NMO). 3. Use of experimental or investigational drugs (including dimethyl fumarate and Teriflunomide)and/or participation in drug clinical studies within 6 months prior to randomization. 4. Use of immunosuppressive agents, including fingolimod (Gilenya) or cytotoxic agents, including Cyclophosphamide within 6 months prior to randomization. 5. Use of either of the following within 2 years prior to randomization: natalizumab (Tysabri), rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab. 6. Previous treatment with glatiramer acetate (Copaxone) Interferon-β (either 1a or 1b) or intravenous immunoglobulin (IVIG) within 2 months prior to randomization. 7. Chronic (more than 30 consecutive days) systemic (IV, IM or PO) corticosteroid treatment within 2 months prior to randomization. 8. Previous use of Mitoxantrone (Novantrone), Cladribine, or alemtuzumab (CAMPATH-1H). 9. Previous use of laquinimod. 10. Previous total body irradiation or total lymphoid irradiation. 11. Previous stem cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation. 12. Use of moderate/strong inhibitors of CYP3A4 within 2 weeks prior to randomization. 13. Use of inducers of CYP3A4 within 2 weeks prior to randomization. 14. Pregnancy or breastfeeding. 15. Serum levels ≥3xULN of either ALT or AST at screening. 16. Serum direct bilirubin which is ≥2xULN at screening. 17. Subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history,physical examinations, ECG, laboratory tests MRI or chest X-ray. 18. A known history of sensitivity to gadolinium (Gd). 19. GFR ≤ 60 mL/min at the screening visit. 20. Inability to successfully undergo MRI scanning. 21. Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI) within 3 months prior to randomization. 22. Known hypersensitivity that would preclude administration of laquinimod capsule, such as hypersensitivity to: mannitol, meglumine or sodium stearyl fumarate.
    1. Soggetti con forme progressive di SM. 2. Soggetti affetti da Neuromielite Ottica (NMO). 3. Uso di farmaci sperimentali o di studio (fra cui il dimetil fumarato e il Teriflunomide) e/o partecipazione in studi clinici di un prodotto medicinale nei 6 mesi precedente la randomizzazione. 4. Uso di agenti immunosoppressore, fra cui il fingolimod (Gilenya) oppure agenti citotossici, fra cui Ciclofosfamide, nei 6 mesi precedenti la randomizzazione. 5. Uso di uno dei seguenti agenti nei 2 anni precedenti la randomizzazione: natalizumab (Tysabri), rituximab, ocrelizumab, atacicept, belimumab o ofatumumab. 6. Trattamento precedente con glatiramer acetato (Copaxone) Interferone-β (sia 1a che 1b) oppure immunoglobuline per via endovenosa (IVIG) nei 2 mesi precedenti la randomizzazione. 7. Trattamento sistemico (per EV, IM o PO) cronico (di oltre 30 giorni consecutivi) con corticosteroidi nei 2 mesi precedenti la randomizzazione. 8. Uso pregresso di Mitoxantrone (Novantrone), Cladribina o alemtuzumab (CAMPATH-1H). 9. Uso pregresso di laquinimod. 10. Pregressa Radiazione total body (TBI) oppure limitata alle stazioni linfatiche. 11. Trattamento pregresso con cellule staminali, trapianto midollare autologo o trapianto midollare allogenico. 12. Uso di inibitori moderati/potenti del CYP3A4 nelle 2 settimane precedenti la randomizzazione. 13. Uso di induttori del CYP3A4 nelle 2 settimane precedenti la randomizzazione. 14. Gravidanza oppure allattamento 15. Livelli sierici diALT o AST ≥ 3 volte il limite superiore della norma (ULN) allo screening. 16. Livelli sierici di bilirubina diretta ≥ 2 x ULN allo screening. 17. Soggetti con patologia medico-chirurgica clinicamente significativa o instabile o qualsiasi altra condizione che non possa essere controllata in maniera soddisfacente utilizzando medicinali permessi dal protocollo dello studio, e tale da impedire al soggetto di partecipare in maniera completa e sicura allo studio; tale criterio sarà determinato in base all'anamnesi, all'esame obiettivo, ECG, analisi di laboratorio, RMN oppure radiografie del torace. 18. Nota storia di sensibilità al gadolinio (Gd). 19. GFR ≤ 60 mL/min alla visita di screening. 20. Impossibilità di sottoporsi a RMN e portare a termine la scansione. 21. Soggetti sottoposti in precedenza a trattamento endovascolare per insufficienza venosa cronica cerebrospinale (Chronic Cerebrospinal Venous Insufficiency – CCSVI) nel 3 mesi precedenti la randomizzazione. 22. Nota ipersensibilità che impedirebbe la somministrazione delle capsule di laquinimod, ad esempio ipersensibilità ai seguenti elementi: mannitolo, meglumina o sodio stearil fumarato.
    E.5 End points
    E.5.1Primary end point(s)
    Time to Confirmed Disease Progression (CDP) during Period 1.
    CDP is defined as an increase in EDSS of greater than or equal 1 point from baseline for subjects with baseline EDSS of less than or equal 5.0, or an increase in EDSS of greater than or equal 0.5 points from baseline for subjects with baseline EDSS of 5.5. Analysis will be performed at the completion of Period 1.
    L'endpoint primario sarà rappresentato dal Tempo al raggiungimento della progressione confermata della malattia (Confirmed Disease Progression – CDP) durante il Periodo 1. Per CDP si intende un aumento del punteggio al questionario EDSS maggiore o uguale a 1 punto rispetto al baseline per i soggetti con punteggio EDSS basale minore o uguale a 5.0, oppure un aumento del punteggio EDSS maggiore o uguale a 0.5 punti rispetto al baseline per i soggetti con punteggio EDSS basale pari al 5.5. L’analisi verrà eseguita alla conclusione del Periodo 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation will be performed at months -1 (screening), 0 (baseline) and every 3 months thereafter and until completion visit of Period 1.
    La valutazione sarà effettuata ai mesi -1 (screening), 0 (baseline) e ogni 3 mesi fino al completamento della visita nel periodo 1.
    E.5.2Secondary end point(s)
    -Brain atrophy as defined by the percent change in brain volume from baseline to month 15. -The time to first confirmed relapse during Period 1.
    - Atrofia cerebrale definita in base alla variazione percentuale del volume cerebrale rispetto al baseline e rilevata al mese 15. - Tempo a raggiungere la prima recidiva confermata durante il Periodo 1.
    E.5.2.1Timepoint(s) of evaluation of this end point
    In terms of brain atrophy: evaluation at baseline and at month 15. In terms relapse evaluation: evaluation will be done at each timepoint during the study once any symptoms suggestive of a relapse appear/are reported by any subject.
    In termini di atrofia cerebrale: valutazione al basale e al mese 15. In termini di ricaduta di valutazione: la valutazione sarà effettuata ad ogni timepoint nel corso dello studio, una volta ogni sintomi predittivi di una ricaduta sembrano/sono riportati da qualsiasi soggetto.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial3
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    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
    Albania
    Belarus
    Bosnia and Herzegovina
    Canada
    Chile
    Croatia
    Georgia
    Israel
    Kazakhstan
    Korea, Democratic People's Republic of
    Korea, Republic of
    Macedonia, the former Yugoslav Republic of
    Mexico
    Moldova, Republic of
    Puerto Rico
    Russian Federation
    South Africa
    Ukraine
    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 years0
    E.8.9.1In the Member State concerned months63
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months63
    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: 1800
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 1800
    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)
    Standard of care treatment.
    Trattamento di cura standard.
    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 Decision2013-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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