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    EudraCT Number:2010-024423-24
    Sponsor's Protocol Code Number:AB10015
    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:2014-02-04
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-024423-24
    A.3Full title of the trial
    Studio prospettico, multicentrico, randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli, di fase 2/3 sull'efficacia e la sicurezza di masitinib a confronto con placebo nel trattamento di pazienti affetti da Sclerosi Laterale Amiotrofica (SLA)
    A prospective, multicenter, randomized, double-blind, placebocontrolled,parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)
    Valutazione di masitinib nella Sclerosi Laterale Amiotrofica (SLA)
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberAB10015
    A.5.4Other Identifiers
    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 SponsorAB SCIENCE
    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 supportAzienda Farmaceutica: AB Scienc
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAB Science
    B.5.2Functional name of contact pointVincent Arnold
    B.5.3 Address:
    B.5.3.1Street Address3 avenue George V
    B.5.3.2Town/ cityParigi
    B.5.3.3Post code75008
    B.5.4Telephone number0033 1 47 20 23 11
    B.5.5Fax number0033 1 47 20 23 11
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameMasitinib
    D.3.2Product code AB1010
    D.3.4Pharmaceutical form Tablet
    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 INNMasitinib Mesylate
    D.3.9.1CAS number 790299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.9.3Other descriptive nameMASITINIB MESYLATE
    D.3.9.4EV Substance CodeSUB126308
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMasitinib Mesylate
    D.3.9.1CAS number 790299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.9.3Other descriptive nameMASITINIB MESYLATE
    D.3.9.4EV Substance CodeSUB126308
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboTablet
    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
    patients suffering from Amyotrophic Lateral Sclerosis (ALS)
    pazienti affetti da Sclerosi Laterale Amiotrofica (SLA)
    E.1.1.1Medical condition in easily understood language
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral 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 objective is to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS).
    L'obiettivo dello studio consiste nel confrontare l'efficacia e la sicurezza di masitinib in combinazione con riluzolo a confronto con placebo in combinazione con riluzolo nel trattamento di pazienti affetti da Sclerosi Laterale Amiotrofica (SLA)
    E.2.2Secondary objectives of the trial
    non applicabile
    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
    PharmacoKinetic (PK) study:
    A Pharmacokinetic study, in up to 10 patients, to evaluate PK parameters of riluzole will be conducted
    Studio di Farmacocinetica (PK):
    verrà condotto uno studio di Farmacocinetica su un massimo di 10 pazienti per valutare i parametri di Farmacocinetica del Riluzolo
    E.3Principal inclusion criteria
    1. Female or male patient aged between 18 and 75 years of age, with a weight > 50 kg and BMI between 18 and 35 kg/m².
    2. Familial or sporadic ALS
    3. Patient diagnosed with laboratory supported, clinically probable or definite ALS according to the World Federation of Neurology Revised El
    Escorial criteria (Brooks, 1994)
    4. Disease duration from symptoms onset no longer than 36 months at the screening visit
    5. Patient treated with a stable dose of riluzole (100 mg/day) for at least 30 days prior to screening
    6. Patient with a FVC (Forced Vital Capacity) equal to or more than 60% predicted normal value for gender, height, and age at the screening visit
    7. Patient with life expectancy ≥ 6 months
    8. Patient with adequate organ function at screening and baseline:
    • Absolute Neutrophils Count (ANC) ≥ 2 x 109/L
    • Hemoglobin ≥ 10 g/dL
    • Platelets (PTL) ≥ 100 x 109/L
    • AST/ALT ≤ 3 ULN
    • Bilirubin ≤ 1.5 ULN
    • Albuminemia > 1 x LLN
    • Creatinine clearance > 60 mL/min (Cockcroft and Gault formula)
    • Proteinuria < 30 mg/dL (1+) on dipstick; in case of the proteinuria ≥ 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours
    9. Male patient or female patient of child bearing potential, who must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception (with failure rate < 1%) during the study and for three months after the last treatment intake
    10. Female patient of childbearing potential must have a negative pregnancy test at screening and baseline
    11. Patient able and willing to comply with study procedures as per protocol
    12. Patient able to understand, and willing to sign, and date the written informed consent form at screening visit prior to any protocol-specific
    13. Patient able to understand, and willing to follow the safety procedures mentioned on the patient card in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first two months of treatment
    1. Paziente maschio o femmina, di età compresa tra i 18 e i 75 anni, peso > 50 kg e BMI compreso tra 18 e 35 kg/m².
    2. SLA familiare o sporadica
    3. Paziente affetto da SLA definita o clinicamente probabile supportata da analisi di laboratorio secondo i criteri World Federation of Neurology
    Revised El Escorial (Brooks, 1994)
    4. Durata della malattia dalla comparsa dei sintomi non superiore a 36 mesi alla visita di screening
    5. Paziente trattato con dose stabile di riluzolo (100 mg/giorno) per almeno 30 giorni prima dello screening
    6. Paziente con FVC (Capacità vitale forzata) pari o superiore al 60% del valore normale previsto per sesso, altezza ed età alla visita di screening
    7. Paziente con aspettativa di vita ≥ 6 mesi
    8. Paziente con adeguate funzioni degli organi allo screening e al basale:
    • Conta assoluta dei neutrofili (ANC) ≥ 2 x 109/L
    • Emoglobina ≥ 10 g/dL
    • Piastrine (PTL) ≥ 100 x 109/L
    • AST/ALT ≤ 3 ULN
    • Bilirubina ≤ 1,5 ULN
    • Albuminemia > 1 x LLN
    • Clearance della creatinina > 60 mL/min (formula di Cockcroft-Gault)
    • Proteinuria < 30 mg/dL (1+) su striscia reattiva; in caso di proteinuria ≥ 1+ sulla striscia reattiva, la proteinuria delle 24 ore deve essere < 1,5g/24 ore
    9. Donne in età fertile (che comincerà lo studio dopo un ciclo mestruale e che dovrà sottoporsi a un test di gravidanza con esito negativo) che acconsentirà all'utilizzo di due metodi (uno per il paziente e uno per il partner) contraccettivi in forma accettabile da un punto di vista medico durante lo studio e per tre mesi dopo l'ultima somministrazione del trattamento.
    10. Uomini in età fertile devono utilizzare un'accettabile metodo contraccettivo qualora la partner sia in gravidanza, dal giorno della
    prima somministrazione del farmaco in studio fino a tre mesi dopo l'ultima somministrazione. I pazienti di sesso maschile devono utilizzare
    due accettabili metodi anticoncezionali ad alta efficienza (uno per sé stessi, l'altro per la partner) durante lo studio e fino a tre mesi dopo
    l'ultima dose di trattamento assunta.
    11. La paziente donna in età fertile dovrà sottoporsi a un test di gravidanza con esito negativo allo screening e al basale
    12. Paziente disposto e in grado di attenersi alle procedure dello studio come definite nel protocollo
    13. Paziente in grado di comprendere, e disposto a firmare e datare il modulo del consenso informato durante la visita di screening prima di
    qualsiasi procedura specifica del protocollo
    14. Paziente in grado di comprendere, e disposto a seguire le procedure di sicurezza riportate sulla scheda del paziente in caso di segni o sintomi
    di grave neutropenia o tossicità cutanea acuta durante i primi due mesi di trattamento
    E.4Principal exclusion criteria
    1. Patient with history of hematologic, hepatic, respiratory disorder that is clinically significant for his/her participation in the study
    2. Patient who underwent tracheotomy and /or gastrostomy
    3. Patient with a diagnosis of cancer or evidence of continued disease within five years before starting study treatment
    4. Patient with significant sensory abnormalities, dementia, other neurologic diseases, uncompensated medical illness and psychiatric
    5. Patient who have participated in a clinical trial within 3 months prior to screening
    6. Pregnant, or nursing female patient
    7. Patient with a known diagnosis of human immunodeficiency virus
    (HIV) infection
    8. Patient with known hepatitis B, hepatitis C or tuberculosis
    9. Patient with any severe and/or uncontrolled medical condition
    10. Patient having cardiac disorders defined by at least one of the following conditions:
    • Patient with recent cardiac history (within 6 months) of:
    - Acute coronary syndrome
    - Acute heart failure (class III or IV of the NYHA classification)
    - Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
    • Patient with cardiac failure class III or IV of the NYHA classification
    • Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
    • Syncope without known aetiology within 3 months
    • Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension
    11. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
    12. Patient treated with any investigational agent within 3 months prior to screening
    1. Paziente con storia di disturbi ematologici, epatici, respiratori clinicamente significativi per la sua partecipazione allo studio
    2. Paziente sottoposto a tracheotomia e/o gastrostomia
    3. Paziente con diagnosi di tumore o evidenza di progressione di malattia negli ultimi cinque anni prima dell'inizio del trattamento dello studio
    4. Paziente con anomalie sensoriali significative, demenza, altre patologie neurologiche, malattia scompensatae patologia psichiatrica
    5. Paziente che abbia partecipato ad uno studio clinico nei 3 mesi precedenti lo screening
    6. Gravidanza o allattamento in corso
    7. Paziente con diagnosi nota di infezione da virus
    dell'immunodeficienza umana (HIV)
    8. Paziente con nota epatite B, epatite C o tubercolosi
    9. Paziente affetto da condizione medica grave e/o non controllata
    10. Paziente affetto da disturbi cardiaci definiti da almeno una delle seguenti condizioni:
    • Paziente avente precedenti cardiaci recenti (ultimi 6 mesi) tra cui:
    - Sindrome coronarica acuta
    - Insufficienza cardiaca acuta (classe III o IV della classificazione
    - Aritmia ventricolare significativa (tachicardia ventricolare sostenuta,
    fibrillazione ventricolare, morte improvvisa rianimata)
    • Paziente affetto da insufficienza cardiaca di classe III o IV della
    classificazione NYHA
    • Paziente affetto da gravi disturbi di conduzione non prevenuti con
    pacemaker permanente (blocco atrioventricolare di 2° e 3° grado, blocco senoatriale)
    • Sincope senza eziologia nota negli ultimi 3 mesi
    • Grave ipertensione incontrollata secondo il giudizio dello sperimentatore, o ipertensione sintomatica
    11. Paziente con storia di scarsa compliance o storia di abuso di sostanze stupefacenti/alcol, o consumo eccessivo di bevande alcoliche
    che potrebbero interferire con la capacità di aderire al protocollo di studio, o patologia psichiatrica attuale o pregressa che potrebbe interferire con la capacità di aderire al protocollo di studio o prestare il consenso informato
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to week 48 in Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised
    Variazione della Scala di valutazione funzionale SLA (ALSFRS)-Revised dal baseline alla settimana 48.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 settimane
    E.5.2Secondary end point(s)
    Combined Assessment of Function and Survival (CAFS) • Survival defined as the time from randomisation to the date of documented death or first tracheotomy • Time to first tracheotomy defined as the time from randomisation to the time of the first tracheotomy • Change of Forced Vital Capacity (FVC) from baseline to each time point (week 4, 8, 12, 24, 36, 48) • Number of failure defined as a 9-point drop in ALSFRS-R or death from baseline • Change from baseline to each time point (week 4, 8, 12, 24 and 36) in Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)- Revised • Survival rate defined as the rate of patients alive without tracheotomy at each time point (week 12, 24, 36 and 48) • Change in cystatin C level from baseline to each time point • Time to first gastrectomy defined as the time from randomisation to the time of the first gastrectomy • Absolute and relative change in ALSAQ- 40 at each time point • Safety: occurrence of Adverse Events (AE), changes on clinical examination including vital signs and weight, ECG and laboratory exams(biochemistry, hematology and urinalysis)
    Valutazione combinata di Funzione e Sopravvivenza (CAFS) • Sopravvivenza intesa come il tempo intercorso tra la randomizzazione e la morte documentata o la prima tracheotomia • Tempo della prima tracheotomia, inteso come periodo intercorso tra la randomizzazione e la prima tracheotomia • Variazione della capacità vitale forzata (FVC) dal basale ad ogni timepoint (settimana 4, 8, 12, 24, 36, 48) • Numero di declini definiti come diminuzione di 9 punti nella scala di valutazione funzionale (ALSFRS-R) rispetto al basale oppure morte • Variazione del punteggio della scala di valutazione funzionale (ALSFRS)-Revised dal basale ad ogni timepoint (settimana 4, 8, 12, 24,36, 48) Tasso di sopravvivenza inteso come il numero di pazienti vivi non tracheotomizzati ad ogni timepoint (settimana 12, 24, 36 e 48) • Variazione del livello di Cistatina C rispetto al basale ad ogni timepoint • Tempo della prima gastrectomia intesa come periodo intercorso tra la randomizzazione e la prima gastrectomia • Variazione assoluta e relativa nella Qualità della vita ALSAQ-40 dal basale ad ogni timepoint • Sicurezza: Eventi Avversi (EA), variazioni all'esame clinico compresi parametri vitali e peso, ECG ed esami di laboratorio (analisi biochimiche,ematologiche e analisi delle urine)
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 4, 8, 12, 24, 36
    4, 8, 12, 24, 36 settimane
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    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 No
    E.8.2.3Other No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    United Kingdom
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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: 300
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 81
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 381
    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)
    Maximum treatment exposure of 96 weeks.
    At Week 96 patient visit, patients will be proposed to carry on their study treatment at the same dose level.
    As soon as the treatment groups will be known, patients receiving placebo will be withdrawn from the study.
    La durata massima del trattamento sarà di 96 settimane.
    Alla visita della settimana 96, ai pazienti verrà proposto di continuare il trattamento in studio alla stessa dose assunta.
    Non appena i gruppi di trattamento saranno noti, i pazienti che ricevono placebo saranno sospesi dallo studio.
    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 Decision2015-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-01
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