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    Summary
    EudraCT Number:2017-002297-39
    Sponsor's Protocol Code Number:EFC14660
    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:2018-05-23
    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 number2017-002297-39
    A.3Full title of the trial
    An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia
    Studio in aperto per valutare l’efficacia e la sicurezza di alirocumab in bambini e adolescenti con ipercolesterolemia familiare omozigote
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia
    Studio per valutare l’efficacia e la sicurezza di alirocumab in bambini e adolescenti con ipercolesterolemia familiare omozigote
    A.4.1Sponsor's protocol code numberEFC14660
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1200-2046
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/269/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSanofi-Aventis Recherche & Développement
    B.1.3.4CountryFrance
    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 supportSanofi-Aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi S.p.A.
    B.5.2Functional name of contact pointContact Point
    B.5.3 Address:
    B.5.3.1Street Addressviale Bodio 37/B
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number800226343
    B.5.5Fax number0239394168
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi.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 nameAlirocumab
    D.3.2Product code SAR236553
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAlirocumab
    D.3.9.1CAS number 1245916-14-6
    D.3.9.2Current sponsor codeSAR236553 (RGN727)
    D.3.9.3Other descriptive nameALIROCUMAB
    D.3.9.4EV Substance CodeSUB170596
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 nameAlirocumab
    D.3.2Product code SAR236553
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAlirocumab
    D.3.9.1CAS number 1245916-14-6
    D.3.9.2Current sponsor codeSAR236553 (RGN727)
    D.3.9.3Other descriptive nameALIROCUMAB
    D.3.9.4EV Substance CodeSUB170596
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for infusion in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Homozygous Familial Hypercholesterolemia
    Ipercolesterolemia familiare Omozigote
    E.1.1.1Medical condition in easily understood language
    Homozygous Familial Hypercholesterolemia
    Ipercolesterolemia familiare Omozigote
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10020603
    E.1.2Term Hypercholesterolaemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition 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 efficacy of alirocumab administered every 2 weeks (Q2W), on low-density lipoprotein cholesterol (LDL-C) levels of treatment in children with homozygous familial hypercholesterolemia (hoFH) 8 to 17 years of age on top of background treatments.
    Valutare l’efficacia di alirocumab somministrato ogni 2 settimane (Q2W) sui livelli di colesterolo-lipoproteine a bassa densità (C-LDL), nel trattamento di bambini con ipercolesterolemia familiare omozigote (hoFH) tra 8 e 17 anni di età, in aggiunta ai trattamenti di base
    E.2.2Secondary objectives of the trial
    -To evaluate the efficacy of alirocumab after treatment on LDL-C levels.
    -To evaluate the effects of alirocumab on other lipid parameters.
    -To evaluate the safety and tolerability of alirocumab.
    -Valutare l’efficacia di alirocumab sui livelli di C-LDL dopo il trattamento.
    -Valutare gli effetti di alirocumab su altri parametri lipidici
    -Valutare la sicurezza e la tollerabilità di alirocumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients genetically diagnosed with homozygous familial hypercholesterolemia (hoFH).
    -Patients treated with optimal dose of statin +/- other lipid modifying therapies (LMTs), or non-statin LMTs if statin-intolerant at stable dose(s) for at least 4 weeks prior to screening lipid sample.
    -A signed informed consent indicating parental permission with or without patient assent.
    -For patients on apheresis, currently undergoing stable low-density lipoprotein (LDL) apheresis therapy prior to the screening and have initiated apheresis treatment for at least 6 months.
    -pazienti con diagnosi genetica di ipercolesterolemia familiare omozigote (hoFH)
    -Pazienti trattati con dose ottimale di statine +/- altre terapie ipolipomizzanti (LMTs), o LMT non statiniche se intolleranti alle statine a dose stabile per almeno 4 settimane prima dello screening del campione lipidico

    - Un consenso informato firmato indicante l’autorizzazione dei genitori con o senza l’assenso del paziente

    - Per i pazienti che sono in trattamento con aferesi e sono attualmente sottoposti a terapia continuativa di aferesi delle lipoproteine a bassa densità (LDL) prima della visita di screening, avendo iniziato questo trattamento da almeno 6 mesi
    E.4Principal exclusion criteria
    -Patients with low-density lipoprotein - cholesterol (LDL-C) less than 130 mg/dL (3.37 mmol/L) obtained during the screening period after the patient has been on stable apheresis procedure or lipid modifying therapy (LMT) (i.e., stable optimal dose of statin ± other stable LMTs, or stable non statin LMTs in statin-intolerant patients) treatment for at least 4 weeks.
    -Patients with body weight less than 25 kg.
    -Patients aged 8 to 9 years not at Tanner Stage 1 and patients aged of 10 to 17 years not at least at Tanner Stage 2 in their development.
    -Patients with uncontrolled Type 1 or 2 diabetes mellitus.
    -Patients with known uncontrolled thyroid disease.
    -Patients with uncontrolled hypertension.
    -Fasting triglycerides >350 mg/dL.
    -Severe renal impairment (i.e., estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m^2) at the screening visit.
    -Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 x upper limit of normal (ULN).
    -Creatine phosphokinase (CPK) >3 x ULN.
    -I pazienti con C-LDL inferiore a 130 mg/dl (3,37 mmol/l) ottenuto durante il periodo di screening dopo che il paziente ha mantenuto una procedura stabile di aferesi o un trattamento LMT (ossia una dose ottimale stabile di statine ± un’altra LMT stabile, oppure la dose stabile di LMT non statinica nei pazienti intolleranti alle statine) per almeno 4 settimane

    - pazienti con peso corporeo inferiore ai 25 kg

    I pazienti di età compresa tra 8 e 9 anni con uno sviluppo inferiore allo stadio 1 di Tanner e i pazienti di età compresa tra 10 e 17 anni che non si trovino almeno allo stadio 2 di Tanner.

    -Pazienti con diabete mellito di tipo 1 e 2 non controllato

    -Pazienti con nota malattia tiroidea, non controllata

    -Pazienti con ipertensione non controllata

    -Trigliceridi a digiuno > 350 mg/dl

    -Grave insufficienza renale (ossia un tasso di filtrazione glomerulare stimata [estimated glomerular filtration rate, eGFR] < 30 ml/min/1,73 m2) alla visita di screening.

    -Alanina aminotransferasi (ALT) o aspartato aminotransferasi (AST)
    > 2 volte il limite superiore normale (upper limit of normal, ULN)

    -Creatina fosfochinasi (creatine phosphokinase, CPK) > 3 x ULN
    E.5 End points
    E.5.1Primary end point(s)
    Percent change in LDL-C (pre-apheresis, if applicable) from baseline to Week 12, using all LDL-C values (pre-apheresis, if applicable) regardless of adherence to treatment.
    Variazione percentuale del C-LDL (pre-aferesi, se applicabile) dal basale alla Settimana 12, usando tutti i valori di C-LDL (pre-aferesi, se applicabile) a prescindere dall’aderenza al trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 12
    Dal Basale alla settimana 12
    E.5.2Secondary end point(s)
    1. Percent change in LDL-C (pre-apheresis, if applicable) from baseline to Week 12, using all LDL-C values during the treatment period.
    2. Percent change in LDL-C (pre-apheresis, if applicable).
    3. Percent change in apolipoprotein B (Apo B) (pre-apheresis, if applicable).
    4. Percent change in non-high density lipoprotein cholesterol (non-HDL-C) (pre-apheresis, if applicable).
    5. Percent change in total cholesterol (total-C) (pre-apheresis, if applicable).
    6. Percent change in lipoprotein (a) (Lp(a)) (pre-apheresis, if applicable).
    7. Percent change in high-density lipoprotein cholesterol (HDL-C) (pre-apheresis, if applicable).
    8. Percent change in fasting triglycerides (TG) (pre-apheresis, if applicable).
    9. Percent change in apolipoprotein A1 (Apo A-1) (pre-apheresis, if applicable).
    10. Proportion of patients with ≥15% reduction in LDL-C (pre-apheresis, if applicable).
    11. Absolute change in LDL-C.
    12. Number of patients with adverse events.
    13. Tanner stage : the Tanner stage will be measured to assess stages of pubertal development.
    1) Variazione percentuale del C-LDL (pre-aferesi, se applicabile) dal basale alla Settimana 12 usando tutti i valori durante il periodo di trattamento
    2) Variazione percentuale del C-LDL (pre-aferesi, se applicabile)
    3) Variazione percentuale della apolipoproteina B (Apo B) (pre-aferesi, se applicabile)
    4) Variazione percentuale del colesterolo lipoproteine non ad alta densità ( non HDL-C) (pre-aferesi, se applicabile)
    5) variazione percentuale del colesterolo totale ( Total-C) (pre-aferesi, se applicabile)
    6) variazione percentuale della lipoproteina a (Lp(a)) (pre-aferesi, se applicabile)
    7) variazione percentuale del colesterolo lipoproteina ad alta densità (HDL_C) (pre-aferesi, se applicabile)
    8)Variazione percentuale di trigliceridi a digiuno (pre-aferesi, se applicabile)
    9) variazione percentuale della apolipoproteina A1 (Apo A-1) (pre-aferesi, se applicabile)
    10) Percentuale di pazienti con riduzione ≥ 15% del C-LDL (pre-aferesi, se applicabile)
    11) Variazione assoluta del C-LDL
    12) numero di pazienti con eventi avversi
    13) stadio di Tanner: lo stadio di Tanner sarà misurato per assegnare il livello dello sviluppo puberale
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From baseline to Week 12
    2. From baseline to Weeks 24 and 48
    3. From baseline to Week 12, to Week 24, and to Week 48
    4. From baseline to Week 12, to Week 24, and to Week 48
    5. From baseline to Week 12, to Week 24, and to Week 48
    6. From baseline to Week 12, to Week 24, and to Week 48
    7. From baseline to Week 12, to Week 24, and to Week 48
    8. From baseline to Week 12, to Week 24, and to Week 48
    9. From baseline to Week 12, to Week 24, and to Week 48
    10. From baseline to Weeks 12, 24 and 48
    11. From baseline to Weeks 12, 24 and 48
    12. Up to Week 62
    13. At Weeks 24, 24, and 48
    1) Dal basale alla settimana 12
    2) Dal basale alla settimana 24 e alla settimana 48
    3) Dal basale alla settimana 12, alla settimana 24 e alla settimana 48
    4) Dal basale alla settimana 12, alla settimana 24 e alla settimana 48
    5) Dal basale alla settimana 12, alla settimana 24 e alla settimana 48
    6) Dal basale alla settimana 12, alla settimana 24 e alla settimana 48
    7) Dal basale alla settimana 12, alla settimana 24 e alla settimana 48
    8) Dal basale alla settimana 12, alla settimana 24 e alla settimana 48
    9) Dal basale alla settimana 12, alla settimana 24 e alla settimana 48
    10)Dal basale alle settimane 12,24 e 48
    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
    hoFH genotyping
    Genotipizzazione hoFH
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Argentina
    Austria
    Brazil
    Bulgaria
    Canada
    France
    Italy
    Mexico
    Netherlands
    Norway
    Russian Federation
    Slovenia
    Spain
    Taiwan
    Turkey
    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 years1
    E.8.9.1In the Member State concerned months6
    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 months1
    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 Yes
    F.1.1Number of subjects for this age range: 50
    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: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children and adolescents
    bambini e Adolescenti
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 23
    F.4.2.2In the whole clinical trial 50
    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 Decision2018-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-16
    P. End of Trial
    P.End of Trial StatusCompleted
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