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    Summary
    EudraCT Number:2019-001076-11
    Sponsor's Protocol Code Number:CTQJ230A12301
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-12-12
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-001076-11
    A.3Full title of the trial
    A randomized double-blind, placebo-controlled, multicenter trial assessing the impact of lipoprotein (a) lowering with pelacarsen (TQJ230) on major cardiovascular events in patients with established cardiovascular disease.
    Etude multicentrique, randomisée en double aveugle, contrôlée par placebo, évaluant l'impact de l'abaissement du taux de lipoprotéine (a) avec le pelacarsen (TQJ230) sur les événements cardiovasculaires majeurs chez des patients présentant une maladie cardiovasculaire établie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter trial assessing the impact of lipoprotein (a) lowering with pelacarsen (TQJ230) on major cardiovascular events in patients with cardiovascular disease.
    Etude multicentrique évaluant l'impact de l'abaissement du taux de lipoprotéine (a) avec le pelacarsen (TQJ230) sur les événements cardiovasculaires majeurs chez des patients présentant une maladie cardiovasculaire.
    A.4.1Sponsor's protocol code numberCTQJ230A12301
    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 SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma S.A.S
    B.5.2Functional name of contact pointInformation&Communication Médicales
    B.5.3 Address:
    B.5.3.1Street Address8/10 rue Henry Sainte Claire Deville, CS 40150
    B.5.3.2Town/ cityRueil-Malmaison
    B.5.3.3Post code92563
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 1 5547 6600
    B.5.5Fax number+33 1 5547 6100
    B.5.6E-mailicm.phfr@novartis.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.3.2Product code TQJ230
    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 INNPelacarsen
    D.3.9.1CAS number 1637637-70-7
    D.3.9.2Current sponsor codeTQJ230
    D.3.9.4EV Substance CodeSUB199332
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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 injection 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
    Cardiovascular Disease
    Maladie cardiovasculaire
    E.1.1.1Medical condition in easily understood language
    Atherosclerosis
    Athérosclérose
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10051614
    E.1.2Term Arteriosclerotic cardiovascular disease
    E.1.2System Organ Class 100000004866
    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 objectives of this study is to demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in 1) the overall study population with established CVD (Lp(a) ≥ 70 mg/dL) and/or 2) in a subpopulation with established CVD and Lp(a) ≥ 90 mg/dL.
    L'objectif primaire de cette étude est de démontrer la supériorité du pelacarsen (TQJ230) sur le placebo dans la réduction du risque d'événement MACE élargi (mort cardiovasculaire, IM non fatal, accident vasculaire cérébral non fatal et revascularisation coronaire urgente nécessitant une hospitalisation) dans 1) l'ensemble de la population de l'étude présentant une MCV établie et un taux de Lp(a) ≥ 70 mg/dl et/ou 2) dans une sous-population présentant une MCV établie et un taux de Lp(a) ≥ 90 mg/dl
    E.2.2Secondary objectives of the trial
    In the overall trial population and in subpopulation (≥ 90 mg/dL):
    Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of the MACE composite of CV death, non-fatal MI and non-fatal stroke.
    Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of the composite of coronary heart disease (CHD) outcomes: death due to CHD, non-fatal MI and urgent coronary re-vascularization requiring hospitalization .
    Evaluate the rate of all cause death.
    Demonstrate the superiority of pelacarsen (TQJ230) compared to
    placebo in lowering the Lp(a) level at 1 year.
    Dans l'ensemble de la population de l’étude et dans la sous-population (≥ 90 mg/dl) :
    Démontrer la supériorité du pelacarsen (TQJ230) sur le placebo à réduire le risque du critère composite MACE associant décès d'origine CV, IM non fatal et d'accident vasculaire cérébral non fatal.
    Démontrer la supériorité du pelacarsen (TQJ230) sur le placebo à réduire le risque du critère composite de maladie coronarienne : décès par cardiopathie congénitale, IM non fatal et revascularisation coronaire urgente nécessitant une hospitalisation.
    Evaluer le taux de décès toutes causes confondues.
    Démontrer la supériorité du pelacarsen (TQJ230) sur le placebo pour diminuer le Lp(a) à 1 an
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Lp(a) ≥ 70 mg/dL at the screening visit
    - Optimal LDL-cholesterol lowering treatment
    - Optimal treatment of other CV risk factors
    - Myocardial infarction: ≥ 3 months from screening and randomization
    visits to ≤ 10 years prior to the screening visit, and/or
    - Ischemic stroke: ≥ 3 months from screening and randomization visits
    to ≤ 10 years prior to the screening visit
    - Clinically significant symptomatic peripheral artery disease
    - Lp(a) ≥ 70 mg/dl lors de la visite de sélection
    - Traitement optimal visant à réduire le LDL-cholestérol
    - Traitement optimal pour les autres facteurs de risque CV
    - Infarctus du myocarde : ≥ 3 mois à ≤ 10 ans avant la période de sélection
    - AVC ischémique : ≥ 3 mois à ≤ 10 ans avant la période de sélection
    - Maladie artérielle périphérique symptomatique cliniquement significative
    E.4Principal exclusion criteria
    - Uncontrolled hypertension
    - Heart failure New York Heart Association (NYHA) class IV
    - History of malignancy of any organ system
    - History of hemorrhagic stroke or other major bleeding
    - Platelet count <140,000 per mm3
    - Active liver disease or hepatic dysfunction
    - Significant kidney disease
    - Pregnant or nursing women
    - Hypertension non contrôlée
    - Insuffisance cardiaque, classe IV de la New York Heart Association (NYHA)
    - Antécédents de tumeur maligne de tout système d'organes
    - Antécédents d'accident vasculaire cérébral hémorragique ou d'autres saignements majeurs
    - Nombre de plaquettes <140,000 per mm3
    - Maladie hépatique active ou dysfonctionnement hépatique
    - Maladie glomérulaire significative
    - Grossesse ou allaitement
    E.5 End points
    E.5.1Primary end point(s)
    1. Time to first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in patients with elevated Lp(a) ≥ 70 mg/dL
    2.Time to the first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in a population of patients with elevated Lp(a) ≥ 90 mg/dL.
    1. Délai jusqu’à la première occurrence du critère d'évaluation confirmé par le Comité d’adjudication des événements cardiovasculaires, dans une population de patients présentant un taux de Lp(a) élevé ≥ 70 mg/dl.
    2. Délai jusqu’à la première occurrence du critère d'évaluation confirmé par le Comité d’adjudication des événements cardiovasculaires, dans une sous-population de patients présentant un taux de Lp(a) élevé ≥ 90 mg/dl.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4.25 years for both endpoints
    4,25 ans pour les deux critères
    E.5.2Secondary end point(s)
    1.Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of major adverse cardiovascular events (CV death, non-fatal MI, and non-fatal stroke)
    2.Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of coronary heart disease: coronary heart disease death, non-fatal MI, urgent coronary re-vascularization requiring hospitalization
    3.Change in Lp(a) in the log scale from baseline at 1 year
    4.CEC confirmed all-cause death from randomization to the end of study
    1. Délai jusqu’à la première occurrence du critère d'évaluation confirmé par le Comité d’adjudication des événements cardiovasculaires (décès d’origine CV, IM non fatal et accident vasculaire cérébral non fatal).
    2. Délai jusqu’à la première occurrence du critère composite de maladies coronariennes (CHD) confirmé par le CEC : Décès dû à une maladie coronarienne (CHD), IM non fatal, revascularisation coronaire urgente nécessitant une hospitalisation.
    3. Variation due la Lp(a) ensur l’échelle logarithmique à 1 an par rapport à la baseline
    4.Décès toutes causes confondues confirmé par le CEC entre la randomisation et la fin de l'étude.
    E.5.2.1Timepoint(s) of evaluation of this end point
    4.25 years for endpoints 1,2 and 4
    1 year for endpoint 3
    4,25 ans pour critères 1, 2 and 4
    1 an pour critère 3
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA395
    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
    Australia
    Brazil
    Canada
    Chile
    China
    Colombia
    Guatemala
    Hong Kong
    India
    Israel
    Japan
    Korea, Republic of
    Lebanon
    Mexico
    Peru
    Philippines
    Russian Federation
    South Africa
    Taiwan
    Turkey
    United States
    Austria
    Belgium
    Bulgaria
    Denmark
    France
    Germany
    Greece
    Hungary
    Iceland
    Italy
    Netherlands
    Norway
    Poland
    Portugal
    Romania
    Slovakia
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    Argentina
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 4800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2880
    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 state105
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3000
    F.4.2.2In the whole clinical trial 7680
    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
    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 Decision2021-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-21
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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