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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-004601-47
    Sponsor's Protocol Code Number:CKJX839D12303
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-04-11
    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 ConcernedIreland - HPRA
    A.2EudraCT number2021-004601-47
    A.3Full title of the trial
    A multi-center, randomized, double-blind, placebo controlled, parallel-group Phase IIIb study evaluating the effect of inclisiran on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of non-obstructive coronary artery disease without previous cardiovascular events (VICTORION-PLAQUE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Coronary computed tomography study to assess the effect of inclisiran on atherosclerotic plaque progression in participants with a diagnosis of non-obstructive coronary artery disease without previous cardiovascular events
    A.3.2Name or abbreviated title of the trial where available
    VICTORION-PLAQUE
    A.4.1Sponsor's protocol code numberCKJX839D12303
    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 Ireland Limited
    B.5.2Functional name of contact pointMedical Information Department
    B.5.3 Address:
    B.5.3.1Street AddressBeech House
    B.5.3.2Town/ cityBeech Hill Office Campus, Dublin 4
    B.5.3.3Post codeClonskeagh
    B.5.3.4CountryIreland
    B.5.4Telephone number+353 1 2601255
    B.5.5Fax number+353 1 2601263
    B.5.6E-mailmedinfo.dublin@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 Yes
    D.2.1.1.1Trade name Leqvio 284 mg solution for injection in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameInclisiran
    D.3.2Product code KJX839
    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 INNINCLISIRAN
    D.3.9.1CAS number 1639324-62-1
    D.3.9.2Current sponsor codeKJX839
    D.3.9.3Other descriptive nameInclisiran sodium
    D.3.9.4EV Substance CodeSUB182427
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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
    Non-obstructive coronary artery disease
    E.1.1.1Medical condition in easily understood language
    atherosclerotic plaque (fatty deposits that can lead to heart disease) in the heart with less than 50% obstruction of blood flow
    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 10011078
    E.1.2Term Coronary artery disease
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Inclisiran compared to placebo, on top of maximally tolerated statin therapy, in reducing the total coronary atheroma volume assessed by CCTA from baseline to month 24
    E.2.2Secondary objectives of the trial
    - Inclisiran compared to placebo, administered on top of maximally tolerated statin therapy, in reducing the LDL-C from baseline to month 24
    - Inclisiran compared to placebo in percentage change in low attenuation plaque volume evaluated by CCTA
    - Inclisiran compared to placebo in percentage of participants experiencing progression, regression, or no change of total plaque atheroma volume (progression, regression, or no change will be defined in the Statistical analysis plan (SAP)
    - Assess the safety and tolerability profile of inclisiran
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent must be obtained before any assessment is
    performed.
    2. Male or female ≥18 to ≤80 years of age at signing of informed
    consent.
    3. Fasting LDL-C local lab value at the Screening Visit of either i) ≥100
    mg/dL (2.6 mmol/L) if participant is on statin therapy but not on a
    maximally tolerated statin therapy; ii) ≥150 mg/dL (3.9 mmol/L) if
    participant is statin naive and without documented statin intolerance; or
    iii) ≥55 mg/dL (1.4 mmol/L) if participant is on a stable (≥4 weeks)
    dose of maximally tolerated statin therapy or if statin intolerant. Local
    laboratory values should be calculated using the Friedewald formula for
    consistency across study sites if the Screening visit occurs prior to the
    Baseline CCTA Visit. If the Screening and Baseline Visits occur on the same day, then the LDL-C value will be assessed on the central
    laboratory sample. If the center can only perform the direct LDL-C test,
    then the local lab should also obtain the total cholesterol, HDL-C, and
    triglycerides results so that the LDL-C can be calculated using the
    Friedewald estimation.
    4.Fasting LDL-C local lab value ≥55 mg/dL (1.4 mmol/L) at the
    assessment performed during the Statin Optimization Period 3 Visit for
    participants going through the Statin Optimization Period. Local
    laboratory values should be calculated using the Friedewald formula for
    consistency across study sites. If the center can only perform the direct
    LDL-C test, then the local lab should also obtain the total cholesterol,
    HDL-C, and triglycerides results so that the LDL-C can be calculated
    using the Friedewald estimation.
    5. Participants having Non-Obstructive Coronary Artery (NOCAD)*
    without previous cardiovascular events: NOCAD is defined as:
    (1) Participants with a CT-adapted Leaman score >5 and a diameter
    stenosis <50%***
    OR
    (2) Participants with a CT-adapted Leaman score >5 and a diameter
    stenosis ≥50%*but with FFRCT ≥0.76**. Notes: *=In case of left main
    CAD, diameter stenosis is ≥40%. **=In case of FFRCT between ≥0.76
    and 0.80, participant eligibility will be assessed and determined by the
    Imaging Core Lab based on the location of the lesion, proximality of the
    lesion, delta FFRCT, and diffuseness of coronary artery disease
    FFRCT and CT-adapted Leaman score will be determined by the Imaging
    Core Lab.
    A standard of care CCTA may serve as the study baseline CCTA scan if it
    is performed within 3 months prior to the participant's Screening Visit
    and meets the inclusion criteria as described above and as assessed by
    the Imaging Core Lab.
    6. At the Baseline Visit, participants must be on a stable (≥4 weeks)
    dose of maximally tolerated statin therapy. Participants not on
    maximally tolerated statin therapy and who do not have documented
    statin intolerance can be screened but must enter the study via a Statin
    Optimization Period.
    7.Fasting LDL-C lab value ≥55 mg/dL (1.4 mmol/L) at the Baseline Visit,
    measured at the central laboratory. If the Baseline and Screening Visits
    occur on the same day, then the LDL-C assessment will be assessed on
    the central laboratory sample. If a participant qualifies at Screening but
    the fasting central LDL-C value at the Baseline Visit does not meet
    eligibility, the eligibility will be determined based on the central lab
    result.
    8.Fasting triglycerides value <400 mg/dL (4.52 mmol/L) based on the
    local lab results at the Screening visit and on the central lab results at
    the CCTA visit.
    E.4Principal exclusion criteria
    1. Previous myocardial infarction (MI), or prior coronary revascularization [percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)].
    2. Planned revascularization (PCI or CABG).
    3. Previous ischemic cerebrovascular event including:
    • Prior ischemic stroke thought not to be caused by atrial fibrillation, valvular heart disease or mural thrombus.
    • History of prior percutaneous or surgical carotid artery revascularization.
    4. History of Peripheral Artery Disease (PAD):
    • Prior documentation of a resting ankle-brachial index <0.85.
    • History of prior percutaneous or surgical revascularization of an iliac, femoral, or popliteal artery.
    • Prior non-traumatic amputation of a lower extremity due to peripheral artery disease.
    5. Cardiac disorders, including any of the following:
    • Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, atrial fibrillation) within 3 months prior to randomization that is not controlled by medication or via ablation at the time of the Screening Visit.
    • Complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block) prior to randomization.
    6. NOCA participant who was prescreened by the Investigator with visual diameter stenosis >50% but FFR <0.8.
    7. Contraindication for CCTA (e.g., allergic reactions to the contrast dye) or CCTA not meeting entry standards after two attempts during the Baseline CCTA Visit as assessed by the Imaging Core Lab.
    8. Pacemaker or implantable cardioverter-defibrillator (ICD) in situ.
    9. Systolic Left Ventricle Ejection Fraction <30% at the Screening Visit.
    10. Uncontrolled severe hypertension: mean systolic blood pressure >180 mmHg or mean diastolic blood pressure >110 mmHg prior to randomization (assessed at the Screening Visit) despite antihypertensive therapy.
    11. Heart failure New York Heart Association (NYHA) class III or class IV at the Screening Visit.
    12. Renal insufficiency (eGFR <30 mL/min/1.73m2) as measured by the Modification of Diet in Renal Disease (MDRD) formula at the Screening Visit and at the Statin Optimization 3 Visit.
    13. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Screening Visit.
    Participants who enter Screening or the Statin Optimization Visit must
    have AST and ALT ≤3x ULN to be allowed to continue in the Screening or
    Statin Optimization Period.
    13.Local creatine kinase (CK) values of either, unless a more stringent
    threshold is mandated by a local regulatory authority (e.g., ≥3x ULN in
    Korea according to MFDS internal guideline):
    • CK values ≥5x ULN at the Screening Visit for participants on
    maximally tolerated statin therapy or who are statin intolerant.
    • CK values ≥5x ULN at Screening and before entering the Statin
    Optimization Period and confirmed by repeat test within 7 days at
    Screening or based on Investigator's judgement for participants entering
    the Statin Optimization Period (who will be switched to or initiated on
    the protocol-specified dose of high-intensity statin of atorvastatin ≥40
    mg QD or rosuvastatin ≥20 mg QD during the Statin Optimization
    Period).
    14. Local CK values ≥5x ULN at the Statin Optimization 3 Visit unless a
    more stringent threshold is mandated by a local regulatory authority
    (e.g., ≥3x ULN in Korea according to MFDS internal guideline) and
    monitored according to national guidelines and statin label during the
    Statin Optimization Period.
    15. Participant with myopathy at the Statin Optimization 3 Visit.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage change from baseline to month 24 in total coronary atheroma volume
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to month 24.
    E.5.2Secondary end point(s)
    -percentage change in LDL-C from baseline to month 24
    -percentage change in low attenuation plaque volume evaluated by CCTA
    -percentage of participants with progression, regression, or no change of total plaque atheroma volume
    -Incidence, severity, and relationship to study drug of TEAEs and Serious
    Adverse Events (SAEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to month 24.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Chile
    Switzerland
    Australia
    Brazil
    Canada
    China
    India
    Japan
    Korea, Republic of
    United Kingdom
    United States
    Belgium
    France
    Germany
    Hungary
    Ireland
    Italy
    Spain
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 330
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 270
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 223
    F.4.2.2In the whole clinical trial 600
    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)
    A post trial access program may be initiated to allow for the investigational drug to be made available to qualified patients participating in the study, in countries where it is not commercially available at the time of study completion.
    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 Decision2022-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-26
    P. End of Trial
    P.End of Trial StatusOngoing
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