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    Summary
    EudraCT Number:2017-001508-31
    Sponsor's Protocol Code Number:R1500-CL-1643
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-08-04
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2017-001508-31
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Doses and Dose Regimens of Evinacumab in Patients with Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying Therapy
    Randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie bezpečnosti a účinnosti různých dávek a dávkovacích režimů evinacumabu u pacientů s perzistentní hypercholesterolémií i přes maximální tolerovanou léčbu na úpravu hladin lipidů
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in which patients will be assigned, by chance, to receive either the active drug Evinacumab or a dummy-drug, (a placebo), without anybody knowing what that are assigned to, to determine safety and efficacy of different dose regimens of Evinacumab in patients with persistent high cholesterol despite taking the maximum tolerated lipid modifying therapy
    A.4.1Sponsor's protocol code numberR1500-CL-1643
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03175367
    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 SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown, NY
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@regeneron.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 nameEvinacumab (REGN1500) 3ml vial
    D.3.2Product code REGN1500
    D.3.4Pharmaceutical form Solution for injection
    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 INNEvinacumab
    D.3.9.1CAS number 1446419-85-7
    D.3.9.2Current sponsor codeREGN1500
    D.3.9.3Other descriptive nameEVINACUMAB
    D.3.9.4EV Substance CodeSUB181899
    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.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 nameEvinacumab (REGN1500) 20ml vial
    D.3.2Product code REGN1500
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEvinacumab
    D.3.9.1CAS number 1446419-85-7
    D.3.9.2Current sponsor codeREGN1500
    D.3.9.3Other descriptive nameEVINACUMAB
    D.3.9.4EV Substance CodeSUB181899
    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 injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying Therapy
    E.1.1.1Medical condition in easily understood language
    Hypercholesterolemia, also called dyslipidemia, is the presence of high
    levels of cholesterol in the blood, despite previous and concomitant treatment with Maximally Tolerated Lipid Modifying Therapy
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10020604
    E.1.2Term Hypercholesterolemia
    E.1.2System Organ Class 100000004861
    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 objective of the study is to evaluate the reduction of LDL-C by evinacumab in comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (HeFH, or non-HeFH with a history of clinical ASCVD) with persistent hypercholesterolemia despite receiving maximally-tolerated lipid-modifying treatment (LMT). Persistent hypercholesterolemia is defined as LDL -C ≥ 70 mg/dL (1.81 mmol/L) for those patients with clinical ASCVD and LDL -C ≥ 100 mg/dL (2.59 mmol/L) for those patients without clinical ASCVD.
    E.2.2Secondary objectives of the trial
    •To evaluate the dose-response effect of evinacumab on other lipid parameters (ie, ApoB, non-high-density lipoprotein cholesterol [non-HDL-C], total cholesterol [TC], Lp (a), triglycerides [TGs], ApoA1, apolipoprotein CIII [ ApoCIII ], and total Angiopoietin-like 3 [ANGPTL3]) in patients with primary hypercholesterolemia
    •To evaluate the safety and tolerability of SC and IV doses of evinacumab in patients with primary hypercholesterolemia
    •To assess systemic serum concentrations of evinacumab in patients with primary hypercholesterolemia
    •To evaluate the potential development of anti-evinacumab antibodies
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    An optional genomic sub-study will be conducted to identify genomic associations with clinical or biomarker response, other clinical outcome measures and possible AEs.
    Title : Genomic sub-study optional.
    Version and date: R1500-CL-1643.01, 22Jun2017
    Objectives: The purpose of the pharmacogenomic analyses is to identify genomic associations with clinical or biomarker response, other clinical outcome measures and possible AEs. In addition, associations between genomic variants and prognosis or progression of as well as other diseases may also be studied. These data may be used or combined with data collected from other studies to identify and validate genomic markers related to the study drug or and other diseases. Analyses may include sequence determination or single nucleotide polymorphism studies of candidate genes and surrounding genomic regions. Other methods, including whole exome sequencing, whole-genome sequencing, DNA copy number variation. The list of methods may be expanded to include novel methodology that may be developed during the course of this study or sample storage period.
    E.3Principal inclusion criteria
    1. Men and women, ages 18 through 80 at the screening visit
    2. Diagnosis of primary hypercholesterolemia, either HeFH or non-HeFH with clinical ASCVD
    3. A history of clinical ASCVD, for those patients who are non-HeFH.
    4. Receiving a stable maximally tolerated statin (± ezetimibe) for at least 4 weeks at screening
    5. Receiving alirocumab 150 mg SC Q2W, OR evolocumab 140 mg SC Q2W or 420 mg SC Q4W for at least 8 weeks prior to the screening visit
    6. Serum LDL-C ≥ 100 mg/dL at screening (1 repeat lab is allowed)
    7. Provide signed informed consent
    E.4Principal exclusion criteria
    1. Known history of homozygous FH (clinically, or by previous genotyping)
    2. Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
    3. Newly diagnosed diabetes (within 3 months prior to screening)
    4. Use of thyroid medications (except for replacement therapy which has been stable for at least 12 weeks before screening)
    5. Laboratory findings during screening period (not including randomization labs):
    - Triglycerides > 400 mg/dL (> 4.52 mmol/L) for patients without a known history of diabetes mellitus; OR Triglycerides > 300 mg/dL (> 3.39 mmol/L) for patients with a known history of diabetes mellitus
    - Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody (associated with a positive HCV ribonucleic acid [RNA] polymerase chain reaction)
    - Positive serum beta-human chorionic gonadotropin or urine pregnancy test in women of childbearing potential
    - Estimated glomerular filtration rate < 30 mL/min/1.73 m^2
    - TSH > 1.5 x upper limit of normal (ULN)
    - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x ULN
    - Creatine phosphokinase (CPK) > 3 x ULN at screening (1 repeat lab is allowed)
    6. Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at screening visit or time of randomization
    7. History of heart failure (New York Heart Association [NYHA] Class II-IV) within 12 months before screening
    8. History of MI, unstable angina leading to hospitalization, CABG surgery, PCI, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, TIA, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease within 3 months prior screening
    9. History of cancer within the past 5 years (except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer)
    10. Having received LDL apheresis within 2 months before screening
    11. Pregnant or breast-feeding women
    12. Women of childbearing potential who are unwilling to practice a highly effective birth control method
    13. Sexually active men unwilling to use acceptable birth control
    E.5 End points
    E.5.1Primary end point(s)
    Percent change in calculated low-density lipoprotein cholesterol (LDL-C) from baseline to week 16 in the intent-to-treat (ITT) population, using all LDL-C values regardless of adherence to treatment and subsequent therapies
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Week 16
    E.5.2Secondary end point(s)
    • Percent change in ApoB from baseline to week 16
    •Percent change in non-HDL-C from baseline to week 16
    •Percent change in TC from baseline to week 16
    •Proportion of patients with ≥ 30% reduction in calculated LDL-C at week 16
    •Proportion of patients with ≥ 50% reduction in calculated LDL-C at week 16
    •Percent change in TGs from baseline to week 16
    •Percent change in Lp(a) from baseline to week 16
    •Proportion of patients with calculated LDL-C < 100 mg/dL (2.59 mmol/L) at week 16
    •Proportion of patients with calculated LDL-C < 70 mg/dL (1.81 mmol/L) at week 16
    • Proportion of patients with calculated LDL-C < 50 mg/dL (1.30 mmol/L) at week 16
    •Percent change in calculated LDL-C, ApoB, non-HDL-C, TC, TG, and Lp(a) from baseline to week 24 (only applicable to those patients receiving IV route of study treatment administration)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and Week 16 for all endpoints except last endpoint regarding the Percent change in calculated LDL-C, ApoB, non-HDL-C, TC, TG, and Lp(a) that will be calculated on Baseline and week 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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    dose ranging study to assess varying doses of SC and IV regimens
    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 trial7
    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 EEA38
    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
    Austria
    Canada
    Czech Republic
    Denmark
    Israel
    Italy
    Netherlands
    New Zealand
    Norway
    Poland
    Russian Federation
    South Africa
    Spain
    Sweden
    United Kingdom
    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
    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 months5
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days10
    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: 152
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 114
    F.4.2.2In the whole clinical trial 252
    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)
    All patients who successfully complete this study have the opportunity to enroll in a separate open-label extension study. All patients that enroll in the separate open-label extension study will continue to receive evinacumab.
    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 Decision2017-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-03
    P. End of Trial
    P.End of Trial StatusOngoing
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