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    Summary
    EudraCT Number:2015-001343-37
    Sponsor's Protocol Code Number:20140316
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-10
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-001343-37
    A.3Full title of the trial
    A Randomized, Actively Controlled, Open-label, Multicenter Study of Efficacy and Safety of Evolocumab Compared With Low Density Lipoprotein Cholesterol (LDL-C) Apheresis, Followed by Single-Arm Evolocumab
    Administration in Subjects Receiving LDL-C Apheresis Prior to Study Enrollment
    Estudio multicéntrico, aleatorizado, abierto y con control activo de la eficacia y la seguridad de evolocumab en comparación con la aféresis del colesterol ligado a lipoproteínas de baja densidad (C-LDL), seguido de un solo grupo al que se administra evolocumab, en sujetos sometidos a aféresis del C-LDL antes de la inclusión en el estudio
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Evolocumab in Patients Undergoing Low-Density Lipoprotein Apheresis
    Estudio de evolocumab para pacientes sometidos a aféresis del C-LDL
    A.4.1Sponsor's protocol code number20140316
    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 SponsorAmgen 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 supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info - Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post code(CH-)6300
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34900850153
    B.5.6E-mailMedinfoInternational@amgen.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 nameEvolocumab
    D.3.2Product code AMG 145
    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 INNEVOLOCUMAB
    D.3.9.2Current sponsor codeAMG 145
    D.3.9.4EV Substance CodeSUB128552
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 Yes
    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 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
    Hypercholesterolemia
    Hipercolesterolemia
    E.1.1.1Medical condition in easily understood language
    Elevated LDL-cholesterol
    Elevado colesterol ligado a lipoproteínas de baja densidad (C-LDL)
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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 subcutaneous (SC) evolocumab, compared to regularly scheduled LDL-C apheresis, on reducing the need for future apheresis.
    Evaluar la eficacia de evolocumab administrado por vía subcutánea (SC), en comparación con la aféresis del C-LDL programada con regularidad, en la reducción de la necesidad de aféresis futuras
    E.2.2Secondary objectives of the trial
    To assess the effects of SC evolocumab compared with apheresis on percent change from baseline to week 4 in LDL-C, non-high-density lipoprotein cholesterol (non-HDL-C), and total cholesterol/high-density lipoprotein cholesterol (HDL-C) ratio
    Evaluar los efectos de evolocumab administrado por vía SC en comparación con la aféresis en el cambio porcentual entre el nivel basal y la semana 4 en el C-LDL, el colesterol ligado a lipoproteínas de no alta densidad (C-no-HDL) y la relación colesterol total/colesterol ligado a lipoproteínas de alta densidad (C-HDL).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female, ? 18 years of age at signing of informed consent.
    - Subject has been receiving regular apheresis for LDL-C lowering for at least 3 months immediately prior to lipid screening (per subject or physician report), has a treatment goal of LDL-C < 100 mg/dL (2.6 mmol/L) according to the physician managing the subject?s hypercholesterolemia, and has been receiving LDL-C apheresis during the last ? 4 weeks prior to lipid screening at regular QW or Q2W schedule and with no changes in apheresis type.
    - Subject is receiving lipid-lowering pharmacological background therapy which includes a high-intensity statin dose (moderate-intensity statin dose with attestation that a higher dose is not appropriate for the subject) per Appendix D, unless the subject has a history of statin intolerance.
    - Pre-apheresis LDL-C is ? 100 mg/dL (? 2.6 mmol/L) and ? 190 mg/dL (? 4.9 mmol/L) at screening.
    - Fasting triglycerides ? 400 mg/dL (4.5 mmol/L) at screening.
    - Hombre o mujer de ? 18 años de edad en el momento de firmar el consentimiento informado.
    - El sujeto ha estado recibiendo aféresis con regularidad para reducir el C-LDL durante al menos los 3 meses inmediatamente anteriores a la evaluación de lípidos (según la notificación del sujeto o médico), tiene un objetivo de tratamiento de C-LDL < 100 mg/dL (2,6 mmol/L) de conformidad con el médico responsable del tratamiento de la hipercolesterolemia del sujeto, y ha estado recibiendo aféresis del C-LDL durante las últimas ? 4 semanas antes de la evaluación de lípidos con una pauta QW o Q2W regular y sin cambios en el tipo de aféresis.
    - El sujeto está recibiendo un tratamiento farmacológico hipolipemiante de base que incluye una dosis de una estatina de alta intensidad (una dosis de una estatina de intensidad moderada si se confirma que una dosis más elevada no es adecuada para el sujeto) según el apéndice D, a menos que el sujeto tenga antecedentes de intolerancia a las estatinas.
    - El estado del tratamiento hipolipemiante (es decir, cualquier terapia para la disminución de los lípidos, incluido el tipo y la frecuencia de la aféresis) no debe modificarse durante ? 4 semanas antes de la determinación del C-LDL de selección.
    - El C-LDL previo a la aféresis es ? 100 mg/dL (? 2,6 mmol/L) y ? 190 mg/dL (? 4,9 mmol/L) en la selección; la muestra debe obtenerse 7 ± 1 días después de la aféresis QW más reciente o 14 ± 2 días después de la aféresis Q2W más reciente, respectivamente.
    - Triglicéridos en ayunas ? 400 mg/dL (4,5 mmol/L) en la selección.
    E.4Principal exclusion criteria
    - Known homozygous familial hypercholesterolemia.
    - Missing any apheresis session is medically contraindicated or inappropriate based on the opinion of the investigator.
    - Stopping apheresis would be inappropriate in the opinion of the investigator even if LDL-C is controlled to < 100 mg/dL with other therapies (eg, subject with Lp(a) > 60 mg/dL and for whom investigator would continue apheresis for Lp(a) reduction even with LDL-C <100 mg/dL).
    - Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization.
    - Known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction (except diabetes) or receiving renal replacement therapy.
    - Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) > 180 mmHg or diastolic blood pressure (DBP) > 110 mmHg.
    - Subject has taken a cholesterylester transfer protein (CETP) inhibitor such as anacetrapib, dalcetrapib or evacetrapib in the last 12 months, or mipomersen or lomitapide in the last 5 months prior to LDL-C screening.
    - Subject has previously received fully human anti-PCSK9 antibody therapy (eg, evolocumab) within < 12 weeks prior to lipid screening or has received any other therapy to inhibit PCSK9 at any time.
    - Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s) or planning to receive other investigational procedures while participating in this study.
    - Female subject who has (1) not used (an) acceptable method(s) of birth control for at least 1 month prior to screening and/or (2) is not willing to inform her partner of her participation in this clinical study and to use such (an) acceptable method(s) of effective birth control during treatment with IP
    (evolocumab) and for an additional 15 weeks after the end of treatment with IP (evolocumab), unless the female subject is permanently sterilized or postmenopausal (see protocol);
    - Subject is pregnant or breast feeding, or planning to become pregnant or planning to breastfeed during treatment with IP (evolocumab) and/or within 15 weeks after the end of treatment with IP (evolocumab).
    -Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 1 year prior to screening.
    - Hipercolesterolemia familiar homocigótica conocida.
    - Omitir cualquier sesión de aféresis está contraindicado y se considera inadecuado médicamente según la opinión del investigador.
    - Detener la aféresis sería inadecuado según el criterio del investigador incluso si se controla el C-LDL hasta < 100 mg/dL con otros tratamientos (por ejemplo, sujeto con Lp(a) > 60 mg/dL y para el cual el investigador continuaría la aféresis para reducir la Lp(a) incluso con C-LDL < 100 mg/dL).
    - Infarto de miocardio, angina inestable, intervención coronaria percutánea (ICP), injerto de derivación de arteria coronaria (IDAC) o infarto cerebral en los 3 meses previos a la aleatorización.
    - Infección activa conocida o disfunción hematológica, renal, metabólica, gastrointestinal o endocrina importante (excepto diabetes) o estar recibiendo tratamiento sustitutivo renal.
    - Hipertensión no controlada definida como presión arterial sistólica (PAS) en reposo > 180 mmHg o presión arterial diastólica (PAD) > 110 mmHg.
    - El sujeto ha sido tratado con inhibidores de la proteína de transferencia de ésteres de colesterol (CETP) como anacetrapib, dalcetrapib, evacetrapib en los últimos 12 meses, o con mipomersen o lomitapida en los últimos 5 meses previos a la determinación del C-LDL de selección.
    - El sujeto ha recibido previamente tratamiento con anticuerpos anti-PCSK9 completamente humanos (por ejemplo, evolocumab) en un período de < 12 semanas antes de la evaluación de lípidos o ha recibido cualquier otro tratamiento para inhibir la PCSK9 en cualquier momento.
    - Estar recibiendo actualmente tratamiento en otro estudio de un fármaco o dispositivo en investigación o haber transcurrido menos de 30 días desde el fin del tratamiento en otro estudio de un fármaco o dispositivo en investigación o tener previsto recibir otros procedimientos de investigación durante la participación en este estudio.
    - Mujer que (1) no haya utilizado (un) método/s anticonceptivo/s aceptable/s (véase a continuación) durante al menos 1 mes antes de la selección y/o (2) no esté dispuesta a informar a su pareja de su participación en este estudio clínico y a utilizar (un) método/s anticonceptivo/s aceptable/s eficaz/ces durante el tratamiento con el PI (evolocumab) y durante 15 semanas adicionales después del fin del tratamiento con el PI (evolocumab), a menos que haya sido esterilizada de forma permanente o sea posmenopáusica (ver protocolo).
    - Mujer embarazada o en período de lactancia, o que planee quedarse embarazada o dar el pecho durante el tratamiento con el PI (evolocumab) y/o en las 15 semanas posteriores al fin del tratamiento con el PI (evolocumab).
    - Tumor maligno (excepto cáncer de piel no melanomatoso, carcinoma cervical in situ, carcinoma ductal de mama in situ o carcinoma de próstata en estadio 1) en el último año antes de la selección.
    - Según informan el sujeto y el investigador, es probable que el sujeto no esté disponible para completar todas las visitas o procedimientos del estudio requeridos por el protocolo, o falta de fiabilidad como participante en el estudio (por ejemplo, consumo abusivo de alcohol u otras drogas en el último año o psicosis).
    - Antecedentes o signos de cualquier otro trastorno, condición o enfermedad clínicamente significativa que, en opinión del investigador o del médico de Amgen, si se consultan, puedan suponer un riesgo para la seguridad del sujeto o interferir en la evaluación, los procedimientos o la finalización del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Apheresis avoidance at the end of randomized therapy, defined as no apheresis at week 5 and week 6
    Evitación de la aféresis al final del tratamiento aleatorizado, definida como la ausencia de aféresis en la semana 5 y la semana 6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 5 and 6
    Semanas 5 y 6
    E.5.2Secondary end point(s)
    Percent change from baseline to week 4 in the following:
    ? LDL-C
    ? non-HDL-C
    ? total cholesterol/HDL-C ratio
    Cambio porcentual entre el nivel basal y la semana 4 en los siguientes parámetros:
    - C-LDL.
    - C-no-HDL.
    - Relación colesterol total/C-HDL.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and week 4
    Nivel Basal y semana 4
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 Yes
    E.8.2.3.1Comparator description
    LDL-C apheresis
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Czech Republic
    France
    Germany
    Italy
    Spain
    United Kingdom
    United States
    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
    LSLV
    Último sujeto, última visita
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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 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: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    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
    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 Decision2015-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-20
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