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    Summary
    EudraCT Number:2015-004735-12
    Sponsor's Protocol Code Number:20130286
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-06-24
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-004735-12
    A.3Full title of the trial
    A Double Blind, Randomized, Placebo Controlled, Multicenter Study toEvaluate Safety, Tolerability, and Efficacy on LDL-C of Evolocumab (AMG 145) in Subjects with HIV and with Hyperlipidemia and/or Mixed Dyslipidemia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study is to find out more about evolocumab in HIV-positive patient`s and with high cholesterol (hyperlipidemia and/or mixed dyslipidemia).
    A.3.2Name or abbreviated title of the trial where available
    BEIJERINCK
    A.4.1Sponsor's protocol code number20130286
    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 Biotechnologia Sp. z o.o.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressPulawska 145
    B.5.3.2Town/ cityWarszawa
    B.5.3.3Post code02-715
    B.5.3.4CountryPoland
    B.5.4Telephone number48225813000
    B.5.5Fax number48225813001
    B.5.6E-mailMedinfo-pol@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 Yes
    D.2.1.1.1Trade name Repatha 140 mg solution for injection in pre-filled pen
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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 nameEvolocumab
    D.3.2Product code AMG 145
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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.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 nameEvolucumab
    D.3.2Product code AMG 145
    D.3.4Pharmaceutical form Solution for injection in cartridge
    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 number120
    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
    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 injection
    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
    HIV and hyperlipidemia or mixed dyslipidemia.
    E.1.1.1Medical condition in easily understood language
    HIV and high cholesterol ( elevated LDL cholesterol
    in blood) and/or mixed dyslipidemia (abnormal amounts of
    lipids in blood).
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10020604
    E.1.2Term Hypercholesterolemia
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10020667
    E.1.2Term Hyperlipidemia
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020180
    E.1.2Term HIV positive
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10058110
    E.1.2Term Dyslipidemia
    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
    To evaluate the effect of 24 weeks of subcutaneous (SC) evolocumab administered every month (QM) compared with placebo QM on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in human immunodeficiency virus (HIV)-positive subjects with hyperlipidemia or mixed dyslipidemia.
    E.2.2Secondary objectives of the trial
    • To assess the effects of 24 weeks of SC evolocumab QM compared with placebo QM on change from baseline in LDL-C, and percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), total cholesterol (TC), lipoprotein(a) [Lp(a)], triglycerides, HDL-C, and very low-density lipoprotein cholesterol (VLDL-C), in HIV-positive subjects with hyperlipidemia or mixed dyslipidemia
    • To assess the effects of 24 weeks of SC evolocumab QM compared with placebo QM on percent of subjects attaining LDL-C < 70 mg/dL (1.8 mmol/L) in HIV-positive subjects with hyperlipidemia or mixed dyslipidemia
    • To assess the effects of 24 weeks of SC evolocumab QM compared with placebo QM on percent of subjects attaining a 50% reduction in LDL-C from baseline in HIV-positive subjects with hyperlipidemia or mixed dyslipidemia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    * Subject has provided written informed consent
    * Male or female ≥ 18 years of age at signing of informed consent
    * Known HIV infection with stable HIV therapy for ≥ 6 months prior to
    randomization and not expected to change during the duration of study participation. Stable HIV therapy is defined as no new agents added and no dose change of any HIV drug within 6 months prior to randomization
    * Cluster of differentiation 4 (CD4) ≥ 250 cells/mm3 for ≥ 6 months prior to randomization
    * HIV viral load ≤ 50 copies/mL at screening and ≤ 200 copies/mL for ≥ 6 months prior to randomization
    * Subject on stable lipid-lowering therapy for ≥ 4 weeks prior to randomization
    and not expected to change during the duration of study participation. Subjects should be on maximally tolerated dose of statins.
    * Subject without known clinical atherosclerotic CVD (ASCVD): fasting LDL-C of ≥ 100 mg/dL (2.6 mmol/L) or non-HDL-C of ≥ 130 mg/dL (3.4 mmol/L) as determined by the central laboratory at screening. Subject with known clinical ASCVD: fasting LDL-C of ≥ 70 mg/dL (1.8 mmol/L) or non-HDL-C of ≥ 100mg/dL (2.6 mmol/L) as determined by the central aboratory.
    * Fasting triglycerides ≤ 600 mg/dL (6.8 mmol/L) as determined by central laboratory during screening
    * Subject tolerates screening placebo injection
    E.4Principal exclusion criteria
    * Subject taking a combination of background lipid-lowering therapy and HIV therapy known to have significant drug-drug interaction
    * New York Heart Association III or IV heart failure, or last known left ventricular ejection fraction < 30%
    * Known opportunistic infection/AIDS defining illness (including but not limited to candidiasis of bronchi, trachea, esophagus, or lungs, invasive cervical cancer, coccidioidomycosis, cryptococcosis, chronic intestinal (> 1-month duration) cryptosporidiosis, cytomegalovirus disease (particularly cytomegalovirus [CMV] retinitis), HIV-related encephalopathy, herpes simplex: chronic ulcer(s) (> 28 days duration); or bronchitis, pneumonitis, or esophagitis, histoplasmosis,
    chronic intestinal (> 28 days duration) isosporiasis, Kaposi's sarcoma,
    lymphoma, mycobacterium avium complex, tuberculosis, pneumocystis carinii pneumonia, recurrent pneumonia, progressive multifocal leukoencephalopathy, salmonella septicemia, toxoplasmosis of brain, or wasting syndrome due to HIV within 1 year prior to randomization
    * Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke within 3 months prior to randomization
    * Type 1 diabetes, new-onset (hemoglobin A1c [HbA1c] ≥ 6.5% or fasting plasma glucose ≥ 126 mg/dL at screening without known diagnosis) or poorly controlled (HbA1c ≥ 10%) type 2 diabetes by central laboratory during screening
    * Uncontrolled hypertension defined as sitting systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg during screening
    * Subject has taken a cholesterylester transfer protein inhibitor in the last 12 months prior to randomization
    * Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate < 30 mL/min/1.73 m2 during screening
    * Persistent active liver disease or hepatic dysfunction defined as Child-Pugh score of C. Stable (in the opinion of the primary investigator and with aspartate aminotransferase [AST] and alanine aminotransferase [ALT] < 5 times upper limit of normal [ULN] and not expected to require new treatment[s] during study) chronic hepatitis C of at least 1 year duration prior to randomization is allowed
    * Female subject of childbearing potential not willing to use acceptable method(s) of effective birth control during treatment with IP and for an additional 15 weeks after the end of treatment with IP. Female subjects of non-childbearing potential are not required to use contraception during the study and include those who have had a hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or who are postmenopausal.
    * Female subject is pregnant or breast feeding, planning to become pregnant or planning to breastfeed during treatment with IP and/or within 15 weeks after the end of treatment with IP
    * Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 5 years prior to randomization
    * Subject has previously received evolocumab or any other therapy to inhibit PCSK9
    * Currently receiving treatment in another investigational device or drug study, or < 30 days before randomization since ending treatment on another investigational device or drug study(s) or planning to receive other investigational procedures while participating in this study
    * Subject has known sensitivity to any of the active substances or their excipients to be administered during dosing, eg, carboxymethylcellulose
    * Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject’s and investigator’s knowledge
    * History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    *Percent change from baseline in LDL-C at week 24
    Safety endpoints
    *Subject incidence of treatment emergent adverse events
    *Safety laboratory values and vital signs at each scheduled assessment
    *Incidence of anti-evolocumab antibody (binding and neutralizing) formation
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1, week 12, week 20, week 24, week 36, week 52
    E.5.2Secondary end point(s)
    For week 24 the following secondary endpoints will be characterized:
    • Tier 1
    − Change from baseline in LDL-C
    − Percent change from baseline in non-HDL-C
    − Percent change from baseline in ApoB
    − Percent change from baseline in TC
    − Achievement of target LDL-C < 70 mg/dL (1.8 mmol/L)
    − LDL-C response (50% reduction of LDL-C from baseline)
    • Tier 2
    − Percent change from baseline in Lp(a)
    − Percent change from baseline in triglycerides
    − Percent change from baseline in HDL-C
    − Percent change from baseline in VLDL-C
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, week 12, week 20, week 24, week 36, week 52
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Belgium
    Brazil
    Canada
    France
    Greece
    Italy
    Poland
    Portugal
    Romania
    South Africa
    Spain
    Switzerland
    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
    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 months1
    E.8.9.1In the Member State concerned days14
    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 days14
    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: 420
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    HIV positive patients with hyperlipidemia and/or mixed dyslipidemia.
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 151
    F.4.2.2In the whole clinical trial 450
    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 Decision2017-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-27
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