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    Summary
    EudraCT Number:2017-005062-21
    Sponsor's Protocol Code Number:MK1654-002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-05-21
    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 number2017-005062-21
    A.3Full title of the trial
    A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK 1654 in Pre-Term and Full-Term Infants
    Estudio de dosis ascendente únicas, aleatorizado, doble ciego y controlado con placebo para evaluar la seguridad, la tolerabilidad y la farmacocinética de MK-1654 en neonatos prematuros y a término
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 1b Study of MK-1654 Safety and PK in Pre-Term and Full-Term Infants
    Estudio de fase 1b de la seguridad y la farmacocinética de MK-1654 en neonatos prematuros y a término
    A.4.1Sponsor's protocol code numberMK1654-002
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., 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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme de España S.A.
    B.5.2Functional name of contact pointInvestigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josefa Valcárcel, 38
    B.5.3.2Town/ cityMadrid, España
    B.5.3.3Post code28027
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913210600
    B.5.5Fax number+34913210590
    B.5.6E-mailensayos_clinicos@merck.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 MK-1654
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMK-1654
    D.3.9.2Current sponsor codeMK-1654
    D.3.9.3Other descriptive nameAnti RSV F antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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) Yes
    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
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Lower respiratory tract infections (LRI) caused by respiratory syncytial virus (RSV) A and B strains
    Prevención de infecciones de las vías respiratorias inferiores (IVRI) s causadas por cepas A y B del virus respiratorio sincitial (VRS)
    E.1.1.1Medical condition in easily understood language
    This trial indication is RSV (a common respiratory virus)
    La indicación del estudio es VRS (un virus común que causa infecciones respiratorias
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10039247
    E.1.2Term RSV infection
    E.1.2System Organ Class 100000004862
    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 safety and tolerability of MK-1654 through Day 365
    Evaluar la seguridad y la tolerabilidad de MK-1654 hasta el día 365.
    E.2.2Secondary objectives of the trial
    1. To estimate the serum pharmacokinetic (PK) profile of MK-1654 on Days 7, 30, 90, 150, and 365
    2. To describe the incidence of anti-drug antibodies (ADAs) to MK-1654 on Days 30, 90, 150, and 365
    1-Determinar el perfil farmacocinético (FC) en suero de MK-1654 los días 7, 30, 90, 150 y 365.
    2-Describir la incidencia de anticuerpos contra el fármaco (ACF) dirigidos contra MK-1654 los días 30, 90, 150 y 365.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (blood, serum) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questionsnot described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time
    MSD llevará a cabo investigaciones biomédicas futuras en muestras de ADN (sangre y suero) recogidas durante el desarrollo del ensayo clínico. Dicha investigación tiene como objeto el análisis de biomarcadores con el fin de abordar aspectos nuevos que no se describen en otras secciones del protocolo (como parte del estudio principal) y solo se llevarán a cabo en muestras de las participantes que hayan otorgado el consentimiento correspondiente. El objetivo de la obtención y conservación de muestras para investigaciones biomédicas futuras consiste en estudiar e identificar biomarcadores que proporcionen información a los científicos sobre las enfermedades y/o sus tratamientos. El objetivo último es utilizar tal información para desarrollar vacunas y fármacos más seguros y eficaces y/o para garantizar que los participantes reciban la dosis correcta del fármaco o la vacuna adecuadas en el momento preciso.
    E.3Principal inclusion criteria
    1. Be healthy (based on screening safety laboratory, medical history, and physical examination results) participants
    2. Participant is Male or Female
    3. Participant is a pre-term infant (born at 29 weeks to 35 weeks gestational age [inclusive]) or a full-term infant (born at over 35 weeks gestational age), as confirmed in medical records, at the time of signing the informed consent.
    4. Participant has chronological age between 2 weeks and 8 months (inclusive) at the time of signing the informed consent
    5. Participant weighs at least 2 kg at the time of screening
    6. The participant’s legally acceptable representative provides written informed consent for the study. The participant’s legally acceptable representative may also provide consent for Future Biomedical Research. However, the participant may participate in the main study without participating in Future Biomedical Research
    1. Ser participantes sanos (según los resultados de los análisis de seguridad, los antecedentes médicos y la exploración física de selección).
    2. El participante es de uno u otro sexo
    3. El participante es un neonato prematuro (nacido entre las 29 y 35 semanas de edad gestacional [ambas inclusive]) o a término (nacido a partir de las 35 semanas de edad gestacional), confirmado en la historia clínica, en el momento de firmar el consentimiento informado.
    4. El participante tiene una edad cronológica comprendida entre las 2 semanas y los 8 meses (ambos inclusive) en el momento de firmar el consentimiento informado.
    5. El participante pesa un mínimo de 2 kg en el momento de la selección.
    6. El representante legal del participante otorga su consentimiento informado por escrito para el estudio. El representante legal del participante también podrá otorgar su consentimiento para las investigaciones biomédicas futuras. No obstante, el participante podrá participar en el estudio principal sin necesidad de hacerlo en las investigaciones biomédicas futuras.
    E.4Principal exclusion criteria
    1. Has been recommended to receive palivizumab per local standard of care
    2. Has one or more out-of-range safety laboratory results:
    a. Serum Cr >1.5 x upper limit of normal (ULN) for age
    b. AST/ALT >1.5 X ULN
    c. Hb <9.5 g/dL
    d. WBC <4000 cells/mm3
    e. Platelets <120,000 mm3
    3. Has a known hypersensitivity to any component of the RSV monoclonal antibody
    4. Has a history of congenital or acquired immunodeficiency (eg, splenomegaly)
    5. Mother has documented human immunodeficiency virus (HIV) infection and HIV infection in the infant cannot be ruled out
    6. Mother has documented hepatitis B infection (HBsAg+) or hepatitis C (HCV Ab+) and hepatitis B or hepatitis C infection in the infant cannot be ruled out
    7. Has known or history of functional or anatomic asplenia
    8. Has a recent (within 14 days prior to screening) diagnosis of failure to thrive
    9. Has known or history of a coagulation disorder contraindicating intramuscular injection
    10. Has received a blood transfusion or blood products, including immunoglobulins
    11. Has had prior known RSV infection
    12. Has had congenital heart disease
    13. Has had chronic lung disease of prematurity requiring ongoing medical therapy
    14. Has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that, in the opinion of the investigator, might expose the participant to undue risk by participating in the study, confound the results of the study, or interfere with the participant’s participation for the full duration of the study
    15. Has any history of malignancy prior to randomization
    16. Has had a recent febrile illness (rectal temperature 38.1°C [100.5°F] or higher or axillary temperature 37.8°C [100.0°F] or higher) within 72 hours pre-dose
    17. Is not up-to-date on required vaccinations per local pediatric vaccine schedule at time of screening
    18. Has received inactivated or component vaccines (eg, influenza, hepatitis B) less than 14 days pre-dose.
    19. Has received live, non-study licensed pediatric vaccines less than 30 days pre-dose
    20. Prior administration of any vaccine or monoclonal antibody (mAb) for the prevention of RSV
    21. Is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time prior to first dose administration or while participating in this current study. Participants enrolled in observational studies may be included and will be reviewed on a case-by-case basis for approval by the Sponsor
    22. Has enrolled previously in the current study and been discontinued
    23. Is unable to provide blood sample at screening
    24. Cannot be adequately followed for safety according to the protocol plan
    25. Has a parent/legal guardian/legally acceptable representative who is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study
    26. Has any other reason that in the opinion of the investigator may interfere with the evaluation required by the study
    27. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study
    1. Se le ha recomendado que reciba palivizumab conforme a las normas asistenciales locales.
    2. Tiene uno o más resultados analíticos de seguridad fuera del intervalo normal*,†:
    a. Creatinina sérica > 1,5 veces el límite superior de la normalidad (LSN) para la edad.
    b. AST/ALT > 1,5 veces el LSN.
    c. Hb < 9,5 g/dl.
    d. RAN < 4000 células/mm3.
    e. Plaquetas < 120.000/mm3.
    3. Tiene hipersensibilidad conocida a algún componente del anticuerpo monoclonal contra el VRS.
    4. Tiene antecedentes de inmunodeficiencia congénita o adquirida (por ejemplo, esplenomegalia).
    5. La madre tiene una infección documentada por el virus de la inmunodeficiencia humana (VIH) y no puede descartarse la infección por este virus en el neonato.
    6. La madre tiene una infección documentada por el virus de la hepatitis B (HBsAg+) o C (anti-VHC+) y no puede descartarse la infección por estos virus en el neonato.
    7. Tiene presencia o antecedentes de asplenia funcional o anatómica.
    8. Tiene un diagnóstico reciente (en los 14 días previos a la selección) de retraso del crecimiento.
    9. Tiene presencia o antecedentes de un trastorno de la coagulación que contraindique la inyección intramuscular.
    10. Ha recibido una transfusión de sangre o hemoderivados, incluidas inmunoglobulinas.
    11. Ha tenido una infección previa por el VSR.
    12. Ha tenido una cardiopatía congénita.
    13. Ha tenido una neumopatía crónica de la prematuridad con necesidad de tratamiento médico continuo.
    14. Tiene antecedentes o signos actuales de cualquier proceso, tratamiento, anomalía analítica u otra circunstancia que, en opinión del investigador, pueda exponerle a un riesgo excesivo por participar en el estudio, confundir los resultados del estudio o interferir en su participación durante todo el estudio.
    15. Tiene antecedentes de una neoplasia maligna antes de la aleatorización.
    En caso de cumplirse alguno de los siguientes criterios de Enfermedades, la visita del día 1 podrá reprogramarse para un momento en el que no se cumplan dichos criterios:
    16. Ha tenido una enfermedad febril reciente (temperatura rectal de 38,1° C o superior o temperatura axilar de 37,8° C o superior) en las 72 horas previas a la dosis.
    17. No está al día con las vacunas obligatorias conforme al calendario local de vacunación pediátrica en el momento de selección.
    18. Ha recibido vacunas inactivadas o de componentes (p. ej., antigripal, de hepatitis B) menos de 14 días antes de la dosis.
    19. Ha recibido vacunas pediátricas autorizadas, ajenas al estudio, de microorganismos vivos menos de 30 días antes de la dosis.
    20. Administración previa de cualquier vacuna o anticuerpo monoclonal (AcM) para la prevención del VRS.
    21. Está participando o ha participado en un estudio clínico intervencionista con un compuesto o dispositivo en investigación en cualquier momento antes de la administración de la primera dosis o durante su participación en este estudio. Podrán incluirse participantes reclutados en estudios observacionales; se examinará cada caso con el fin de obtener la aprobación del promotor.
    22. Ha participado anteriormente en el presente estudio y ha sido retirado del mismo.
    23. Imposibilidad de obtener una muestra de sangre en la fase de selección.
    24. Imposibilidad de un seguimiento adecuado en cuanto a seguridad de acuerdo con el plan del protocolo.
    25. Es poco probable que el progenitor, tutor o representante legal cumpla los procedimientos del estudio o acuda a las citas o tiene previsto mudarse durante el estudio.
    26. Cualquier otro motivo que, en opinión del investigador, pueda interferir en la evaluación exigida por el estudio.
    27. El participante o un familiar directo (por ejemplo, cónyuge, progenitor o tutor legal, hermano o hijo) forma parte del personal del centro de investigación o del promotor implicado directamente en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - Proportion of participants experiencing adverse events (AEs) through Day 14
    - Proportion of participants experiencing serious adverse events (SAEs) through Day 365
    -Proporción de participantes que presenten acontecimientos adversos (AA) hasta el día 14.
    -Proporción de participantes que presenten acontecimientos adversos graves (AAG) hasta el día 365.
    E.5.1.1Timepoint(s) of evaluation of this end point
    There is an interim analysis planned to evaluate PK and safety data once Panels A-C complete their day 150 visit
    Hay un análisis intermedio planeado para evaluar datos farmacocinéticos, datos de seguridad cuando los grupos de dosis A-C hayan completado la visita del día 150.
    E.5.2Secondary end point(s)
    The MK-1654 PK variable(s) AUC0-inf, Cmax, Tmax, t1/2, C7days, C30days, C90days, C150days and C365days
    Variables farmacocinéticas de MK-1654: AUC0-inf, Cmáx, Tmáx, t1/2 y concentración (C7días, C30días, C90días, C150días y C365días).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The serum pharmacokinetic (PK) profile of MK-1654 on Days 7, 30, 90, 150, and 365
    El perfil farmacocinético (FC) en suero de MK-1654 los días 7, 30, 90, 150 y 365.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Study to evaluate Safety, Tolerability and Pharmacokinetics
    Estudio para evaluar la seguridad, la tolerabilidad y la farmacocinética
    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 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 trial6
    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 EEA2
    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
    Chile
    Colombia
    South Africa
    Spain
    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
    LPLV
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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 Yes
    F.1.1Number of subjects for this age range: 180
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 90
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 90
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 51
    F.4.2.2In the whole clinical trial 180
    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
    Ninguno
    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 Decision2018-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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