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    Summary
    EudraCT Number:2015-001714-96
    Sponsor's Protocol Code Number:R2222-RSV-1332
    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:2015-09-11
    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 number2015-001714-96
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of a Human Monoclonal Antibody, REGN2222, for the Prevention of Medically Attended RSV Infection in Preterm Infants`
    Estudio en fase 3, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de un anticuerpo monoclonal humano, REGN2222, para la prevención de la infección por el VRS bajo atención médica en lactantes prematuros.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial to Test Effect and Safety of REGN2222 in Preterm Infants
    Un ensayo clínico para evaluar el efecto y la seguridad de REGN2222 en lactantes prematuros
    A.3.2Name or abbreviated title of the trial where available
    NURSERY Pre-Term
    A.4.1Sponsor's protocol code numberR2222-RSV-1332
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02325791
    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 Pharmaceutical, 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 Management
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34900 834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 nameREGN2222
    D.3.2Product code REGN2222
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation Yes
    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 INNREGN2222
    D.3.9.1CAS number 1629615-23-1
    D.3.9.2Current sponsor codeREGN2222
    D.3.9.3Other descriptive nameREGN2222
    D.3.9.4EV Substance CodeSUB176424
    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 placeboLyophilisate for solution 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
    Medically attended respiratory syncytial virus infection
    Infección por el VRS bajo atención médica
    E.1.1.1Medical condition in easily understood language
    RSV infection requiring medical care
    Infección por el VRS que requiere atención médica
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLT
    E.1.2Classification code 10038717
    E.1.2Term Respiratory syncytial viral infections
    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
    Part A:
    -To determine the PK of IM administration of REGN2222
    Part B: Study sites in the EU will only participate in Part B of the trial
    -To demonstrate the efficacy of REGN2222 in preventing medically attended RSV infections (subjects with either RSV-confirmed hospitalizations or outpatient LRTI)
    Parte A:
    -Determinar la farmacocinética (FC) de las administraciones
    intramusculares (IM) de REGN2222
    Parte B: Los centros del estudio en la UE sólo participarán en la parte B
    -Demostrar la eficacia de REGN2222 en la prevención de las
    infecciones por el virus respiratorio sincitial (VRS) bajo atención
    médica (pacientes con hospitalizaciones o con infección de las vías
    respiratorias inferiores [IVRI] ambulatoria por el VRS confirmadas)
    E.2.2Secondary objectives of the trial
    Part A:
    -To evaluate safety, tolerability, and immunogenicity of REGN2222 following IM administration
    Part B:
    -To evaluate safety and tolerability of REGN2222
    -To demonstrate the efficacy of REGN2222 in reducing RSV confirmed hospitalizations, emergency room (ER), urgent care (UC), or paediatric clinic visits
    -To assess monthly serum levels of different dosing regimens of REGN2222
    -To assess immunogenicity of REGN2222
    Parte A:
    -Evaluar la seguridad, tolerabilidad e inmunogenicidad de
    REGN2222 tras la administración IM
    Parte B:
    -Evaluar la seguridad y la tolerabilidad de REGN2222
    -Demostrar la eficacia de REGN2222 para reducir las
    hospitalizaciones, las visitas al servicio de urgencias, la atención de
    urgencias leves o las visitas a centros pediátricos por el VRS
    confirmadas
    - Evaluar mensualmente las concentraciones séricas de diferentes
    pautas posológicas de REGN2222
    -Evaluar la inmunogenicidad de REGN2222
    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 substudy is to collect a cheek swab from subjects for DNA for future use for the purpose of discovery of predictive biomarkers.
    The purpose of the genomic analyses is to identify genomic associations with disease prognosis/severity and long-term outcomes, or other clinical outcome measures. These data may be used or combined with data collected from other studies to identify genomic markers that may predict response and elucidate mechanisms of disease. Analyses may include sequence determination or single nucleotide polymorphism studies of candidate genes and surrounding genomic regions. Genome-wide studies, including (but not limited to) single nucleotide polymorphism analyses, genomic sequencing, and transcriptome sequencing may also be performed. If indicated, genomic analyses may also be performed to identify markers associated with toxicity.
    La finalidad del subestudio opcional es obtener una muestra con hisopo de la mejilla de los pacientes para determinación del ADN con vistas a un uso futuro para descubrir biomarcadores predictivos. La finalidad de los análisis genómicos es identificar relaciones genómicas con el pronóstico/gravedad de la enfermedad y los resultados a largo plazo, u otros criterios de valoración clínicos. Estos datos se podrán emplear o combinar con datos recogidos en otros estudios para identificar marcadores genómicos que predigan la respuesta y esclarezcan los mecanismos de la enfermedad. Los análisis pueden consistir endeterminación secuencial o estudios de polimorfismos de un solo nucleótido de genes candidatos y regiones genómicas circundantes. También se podrán realizar estudios pangenómicos, entre ellos análisis de polimorfismos de un solo nucleótido, secuenciación genómica y secuenciación de transcriptomas. Si está indicado también se podrán efectuar análisis genómicos para identificar marcadores relacionados con la toxicidad.
    E.3Principal inclusion criteria
    A subject must meet the following criteria to be eligible for inclusion in the study:
    1. Preterm, otherwise healthy male or female infant who has a chronological age of <=6 months of age at the time of the first dose (ie., infant must receive the first dose on or before the subject?s 6 month birthday)
    2. Gestational age at birth is no more than 35 weeks, 6 days
    3. Parent(s) or legal guardian(s) of the infant is able to understand the study requirements, willing to provide informed consent, and legally able to provide informed consent.
    Los pacientes deberán cumplir los criterios siguientes para poder participar en el estudio:
    1. Lactante prematuro de sexo masculino o femenino que tenga una edad cronológica <= 6 meses en el momento de la primera dosis (es decir, el lactante debe recibir la primera dosis al cumplir los 6 meses o antes)
    2. Edad de gestación al nacer no superior a 35 semanas, 6 días
    3. Los padres o el tutor del lactante son capaces de entender los requisitos del estudio, están dispuestos a otorgar el consentimiento informado y legalmente están capacitados para ello.
    E.4Principal exclusion criteria
    An infant who meets any of the following criteria will be excluded from the study:
    - Eligible and recommended to receive palivizumab per AAP or other
    local guidelines, standard practice, or by their healthcare provider
    - Children in whom a single blood draw would exceed 1% of their
    estimated total blood volume
    - History of CLD defined as requirement of supplemental oxygen for 28 days after birth
    - Known hemodynamically significant congenital heart disease
    - Known immunodeficiency, neuromuscular disease, or congenital abnormalities of the airway
    - Previously received palivizumab, IV gamma globulin, or any other investigational RSV prophylaxis or vaccine product
    - Previous reaction to IV immunoglobulin, blood products or other foreign proteins, such as vaccines and monoclonal antibodies, or any of the components of the investigational product formulation
    Se excluirá del estudio a los lactantes que cumplan cualquiera de los criterios siguientes:
    - Idoneidad y recomendación de tratamiento con palivizumab según las directrices de la AAP u otras directrices, la práctica habitual o su profesional sanitario
    - Los niños en los que en una sola extracción de sangre se vaya a exceder el 1% del volumen total de sangre estimado serán excluidos del estudio.
    - Antecedente de EPC, definido como necesidad de administración de oxígeno durante 28 días después del parto
    - Cardiopatía congénita hemodinámicamente importante conocida
    - Inmunodeficiencia, enfermedad neuromuscular o anomalías congénitas de las vías respiratorias conocidas
    - Administración previa de palivizumab, gammaglobulinas IV o cualquier otra profilaxis en investigación del VRS o producto vacunal
    - Reacción previa a inmunoglobulinas IV, hemoderivados u otras proteínas extrañas, como vacunas y anticuerpos monoclonales, o a cualquiera de los componentes de la formulación del producto en investigación
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are the following:
    Part A:
    -Serum concentration of REGN2222 over time and other PK parameters
    Part B:
    -Proportion of subjects with a medically attended RSV infection (hospitalization or outpatient LRTI) during the study period. A medically attended RSV infection is defined as an infant with a positive RSV test by RT PCR with any of the following events:
    - Hospitalized (on the basis of the assessment of the admitting physician) for RSV infection
    - Outpatient visit (ER, UC, or paediatric clinic [for either a sick or well visit]) with RSV LRTI.
    An RSV LRTI in an infant is defined as an RSV-proven respiratory infection (ie, positive RSV RT-PCR test) with parent(s)/legal guardian(s) report of cough or difficulty breathing, and with 1 of the following signs of LRTI, as assessed by a healthcare provider:
    -Chest wall indrawing
    -Hypoxemia (peripheral capillary oxygen saturation <95% breathing room air)
    - Wheezing or crackles
    Los criterios de valoración principales son:
    Parte A:
    - Concentración sérica de REGN2222 a lo largo del tiempo y otros
    parámetros FC
    Parte B:
    - Porcentaje de pacientes con una infección por el VRS bajo atención
    médica (hospitalización o IVRI ambulatoria) durante el periodo del estudio. Una infección por el VRS bajo atención médica se define
    como una infección en un lactante con positividad del VRS en la RT-PCR y cualquiera de los siguientes episodios:
    - Hospitalización (según la evaluación del médico responsable
    del ingreso) por infección por el VRS
    - Visita ambulatoria (servicio de urgencias, atención de urgencias leves o centro pediátrico [para una visita por enfermedad o preventiva]) con IVRI por el VRS.
    Una IVRI por el VRS en un lactante se define como una infección
    respiratoria por el VRS confirmada (es decir, positividad en el análisis de RT-PCR del VRS) con informe de los padres o el tutor de tos o dificultad para respirar y con uno de los signos siguientes de IVRI, según la evaluación de un profesional sanitario:
    - Tiraje de la pared torácica
    - Hipoxemia (saturación de oxígeno capilar periférica
    < 95% respirando aire ambiental)
    - Sibilancias ocrepitaciones.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Collected between first dose to study Day 150
    Recogido entre la primera dosis y el Día 150 del estudio
    E.5.2Secondary end point(s)
    The secondary endpoints are the following:
    Part A:
    - Incidence and severity of TEAEs
    - Presence and titer of anti-REGN2222 antibodies
    Part B:
    - Proportion of subjects who have RSV-confirmed hospitalization, ER,UC, or paediatric clinic visits (for upper or lower respiratory infection) during the study period
    Los criterios de valoración secundarios son:
    Parte A:
    - Incidencia e intensidad de los acontecimientos adversos surgidos
    durante el tratamiento (AAST)
    - Presencia y título de anticuerpos anti-REGN2222
    Parte B:
    - Porcentaje de pacientes con hospitalización o visitas al servicio de
    urgencia, atención de urgencias leves o visitas a centros pediátricos
    por el VRS confirmadas (por infecciones de las vías respiratorias superiores o inferiores) durante el periodo del estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Collected between first dose to study Day 150
    Recogido entre la primera dosis y el Día 150 del estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 trial3
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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
    Bulgaria
    Canada
    Chile
    Czech Republic
    Denmark
    Finland
    Hungary
    New Zealand
    Spain
    Sweden
    Turkey
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    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 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: 1539
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 154
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 1385
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Preterm infants<= 6 months of age
    Lactantes prematuros de <= 6 meses de edad
    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 665
    F.4.2.2In the whole clinical trial 1539
    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 Decision2015-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-26
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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