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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-005980-30
    Sponsor's Protocol Code Number:53718678RSV2008
    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:2021-07-08
    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 number2020-005980-30
    A.3Full title of the trial
    A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir (JNJ-53718678) in Adult Outpatients with Respiratory Syncytial Virus (RSV) Infection who are at High Risk for RSV-related Disease Progression
    Estudio en fase IIb, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de rilematovir (JNJ-53718678) en pacientes adultos ambulatorios con infección por el virus respiratorio sincitial (VRS) que presentan un alto riesgo de progresión de la enfermedad relacionada con el VRS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of Rilematovir in Adult Outpatients with RSV Infection who are at High Risk for RSV-related Disease Progression
    Efectos de rilematovir en pacientes adultos ambulatorios con infección por el VRS que presentan un alto riesgo de progresión de la enfermedad relacionada con el VRS
    A.3.2Name or abbreviated title of the trial where available
    PRIMROSE
    A.4.1Sponsor's protocol code number53718678RSV2008
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/030/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJANSSEN CILAG, S.A.
    B.5.2Functional name of contact pointGLOBAL CLINICAL OPERATIONS
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 91 7228100
    B.5.5Fax number+34 91 7228628
    B.5.6E-mailbpiney1@its.jnj.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 namerilematovir
    D.3.2Product code JNJ-53718678
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrilematovir
    D.3.9.2Current sponsor codeJNJ-53718678
    D.3.9.3Other descriptive namerilematovir
    D.3.9.4EV Substance CodeSUB197011
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Respiratory Syncytial Virus
    Virus respiratorio sincitial
    E.1.1.1Medical condition in easily understood language
    Respiratory Syncytial Virus
    Virus respiratorio sincitial
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061603
    E.1.2Term Respiratory syncytial virus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 efficacy of rilematovir compared to placebo with respect to the time to resolution of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) symptoms.
    Evaluar la eficacia del rilematovir en comparación con el placebo con respecto al tiempo de resolución de los síntomas de la enfermedad del tracto respiratorio inferior por el virus sincitial respiratorio (VRS).
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of rilematovir as compared to placebo: 1) with respect to the incidence of post baseline RSV-related complications; 2) on medical resource utilization (MRU) with respect to respiratory therapeutic interventions associated with RSV-related disease progression; 3) on MRU with respect to medically attended visits associated with RSV-related disease progression; 4) on the overall RSV-related disease progression; 5) on the clinical course of RSV infection; 6) Health-Related Quality of Life; 7) on MRU.
    - To evaluate the: 1) safety and tolerability of rilematovir; 2) the antiviral effect of rilematovir as measured by RSV viral load in bilateral nasal mid-turbinate swab samples by quantitative reverse transcription polymerase chain reaction assay; 3) emergence of mutations in the viral genome potentially associated with resistance to rilematovir; 4) pharmacokinetics of rilematovir.
    - Evaluar el efecto del rilematovir en comparación con el placebo: 1) con respecto a la incidencia de complicaciones relacionadas con el VRS después del inicio de la enfermedad; 2) en la utilización de recursos médicos (URM) con respecto a las intervenciones terapéuticas respiratorias asociadas con la progresión de la enfermedad relacionada con el VRS; 3) en la URM con respecto a las visitas con asistencia médica asociadas con la progresión de la enfermedad relacionada con el VRS; 4) en la progresión general de la enfermedad relacionada con el VRS; 5) en el curso clínico de la infección por el VRS; 6) en la calidad de vida relacionada con la salud; 7) en la URM.
    - Evaluar la: 1) la seguridad y la tolerabilidad de rilematovir
    Por favor, consultar el protocolo del estudio para ver la lista completa de objetivos secundarios.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 to 85 years of age.
    2. Presentation to the healthcare facility with symptoms suggestive of a diagnosis of acute RSV infection and have at least any 2 symptoms of LRTD.
    3. Tested positive for RSV infection using a molecular-based diagnostic assay or on a respiratory tract sample.
    4. Participants must have at least one high-risk condition that predispose them to RSV-related disease progression.
    5. Randomized to study intervention treatment within 72 hours after onset of any of the RSV symptoms or worsening of pre-existing symptoms.
    6. Not be hospitalized during screening.
    1. De 18 a 85 años de edad.
    2. Acudir al centro de salud con síntomas que sugieran el diagnóstico de infección aguda por VRS y tener al menos 2 síntomas de EVRB.
    3. Que hayan dado positivo en la prueba de infección por VRS mediante un ensayo de diagnóstico de base molecular o en una muestra del tracto respiratorio.
    4. Los participantes deben tener al menos una condición de alto riesgo que los predisponga a la progresión de la enfermedad relacionada con el VRS.
    5. Ser aleatorizados al tratamiento de intervención del estudio dentro de las 72 horas siguientes a la aparición de cualquiera de los síntomas del VRS o al empeoramiento de los síntomas preexistentes.
    6. No estar hospitalizado durante la selección.
    E.4Principal exclusion criteria
    1. History of or concurrent disease or clinically significant findings during screening or medical history, physical examination, laboratory testing, vital signs, ECG recording, for which, in the opinion of the investigator, participation would not be in the best interest of the participant.
    2. Any condition that could prevent, limit, or confound the protocol-specified assessments.
    3. Known allergies, hypersensitivity, or intolerance to rilematovir or to any of the excipients of rilematovir or placebo formulation.
    4. Participants who are considered by the investigator to be immunocompromised within the past 12 months, whether due to underlying medical condition or medical therapy.
    1. Antecedentes o enfermedades concurrentes o hallazgos clínicamente significativos durante la selección o la historia clínica, el examen físico, las pruebas de laboratorio, los signos vitales, el registro del ECG, para los que, en opinión del investigador, la participación no sería en el mejor interés del participante.
    2. Cualquier condición que pueda impedir, limitar o confundir las evaluaciones especificadas en el protocolo.
    3. Alergias conocidas, hipersensibilidad o intolerancia al rilematovir o a cualquiera de los excipientes de la formulación del rilematovir o del placebo.
    4. Participantes que el investigador considere que están inmunocomprometidos en los últimos 12 meses, ya sea debido a una condición médica subyacente o a una terapia médica.
    E.5 End points
    E.5.1Primary end point(s)
    The time to resolution of RSV lower respiratory tract disease symptoms as assessed by using a Patient Reported Outcome Scale.
    El tiempo hasta la resolución de los síntomas de la enfermedad del tracto respiratorio inferior por el VRS, evaluado mediante una escala de resultados informada por el paciente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Initiation of study treatment up to Day 35
    Inicio del tratamiento del estudio hasta el día 35
    E.5.2Secondary end point(s)
    Key secondary endpoints:
    - Proportion of participants with post-baseline complications.
    - Safety and tolerability, as assessed by adverse events (AEs), clinical laboratory testing, electrocardiograms (ECGs), physical examination, and vital signs.
    - RSV viral load and change from baseline over time.
    - Evaluation of Medical resource utilization throughout the study period.
    - Pharmacokinetic parameters of rilematovir.
    Criterios de valoración secundarios clave:
    - Proporción de participantes con complicaciones posteriores a la línea de base.
    - Seguridad y tolerabilidad, evaluadas por eventos adversos (EA), pruebas de laboratorio clínico, electrocardiogramas (ECG), examen físico y signos vitales.
    - La carga viral del VRS y el cambio en el tiempo respecto al momento de referencia.
    - Evaluación de la utilización de recursos médicos a lo largo del período de estudio.
    - Parámetros farmacocinéticos de rilematovir.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study at specified timepoints.
    A lo largo del estudio en puntos de tiempo específicos.
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers
    Biomarcadores
    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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Brazil
    Canada
    India
    Japan
    Mexico
    Russian Federation
    South Africa
    Taiwan
    Thailand
    Turkey
    Ukraine
    United States
    Bulgaria
    Germany
    Hungary
    Italy
    Poland
    Spain
    Sweden
    Switzerland
    United Kingdom
    Argentina
    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 years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days5
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    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)
    There are no plans for post trial treatment other than standard of care.
    No hay planes para el tratamiento posterior al ensayo que no sea el estándar de atención.
    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 Decision2021-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-04-14
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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
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