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    Summary
    EudraCT Number:2015-002003-28
    Sponsor's Protocol Code Number:53718678RSV1005
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-02-15
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-002003-28
    A.3Full title of the trial
    A Phase 1b, randomized, partially double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of multiple doses of orally administered JNJ-53718678 in infants hospitalized with RSV infection
    Uno studio di fase 1b, randomizzato, parzialmente in doppio cieco controllato verso placebo, per valutare la farmacocinetica, la sicurezza e la tollerabilità di molteplici dosi di JNJ-53718678 somministrato oralmente in bambini ospedalizzati con infezione da VRS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Administered JNJ-53718678 in Infants Hospitalized with Respiratory Syncytial Virus (RSV) Infection
    Uno studio per valutare la farmacocinetica, la sicurezza e la tollerabilità di molteplici dosi di JNJ-53718678 somministrato oralmente in bambini ospedalizzati con infezione da VRS
    A.3.2Name or abbreviated title of the trial where available
    A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Adminis
    Uno studio per valutare la farmacocinetica, sicurezza e tollerabilità di dosi molteplici di JNJ-537
    A.4.1Sponsor's protocol code number53718678RSV1005
    A.5.4Other Identifiers
    Name:.Number:.
    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 SponsorJANSSEN SCIENCES IRELAND UC
    B.1.3.4CountryIreland
    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 CILAG SPA
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportJANSSEN SCIENCES IRELAND UC
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310715242166
    B.5.5Fax number00310715242110
    B.5.6E-mailclinicaltrialsEU@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 nameJNJ-53718678-AAA-G025
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNJNJ-53718678-AAA
    D.3.9.2Current sponsor code.
    D.3.9.3Other descriptive nameJNJ-53718678-AAA
    D.3.9.4EV Substance CodeSUB166668
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.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 nameJNJ-53718678-AAA-G024
    D.3.2Product code .
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNJNJ-53718678-AAA
    D.3.9.2Current sponsor code.
    D.3.9.3Other descriptive nameJNJ-53718678-AAA
    D.3.9.4EV Substance CodeSUB166668
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboOral solution
    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 sinciziale
    E.1.1.1Medical condition in easily understood language
    Respiratory Syncytial Virus
    Virus respiratorio sinciziale
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10038717
    E.1.2Term Respiratory syncytial viral infections
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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
    To evaluate in infants who are hospitalized with RSV infection:
    - the pharmacokinetics of JNJ-53718678 after multiple oral doses;
    - the safety and tolerability of JNJ-53718678 when administered for 7 days.
    Gli obiettivi primari mirano a valutare nei bambini ospedalizzati con infezione da VRS:
    -la farmacocinetica di JNJ-53718678 dopo molteplici dosi orali;
    -la sicurezza e la tollerabilità di JNJ-53718678 somministrato per 7 giorni.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate in infants who are hospitalized with RSV infection:
    - the impact of JNJ-53718678 on the clinical course of RSV infection when administered for 7 days;
    - the antiviral activity of JNJ-53718678 when administered for 7 days.

    Exploratory Objectives:
    The exploratory objectives are to assess in infants who are hospitalized with RSV infection:
    - the relationship between the pharmacokinetics and the pharmacodynamics after repeated oral dosing of JNJ-53718678 for 7 days;
    - the evolution of viral resistance under JNJ-53718678 treatment;
    - the impact of the viral genotype on the antiviral response;
    - the clinical course of RSV during and following hospitalization based on twice daily (bid) or three times daily (tid) caregiver ratings of the severity of RSV symptoms through end of follow-up.
    Gli obiettivi secondari mirano a valutare nei bambini ospedalizzati con infezione da VRS:
    -l’impatto di JNJ-53718678 somministrato per 7 giorni sul decorso clinico dell’infezione da VRS;
    -l’attività antivirale di JNJ-53718678 somministrato per 7 giorni

    Gli obiettivi esplorativi mirano a valutare nei bambini ospedalizzati con infezione da VRS:
    • la relazione tra farmacocinetica e farmacodinamica dopo la somministrazione orale ripetuta di JNJ-53718678 per 7 giorni;
    • l’evoluzione della resistenza virale durante il trattamento con JNJ-53718678;
    • l’impatto del genotipo virale sulla risposta antivirale;
    • l’impatto di JNJ-53718678 somministrato per 7 giorni sul decorso clinico dell’infezione da VRS durante e dopo l’ospedalizzazione, secondo il giudizio espresso dal genitore/persona che si occupa del bambino (caregiver) nelle valutazioni degli esiti clinici (COA) registrate su un dispositivo elettronico fino al termine del follow-up.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participant has presented at the hospital for suspected Respiratory Syncytial Virus (RSV) infection within 72 hours prior to Screening completion
    - Participant has been hospitalized for this suspected RSV infection
    - Participant has been diagnosed with RSV infection using a polymerase chain reaction (PCR)- based assay, preferably commercially available locally
    - Participant was born after a normal term pregnancy (greater than or equal to 37 weeks and 0 days)
    - A legally acceptable representative of the participant must sign an Informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, are willing for their child to participate in the study, are willing for their child to remain in the hospital for the first 3 days of dosing (even if not clinically indicated), and are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
    Il soggetto deve essersi presentato in ospedale per una presunta infezione da VRS entro le 72 ore precedenti al completamento dello screening.
    Il soggetto deve essere stato ospedalizzato per la presunta infezione da VRS.
    Al soggetto deve essere stata diagnosticata un’infezione da VRS mediante un test basato sulla metodica PCR (reazione a catena della polimerasi), preferibilmente disponibile in commercio localmente.
    Il soggetto deve essere nato da una normale gravidanza a termine (≥37 settimane e 0 giorni).
    Il rappresentante legale autorizzato deve firmare un modulo di consenso informato (ICF) indicando di aver compreso lo scopo dello studio e le procedure previste, di acconsentire alla partecipazione del/della bambino/a, di acconsentire alla permanenza in ospedale del/della bambino/a per i primi 3 giorni di trattamento (anche se non clinicamente indicato) e di accettare/essere in grado di rispettare i divieti e le restrizioni specificati nel protocollo e le procedure dello studio
    E.4Principal exclusion criteria
    - Participant who had major surgery within the 28 days prior to randomization or planned major surgery through the course of the study
    - Participant has major congenital anomalies or known cytogenetic disorders
    - Participant has known or suspected immunodeficiency, such as known human immunodeficiency virus (HIV) infection
    - Participant has known or suspected hepatitis B or C infection
    - Participant is upon current admission initially hospitalized in the Intensive care unit (ICU) and/or in need of invasive endotracheal mechanical ventilation
    Il soggetto ha subito un intervento di chirurgia maggiore entro i 28 giorni precedenti alla randomizzazione o ha in programma un intervento di chirurgia maggiore nel corso dello studio
    Il soggetto presenta gravi anomalie congenite o disordini citogenetici noti
    Il soggetto presenta un’immunodeficienza nota o presunta, come per es. un’infezione da virus dell’immunodeficienza umana (HIV).
    Il soggetto presenta un’infezione nota o presunta da epatite B o C
    In occasione dell’attuale ospedalizzazione, il soggetto è inizialmente ricoverato nell’unità di terapia intensiva e/o necessita di ventilazione meccanica invasiva endotracheale.
    E.5 End points
    E.5.1Primary end point(s)
    1-Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678 2- Trough Plasma Concentration (Ctrough) of JNJ-53718678 3- Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) 4- Total Apparent Clearance (CL/F) of JNJ-53718678 5- Apparent Volume of Distribution (Vd/F) of JNJ-53718678 6- Number of Participants With Adverse Events
    1-Concentrazione plasmatica massima osservata (Cmax) di JNJ-53718678 2- Concentrazione plasmatica a valle (Ctrough) di JNJ-53718678 3-Area sotto la curva da tempo zero fino alla fine dell'intervallo di dose (AUCtau) 4-Clearance apparente totale (CL/F) di JNJ-53718678 5- Volume di distribuzione apparente (Vd/F) di JNJ-53718678 6- Numero di soggetti con eventi avversi
    E.5.1.1Timepoint(s) of evaluation of this end point
    1- Days 1, 2 and 3
    2- Days 1, 2 and 3
    3- Days 1, 2 and 3
    4- Days 1, 2 and 3
    5- Days 1, 2 and 3
    6- Up to Follow-up (Day 28)
    1-Giorno 1, 2 e 3
    2- Giorno 1, 2 e 3
    3- Giorno 1, 2 e 3
    4- Giorno 1, 2 e 3
    5- Giorno 1, 2 e 3
    6- Fino al Follow-up (Giorno 28)
    E.5.2Secondary end point(s)
    1.Area Under the Viral Load-time Curve (VL AUC) 2- Viral Load Over Time 3- Peak Viral Load 4- Time To Peak Viral Load 5- Number of Participants Reaching Undetectability of virus Between First Administration of Study Drug and Day 28 6- Total Number of Respiratory Syncytial Virus (RSV) Hospitalization Days from Admission to Discharge 7- Total RSV Hospitalization Days with Supplemental Oxygen Requirement 8- Total Days of RSV Intensive care unit (ICU) Stay 9- Total Days of non-invasive ventilator support During RSV Hospitalization 10- Total Days of Mechanical Ventilation During RSV Hospitalization 11- Changes in Peripheral Capillary Oxygen Saturation (SpO2) 12- Change from Baseline in Respiratory Rate 13- Change from Baseline in Body Temperature 14- Clinician Clinical Outcome Assessment of RSV Disease 15- Amount of food intake 16- Amount of water intake (hydration) 17- Amount of Feeding by Intravenous route
    1.Area sottesa alla curva concentrazione plasmatica virale vs tempo (VL AUC); 2. Concentrazione plasmatica virale nel tempo; 3. Picco di concentrazione virale; 4. Tempo di raggiungimento del picco di concentrazione virale; 5. Numero di partecipanti per cui il virus non è più rilevabile tra la prima somministrazione del farmaco in studio ed il giorno 28; 6. Numero totale di giorni di ospedalizzazione per infezione da virus respiratorio sinciziale (VRS) dall’accettazione in ospedale alla dimissione; 7. Giorni totali di ospedalizzazione da VRS che hanno richiesto un supplemento di ossigeno; 8. Giorni totali di ospedalizzazione da VRS trascorsi in unità di terapia intensiva (ICU); 9. Giorni totali che hanno richiesto l’uso di un respiratore non invasivo durante l’ospedalizzazione per VRS; 10. Giorni totali che hanno richiesto ventilazione meccanica durante l’ospedalizzazione per VRS; 11. Cambiamenti nella saturazione d’ossigeno periferica capillare (SpO2); 12. Variazioni dal basale della frequenza respiratoria; 13. Variazione dal basale della temperatura corporea; 14. Valutazione del medico dell’esito clinico della patologia da VRS; 15. Quantità di cibo assunta; 16. Quantità di acqua assunta (idratazione); 17. Quantità di nutrimento somministrato per via intravenosa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- Up to Follow-up (Day 28)
    2- Up to Follow-up (Day 28)
    3- Up to Follow-up (Day 28)
    4- Up to Follow-up (Day 28)
    5- Day 1 to Day 28
    6-17 - Up to Follow-up (Day 28)
    1.Fino al follow-up (giorno 28)
    2. Fino al follow-up (giorno 28)
    3. Fino al follow-up (giorno 28)
    4. Fino al follow-up (giorno 28)
    5. Dal giorno 1 al giorno 28
    6-17. Fino al follow-up (giorno 28)
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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
    Tolerability
    Antiviral activity
    Tollerabilità
    Attività antivirale
    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
    Multiple ascending dose study
    Studio di dosi molteplici crescenti
    E.7.2Therapeutic exploratory (Phase II) No
    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 No
    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 concerned6
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Belgium
    Brazil
    Germany
    Italy
    Spain
    Sweden
    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
    LPLV
    LVLS
    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 years0
    E.8.9.2In all countries concerned by the trial months14
    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: 1
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 42
    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 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 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
    Subjects are infants between 1 and 24 months
    Pazienti pediatrici fra 1 e 24 mesi
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 42
    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)
    See Protocol
    Vedere il Protocollo
    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 Decision2016-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-11-10
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