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    Summary
    EudraCT Number:2019-001509-25
    Sponsor's Protocol Code Number:53718678RSV2006
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-07-15
    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 ConcernedUK - MHRA
    A.2EudraCT number2019-001509-25
    A.3Full title of the trial
    A Two-Part Study With a Birth Cohort (Observational Stage) for Early Diagnosis of Respiratory Syncytial Virus (RSV), Followed by an Optional Phase 2a, Randomized, Double-blind, Placebo-controlled Study (Interventional Stage) to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 in Infants With Acute Respiratory Tract Infection due to RSV
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A birth cohort study for early diagnosis of RSV followed by an interventional stage to study the antiviral activity, dosing, safety, efficacy, and tolerability of JNJ-53718678 in pediatric participants with RSV.
    A.4.1Sponsor's protocol code number53718678RSV2006
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/081/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Sciences Ireland UC
    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 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 number+310 71524 2166
    B.5.5Fax number+310 71524 2110
    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
    D.3.2Product code JNJ-53718678
    D.3.4Pharmaceutical form Powder and solvent for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNJNJ-53718678
    D.3.9.2Current sponsor codeJNJ-53718678
    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 number23
    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 placeboPowder and solvent for oral solution
    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
    Acute Respiratory Tract Infection due to RSV
    E.1.1.1Medical condition in easily understood language
    Acute Respiratory Tract Infection Due to RSV
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10066740
    E.1.2Term Acute respiratory tract infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    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
    Part 1: Observational Stage
    •To evaluate the onset and evolution of clinical symptoms of pediatric RSV disease
    •To evaluate the relationship between viral load and clinical symptoms at early diagnosis of pediatric RSV disease
    Part 2: Interventional Stage
    The primary objective is to evaluate antiviral activity of JNJ-53718678 as measured by RSV viral load in nasal swab samples by a quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in an early intervention setting in infants (≤4 months of age at enrollment) recruited from a birth cohort.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess:
    •the impact of treatment with JNJ-53718678 on the clinical course of RSV infection
    •the safety and tolerability of JNJ-53718678 after repeated oral doses
    •the pharmacokinetics (PK) of JNJ-53718678 after repeated oral doses
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part 1: Observational Stage
    Each potential participant must satisfy all of the following criteria to be enrolled in the observational stage of the study:
    1.The infant is ≤4 months of age at enrollment and asymptomatic for ARI-like symptoms requiring medical intervention at the time of consent to participate in the study.
    2.Participant’s parent(s) (preferably both if available or as per local requirements) or their legally acceptable representative(s) must sign an ICF (observational stage) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the infant to participate in the study and is willing/able to adhere to the study procedures and assessments to be performed by the parent(s)/caregiver(s) as well as those by the investigator/site staff.
    3.At least 1 parent/caregiver must be able to use the RSV mobile App at home via his/her own Android/iOS electronic device (compatible with RSV mobile App).
    4.At least 1 parent/caregiver should be of legal consent age (according to local regulation).

    Part 2: Interventional Stage
    Each potential participant must satisfy all of the following criteria to be enrolled in the interventional stage of the study:
    1.The participant has been diagnosed with RSV infection using a rapid molecular-based diagnostic assay.
    2.Participant’s parent(s) (preferably both if available or as per local requirements) or their legally acceptable representative(s) has/have signed an ICF (interventional stage) indicating that he or she understands the purpose of, and procedures required for, the interventional stage of the study and is willing to allow the infant to be treated with JNJ 53718678 or placebo and is willing and able to adhere to the prohibitions and restrictions with regards to the concomitant medication (see Section 6.5), the lifestyle consideration (see Section 5.3), and study procedures and assessments to be performed by the parent(s)/caregiver(s) as well as those by the investigator/site staff.
    Refusal to give consent for the interventional stage does not exclude a participant from continued participation in the observational stage of the study.
    3.The participant is at least 28 days old at the time of consent.
    E.4Principal exclusion criteria
    Part 1: Observational Stage
    Any potential participant who meets any of the following criteria will be excluded from participating in the observational stage of the study:
    1.Inclusion in (maternal) RSV vaccine studies or RSV treatment studies.
    2.During the RSV circulation, the infant is experiencing ARI-like symptoms requiring medical intervention on the day of enrollment.
    3.Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
    4.The participant has any physical abnormality which limits the ability to collect regular nasal specimens.
    5.The participant is receiving chronic home oxygen therapy at enrollment.

    Part 2: Interventional Stage
    Any potential participant who meets any of the following criteria will be excluded from participating in the interventional stage of the study:
    1. The participant has major congenital anomalies or known cytogenetic or metabolic disorders other than the ones allowed below.
    Note: Isolated open ductus arteriosus and open foramen ovale are not exclusionary as these are not considered major anomalies. Participants with congenital heart disease, cystic fibrosis, congenital diaphragmatic hernia, or Down Syndrome are allowed to participate.
    2. The participant is considered by the investigator to be immunocompromised, whether due to underlying medical condition (eg, malignancy or genetic disorder other than immunoglobulin A deficiency, or known HIV infection) or medical therapy (eg, immunomodulators other than corticosteroids for the treatment of comorbidities, chemotherapy, radiation, stem cell or solid organ transplant).
    3. The participant has known or clinically suspected hepatitis B or C infection, either acute or chronic active.
    4. Criterion modified per Amendment 2.
    4.1 The participant has other clinically significant abnormal ECG findings not consistent with the present risk factor for severe RSV disease (if applicable) in the study population, as judged by the investigator based on the machine read ECG results at screening.
    5. Criterion modified per Amendment 2.
    5.1 The participant has a QTcF interval >450 ms per the machine read (mean of triplicate) parameter result confirmed by repeat triplicate ECG recording during screening.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1: Observational Stage
    •the total score, over time, of respiratory symptoms as captured by the RSV mobile Application (App) during the pre-diagnostic phase and the post-diagnostic phase for RSV(+) participants that do not enter in the interventional stage
    •the Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS) scores by the clinician (clinician PRESORS) on the day of RSV diagnosis
    •RSV viral load kinetics during the pre-diagnostic phase
    •RSV viral load kinetics from Day 1 to Day 8 after RSV diagnosis over time (if not participating in the interventional stage)
    •the PRESORS scores by parent(s)/caregiver(s) (parent[s]/caregiver[s] PRESORS) over time

    Part 2: Interventional Stage
    The primary efficacy endpoint is the RSV viral load area under the curve (AUC) from immediately prior to first dose of study medication through Day 5 derived from the RSV viral load as measured by a qRT PCR assay in nasal swabs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1- Observational stage:
    1.From Enrollment up to RSV mobile app alert
    2.Day of Diagnosis
    3.Day 1 to 8
    4.Day 1 to 8
    5.Day 1 to 21

    Part 2- Interventional stage:
    Viral load area under the curve: Day 1 to 21
    E.5.2Secondary end point(s)
    Secondary endpoints of the interventional stage can be summarized as follows:
    •virologic parameters derived from the RSV viral load as measured by a qRT-PCR assay in nasal swabs including:
    -RSV viral load and change from baseline (start of study medication) over time
    -RSV viral load AUC from immediately prior to first dose of study medication (baseline) through Day 3, Day 8, and Day 14
    -time to undetectable RSV viral load
    -proportion of participants with undetectable RSV viral load at each time point throughout the study
    •clinical course related endpoints:
    the following endpoints will be based on the PRESORS assessed throughout the interventional stage of the study by parent(s)/caregiver(s) (parent[s]/caregiver[s] PRESORS) and by the investigator (clinician PRESORS) during scheduled visits:
    •duration and severity of signs and symptoms of RSV disease assessed throughout the study by parent(s)/caregiver(s) PRESORS
    •change from baseline in parent(s)/caregiver(s) PRESORS (worsening or improvement)
    •change from baseline in clinician PRESORS (worsening or improvement)
    •time to resolution (ie, to none or mild) of RSV symptoms
    •time to improvement based on general questions on overall health
    •proportion of participants with improvement or worsening of RSV disease based on general questions on overall health on each study day from screening till Day 21
    •time to return to pre-RSV health as rated by the parent(s)/caregiver(s)
    respiratory rate, heart rate, body temperature, and peripheral capillary oxygen saturation (SpO2) over time as measured during scheduled visits
    need for (re)hospitalization during treatment and follow-up
    •safety and tolerability, as assessed by adverse events (AEs), clinical laboratory testing, electrocardiograms (ECGs), and vital signs, throughout the interventional stage of the study
    •PK parameters of JNJ-53718678, as determined by population PK (popPK) modeling
    E.5.2.1Timepoint(s) of evaluation of this end point
    Interventional stage:
    1.Viral load kinetics: Day 1 to 21
    2.Clinical course: D1 to D21
    3.Safety and tolerability: D1 to D28
    4.PK: day 3
    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 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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Observational, Tolerability, Microbiome
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Argentina
    Belgium
    Panama
    Taiwan
    United Kingdom
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days20
    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: 1300
    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: 78
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 611
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 611
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 ≤4 months of age at enrollment.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state170
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 270
    F.4.2.2In the whole clinical trial 1300
    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 Decision2019-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-16
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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