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    Summary
    EudraCT Number:2017-001862-56
    Sponsor's Protocol Code Number:64041575RSV2004
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-10-03
    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 ConcernedFinland - Fimea
    A.2EudraCT number2017-001862-56
    A.3Full title of the trial
    A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected with Respiratory Syncytial Virus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the effects of lumicitabine (JNJ-64041575) in hospitalized infants and children infected with Respiratory Syncytial Virus (RSV)
    A.3.2Name or abbreviated title of the trial where available
    PLUM
    A.4.1Sponsor's protocol code number64041575RSV2004
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/029/2017
    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 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 code2333CM
    B.5.3.4CountryNetherlands
    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 nameLumicitabine
    D.3.2Product code JNJ-64041575
    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 INNLumicitabine
    D.3.9.1CAS number 1445385-02-3
    D.3.9.2Current sponsor codeJNJ-64041575-AAA
    D.3.9.3Other descriptive nameALS-008176
    D.3.9.4EV Substance CodeSUB184536
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 suspension
    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 infection
    E.1.1.1Medical condition in easily understood language
    Respiratory virus infection
    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 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 determine in hospitalized infants and children who are infected with RSV the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using qRT-PCR.
    E.2.2Secondary objectives of the trial
    To determine in hospitalized infants and children who are infected with RSV:
    • The safety and tolerability of lumicitabine.
    • The PK of JNJ-63549109 in whole blood.
    • The impact of lumicitabine on the clinical course of RSV infection.
    • The impact of lumicitabine on the duration and severity of signs and symptoms of RSV infection as assessed by the Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS) questionnaire completed by the clinician in the electronic clinical outcome assessment (eCOA) device.
    • The impact of lumicitabine on the time to undetectable nasal RSV viral load.
    • The impact of lumicitabine on the emergence of RSV strains with resistance-associated mutations.
    • The relationship between the PK of JNJ-63549109 and the PD (antiviral activity, clinical symptoms, and selected safety parameters) after single (LD) and repeated oral dosing (MD) of lumicitabine.
    • The acceptability and palatability of the lumicitabine formulation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female infants and children ≥28 days to ≤36 months of age, defined at the time of randomization.
    • Subjects hospitalized (or in ER) at the time of randomization and unlikely to be discharged for the first 24 hours after randomization.
    • Subjects diagnosed with RSV infection using a PCR-based molecular diagnostic assay, with or without coinfection with another respiratory pathogen (respiratory virus or bacteria).
    • Subjects who have an acute respiratory illness with signs and symptoms consistent with a viral infection (eg, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset ≤5 days from the anticipated time of randomization.
    • With the exception of the symptoms related to the RSV infection or defined comorbid condition for severe RSV disease (prematurity at birth [subject’s gestational age was <37 weeks; for infants <1 year old at randomization], bronchopulmonary dysplasia,congenital heart disease, other congenital diseases, Down syndrome, neuromuscular impairment, or cystic fibrosis), subjects must be medically stable on the basis of physical examination, medical history, vital signs/SpO2, and ECG performed at screening.
    • The subject’s estimated glomerular filtration rate (eGFR) is not below the lower limit of normal for the subject’s age (Schwartz equation calculation).
    E.4Principal exclusion criteria
    • Subjects who are not expected to survive for more than 48 hours.
    • Subjects who have had major thoracic or abdominal surgery in the 6 weeks prior to randomization.
    • Subjects who received (within 12 months prior to screening) or who are currently on a waiting list for a bone marrow, stem cell, or solid organ transplant, who received radiation or chemotherapy, or who are currently taking immunosuppressive medication.
    • Subjects who have a known or suspected immunodeficiency (except immunoglobulin A [IgA] deficiency), such as a known human immunodeficiency virus infection.
    • Subjects who have a history of or concurrent illness (beyond a defined comorbid condition for severe RSV disease) that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject, or that could prevent, limit, or confound the protocol-specified assessments.
    • Subjects aged ≥28 days to 35 days with <8.0 g/dL (Grade 3) hemoglobin or a cardiac failure secondary to anemia (Grade 4) and subjects aged ≥36 days to 36 months with <7.0 g/dL (Grade 3) hemoglobin or cardiac failure secondary to anemia (Grade 4).
    • Subjects aged ≥28 days to 60 days with <899/mm3 absolute neutrophil count) and subjects aged ≥61 days to ≤36 months with <399/mm3 absolute neutrophil count.
    • Subjects aged ≥28 days to ≤36 months with <49,999/mm3 platelet count (Grade 3/4).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study is RSV RNA log10 viral load (measured by qRT-PCR assay in the mid-turbinate nasal swab specimens) AUC immediately prior to first dose of study drug (baseline) over 7 days.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Samples for the determination of RSV viral load will be taken as close as possible and before the LD on Day 1 and once daily at approximately the same time each day prior to study drug administration between Day 2 and Day 6 (whether hospitalized or not), and at the Day 7, Day 10, Day 14, and Day 28 visits.
    E.5.2Secondary end point(s)
    • Safety/tolerability including adverse events (AEs), physical examinations, vital signs/peripheral capillary oxygen saturation (SpO2), electrocardiogram (ECG), and clinical laboratory results.
    • PK parameters of JNJ-63549109.
    • RSV clinical course endpoints:
    o Length of hospital stay from admission to discharge and to readiness for discharge and from study treatment initiation to discharge and to readiness for discharge, with readiness for discharge evaluated by the investigator.
    o Requirement for and duration of intensive care unit (ICU) stay.
    o Requirement for and duration of oxygen supplementation/noninvasive mechanical ventilation support and/or invasive mechanical ventilation support above pre-RSV infection status.
    o Time to no longer requiring supplemental oxygen above pre-RSV infection status.
    o Time to clinical stability defined as the time from initiation of study treatment until the time at which the following criteria are met: return to pre-RSV infection status (hereafter referred to as “normalization”) of blood oxygen level (ie, without additional requirement of supplemental oxygen compared with pre-RSV infection status), normalization of oral feeding, normalization of respiratory rate, and normalization of heart rate.
    o Time from initiation of study treatment until SpO2 ≥93% on room air among subjects who were not on supplemental oxygen prior to the onset of respiratory symptoms.
    o Time to respiratory rate, SpO2, and body temperature return to pre-RSV infection status.
    o Incidence of acute otitis media (defined by the investigator).
    • The duration and severity of signs and symptoms of RSV infection as assessed by the PRESORS questionnaire completed by the clinician in the eCOA device.
    • RSV viral load as measured by qRT-PCR in the mid-turbinate nasal swab specimens, which will be used to determine the following:
    o RSV viral load over time.
    o Peak viral load, time to peak viral load, rate of decline of viral load, and time to RSV RNA being undetectable.
    o Proportion of subjects with undetectable RSV viral load at each timepoint.
    o RSV viral load AUC from immediately prior to first dose of study drug (baseline) until Day 10 and until Day 14.
    o RSV viral load AUC in subjects assigned to a longer dosing duration, if dosing duration is increased by the IDMC, from baseline until 1 day (+2 days) after the last dose of study drug.
    • Sequence changes (postbaseline) in the RSV polymerase L-gene and other regions (if warranted) of the RSV genome compared with baseline sequences.
    • Acceptability and palatability of the lumicitabine formulation as assessed by the parent(s)/caregiver(s) eCOA.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety and tolerability: evaluated throughout the study.

    PK sampling: Post Dose 1 (0.25-2h), Post Dose 2 (0.5-1h OR 7h) and Day 7 visit.

    Clinical evaluation and clinician eCOA: Screening and twice daily for the
    entire duration of hospitalization. After hospital discharge: at the Day 7, Day 10, Day 14, and Day 28 visits.

    Nasal swabs [RSV viral load and viral resistance (genome sequencing)]: before the LD on Day 1, once daily prior to study drug administration between Day 2 and Day 6 (whether hospitalized or not), and at the Day 7, Day 10, Day 14, and Day 28 visits.

    Parent(s)/caregiver(s) eCOA: Screening and twice daily for the entire duration of hospitalization. After hospital discharge: twice daily until the Day 14 visit, and once daily up to the Day 28 visit.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tollerability
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA69
    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
    Austria
    Belgium
    Brazil
    Canada
    Chile
    Colombia
    Czech Republic
    Finland
    France
    Germany
    Hungary
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Malaysia
    Netherlands
    New Zealand
    Panama
    Poland
    Portugal
    Slovakia
    Spain
    Sweden
    Taiwan
    Thailand
    Ukraine
    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
    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 months7
    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 months0
    E.8.9.2In all countries concerned by the trial days12
    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) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 140
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 40
    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 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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 77
    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
    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 Decision2018-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-10-16
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