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    Summary
    EudraCT Number:2020-002023-11
    Sponsor's Protocol Code Number:53718678RSV3001
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-03-18
    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 ConcernedLatvia - SAM
    A.2EudraCT number2020-002023-11
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir in Infants and Children (≥28 Days to ≤5 Years of Age) and Subsequently in Neonates (<28 Days of Age), Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of a medication being studied (rilematovir) in infants and children and subsequently neonates in the hospital with a respiratory infection due to RSV
    A.4.1Sponsor's protocol code number53718678RSV3001
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/081/2019
    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 code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31(0)71524 2166
    B.5.5Fax number+31(0)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.3.4Pharmaceutical 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.3.9.3Other descriptive namerilematovir
    D.3.9.4EV Substance CodeSUB197011
    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 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
    E.1.1.1Medical condition in easily understood language
    Respiratory Syncytial Virus
    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 the superiority of rilematovir compared to placebo treatment with respect to the clinical outcome on the RSV Recovery Scale (RRS).
    E.2.2Secondary objectives of the trial
    -To evaluate the superiority of rilematovir compared to placebo treatment with respect to: 1) clinical resolution of RSV disease; 2)the time from first dosing to resolution of Key RSV Signs/Symptoms including supplementation free; 3)the time from discharge to resolution of Key RSV Signs/Symptoms; 4)the time from first dosing to end of oxygen supplementation; 5)the incidence of post-baseline RSV-related complications.
    -To evaluate the safety and tolerability of rilematovir.(6)
    -To evaluate the effect of rilematovir on the clinical course of RSV disease as assessed electronically by: 7)ObsRO Signs/Symptoms and ObsRO General Health Questions (GHQ); 8)ClinRO Signs/Symptoms and CLinRO GHQ.
    -To evaluate the effect of rilematovir on the clinical course of RSV disease (other than ClinRO and ObsRO assessments).(9)
    -To evaluate the antiviral effect of rilematovir as measured by RSV viral load in nasal mid-turbinate (MT) swab samples by qRT-PCR assay.(10).

    *partial list due to space.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The participant is a boy or girl ≥28 days corrected for gestational age at birth to ≤5 years old at the time of consent. Note: After this main study opens to neonate enrollment: in addition, a neonate (boy or girl) from birth at term (ie, after at least 37 weeks of gestation) to <28 days at the time of consent.
    2. The participant weighs within ≥2.4 kg and ≤24.6 kg.
    3. Each participant’s parent(s) (preferably both if available or as per local requirements) or their legally acceptable representative(s) has/have signed an ICF indicating that (s)he:
    • understands the purpose of, and procedures required for, the study,
    • is willing for their child to participate in the study,
    • is willing for their child to remain in the hospital until at least Day 2,
    • is willing and able to adhere to the prohibitions and restrictions with regards to
    - the concomitant medication,
    - the lifestyle consideration,
    - study procedures and assessments to be performed by the parent(s)/caregiver(s) as well as those by the investigator/study site personnel.
    4. The participant has been diagnosed with RSV infection using a polymerase chain reaction (PCR)- or other molecular-based diagnostic assay. Note: If a participant had a positive RSV test result using a molecular-based diagnostic assay from another study for which (s)he was otherwise ineligible or from a SOC molecular-based diagnostic test within 24 hours prior to start of screening and meets all eligibility criteria for inclusion in this study, this diagnostic test result can be used for determination of eligibility.
    5. The participant has an acute respiratory illness with at least 1 of the signs/symptoms listed in each of the following categories within 24 hours prior to start of screening and at screening, as evaluated by the investigator:
    • Upper respiratory tract infection: nasal congestion or rhinorrhea; AND
    • Lower respiratory tract infection: increased respiratory effort (as evidenced by subcostal, intercostal or tracheosternal retractions, grunting, head bobbing, nasal flaring, or tachypnea), wheezing, cough*, cyanosis, or apnea; AND
    • Systemic/general: feeding difficulties (defined as <75% intake of normal food amounts); dehydration; fever; disturbed sleep, or disturbed activity level (irritable/restless/agitated/less responsive).
    *Cough cannot be the only LRTI sign/symptom present, ie, another LRTI sign/symptom needs to be present for eligibility.
    6. The time of onset of RSV signs/symptoms to the anticipated time of randomization must be ≤3 days. Onset of signs/symptoms is defined as the time of the day (or part of the day if time of the day cannot be specified) the parent(s)/caregiver(s) became aware of the first sign and/or symptom consistent with respiratory or systemic/general manifestation of signs/symptoms of RSV infection. The time of sign/symptom onset has to be assessed as accurately as possible.
    7. The participant is hospitalized or presented to the ER/clinic and expected to be hospitalized. Note: Hospitalized refers to having at least 24 hours with an overnight stay in the hospital.
    8. Participants are otherwise healthy or have (a) risk factor(s) for severe RSV disease. Participants who are immunocompromised are excluded.
    9. The participant must have been assessed per local public health practice and considered not to have SARS-CoV-2 infection during this respiratory infection.
    E.4Principal exclusion criteria
    1. The participant had major surgery within the 28 days prior to randomization or planned major surgery through the course of the study (eg, bidirectional Glenn procedure).
    2. The participant has a neuromuscular disease that affects swallowing or the thoracic muscles, an evolving developmental disorder, major congenital anomalies or known cytogenetic or metabolic disorders other than the ones allowed above (see inclusion criterion #8).
    3. The participant is considered by the investigator to be immunocompromised, whether due to underlying medical condition (eg, known human immunodeficiency virus [HIV] infection, malignancy or genetic disorder other than immunoglobulin A deficiency) or medical therapy (eg, immunomodulators other than corticosteroids for the treatment of comorbidities, chemotherapy, radiation, stem cell or solid organ transplant).
    4. The participant has a known or clinically suspected acute or chronically active hepatitis B or C infection (based on participant’s medical history or on participant’s examination) or history of active maternal hepatitis B or C infection around birth, unless the participant has tested negative for hepatitis B and C infection.
    5. The participant has had either: a) Confirmed SARS-CoV-2 infection (test positive) during the four weeks prior to randomization, OR b) Close contact with a person with COVID-19 (test confirmed or suspected SARS CoV-2 infection) within 14 days prior to randomization.
    6. The participant is being treated with extracorporeal membrane oxygenation.
    7. Confirmed QTcF interval >450 msec per the machine read parameter result at screening. Presence of an abnormal QTcF interval should be confirmed by repeat ECG recording during screening.
    8. Presence of repetitive ventricular premature contractions (>10/min), second or third degree heart block, or complete or incomplete left bundle branch block, or complete right bundle branch block per the machine read ECG result at screening. Presence of any of the above abnormalities should be confirmed by repeat ECG recording during screening.
    9. 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.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is RRS as assessed on the first day when at least 50% of the participants across treatment arms are discharged from the hospital (the day for the RRS evaluation will be determined based on blinded data at the first interim analysis by an independent statistician).
    E.5.1.1Timepoint(s) of evaluation of this end point
    First day when at least 50% of the participants across treatment arms are discharged from the hospital.
    E.5.2Secondary end point(s)
    1) Proportion of participants clinically resolved from RSV disease based on Clinician Rated Outcome (ClinRO) Signs/Symptoms as assessed on the same day as the primary endpoint.
    2) Time from first study dose to resolution of Key RSV Signs/Symptoms (absent or mild) based on parent’s/caregiver’s Observer Rated Outcome (ObsRO) Signs/Symptoms and supplementation free (oxygen and feeding/hydration) for at least 24 hours.
    3) Time from discharge to resolution of Key RSV Signs/Symptoms based on ObsRO Signs/Symptoms (only including participants who did not reach resolution before first discharge).
    4) Time from first dosing to end of oxygen supplementation (only including participants who were receiving oxygen supplementation at the time of first dosing).
    5) Incidence in post-baseline RSV-related complications.
    6) Safety and tolerability, as assessed by adverse events (AEs), clinical laboratory testing, electrocardiograms (ECGs), vital signs throughout the study.
    7) A) The following endpoints will be based on the ObsRO Signs/Symptoms: time to resolution of signs/symptoms (absent or mild) of RSV disease; actual values and changes from baseline in scores.
    B) The following endpoint will be based on the ObsRO GHQ: time to improvement.
    8) a) The following endpoints will be based on the ClinRO Signs/Symptoms:
    - time to resolution of signs/symptoms (absent or mild) of RSV disease;
    - actual values and changes from baseline in scores;
    - proportion of participants clinically resolved from RSV disease based on ClinRO Signs/Symptoms as assessed each day from Day 2 to 8.
    b) The following endpoint will be based on the ClilnRO GHQ: general impression of change.
    9) See list below:
    - RRS as assessed each day separately from Days 2 to 8.
    - Time to hospital discharge from start of dosing.
    - Time to readiness for hospital discharge (as evaluated by the investigator).
    - Proportion of participants requiring intensive care unit (ICU) stay.
    - Duration of requiring ICU stay.
    - Proportion of participants requiring rehospitalization for respiratory/other reasons.
    - Time to end of oxygen supplementation.
    - Proportion of participants requiring oxygen supplementation.
    - Duration of oxygen supplementation.
    - Time to end of supplemental feeding/hydration.
    - Proportion of participants requiring hydration and/or feeding by intravenous (IV) administration or nasogastric tube.
    - Duration of supplemental feeding/hydration.
    - Time to end of supplementation (oxygen and/or feeding/hydration).
    - Number and type of medical encounters.
    - Incidence of antibiotic treatment episodes.
    - Incidence of systemic or inhaled corticosteroids and bronchodilators use.

    NOTE: partial list due to character constraints in section E.5.2.1
    E.5.2.1Timepoint(s) of evaluation of this end point
    Numbers below correspond to numbers in E.5.2:
    1)First day when at least 50% of the participants across treatment arms are discharged from the hospital
    2)Time from first study dose to resolution of Key RSV Signs/Symptoms
    3)Time from discharge to resolution of Key RSV Signs/Symptoms
    4)Time from first dosing to end of oxygen supplementation
    5)post baseline
    6)Throughout the study
    7a)time to resolution of signs/symptoms and actual values/changes from baseline
    7b)time to improvement
    8a)time to resolution of signs/symptoms (absent or mild) of RSV disease; actual values and changes from baseline in scores; proportion of participants clinically resolved from Day 2 to 8
    8b)when questionnaire is administered
    9)Multiple, see E.5.2 #9
    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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    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
    Brazil
    Canada
    Chile
    China
    Colombia
    India
    Israel
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    Panama
    Philippines
    Russian Federation
    South Africa
    Taiwan
    Thailand
    Turkey
    Ukraine
    United States
    Belgium
    Bulgaria
    Estonia
    Germany
    Hungary
    Italy
    Latvia
    Poland
    Slovakia
    Spain
    Sweden
    Czechia
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days8
    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: 737
    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: 657
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 80
    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
    Child's parent(s) or legally acceptable representative(s) to sign ICF.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 442
    F.4.2.2In the whole clinical trial 737
    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.
    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 Decision2021-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-03-18
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