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    Summary
    EudraCT Number:2019-001551-39
    Sponsor's Protocol Code Number:53718678RSV2005
    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:2019-08-07
    Trial 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 number2019-001551-39
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Outcomes, Antiviral Activity, Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics/Pharmacodynamics of JNJ-53718678 in Adult and Adolescent Hematopoietic Stem Cell Transplant Recipients with Respiratory Syncytial Virus Infection of the Upper Respiratory Tract
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of JNJ-53718678 in Adult and Adolescent Patients Who had a Hematopoietic Stem Cell Transplantation and Who are Infected With RSV
    A.3.2Name or abbreviated title of the trial where available
    FREESIA
    A.4.1Sponsor's protocol code number53718678RSV2005
    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 N.V.
    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 715242166
    B.5.5Fax number+31 715242110
    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 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 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 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 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
    The primary objective of the study is to evaluate the effect of JNJ-53718678 on the development of RSV lower tract respiratory infections (LRTIs) in adult hematopoietic stem cell transplant (HSCT) recipients with RSV upper respiratory tract infection (URTI).
    E.2.2Secondary objectives of the trial
    To evaluate:
    1. The effect of JNJ-53718678 on the development of RSV-associated lower respiratory tract complications (LRTC) in adult and adolescent HSCT recipients with RSV URTI.
    2. The safety and tolerability of JNJ-53718678.
    3. The impact of JNJ-53718678 on progression to respiratory failure and on all-cause mortality.
    4. The impact of JNJ-53718678 on the clinical course of RSV infection.
    5. The PK of JNJ-53718678.
    6. The relationship between the PK of JNJ-53718678 and the PD after repeated dosing of JNJ-53718678.
    7. The antiviral effect of JNJ-53718678 as measured by RSV viral load in bilateral mid-turbinate nasal swab samples by quantitative reverse transcription polymerase chain reaction (qRT PCR) assay.
    8. The impact of RSV and its treatment on health-related quality of life (HRQOL).
    9. The emergence of mutations in the viral genome potentially associated with resistance to JNJ-53718678.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each potential participant must satisfy all of the following criteria to be enrolled in the study:
    1. Male or female.
    2. 18 to 75 years of age, inclusive. Subjects ≥13 and <18 years of age may be enrolled in selected countries and study sites consistent with local regulations.
    3. Received an autologous or allogeneic HSCT using any conditioning regimen.
    4. ALC <1,000 cells/µL. The local assessment confirming ALC <1,000 cells/µL should be performed no more than 48 hours prior to randomization.
    5. The participant has been diagnosed with RSV infection using a rapid PCR- or other molecular-based diagnostic assay performed on a bilateral mid-turbinate nasal swab sample as part of the study-specific screening assessment or on an upper respiratory tract sample as part of SOC testing.
    6. New onset of at least 1 of the following respiratory symptoms within 4 days prior to the anticipated start of dosing (Day 1): nasal congestion, rhinorrhea, cough or pharyngitis (sore throat), and/or worsening of one of these chronic (associated with previously existing diagnosis, eg, chronic rhinorrhea, seasonal allergies, chronic lung disease) respiratory symptoms within 4 days prior to the anticipated start of dosing (Day 1).
    7. No evidence of new abnormalities consistent with LRTI on a chest X-ray relative to the most recent chest X-ray, as determined by the local radiologist (preferentially) or the investigator. A chest X-ray should be performed no more than 48 hours prior to randomization. If a chest X-ray has not been obtained as part of SOC, it must be obtained during Screening.
    E.4Principal exclusion criteria
    Any potential participant who meets any of the following criteria will be excluded from participating in the study:
    1. Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the investigator.
    2. Requires supplemental oxygen at Screening or any time between Screening and randomization.
    3. Documented to be positive for other respiratory viruses (limited to influenza, parainfluenza, human rhinovirus, adenovirus, human metapneumovirus, or coronavirus) within 7 days prior to or at the Screening visit, if determined by local SOC testing (additional testing is not required).
    4. Clinically significant bacteremia or fungemia within 7 days prior to or at Screening that has not been adequately treated, as determined by the investigator.
    5. Known allergies, hypersensitivity, or intolerance to JNJ-53718678 or its excipients.
    6. Bacterial, fungal, or viral pneumonia within 2 weeks prior to Screening that has not been adequately treated, as determined by the investigator.
    7. Criterion modified per Amendment 3:
    7.1 Confirmed QTcF interval >450 milliseconds per the machine read parameter result at Screening. Presence of an abnormal QTcF interval should be confirmed by repeat ECG recording during Screening.
    8. Criterion modified per Amendment 5:
    8.1 Clinically significant abnormal ECG findings (other than QTcF interval >450 milliseconds, see exclusion criterion 7) not consistent with the underlying condition in the study population, as judged by the investigator based on the machine read ECG results at Screening.
    9. Has evidence of one of the following ECG abnormalities per the machine read ECG results at Screening confirmed by repeat ECG recording: 1) Repetitive premature ventricular contractions (>10/min); 2) Second- or third-degree heart block; 3) Complete or incomplete left bundle branch block or complete right bundle branch block
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of participants who develop RSV LRTI per the Endpoint Adjudication Committee (EAC)’s assessment through Visit Day 28.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    E.5.2Secondary end point(s)
    1. The proportion of participants who develop RSV-associated LRTC per the EAC’s assessment through Visit Day 28.
    2. Safety and tolerability, as assessed by AEs, clinical laboratory testing, ECGs, vital signs, throughout the study.
    3. The proportion of participants progressing to respiratory failure and all-cause mortality.
    4. Clinical course-related endpoints:
    -Number of supplemental O2 free days through Day 28
    -Incidence of O2 requirement, total length and type (eg, supplemental oxygen, noninvasive pressure ventilation, invasive mechanical ventilation [tracheal tube, laryngeal mask, or tracheostomy])
    -Respiratory rate, heart rate, body temperature, and peripheral capillary oxygen saturation (SpO2) over time as measured by the investigator during scheduled visits
    -Proportion of participants hospitalized (of participants who were not hospitalized at baseline), proportion of participants re-hospitalized (of participants who were hospitalized at baseline and discharged during the study and of participants who were not hospitalized at baseline, required hospitalization, and were discharged during the study)
    -Total length of hospital stay (time in hospital before first dosing is discarded) and total time in the intensive care unit (ICU) (time in ICU before first dosing is discarded)
    -Incidence of Grade 3 and Grade 4 adverse events (AEs) in the Infections and Infestations System Organ Class
    -Incidence of respiratory and thoracic-related AEs
    -Incidence of antibiotic use in participants who develop and in those who do not develop RSV LRTI or RSV-associated LRTC per the EAC’s assessment
    -Time to resolution of symptoms, assessed through an instrument for patient-reported symptoms (Respiratory Infection Intensity and Impact Questionnaire [RiiQ] Symptom Scale)
    -Change from baseline through Day 28 in severity of symptoms reported by subjects in the RiiQ Symptom Scale
    -Time to resolution of respiratory illness, through the Patient Global Impression of Severity (PGI-S) Scale
    -Change in Patient Global Impression of Health (PGI-H) and Patient Global Impression of Change (PGI-C) Scales through Day 28
    5. PK parameters of JNJ-53718678
    6. PK/PD analysis of plasma concentration-time data of JNJ-53718678 using (non)-linear mixed-effects modeling.
    7. Virologic parameters derived from the RSV viral load as measured by a qRT-PCR assay in bilateral mid-turbinate nasal swab samples including:
    - RSV viral load and change from baseline over time.
    - RSV viral load area under the plasma concentration-time curve (AUC) from immediately prior to first dose of study intervention.
    - time to undetectable RSV viral load.
    - proportion of participants with undetectable RSV viral load at each time point throughout the study.
    8. Change from baseline for the HRQOL through Day 28 (as assessed through the 5-level EuroQol 5-Dimension [EQ-5D-5L] and RiiQ Impact Scales].
    9. Changes from baseline in the RSV F gene sequence (and potentially other regions of the RSV genome, at the discretion of the sponsor's virologist).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Through Visit Day 28
    2. Throughout the study
    3. Throughout the study
    4. Throughout the study
    5. D1, D3 ±1, D8 ±1, D15 ±1, D22
    6. Throughout the study (depending on PK modeling)
    7.
    - Baseline
    - Baseline through Day 8, Day 11, Day 15, Day 22, and Day 28
    - During visits
    - During visits
    8. Screening, pre-dose, D3±1, D5±1, D8±1, D11±1, D15±1, D22, D28±3
    9. pre-dose, D3±1, D5±1, D8±1, D11±1, D15±1, D22, D28±3, D35±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 No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability and biomarkers
    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 EEA40
    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
    Australia
    Belgium
    Brazil
    Bulgaria
    Canada
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Malaysia
    Netherlands
    Russian Federation
    Spain
    Sweden
    Switzerland
    Taiwan
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 5
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Adolescent to sign assent; legally authorized representative to sign main informed consent form.
    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 89
    F.4.2.2In the whole clinical trial 249
    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)
    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 Decision2019-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-14
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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