Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-001696-22
    Sponsor's Protocol Code Number:64041575MPN2001
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2018-05-03
    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 ConcernedSweden - MPA
    A.2EudraCT number2017-001696-22
    A.3Full title of the trial
    A Phase 2b, 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 Adult Subjects Infected With Human Metapneumovirus
    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 adults infected with human metapneumovirus
    A.4.1Sponsor's protocol code number64041575MPN2001
    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-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 Film-coated tablet
    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 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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 placeboFilm-coated tablet
    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
    Human metapneumovirus infection
    E.1.1.1Medical condition in easily understood language
    Human metapneumovirus 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 10066226
    E.1.2Term Metapneumovirus 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 adult subjects who are infected with hMPV the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal hMPV shedding using qRT-PCR.
    E.2.2Secondary objectives of the trial
    To determine in hospitalized adult subjects who are infected with hMPV:
    - The safety and tolerability of lumicitabine.
    - The PK of JNJ-63549109 in plasma.
    - The impact of lumicitabine on the clinical course of hMPV infection.
    - The impact of lumicitabine on the evolution of Activities of Daily Living (ADL) as assessed by Katz ADL score.
    - The impact of lumicitabine on the time to undetectable nasal hMPV viral load.
    - The impact of lumicitabine on the emergence of hMPV strains with resistance-associated mutations.
    - The relationship between the PK of JNJ-63549109 and pharmacodynamics (antiviral activity, clinical symptoms, and selected safety parameters) after single loading dose and repeated oral maintenance dosing of lumicitabine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Men or women ≥18 years old (or the legal age of consent in the jurisdiction in which the study is taking place), defined at the time of randomization.

    - Subjects hospitalized (or in ER prior to hospitalization) at the time of randomization and unlikely to be discharged for the first 24 hours after randomization.

    - Subjects diagnosed with hMPV infection using a rapid 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. As long as the underlying precipitant of the illness is considered by the investigator to be due to hMPV infection, the viral infection may present in one or more of the following ways:
    • A lower respiratory tract infection, which may present in one of the following ways:
    - Tracheobronchitis, defined as cough associated with rhonchi on lung auscultation and a clear chest imaging (eg, X-ray, computed tomography).
    - Pneumonia, defined as acute respiratory symptoms occurring in a subject with a new pulmonary infiltrate on a radiological examination.
    • Respiratory distress.
    • Asthma exacerbation.
    • COPD exacerbation.

    - With the exception of the symptoms related to hMPV infection, subjects must be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population, and/or the hMPV infection. This determination must be recorded in the subject's source documents and initialed by the investigator.

    - Subjects must be medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel or hematology are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal do not pose an unacceptable risk to the subject, are not clinically significant or are appropriate and reasonable for the population under study, and have no specific cut-off per the exclusion criteria. This determination must be recorded in the subject's source documents and initialed by the investigator. A single repeat laboratory evaluation is allowed for eligibility determination.

    - Subjects (or their legally acceptable representative) must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.

    - A woman must have a negative urine pregnancy test (β-human chorionic gonadotropin [β-hCG]) at screening.
    E.4Principal exclusion criteria
    1. Subjects who are not expected to survive for more than 48 hours.
    2. Subjects who have had major thoracic or abdominal surgery in the 6 weeks prior to randomization.
    3. Subjects who are considered by the investigator to be immunocompromised within the past 12 months, whether due to underlying medical condition (eg, malignancy or genetic disorder) or medical therapy (eg, medications other than corticosteroids for the treatment of COPD or asthma exacerbations, chemotherapy, radiation, stem cell or solid organ transplant).
    4. Subjects who have used systemic corticosteroids for >7 consecutive days immediately prior to randomization at doses higher than 20 mg/day of prednisone or equivalent.
    5. Subjects who have taken any disallowed therapies as noted in Section 8, Prestudy and Concomitant Therapy before the planned first dose of study drug.
    6. Subjects with a known history of human immunodeficiency virus (HIV) or chronic viral hepatitis.
    7. Subjects with ALT ≥3x the upper limit of normal (ULN) AND bilirubin ≥2×ULN (direct >35%) OR ALT ≥5×ULN at screening.
    8. Subjects with 1 or more of the following laboratory abnormalities at screening:
    - Hemoglobin <9.5 g/dL
    - Platelet count <75,000/mm3
    - White blood cell count <1,000/mm³
    - Absolute neutrophil count <1,000/mm³
    9. Subjects undergoing peritoneal dialysis, hemodialysis, or hemofiltration or with an estimated glomerular filtration rate (GFR) (determined by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) of <60 mL/min/1.73m².
    10. Subjects who have known allergies, hypersensitivity, or intolerance to lumicitabine or its excipients (refer to Investigator's Brochure).
    11. Subjects unwilling to undergo mid-turbinate nasal swab procedures or with any physical abnormality which limits the ability to collect regular nasal specimens.
    12. Subjects unable to take medications enterally or with a known gastrointestinal-related condition that is considered by the sponsor or investigator to be likely to interfere with study drug absorption.
    13. Subjects who received prescription medications intended to prevent or treat the hMPV infection itself (eg, ribavirin, IV immunoglobulin), an investigational drug, an investigational vaccine, or used an invasive investigational medical device within 30 days or 5 half-lives (whichever is longer) before the planned first dose of study drug or are currently enrolled in an investigational study.
    14. Subjects being treated with extracorporeal membrane oxygenation.
    15. Women who are pregnant or breast-feeding.
    16. Men who plan to father a child while enrolled in this study or within 104 days after the last dose of study drug.
    17. Subjects with any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is hMPV viral load (measured by qRT-PCR in the mid-turbinate nasal swab specimens) AUC from immediately prior to first dose of study drug (baseline) until Day 7.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Days 1 to 7
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    • Safety/tolerability including AEs, physical examinations, vital signs/peripheral capillary oxygen saturation (SpO2), ECGs, and clinical laboratory results.

    • PK parameters of JNJ-63549109.

    • hMPV clinical course endpoints:
    - The ordinal scale.
    - 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 defined by the investigator.
    - Requirement for and duration of intensive care unit (ICU) stay.
    - Requirement for and duration of oxygen supplementation/noninvasive mechanical ventilation support (eg, nasal cannula, face mask, continuous positive airway pressure, bilevel positive airway pressure) and/or invasive mechanical ventilation support (eg, endotracheal-mechanical ventilation or mechanical ventilation via tracheostomy) above pre-hMPV infection status.
    - Time to no longer requiring supplemental oxygen above pre-hMPV infection status.
    - 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-hMPV infection status (hereafter referred to as "normalization") of blood oxygen level (without additional requirement of supplemental oxygen compared with pre-hMPV infection status), normalization of oral feeding, normalization of respiratory rate, and normalization of heart rate.
    - 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.
    - Time to respiratory rate, SpO2, and body temperature return to pre-hMPV infection status.
    - Requirement for hydration and/or feeding by intravenous (IV) catheter/nasogastric tube.
    - Presence of bacterial superinfections reported as AEs (eg, pneumonia, acute otitis media, sinusitis, bronchitis, bacteremia), with bacterial superinfections defined by the investigator based on clinical judgment and/or increasing procalcitonin levels.
    - Presence of treatment-emergent complications, including cardiovascular events and cerebrovascular events (eg, myocardial infarction, congestive heart failure exacerbation, arrhythmia, stroke) or Clostridium difficile-associated diarrhea.
    - Change from baseline in the National Early Warning Score (NEWS) over time.
    - Day 28 all-cause mortality.

    • Time to return to pre-hMPV infection functional status (Katz ADL score).

    • hMPV viral load as measured by qRT-PCR of the mid-turbinate nasal swab specimens which will be used to determine the following:
    - hMPV viral load over time.
    - Peak viral load, time to peak viral load, rate of decline of viral load, and time to hMPV RNA being undetectable.
    - Proportion of subjects with undetectable hMPV viral load at each timepoint.
    - hMPV viral load AUC from immediately prior to first dose of study drug (baseline) until Day 10 and until Day 14.
    - hMPV viral load AUC in subjects assigned to a longer dosing duration, if dosing duration is increased by the Independent Data Monitoring Committee (IDMC), from baseline until 1 day (+2 days) after the last dose of study drug.

    • Sequence changes (postbaseline) in the hMPV polymerase L-gene and other regions (if warranted) of the hMPV genome compared with baseline sequences.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety/tolerability - evaluated throughout the study

    PK - Dose 1: 0.5-1h postdose & 2-3h postdose; Dose 2: predose and 3-6h postdose; Dose 3 and Dose 10 (preferably predose or random sample); Day 7, Day 10 and day of discharge if still on study drug (random sample)

    Clinical evaluation & Katz-ADL - Screening, daily for the entire duration of hospitalization and on Days 7, 10, 14, and 28 if the subject is discharged.

    SpO2 - Q4h while hospitalized through Day 7. For subjects who remain hospitalized after Day 7, Q8h until 24 hours after the cessation of supplemental oxygen. After discharge, Days 7, 10, 14 and 28.

    Subject eCoA - Daily for the duration of the study

    Nasal swabs - Screening, Days 1-7, 10, 14, 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 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 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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Brazil
    Bulgaria
    France
    Italy
    Japan
    Korea, Republic of
    Malaysia
    Netherlands
    Poland
    Russian Federation
    Spain
    Sweden
    Taiwan
    Ukraine
    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 years1
    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 years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 63
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 117
    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 No
    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 62
    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 Decision2018-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-07
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 08:58:12 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA