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    Summary
    EudraCT Number:2012-004920-39
    Sponsor's Protocol Code Number:38518168ASH2001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-24
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-004920-39
    A.3Full title of the trial
    A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-38518168 in Symptomatic Adult Subjects with Uncontrolled, Persistent Asthma
    Uno studio di fase IIa multicentrico, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli su JNJ-38518168 in soggetti adulti sintomatici con asma persistente non controllato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of JNJ-38518168 in Symptomatic Adult Participants with Uncontrolled, Persistent Asthma
    Uno studio di JNJ-38518168 su soggetti adulti sintomatici con asma persistente non controllato
    A.3.2Name or abbreviated title of the trial where available
    Not Applicable
    A.4.1Sponsor's protocol code number38518168ASH2001
    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 N.V.
    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, L.L.C.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportJANSSEN-CILAG SPA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Research and Development
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressJanssen Biologics BV - Clinical Registry Group
    B.5.3.2Town/ cityArchimedesweg 29
    B.5.3.3Post code2333CM Leiden
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31 (0)71 524 21 66
    B.5.5Fax number31 (0)71 524 21 10
    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-38518168-ZBQ
    D.3.2Product code JNJ-38518168
    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 INNNot assigned
    D.3.9.2Current sponsor codeJNJ-38518168-ZBQ
    D.3.9.3Other descriptive nameJNJ-38518168-ZBQ
    D.3.9.4EV Substance CodeSUB92220
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Asthma
    Asma
    E.1.1.1Medical condition in easily understood language
    Asthma
    Asma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10068462
    E.1.2Term Eosinophilic asthma
    E.1.2System Organ Class 100000004855
    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 is to assess the efficacy (as measured by the change from baseline in prebronchodilator percent-predicted forced expiratory volume in 1 second [FEV1]) of JNJ-38518168 compared with placebo in subjects with eosinophilic persistent asthma that is inadequately controlled despite current treatment.
    L'obiettivo principale è la valutazione dell'efficacia (misurata dalla variazione, rispetto al valore percentuale basale predetto, del VEMS [volume espiratorio forzato in un secondo] di JNJ-38518168 rispetto al placebo in soggetti con asma eosinofilo persistente non adeguatamente controllato nonostante il trattamento attuale.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the safety, efficacy (as measured by improvement in asthma control), tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of JNJ-38518168 compared with placebo in subjects with eosinophilic persistent asthma that is inadequately controlled despite current treatment.
    Gli obiettivi secondari sono la valutazione di sicurezza, efficacia (misurata dal miglioramento del controllo dell'asma), tollerabilità, farmacocinetica (PK) e farmacodinamica (PD) di JNJ-38518168 rispetto al placebo in soggetti con asma eosinofilo persistente non adeguatamente controllato nonostante il trattamento attuale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Principal Inclusion Criteria in Lay Language (for a complete list of
    inclusion criteria refer to the protocol):

    Have a diagnosis of asthma for at least 26 weeks, confirmed by the investigator at Screening Visit 1 -Have been receiving inhaled corticosteroid (ICS) (≤1000 μg/day fluticasone or its equivalent) for at least 12 weeks prior to Screening Visit 1 -At Screening Visit 1, be receiving the same dose of ICS ≤1000 μg/day fluticasone (or equivalent) alone or in conjunction with long-acting β2-agonist
    (LABA) and/or montelukast for at least 4 weeks prior to screening with no changes in dose or dosing regimen of any of these therapies during that 4 week period prior to screening -Have an Asthma Control Questionnaire (ACQ) score ≥1.5 at Screening Visit 1 -Have a prebronchodilator forced expiratory volume in
    1 second (FEV1) equal to 40% to 80%, inclusive, of predicted value at Screening Visit 1 -Have a ≥12% relative change and ≥200 mL change in FEV1 postbronchodilator at either Screening Visit 1 or 2
    Criteri di inclusione principali in linguaggio semplice (per l’elenco complete fare riferimento al protocollo)



    - Diagnosi di asma da almeno 26 settimane, confermata dallo sperimentatore alla visita di screening 1.
    - Assunzione di corticosteroidi per via inalatoria (ICS) (≤ 1000 µg/giorno di fluticasone o equivalente) per almeno 12 settimane prima della visita di screening 1.
    - Alla visita di screening 1, assunzione della stessa dose di ICS ≤ 1000 µg/giorno (fluticasone o equivalente) in monoterapia o in associazione a LABA e/o montelukast per almeno 4 settimane prima dello screening senza variazioni della dose o del regime posologico delle due terapie durante tale periodo di 4 settimane precedente allo screening.
    - Punteggio del questionario ACQ ≥ 1,5 alla visita di screening 1.
    - VEMS prima del broncodilatatore pari al 40-80%, inclusi, del valore predetto alla visita di screening 1.
    - Variazione relativa ≥ 12% e variazione del VEMS dopo il broncodilatatore ≥ 200 ml dopo la somministrazione di un massimo di 8 inalazioni di un SABA alla visita di screening 1 o 2.
    E.4Principal exclusion criteria
    Principal Exclusion Criteria in Lay Language (for a complete list of
    exclusion criteria refer to the protocol):

    Has ever had a life-threatening asthma attack including respiratory arrest, intubation, or intensive care unit (ICU) admission due to asthma -Has a history of any other chronic respiratory condition including, but not limited to, chronic obstructive pulmonary disease (COPD), bronchiolitis, bronchiectasis, allergic
    bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea, pulmonary hypertension, or any other obstructive pulmonary disease -Has any use of the following asthma therapies: systemic corticosteroids within 6 weeks of Screening Visit 1; oral beta-agonists within 4 weeks of Screening Visit 1;
    cromolyns within 4 weeks of Screening Visit 1; leukotriene inhibitors other than montelukast within 4 weeks
    of Screening Visit 1; theophylline within 4 weeks of S reening Visit 1; inhaled anti-cholinergic agents within 4 weeks of Screening Visit 1; or omalizumab within 130 days of Screening Visit 1 -Has initiated or discontinued allergen immunotherapy within 12 weeks of Screening Visit 1 -Has smoked within 3 years of Screening Visit 1 or has a history of smoking ≥ 10 pack years -Body-Mass Index (BMI) >32 kg/m2
    Criteri di esclusione principali in linguaggio semplice (per l’elenco complete fare riferimento al protocollo)


    - Ha subito un attacco di asma potenzialmente fatale, con arresto respiratorio, intubazione o ricovero nell'unità di terapia intensiva per asma.
    - Ha una storia pregressa di altre patologie respiratorie croniche, incluse, a titolo esemplificativo, pneumopatia cronica ostruttiva (COPD), bronchiolite, bronchiectasia, aspergillosi broncopolmonare allergica (micosi), asma occupazionale, apnea notturna, ipertensione polmonare o qualsiasi altra pneumopatia ostruttiva.


    - Utilizza in qualche misura le seguenti terapie per l’asma non consentite:
    • corticosteroidi sistemici entro le 6 settimane precedenti alla visita di screening 1;
    • beta-agonisti orali entro le 4 settimane precedenti alla visita di screening 1;
    • cromolin entro le 4 settimane precedenti alla visita di screening 1;
    • inibitori dei leucotrieni diversi dal montelukast entro le 4 settimane precedenti alla visita di screening 1;
    • teofillina entro le 4 settimane precedenti alla visita di screening 1;
    • agenti anticolinergici per via inalatoria entro le 4 settimane precedenti alla visita di screening 1;
    • omalizumab entro i 130 giorni (5 emivite) precedenti alla visita di screening 1;

    - Ha iniziato o interrotto l'immunoterapia allergenica entro le 12 settimane precedenti alla visita di screening 1

    - Ha fumato entro i 3 anni precedenti alla visita di screening 1 o ha fumato in precedenza ≥ 10 pacchetti all’anno




    - Presenta un indice di massa corporea (IMC) > 32 kg/m2.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in prebronchodilator forced expiratory
    volume in 1 second (preBD FEV1)
    Modifica dalla baseline del volume espiratorio forzato in un secondo (preBD FEV1) prima del broncodilatatore
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 16
    Dalla baseline alla settimana 16
    E.5.2Secondary end point(s)
    1. Change from baseline in Asthma Control Questionnaire (ACQ)
    2. Change from baseline in postbronchodilator forced expiratory volume in 1 second (postBD FEV1)
    3. Change from baseline in weekly average of daytime asthma diary
    symptom scores
    4. Change from baseline in weekly average of nighttime asthma diary symptom scores
    5. Change from baseline in weekly average of number of puffs in a day that rescue medication is used
    •Variazione rispetto al basale del questionario ACQ
    •Variazione rispetto al basale del VEMS (valore percentuale predetto) dopo il broncodilatatore
    •Variazione rispetto al basale della media settimanale del punteggio dei sintomi annotati nel diario sull'asma diurno
    •Variazione rispetto al basale della media settimanale del punteggio dei sintomi annotati nel diario sull'asma notturno
    •Variazione rispetto al basale del numero medio settimanale di inalazioni giornaliere di farmaci di salvataggio
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to Week 16
    Dalla baseline alla settimana 16
    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
    Biomarker Analysis
    Analisi dei biomarcatori
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    Canada
    France
    Germany
    Israel
    Italy
    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
    last visit of the last subject
    ultima visita dell'ultimo paziente
    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 months10
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days3
    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: 128
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 98
    F.4.2.2In the whole clinical trial 160
    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)
    Not applicable
    NON APPLICABILE
    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 Decision2013-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-11
    P. End of Trial
    P.End of Trial StatusCompleted
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