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    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).

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    Summary
    EudraCT Number:2018-004267-32
    Sponsor's Protocol Code Number:CQAW039E12201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-09-04
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-004267-32
    A.3Full title of the trial
    A multi-center, proof-of-mechanism study of multiple, oral doses of fevipiprant (QAW039) in COPD patients with eosinophilia
    Estudio multicéntrico de prueba de mecanismo de múltiples dosis de fevipiprant (QAW039) por vía oral en pacientes con EPOC y eosinofilia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A proof-of-mechanism study of multiple, oral doses of fevipiprant (QAW039) in COPD patients with eosinophilia
    Estudio de prueba de mecanismo de múltiples dosis de fevipiprant (QAW039) por vía oral en pacientes con EPOC y eosinofilia
    A.4.1Sponsor's protocol code numberCQAW039E12201
    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 SponsorNovartis Farmaceutica, S.A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmaceutica, S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMo)
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number0034900353036
    B.5.5Fax number0034932479903
    B.5.6E-maileecc.novartis@novartis.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 nameFevipiprant
    D.3.2Product code QAW039
    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 INNFevipiprant
    D.3.9.1CAS number 872365-14-5
    D.3.9.2Current sponsor codeQAW039
    D.3.9.3Other descriptive nameQAW039-NXA.001
    D.3.9.4EV Substance CodeSUB32073
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number450
    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
    Chronic obstructive pulmonary disease with eosinophilia
    Enfermedad pulmonar obstructiva crónica con eosinofilia
    E.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disease (COPD) and high levels of a type of cell called eosinophils in their blood and sputum
    Enfermedad pulmonar obstructiva crónica(EPOC) y altos niveles en la sangre y esputo de un tipo de celula llamada eosinófilo
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    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 of this study is to assess the change from baseline in sputum eosinophil levels (% of total count) in COPD patients with eosinophilia after multiple oral doses of fevipiprant when compared to placebo.
    El objetivo principal de este estudio es evaluar el cambio respecto a la basal en los niveles de eosinófilos en esputo (porcentaje del recuento total) en pacientes con EPOC y eosinofilia después de múltiples dosis de fevipiprant por vía oral en comparación con placebo.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of fevipiprant in COPD patients with eosinophilia.
    Evaluar la seguridad y tolerabilidad de fevipiprant en pacientes con EPOC y eosinofilia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Acceptable and reproducible spirometry with post-bronchodilator FEV1/FVC < 0.7 and post-bronchodilator FEV1≥ 30 and ≤ 80% of predicted at the screening and baseline visits (GOLD stage II or III COPD).
    2. Patients with a physician-diagnosed history of COPD for at least 1 year prior to screening visit, and a documented history of at least one COPD exacerbation within the year prior to screening visit and on a stable therapy regimen for COPD for at least 4 weeks prior to screening visit with inhaled glucocorticoid + one or more long acting bronchodilator.
    3. Current or ex-smokers who have a smoking history of at least 10 pack-years (10 pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, or equivalent).
    4. Circulating eosinophils ≥ 300 cells/μL blood AND sputum eosinophils ≥ 3% of total cell count during screening period.
    1. Espirometría aceptable y reproducible con FEV1/FVC posbroncodilatador <0,7 y FEV1 teórico posbroncodilatador >=30 y <=80 % en las visitas de selección y basal (EPOC en estadio II o III de GOLD).
    2. Pacientes con historia de EPOC diagnosticada por un médico durante al menos el año anterior a la visita de selección y antecedentes documentados de al menos una exacerbación de la EPOC durante el año anterior a la visita de selección y que estén recibiendo una pauta de tratamiento estable para la EPOC durante al menos las 4 semanas anteriores a la visita de selección con glucocorticoides inhalados y uno o varios broncodilatadores de acción prolongada.
    3. Fumadores actuales o ex fumadores que tengan antecedentes de tabaquismo de al menos 10 paquetes- año (10 paquetes--año se define como 20 cigarros al día durante 10 años o 10 cigarros al día durante 20 años, o equivalente).
    4. Eosinófilos circulantes en sangre >=300 células/µl Y eosinófilos en esputo >=3 % del recuento celular total durante el periodo de selección
    E.4Principal exclusion criteria
    1. Patients with a past or current medical history of asthma.
    2. Patients with a past or current medical history of conditions other than COPD or allergic rhinitis that could result in elevated sputum eosinophils (e.g., asthma, hypereosinophilic syndrome, Churg-Strauss Syndrome). Patients with known parasitic infestation within 6 months prior to screening are also excluded.
    3. Patients who have had a respiratory tract infection or COPD worsening or systemic steroid use within 4 weeks prior to screening visit or between screening and randomization visits.
    4. Patients with history of concomitant chronic or severe pulmonary disease (e.g., sarcoidosis, interstitial lung disease, cystic fibrosis, tuberculosis). Exception: patients with concomitant mild or moderate pulmonary hypertension or bronchiectasis are permitted to participate.
    5. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective contraception (also called basic contraception) methods during the study.
    6. Patients on any statin therapy with a CK level > 2 X ULN at screening.
    7. Patients who have a clinically significant laboratory abnormality at the screening visit including (but not limited to):
    --Total white blood cell count <2500 cells/uL
    --AST or ALT > 2.0 X ULN or total bilirubin > 1.3 X ULN
    --Estimated Glomerular Filtration Rate (eGFR) by the Modification of Diet in Renal Disease (MDRD) equation or Bedside Schwartz equation <55 mL/minute/1.73 m2.
    8. Patients with any of the following cardiac related concerns:
    --A resting QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female) at screening visit
    --A history of familial long QT syndrome or known family history of Torsades de Pointe
    --Receiving any medications or other agents known to prolong the QT interval
    --patients with a history of moderate or severe uncontrolled tachyarrhythmias
    --History of a clinically significant cardiovascular event within 1 year prior to the screening visit, such as acute myocardial infarction, congestive heart failure, unstable arrhythmia
    --Patients who, in the judgment of the investigator have a clinically significant ECG abnormality such as (but not limited to) sustained ventricular tachycardia, or clinically significant second or third degree AV block without a pacemaker
    1. Pacientes con historia clínica anterior o actual de asma.
    2. Pacientes con historia clínica anterior o actual de otras enfermedades salvo EPOC o rinitis alérgica que pudieran dar lugar a un nivel elevado de eosinófilos en esputo (p. ej., asma, síndrome hipereosinofílico o síndrome de Churg-Strauss). Pacientes con una infestación parasitaria durante los 6 meses anteriores a la selección también quedarán excluidos.
    3. Pacientes que hayan tenido una infección del tracto respiratorio, empeoramiento de la EPOC o uso de esteroides sistémicos durante las 4 semanas anteriores a la visita de selección o entre las visitas de selección y aleatorización.
    4. Pacientes con antecedentes de enfermedad concomitante pulmonar crónica o grave (p. ej., sarcoidosis, enfermedad pulmonar intersticial, fibrosis quística y tuberculosis). Excepción: los pacientes con hipertensión pulmonar leve o moderada o bronquiectasia concomitantes pueden participar.
    5. Mujeres en edad fértil, definidas como toda mujer fisiológicamente capaz de quedarse embarazada, salvo que estén utilizando métodos anticonceptivos eficaces (también denominados métodos anticonceptivos básicos) durante el estudio.
    6. Pacientes en tratamiento con cualquier estatina con un nivel de CK >2 x LSN en la selección.
    7. Pacientes con alguna anomalía clínicamente significativa en las pruebas analíticas de la visita de selección, incluyendo (pero no limitándose a):
    - Recuento total de leucocitos <2500 células/µl.
    - AST o ALT >2 x LSN o bilirrubina total >1,3 x LSN.
    - Tasa de filtración glomerular estimada (TFGe) determinada mediante la ecuación MDRD (Modification of Diet in Renal Disease) o la ecuación de Bedside Schwartz < 55 ml/min/1,73 m2.
    8. Pacientes con alguno de los siguientes problemas cardíacos:
    - QTcF en reposo (Fridericia) >=450 ms (hombres) o >=460 ms (mujeres) en la visita de selección.
    - Antecedentes familiares de síndrome de QT largo o antecedentes familiares de Torsades de Pointe.
    - Pacientes que estén recibiendo medicación u otros agentes que prolonguen el intervalo QT.
    - Pacientes con antecedentes de taquiarritmias moderadas o graves no controladas.
    - Antecedentes de acontecimientos cardiovasculares clínicamente significativos durante el año anterior a la visita de selección, como infarto agudo de miocardio, insuficiencia cardíaca congestiva o arritmia inestable.
    - Pacientes que, a criterio del investigador, presenten alguna anomalía clínicamente evidente en el ECG, como entre otras, taquicardia ventricular prolongada o bloqueo AV de segundo o tercer grado clínicamente relevante sin marcapasos
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in sputum eosinophil % of total cell count in COPD patients with eosinophilia after multiple oral doses of fevipiprant when compared to placebo
    Cambio respecto a la basal en los niveles de eosinófilos en esputo (porcentaje del recuento total) en pacientes con EPOC y eosinofilia después de múltiples dosis de fevipiprant por vía oral en comparación con placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks
    6 semanas
    E.5.2Secondary end point(s)
    Physical examination, ECG intervals, vital signs, standard clinical laboratory evaluations (hematology, blood chemistry, and urinalysis), adverse events including COPD exacerbations.
    Exploración física, intervalos de ECG, constantes vitales, pruebas analíticas estándares (hematología, análisis bioquímico de la sangre y análisis de orina) y monitorización de acontecimientos adversos incluyendo las exacerbaciones de la EPOC
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 weeks
    6 semanas
    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 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) 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Belgium
    Germany
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Ultima Visita del Ultimo Sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    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 months2
    E.8.9.2In all countries concerned by the trial days25
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 42
    F.4.2.2In the whole clinical trial 50
    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
    Ninguno
    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 Decision2019-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-12-16
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