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    Summary
    EudraCT Number:2015-002553-35
    Sponsor's Protocol Code Number:CQAW039A2307
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-21
    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 number2015-002553-35
    A.3Full title of the trial
    A 52-week, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of QAW039 when added to existing asthma therapy in patients with uncontrolled severe asthma.
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo
    de 52 semanas de duración para evaluar la eficacia y la seguridad de
    QAW039 añadido al tratamiento existente para el asma en pacientes con
    asma grave no controlada.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy and safety of QAW039 in patients with severe asthma inadequately controlled with standard of care asthma treatment.
    Estudio de la eficacia y la seguridad de QAW039 en pacientes con asma grave controlada de forma inadecuada con el tratamiento estándar para el asma.
    A.4.1Sponsor's protocol code numberCQAW039A2307
    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 Farmacéutica, 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 Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMo)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number++3493306 44 64
    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 number150
    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.IMP: 2
    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
    D.8 Placebo: 2
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In patients with severe asthma and high eosinophil counts (>=250 cells/μl) receiving SoC asthma therapy, to demonstrate the efficacy (as measured by rate of moderate-to-severe asthma exacerbations) of at least one dose level of QAW039 (150 mg or 450 mg once daily), compared with placebo, at the end of the 52-week active-treatment epoch.
    In patients with severe asthma receiving SoC asthma therapy, to demonstrate the efficacy (as measured by rate of moderate-to-severe
    asthma exacerbations) of at least one dose level of QAW039 (150 mg or 450 mg once daily), compared with placebo, at the end of the 52-week active-treatment epoch.
    En pacientes con asma grave y recuentos de eosinófilos (>=250
    células/μl) que reciben tratamiento estándar (SOC) para el asma,
    demostrar la eficacia (medida según la tasa de exacerbaciones
    asmáticas de moderadas a graves) de al menos un nivel de dosis de
    QAW039 (150 o 450 mg una vez al día), en comparación con placebo, al final de la fase de tratamiento activo de 52 semanas.
    En pacientes con asma grave que reciben tratamiento estándar (SOC)
    para el asma, demostrar la eficacia (medida según la tasa de
    exacerbaciones asmáticas de moderadas a graves) de al menos un nivel de dosis de QAW039 (150 o 450 mg una vez al día), en comparación con placebo, al final de la fase de tratamiento activo de 52 semanas.
    E.2.2Secondary objectives of the trial
    In patients with severe asthma and high eosinophil counts (>=250 cells/μl) receiving SoC asthma therapy to demonstrate the efficacy of at least one dose level of QAW039 (150 mg or 450 mg once daily), compared with placebo, with respect to change from baseline, at the end of the 52-week active-treatment epoch, in AQLQ+12 scores, ACQ-5 score and pre-dose FEV1.

    In all patients with severe asthma receiving SoC asthma therapy to demonstrate the efficacy of at least one dose level of QAW039 (150 mg or 450 mg once daily), compared with placebo, with respect to change from baseline, at the end of the 52-week active-treatment epoch, in : AQLQ+12 scores , ACQ-5 score and pre-dose FEV1.

    To assess the safety of QAW039 (150 mg and 450 mg once daily), compared with placebo, with respect to adverse events, ECGs, vitals sign, laboratory tests and hypersensitivity reactions.
    En pacientes con asma grave y recuentos eosinófilos (>=250 cells/μl) que reciben tratamiento estándar para el asma para demostrar la eficacia de al menos un nivel de dosis de QAW039 (150 o 450 mg una vez al día), en comparación con placebo, en relación con el cambio respecto a la basal, al final de la fase de tratamiento activo de 52 semanas, en resultados (AQLQ+12), resultado(ACQ-5) y FEV1 predosis
    -Demostrar la eficacia de al menos un nivel de dosis de QAW039 (150 o 450 mg una vez al día), en comparación con placebo, en relación con el cambio respecto a la basal en FEV1 predosis al final de la fase de tratamiento activo de 52 semanas
    -Evaluar la seguridad de QAW039 (150 y 450 mg una vez al día), en comparación con placebo, respecto a los acontecimientos adversos, electrocardiogramas (ECG), constantes vitales, pruebas analíticas y
    reacciones de hipersensibilidad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Written informed consent and assent if applicable
    -Male and female patients aged >=12 years (or >= lower age limit allowed by health authority and/or ethics committee/institutional review board approvals).
    -A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.
    -Evidence of airway reversibility or airway hyper-reactivity.
    -For patients aged >=18 years, FEV1 of <=80% of the predicted normal value for the patient, after withholding bronchodilators at Visit 1 and Visit 101. For patients aged 12 to <18 years, FEV1 of <=90% of the predicted normal value for the patient, after withholding bronchodilators at Visit 1 and Visit 101.
    -An ACQ score >=1.5.
    -A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.

    Other inclusion criteria apply. See protocol for full details
    -Consentimiento informado y asentimiento por escrito si corresponde
    -Pacientes de ambos sexos >=12 años de edad (o límite de edad inferior permitido por las Autoridades Sanitarias y/o los Comités Éticos de Investigación Clínica)
    -Un diagnóstico de asma grave, no controlado con medicamentos para el asma GINA 2016.
    -Evidencia de reversibilidad de las vías respiratorias o hiperreactividad de las vías respiratorias
    -Para pacientes >=18 años de edad, FEV1 <=80 % del valor teórico normal para el paciente después de suspenderse el tratamiento con broncodilatadores en las visitas 1 y 101. Para pacientes de 12 a < 18 años de edad, FEV1 =<90 % del valor teórico normal para el paciente después de suspenderse el tratamiento con broncodilatadores en las visitas 1 y 101
    -Puntuación de ACQ>=1.5.
    -Antecedentes de 2 o más exacerbaciones asmáticas durante los 12 meses anteriores a participar en el estudio.
    Se aplican otros criterios de inclusión. Ver protocolo para más detalles
    E.4Principal exclusion criteria
    -Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.
    -Subjects who have participated in another trial of QAW039.
    -A QTcF (Fridericia) >=450 msec (male) or >=460 msec (female).
    -History of malignancy with the exception of local basal cell carcinoma of the skin.
    -Pregnant or nursing (lactating) women.
    -Serious co-morbidities.
    -Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, and >2 mg of pitavastatin

    Other exclusion criteria apply. See protocol for full details
    -Uso de cualquier otro fármaco en investigación dentro de un tiempo de 5 vidas medias o 30 días (aquel periodo que sea más largo).
    -Pacientes que hayan participado en otro ensayo de QAW039
    -Pacientes con un QTcF (Friderica) >= 450 ms (hombres) o >=460 ms (mujeres)
    -Pacientes con tumores malignos con la excepción de carcinoma cutáneo de células basales localizado.
    -Mujeres embarazadas o en periodo de lactancia
    -Pacientes con comorbilidades graves,
    -Pacientes que reciban >20 mg de simvastatina, > 40 mg de atorvastatina, >40 mg de pravastatina o >2 mg de pitavastatina

    Se aplican otros criterios de exclusión. Ver protocolo para más detalles
    E.5 End points
    E.5.1Primary end point(s)
    Reduction in the rate of moderate-to-severe asthma exacerbations. A severe asthma exacerbation is defined as treatment with ‘rescue’ systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with ‘rescue’ systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours); or death due to asthma. A moderate asthma exacerbation is defined as treatment with ‘rescue’ systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours).
    Reducción de la tasa de exacerbaciones de asma moderadas a graves. Una exacerbación grave del asma se define como el tratamiento con corticosteroides sistémicos de "rescate" durante más de tres días o más y la hospitalización; o tratamiento con corticosteroides sistémicos de "rescate" durante más de 3 días o más y visita al departamento de emergencia (más de 24 horas); o muerte debido al asma. Una exacerbación moderada del asma se define como el tratamiento con corticosteroides sistémicos de "rescate" durante más de 3 días, ya sea como paciente ambulatorio o en visitas a urgencias (visita a urgencias menor o igual a 24 horas)
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 semanas
    E.5.2Secondary end point(s)
    - Change from baseline in AQLQ+12 score. AQLQ+12 consists of 32 questions each scaled from 1 to 7, where 1 indicates maximal impairment and 7 indicates no impairment.
    - Change from baseline in ACQ-5 score. The ACQ- 5 consists of 5 questions on a 7-point scale (0=no impairment, 6=maximum impairment).
    - Change from baseline in pre-dose FEV1 (liters).
    - Adverse event monitoring.
    - Cambio desde la basal en la puntuación AQLQ + 12. AQLQ + 12 consta de 32 preguntas, cada en una escala de 1 a 7, donde 1 indica un deterioro máximo y 7 indica que no hay deterioro
    - Cambio desde la basal en la puntuación ACQ-5. El ACQ-5 consiste en 5 preguntas en una escala de 7 puntos (0 = ninguna afectación, 6 = afectación máximo).
    - Cambio desde el inicio en la predosis FEV1 (litros).
    - Monitorización de acontecimientos adversos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 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 No
    E.6.7Pharmacodynamic No
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA122
    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
    Austria
    Belgium
    Brazil
    China
    Denmark
    Estonia
    Finland
    France
    Germany
    Greece
    Guatemala
    Hungary
    Ireland
    Latvia
    Lithuania
    Luxembourg
    Malaysia
    Philippines
    Poland
    Romania
    Singapore
    Spain
    Switzerland
    United Kingdom
    United States
    Vietnam
    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: 17-October-2019
    LVLS: 17-October-2019
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    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: 127
    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: 127
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 709
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 495
    F.4.2.2In the whole clinical trial 846
    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)
    Patients completing the treatment period will not be given further access to study drug because the risk/benefit ratio will not yet have been substantiated and there are already other marketed therapeutic alternatives available to treat these patients. At the time of study completion or early termination, all patients will be placed on the appropriate asthma treatment as prescribed by the investigator.
    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 Decision2018-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-04
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