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    Summary
    EudraCT Number:2016-001560-11
    Sponsor's Protocol Code Number:CQAW039A2315
    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:2017-07-04
    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 number2016-001560-11
    A.3Full title of the trial
    A 2-treatment period, randomized, placebo-controlled, multicenter parallel-group study to assess the safety of QAW039 when added to existing asthma therapy in GINA steps 3, 4 and 5 patients with uncontrolled asthma.
    Estudio multicéntrico, aleatorizado, controlado con placebo, de grupos paralelos en dos periodos de tratamiento para evaluar la seguridad de QAW039 añadido al tratamiento existente en pacientes con asma no controlada con los pasos 3, 4 y 5 de la GINA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of safety of QAW039 in patients (≥ 12 yrs) with asthma inadequately controlled on standard-of-care asthma therapy
    Estudio de la seguridad de QAW039 en pacientes de ambos sexos (≥ 12 años de edad) con asma controlada de forma inadecuada con el tratamiento estándar para el asma.
    A.3.2Name or abbreviated title of the trial where available
    SPIRIT
    A.4.1Sponsor's protocol code numberCQAW039A2315
    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 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 pointClinical Trial Information Desk
    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.5.6E-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
    Treatment Period 1 (double-blind, 52-week treatment period):
    In patients with moderate-to-severe asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by:
    -treatment emergent adverse events (AEs);
    -treatment emergent serious adverse events (SAEs); and
    -study discontinuations due to treatment emergent AEs.

    Treatment Period 1 and Treatment Period 2 combined:
    In patients with moderate-to-severe-asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by:
    -treatment emergent AEs
    -treatment emergent SAEs; and
    -study discontinuations due to treatment emergent AEs.
    Periodo de tratamiento 1 (periodo de tratamiento doble ciego de 52 semanas):
    En los pacientes con asma de moderada a grave que reciben tratamiento de referencia del asma, evaluar la seguridad a largo plazo de QAW039 (150 mg una vez al día y 450 mg una vez al día), en comparación con placebo, mediante la evaluación de:
    -Acontecimientos adversos causados por el tratamiento (AA)
    -acontecimientos adversos graves causados por el tratamiento (AAG) y
    -retiradas del estudio por AA causados por el tratamiento.
    Periodo de tratamiento 1 y periodo de tratamiento 2 combinados:
    En los pacientes con asma de moderada a grave que reciben tratamiento de referencia del asma, evaluar la seguridad a largo plazo de QAW039 (150 mg una vez al día y 450 mg una vez al día), en comparación con placebo, mediante la evaluación de:
    -AA causados por el tratamiento
    -AAG causados por el tratamiento y retiradas del estudio por AA causados por el tratamiento.
    E.2.2Secondary objectives of the trial
    Treatment Period 1 (double-blind, 52-week treatment period):
    In patients with moderate-to-severe asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by:
    -rate of patients with at least 1 treatment emergent AE by primary system organ class;
    -rate of treatment emergent patient deaths and patient hospitalizations due to an asthma exacerbation.

    Treatment Period 1 and Treatment Period 2 combined:
    In patients with moderate-to-severe-asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by:
    -rate of patients with at least 1 treatment emergent AE by primary system organ class; and
    -rate of treatment emergent patient deaths and patient hospitalizations due to an asthma exacerbation.
    Periodo de tratamiento 1 (periodo de tratamiento doble ciego de 52
    sem):
    En los pacientes con asma de moderada a grave que reciben tratamiento de referencia del asma, evaluar la seguridad a largo plazo de QAW039 (150 mg una vez al día y 450 mg una vez al día), en comparación con placebo, mediante la evaluación de:
    -la tasa de pacientes con al menos un AA causado por el tratamiento por clase de órgano, aparato o sistema principal; y
    -la tasa de muertes y hospitalizaciones de pacientes causadas por el tratamiento debido a una exacerbación asmática.
    Periodo de tratamiento 1 y periodo de tratamiento 2 combinados:
    En los pacientes con asma de moderada a grave que reciben tratamiento de referencia del asma, evaluar la seguridad a largo plazo de QAW039 (150 mg una vez al día y 450 mg una vez al día), en comparación con placebo, mediante la evaluación de:
    Para resto de objetivos por favor refierase al protocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients completing a prior Phase 3 study of QAW039:
    - Informed consent and assent (if applicable).
    -Completion of the Treatment Period (on blinded study drug) of a prior Phase 3 study of QAW039.
    -Patient is able to safely continue into the study as judged by the investigator.

    Patients who have not previously participated in a study of QAW039:
    -Written informed consent.
    -Male and female patients aged ≥12 years.
    -A diagnosis of asthma, uncontrolled on GINA 3/4/5 asthma medication.
    -Evidence of airway reversibility or airway hyper- reactivity.
    -FEV1 of ≥40% and ≤85% of the predicted normal value.
    -An ACQ score ≥1.5 prior to entering the study.
    Pacientes que hayan finalizado un estudio anterior de fase 3 de QAW039:
    -Consentimiento informado y asentimiento (si procede)
    -Finalización del periodo de tratamiento (con el fármaco enmascarado del estudio) de un estudio anterior de fase 3 de QAW039.
    -El paciente puede continuar en el estudio de forma segura según el criterio del investigador.

    Pacientes que no hayan participado anteriormente en ningún estudio de QAW039:
    -Consentimiento informado y asentimiento.
    -Pacientes de ambos sexos con una edad mínima de 12 años .
    -Diagnóstico de asma no estabilizado con medicación de asma GINA 3/4/5.
    -Demostración de control inadecuado del asma basándose en una puntuación del cuestionario de control del asma (ACQ) ≥ 1,5 en la visita 1.
    - FEV1 ≥ 40 % y ≤ 85 % del valor teórico normal para el paciente después de suspenderse el tratamiento con
    E.4Principal exclusion criteria
    Patients completing a prior phase 3 study of QAW039:
    - Pregnant or nursing (lactating) women.
    - Women of child-bearing potential unless they are using basic methods of contraception during dosing of study drug
    - Patients who did not complete the Treatment Period on blinded study drug of the prior QAW039 study they participated in.
    - Inability to comply with all study requirements.
    - Patient who experienced a serious and drug-related AE in the prior QAW039 study they participated in.
    - Patient who developed a condition during the prior study that would have excluded them from participation in that study.

    Patients who have not previously participated in a study of QAW039:
    -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 greater than 20 mg of simvastatin
    Pacientes que hayan finalizado un estudio anterior de fase 3 de principales QAW039:
    -Mujeres embarazadas o en periodo de lactancia.
    -Mujeres en edad fértil, definidas como toda mujer fisiológicamente capaz de quedarse embarazada, salvo que estén utilizando métodos anticonceptivos básicos durante la administración del fármaco del estudio.
    -Pacientes que no hayan finalizado el periodo de tratamiento con el fármaco enmascarado del estudio anterior de fase 3 de QAW039 en el que participaran.
    -PAcientes incapaces de cumplir los todos requisitos del studio.
    - Pacientes que hayan experimentado un AA grave y relacionado con el fármaco en el estudio anterior de fase 3 de QAW039 en el que participaran.
    -Pacientes que hayan desarrollado alguna condición durante el estudio anterior de fase 3 de QAW039 que les haya excluido de participar en ese estudio.
    Pacientes que no hayan participado anteriormente en ningún estudio de QAW039:
    -Uso de otros fármacos en investigación durante las 5 vidas medias o los 30 días anteriores a la inclusión, aquel periodo que sea más largo.
    -Pacientes que hayan participado en otro ensayo de QAW039.
    - Pacientes con un QTcF (Fridericia) en reposo ≥ 450 ms (hombres) o ≥ 460 ms (mujeres).
    -Antecedentes de cáncer de cualquier sistema orgánico (salvo carcinoma cutáneo de células basales localizado o cáncer de cuello uterino in situ), tratado o no tratado, durante los últimos 5 años, independientemente de que existan o no pruebas de recurrencia local o metástasis.
    -Mujeres embarazadas o en periodo de lactancia.
    - Comorbilidades graves
    -Pacientes que reciban > 20 mg de simvastatina.
    E.5 End points
    E.5.1Primary end point(s)
    -treatment emergent adverse events (AEs)
    -treatment emergent serious adverse events
    -treatment emergent AEs leading to discontinuation from the study
    -tiempo hasta primer acontecimientio adverso (AA) causado por el tratamiento.
    -tiempo hasta primer acontecimientio adverso grave (AAG) causado por el tratamiento.
    - tiempo hasta el primer AA causado por eltratamiento que dé lugar a la retirada del estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks (end Treatment Period 1)
    160 weeks (end Treatment Period 2)
    52 semanas (fin de periodo de tratamiento 1)
    160 semanas (fin de periodo de tratamiento 2)
    E.5.2Secondary end point(s)
    -Rate of patients with at least 1 treatment emergent AE by primary system organ class
    -Rate of treatment emergent patient deaths for asthma exacerbations
    -Rate of treatment emergent patient hospitalizations for an asthma exacerbation
    -la tasa de pacientes con al menos un AA causado por el tratamiento por clase de órgano, aparato o sistema principal
    -la tasa de muertes causadas por el tratamiento debido a una exacerbación asmática.
    -la tasa hospitalizaciones de pacientes (cualquier visita al hospital que precise un ingreso durante una noche o una estancia en urgencias de más de 24 horas) causadas por el tratamiento debido a una exacerbación asmática.
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks (end Treatment Period 1)
    160 weeks (end Treatment Period 2)
    52 semanas (fin de periodo de tratamiento 1)
    160 semanas (fin de periodo de tratamiento 2)
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    La Parte 1 es doble ciego mientras que la parte 2 es ciego simple.
    While Part 1 is double-blind, Part 2 is single-blind
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA175
    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
    Bulgaria
    Canada
    China
    Czech Republic
    Egypt
    Estonia
    Finland
    France
    Germany
    Greece
    Guatemala
    Hungary
    India
    Israel
    Japan
    Kuwait
    Latvia
    Lebanon
    Lithuania
    Malaysia
    Mexico
    Netherlands
    Philippines
    Poland
    Romania
    Russian Federation
    Saudi Arabia
    Serbia
    Singapore
    Slovakia
    Spain
    Switzerland
    Taiwan
    Turkey
    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: 15-July-2022
    Última visita del último paciente: 15Jul2022
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    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: 80
    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: 80
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2031
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 233
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 632
    F.4.2.2In the whole clinical trial 2344
    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 study after Treatment Period 1 or Treatment Period 2 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.
    Los Pacientes que hayan completado el estudio tras finalizar Periodo de Tratamiento 1 o Periodo de Tratamiento 2 no tendrán acceso a la medicación del ensayo debido a que el ratio riesgo/beneficio no estará establecido y al exististir alternativas terapéuticas el el Mercado para tratarles. Los pacientes serán tratados con el tratamiento de asma apropiado una vez hayan completado el estudio o hayan acabado de forma prematura el estudio.
    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 Decision2017-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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