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    Summary
    EudraCT Number:2018-000212-25
    Sponsor's Protocol Code Number:CQAW039A2323
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-12-05
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-000212-25
    A.3Full title of the trial
    A 52-week, multicenter, randomized, double-blind, double-dummy, parallel-group, placebo-controlled study of fevipiprant once daily plus standard-of-care (SoC) for reduction of systemic corticosteroids (oral and parenteral) use in patients with severe asthma
    Étude multicentrique de 52 semaines, randomisée, contrôlée, en double aveugle et double placebo, en groupes parallèles visant à évaluer la réduction des corticoïdes systémiques (voie orale et parentérale) par le fevipiprant administré 1 fois/jour en association au traitement standard chez des patients souffrant d'asthme sévère
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate reduction of systemic corticosteroids with QAW039 in patients with severe asthma.
    Étude visant à évaluer la réduction des corticoïdes systémiques par le QAW039 chez des patients souffrant d'asthme sévère.
    A.3.2Name or abbreviated title of the trial where available
    Systemic Corticosteroids Avoidance Study in Severe Asthma Patients.
    Étude de réduction des corticoïdes systémiques chez des patients souffrant d'asthme sévère.
    A.4.1Sponsor's protocol code numberCQAW039A2323
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03629249
    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 Pharma AG
    B.1.3.4CountrySwitzerland
    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 Pharma S.A.S
    B.5.2Functional name of contact pointInformation&Communication Médicales
    B.5.3 Address:
    B.5.3.1Street Address2 et 4 rue Lionel Terray
    B.5.3.2Town/ cityRueil-Malmaison
    B.5.3.3Post code92500
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 1 5547 6600
    B.5.5Fax number+33 1 5547 6100
    B.5.6E-mailicm.phfr@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
    Asthme
    E.1.1.1Medical condition in easily understood language
    Asthma
    Asthme
    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
    To demonstrate a reduction in the use of systemic corticosteroids with fevipiprant, compared with placebo.
    Démontrer une réduction de l’utilisation des corticoïdes systémiques avec le fevipiprant comparativement au placebo.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of fevipiprant in terms of difference in daytime and night-time symptom scores using an electronic diary
    2. To evaluate the effect of fevipiprant with respect to change from baseline in Asthma Control Questionnaire (ACQ-5) total score
    3. To evaluate the effect of fevipiprant with respect to change from baseline in Asthma Related Quality of Life Questionnaire (AQLQ+12) total score
    4. To evaluate the effect of fevipiprant in terms of proportion of patients requiring ≥ 7.5mg systemic corticosteroid dose in mg per day continuously for at least 30 days
    5. To evaluate the effect of fevipiprant in terms of proportion of patients with no systemic corticosteroid use
    6. To evaluate the effect of fevipiprant in terms of time to first prescription of biologic therapy from first dose of study treatment received
    1. Évaluer l'effet de fevipiprant en termes de différence des scores des symptômes diurnes et nocturnes en utilisant un carnet électronique
    2. Évaluer l'efficacité de fevipiprant par rapport aux valeurs initiales du score total du Questionnaire de contrôle de l'asthme (ACQ-5)
    3. Évaluer l'effet de fevipiprant par rapport aux valeurs initiales du score total du Questionnaire sur la qualité de vie liée à l’asthme (AQLQ+12)
    4. Évaluer l'effet de fevipiprant en termes de proportion de patients recevant une dose de CSS ≥ 7,5 mg/jour en mg par
    jour en continu pendant au moins 30 jours
    5. Évaluer l'effet de fevipiprant en termes de proportion de patients n’utilisant pas de CSS
    6. Évaluer l'effet de fevipiprant en termes de délai avant la première prescription d’une biothérapie à compter de
    l’administration de la première dose de traitement de l’étude
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Patients with a diagnosis of asthma for a period of at least 3 months prior to Screening Visit with current asthma severity step 4 or 5 (GINA 2018)
    • Currently on treatment with medium or high dose ICS/LABA +/- other controller (i.e.LAMA, LTRA etc. as per GINA) for a minimum of 6 weeks prior to Screening Visit
    • At screening, patients with FEV1 of ≤80% of the predicted normal value for the patient, after withholding bronchodilators at Screening Visit and beginning of Run-In Visit .
    • An increase of ≥12% and ≥200 ml in FEV1 approximately 10 to 15 minutes after administration of 400 mcg of salbutamol/albuterol prior to randomization (documented historical reversibility is accepted).
    • Demonstration of inadequate control of asthma based on an ACQ-5 score ≥1.5 at Screening Visit and Treatment Day 1 Visit
    • Documented history of at least 1 asthma exacerbation within 1 year prior to enrolment
    •Diagnostic d'asthme depuis au moins 3 mois avant la visite de sélection avec un palier 4 ou 5 de sévérité de l'asthme (GINA 2018)
    •Traitement en cours avec une dose moyenne ou élevée de CSI/LABA ± un autre médicament de contrôle (LAMA, LTRA, etc. selon GINA) depuis au moins 6 semaines avant la visite de sélection
    •À la sélection, VEMS ≤ 80% de la valeur normale prédite pour le patient, sans recours aux bronchodilatateurs lors de la visite de sélection et au début de la visite de pré-inclusion
    •Augmentation ≥ 12% et ≥ 200 ml du VEMS environ 10 à 15 minutes suivant l'administration de 400 μg de salbutamol/albutérol avant la randomisation (un test de réversibilité historique est accepté).
    •Preuve d'un contrôle insuffisant de l'asthme fondée sur un score ≥ 1,5 au Questionnaire de contrôle de l'asthme (ACQ), à la visite de sélection et à la visite 1
    •Antécédents documentés d'au moins 1 exacerbation de l'asthme dans l’année (1 an) qui précède le recrutement
    E.4Principal exclusion criteria
    • Asthma exacerbation, within 6 weeks prior to enrolment (screening) that required SCS, hospitalization, or emergency room visit.
    • Chronic/ maintenance use of OCS for asthma ( total OCS use days greater than 6 months; continuously or intermittently) within the last year
    • Prior use of biologics that has potential to interfere/ affect asthma disease progression, in the previous 6 months from run-in period.
    • Any contra-indications of SCS use e.g. diabetes, narrow angle glaucoma, or any other as defined by the treating physician
    • Pregnant or nursing (lactating) women
    • Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer
    •Exacerbation de l'asthme dans les 6 semaines précédant la visite de sélection ayant nécessité le recours aux corticoïdes systémiques, une hospitalisation ou un passage aux urgences.
    •Administration chronique/en traitement d'entretien d’un corticostéroïde oral (CSO) pour l'asthme (durée totale d'utilisation du CSO supérieur à 6 mois ; en continu ou par intermittence) au cours de la dernière année.
    •Utilisation antérieure de produits biologiques susceptibles d’interférer/d’avoir une incidence sur la progression de l’asthme, dans les 6 mois précédant la période de pré-inclusion.
    •Toutes contre-indications à l’administration de CSS, par exemple diabète, glaucome à angle fermé ou tout autre type défini par l’investigateur
    •Grossesse ou allaitement
    •Administration d’autres médicaments à l'essai dans les 5 demi-vies du médicament ou dans les 30 jours précédant le recrutement, selon la plus longue de ces deux durées
    E.5 End points
    E.5.1Primary end point(s)
    Total systemic corticosteroid dose use
    Dose totale de corticoïde systémique
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 semaines
    E.5.2Secondary end point(s)
    - Change from baseline in daytime and night-time symptoms using an electronic diary. The diary consists of 5 questions regarding daytime and nocturnal asthma symptom
    - Change from baseline in Asthma Control Questionnaire total score. The ACQ-5 consists of 5 questions on a 7-point scale (0=no impairment, 6=maximum impairment).
    - Change from baseline in Asthma Related Quality of Life Questionnaire total score. AQLQ+12 consists of 32 questions each scaled from 1 to 7, where 1 indicates maximal impairment and 7 indicates no impairment
    - Proportion of patients requiring ≥ 7.5mg systemic corticosteroid dose in mg per day continuously for at least 30 days
    - Proportion of patients with no systemic corticosteroid use
    - Time to first prescription of biologic therapy from first dose of study treatment received
    -Variation par rapport aux valeurs initiales des scores des symptômes diurnes et nocturnes en utilisant un carnet électronique. Le carnet comprend 5 questions sur les symptômes d'asthme diurnse et nocturnes
    -Variation par rapport aux valeurs initiales du score total du Questionnaire de contrôle de l'asthme (ACQ-5). L’ACQ-5 comprend 5 questions sur une échelle de 7 points (0 = aucune diminution, 6 = diminution maximale).
    -Variation par rapport aux valeurs initiales du score total du Questionnaire sur la qualité de vie liée à l’asthme
    (AQLQ+12). L'AQLQ+12 comprend 32 questions, chacune échelonnée de 1 à 7, où 1 indique une diminution maximale et 7, aucune diminution.
    -Proportion de patients recevant une dose de CSS ≥ 7,5 mg/jour en mg par jour administrés en continu pendant au moins 30 jours
    -Proportion de patients n’utilisant pas de CSS
    -Délai avant la première prescription d’une biothérapie à compter de l’administration de la première dose de traitement de l’étude
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 semaines
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA94
    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
    Belgium
    Bulgaria
    Chile
    Colombia
    Costa Rica
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Peru
    Philippines
    Russian Federation
    Slovakia
    South Africa
    Spain
    Thailand
    Turkey
    United Kingdom
    United States
    Vietnam
    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
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    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 months4
    E.8.9.2In all countries concerned by the trial days10
    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: 602
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 67
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 321
    F.4.2.2In the whole clinical trial 669
    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
    Aucun
    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 Decision2018-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-27
    P. End of Trial
    P.End of Trial StatusCompleted
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