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    Summary
    EudraCT Number:2012-003351-11
    Sponsor's Protocol Code Number:20120141
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-02-26
    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 ConcernedGreece - EOF
    A.2EudraCT number2012-003351-11
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Inadequately Controlled Asthma and High Bronchodilator Reversibility
    Μία τυχαιοποιημένη, διπλά τυφλή, ελεγχόμενη με εικονικό φάρμακο μελέτη για την εκτίμηση της ασφάλειας και της αποτελεσματικότητας του brodalumab σε ασθενείς με ανεπαρκώς ελεγχόμενο άσθμα και υψηλή βρογχοδιασταλτική αναστρεψιμότητα
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy Study of Brodalumab in Subjects with Inadequately Controlled Asthma and High Reversibility

    Μελέτη για την εκτίμηση της ασφάλειας και της αποτελεσματικότητας του brodalumab σε ασθενείς με ανεπαρκώς ελεγχόμενο άσθμα και υψηλή βρογχοδιασταλτική αναστρεψιμότητα
    A.4.1Sponsor's protocol code number20120141
    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 SponsorAmgen Inc.
    B.1.3.4CountryUnited States
    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 supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info - Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6300
    B.5.3.4CountrySwitzerland
    B.5.4Telephone numberN/A
    B.5.5Fax numberN/A
    B.5.6E-mailMedinfoInternational@amgen.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 namebrodalumab (140 mg/ml)
    D.3.2Product code AMG 827
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbrodalumab
    D.3.9.1CAS number 1174395-19-7
    D.3.9.2Current sponsor codeAMG 827
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 namebrodalumab (70 mg/0.5 ml)
    D.3.2Product code AMG 827
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbrodalumab
    D.3.9.1CAS number 1174395-19-7
    D.3.9.2Current sponsor codeAMG 827
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asthma
    Άσθμα
    E.1.1.1Medical condition in easily understood language
    Asthma
    Άσθμα
    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 15.1
    E.1.2Level LLT
    E.1.2Classification code 10003561
    E.1.2Term Asthma, unspecified
    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
    To evaluate the efficacy of brodalumab compared with placebo as measured by the change in asthma control (based on the Asthma Control Questionnaire [ACQ]) from baseline at week 24 in subjects with inadequately controlled asthma and high reversibility despite standard of care.
    Ο κύριος στόχος είναι η εκτίμηση της αποτελεσματικότητας του brodalumab σε σύγκριση με το εικονικό φάρμακο, όπως προκύπτει από τη μεταβολή του ελέγχου του άσθματος (βάσει του ερωτηματολογίου για τον έλεγχο του άσθματος [ACQ]) από την έναρξη έως την εβδομάδα 24 σε ασθενείς με ανεπαρκώς ελεγχόμενο άσθμα και υψηλή αναστρεψιμότητα παρόλη τη χορήγηση συνήθους θεραπείας.
    E.2.2Secondary objectives of the trial
    Key Secondary Objectives:
    To evaluate the effect of brodalumab compared to placebo at week 24 on:
    • asthma exacerbations (event rate defined as the number of events per subject year)
    • ACQ in inhaled corticosteroid (ICS)+long acting β-agonist (LABA) strata
    • asthma exacerbations (event rate) in ICS+LABA strata
    Δευτερεύοντες στόχοι:
    Η εκτίμηση της επίδρασης του brodalumab στα ακόλουθα σε σύγκριση με το εικονικό φάρμακο την εβδομάδα 24:
    • ασθματικοί παροξυσμοί (ως συχνότητα των συμβαμάτων ορίζεται ο αριθμός συμβαμάτων ανά έτος ασθενή)
    • ερωτηματολόγιο ACQ στις υποομάδες που λαμβάνουν εισπνεόμενο κορτικοστεροειδές (ICS) + β-διεγέρτη μακράς δράσης (LABA)
    • ασθματικοί παροξυσμοί (συχνότητα συμβαμάτων) στις υποομάδες που λαμβάνουν ICS+LABA
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Brodalumab Pharmacokinetic Substudy Objective: To characterize the pharmacokinetics of brodalumab

    Biomarker development and pharmacogentic substudy (optional):
    Objective: to collect samples for biomarker analysis; to investigate the effects of genetic variation in disease genes and drug target genes on asthma and/or subject response to brodalumab
    Στόχος της Φαρμακοκινητικής υπομελέτης του brodalumab: Η υπομελέτη θα παρέχει δεδομένα για τον προσδιορισμό της φαρμακοκινητικής του brodalumab.

    Aνάπτυξη βιολογικών δεικτών και Φαρμακογενετική υπομελέτη (προαιρετική):
    Στόχοι:
    • Να συλλεχθούν δείγματα για την ανάλυση βιολογικών δεικτών
    • Να διερευνήσει τα αποτελέσματα των γενετικών διαφορών σε γονίδια που σχετίζονται με το άσθμα και που είναι δυνητικά φαρμακευτικοί στόχοι και / ή η ανταπόκριση των ασθενών στο brodalumab
    E.3Principal inclusion criteria
    - Men or women ≥ 18 to ≤ 75 years of age at the time of screening
    - Diagnosis of asthma, and presently has reversibility over pre-bronchodilator FEV1 of ≥ 20% at screening and ≥ 15% at baseline, demonstrated in the office with SABA inhalation (up to 8 puffs) or nebulized equivalent (up to 2 treatments with 2.5 mg albuterol/salbutamol)
    - Percent of predicted FEV1 ≥ 40% and ≤ 80% at screening and baseline visits
    - ICS ≥ 200 and ≤ 1000/μg/day fluticasone powder or equivalent. Stable ICS dose for ≥ 30 days before screening. Must have used ICS for at least the last 3 consecutive months prior to screening
    - Ongoing asthma symptoms with ACQ composite score at screening and baseline ≥ 1.5 points
    - At least 1 asthma exacerbation in the year before screening
    - Nonsmoker or ex-smoker with < 10/pack-years (eg, 1 pack per day for 10 years) who stopped ≥ 1 year before screening
    • Άνδρες ή γυναίκες ηλικίας ≥ 18 έως ≤ 75 ετών κατά το χρόνο διενέργειας της αρχικής αξιολόγησης.
    • Διάγνωση άσθματος και αναστρεψιμότητα του FEV1 προ βρογχοδιαστολής ≥ 20% κατά την αρχική αξιολόγηση και ≥ 15% κατά την έναρξη της μελέτης, η οποία θα μετρηθεί στο ιατρείο με εισπνοή SABA (μέχρι 8 εισπνοές) ή κάποιο ισοδύναμο σε νεφελοποιημένη μορφή (μέχρι 2 θεραπείες με 2,5 mg αλβουτερόλης/σαλβουταμόλης).
    • Ποσοστό προβλεπόμενου FEV1 ≥ 40% και ≤ 80% κατά τις επισκέψεις αρχικής αξιολόγησης και έναρξης της μελέτης.
    • Χορήγηση ICS η οποία συνίσταται σε ≥ 200 και ≤ 1000 µg φλουτικαζόνης σε μορφή σκόνης ημερησίως ή κάποιο ισοδύναμο. Σταθερή δόση ICS για ≥ 30 ημέρες πριν από την αρχική αξιολόγηση. Οι ασθενείς πρέπει να έχουν λάβει ICS τουλάχιστον κατά τους 3 τελευταίους συνεχόμενους μήνες πριν από την αρχική αξιολόγηση.
    • Συνεχιζόμενα συμπτώματα άσθματος με σύνθετη βαθµολογία στο ερωτηματολόγιο ACQ κατά την αρχική αξιολόγηση και την έναρξη της μελέτης ≥ 1,5 βαθμούς.
    • Τουλάχιστον ένας ασθματικός παροξυσμός κατά το έτος πριν από την αρχική αξιολόγηση.
    • Μη καπνιστές ή πρώην καπνιστές με < 10 πακετοέτη (π.χ., 1 πακέτο την ημέρα για 10 χρόνια) οι οποίοι διέκοψαν το κάπνισμα ≥ 1 χρόνο πριν από την αρχική αξιολόγηση.
    E.4Principal exclusion criteria
    - History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
    - Any, systemic disease considered by the investigator to be clinically significant and uncontrolled or unstable (eg, diabetes, liver disease, renal failure, congestive heart failure, coronary artery disease, myocardial infarction or unstable angina within 12 months prior to screening, angina pectoris within 12 months before screening).

    For full detail, please refer to section 4.2 of the protocol.
    • Ιστορικό χρόνιας αποφρακτικής πνευμονοπάθειας ή άλλης χρόνιας πνευμονοπάθειας εκτός από το άσθμα.
    • Οποιαδήποτε συστηματική νόσος που θεωρείται από τον ερευνητή ως κλινικά σημαντική και μη ελεγχόμενη ή ασταθής (π.χ., διαβήτης, ηπατική νόσος, νεφρική ανεπάρκεια, συμφορητική καρδιακή ανεπάρκεια, στεφανιαία νόσος, έμφραγμα του μυοκαρδίου ή ασταθής στηθάγχη μέσα σε διάστημα 12 μηνών πριν από την αρχική αξιολόγηση, στηθάγχη μέσα σε διάστημα 12 μηνών πριν από την αρχική αξιολόγηση).
    E.5 End points
    E.5.1Primary end point(s)
    Change in ACQ composite score from baseline at week 24
    Η μεταβολή της βαθμολογίας στο ερωτηματολόγιο ACQ από την έναρξη της μελέτης έως την εβδομάδα 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Εβδομάδα 24
    E.5.2Secondary end point(s)
    Key Secondary:
    • number of asthma exacerbations (defined by use of oral corticosteroids) from baseline to week 24
    • change in ACQ from baseline at week 24 in ICS+LABA strata
    • number of asthma exacerbations from baseline to week 24 in ICS+LABA strata
    • αριθμός ασθματικών παροξυσμών (που ορίζεται από τη χρήση κορτικοστεροειδών από το στόμα) από την έναρξη έως την εβδομάδα 24
    • μεταβολή της βαθμολογίας του ερωτηματολογίου ACQ από την έναρξη έως την εβδομάδα 24 στις υποομάδες που λαμβάνουν ICS+LABA
    • αριθμός ασθματικών παροξυσμών από την έναρξη έως την εβδομάδα 24 στις υποομάδες που λαμβάνουν ICS+LABA
    E.5.2.1Timepoint(s) of evaluation of this end point
    • number of asthma exacerbations (defined by use of oral corticosteroids) from baseline to week 24
    • change in ACQ from baseline at week 24 in ICS+LABA strata
    • number of asthma exacerbations from baseline to week 24 in ICS+LABA strata
    Full details can be found in table 1 "schedule of Assessments in the protocol"
    • αριθμός ασθματικών παροξυσμών (που ορίζεται από τη χρήση κορτικοστεροειδών από το στόμα) από την έναρξη έως την εβδομάδα 24
    • μεταβολή της βαθμολογίας του ερωτηματολογίου ACQ από την έναρξη έως την εβδομάδα 24 στις υποομάδες που λαμβάνουν ICS+LABA
    • αριθμός ασθματικών παροξυσμών από την έναρξη έως την εβδομάδα 24 στις υποομάδες που λαμβάνουν ICS+LABA
    Για πλήρης λεπτομέρειες, παρακαλώ ανατρέξτε στο Πίνακα 1 «Χρονοδιάγραμμα αξιολογήσεων» του Πρωτόκολλου.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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) Yes
    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 Information not present in EudraCT
    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 EEA30
    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
    Australia
    Canada
    France
    Germany
    Greece
    Ireland
    Italy
    New Zealand
    Poland
    Russian Federation
    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"
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days0
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 66
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 566
    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)
    Plans for treatment of care after the subject has ended participation are not different from the expected normal treatment for this condition.
    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 Decision2013-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-05-01
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