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    Summary
    EudraCT Number:2010-021495-29
    Sponsor's Protocol Code Number:AB09001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prohibited by CA
    Date on which this record was first entered in the EudraCT database:2010-09-06
    Trial 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 number2010-021495-29
    A.3Full title of the trial
    A prospective, multicentre, randomised, double-blind, placebo-controlled, phase 2a study to compare the efficacy and the safety of 24-week treatment with masitinib at 6 mg/kg/day versus placebo in patients with severe Chronic Obstructive Pulmonary Disease (COPD)
    A.4.1Sponsor's protocol code numberAB09001
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAB Science
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 namemasitinib
    D.3.2Product code AB1010
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNmasitinib mesylate
    D.3.9.1CAS number 790-299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmasitinib mesylate
    D.3.9.1CAS number 790-299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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
    severe Chronic Obstructive Pulmonary Disease (COPD)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with severe COPD.
    Primary endpoint:
    • Absolute change from randomisation in the 6-minutes walking distance test at Week 24
    E.2.2Secondary objectives of the trial
    Absolute change from randomisation in the 6-minutes walking distance test at each time point.
    Absolute change from randomisation in the post-bronchodilator FEV1 (Forced Expiratory Volume in one second) at Week 4, 8, 12, 18 and 24
    Absolute change from randomisation over 24 weeks in the weekly dose of rescue medication (salbutamol)
    Absolute change from randomisation in the TDI (Transitional Dyspnoea Index) Focal Score (i.e. change from BDI or Baseline Dyspnoea Index at randomisation [W0]) over 24 weeks of treatment
    Absolute change from randomisation in the SGRQ (Saint George Respiratory Questionnaire) at Week 4, 8, 12, 18 and 24
    Absolute change from randomisation in symptoms of cough and sputum
    Exacerbation rate (number of COPD exacerbation per patient per year) during the W0 W24 period
    Rate of Severe exacerbations defined as a need for hospitalization or emergency department visit during the W0 W24 period
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient with history of chronic obstructive pulmonary disease for at least 12 months prior to screening visit (ATS/ERS 2005) and chronic productive cough for 3 months in each of the 2 years prior to screening visit (if other causes of productive cough have been excluded), and present during the 4 weeks preceding screening.
    2. Patient with at least one exacerbation during the preceding year.
    3. Patient with FEV1/FVC ratio (post-bronchodilator)  70%.
    4. Patient with FEV1 (post-bronchodilator) between ≥ 30 % and  50 % of predicted value
    5. Patient pre-treated with adequate and stable symptomatic treatment for at least 3 months prior to screening visit.
    6. Former smoker (defined as: smoking cessation at least one year ago) or current smoker both with a smoking history of at least 10 pack years
    7. Patient with normal organ function defined as:
    • absolute neutrophils count (ANC) ≥ 2.0 x 109/L,
    • haemoglobin ≥ 10 g/dL
    • platelets (PTL) ≥ 100 x 109/L
    • AST/ALT ≤ 2.5x ULN
    • bilirubin ≤ 1.5x ULN
    • creatinin ≤ 1.5 x ULN
    • albumin > 1 x LLN
    • urea ≤ 1.5 x ULN
    • dipstick proteinuria < 30 mg/dL. In case of dipstick proteinuria ≥ 30 mg/dL, 24 hours proteinuria < 1.5g/24 hours.
    8. Male or female patient, aged 40 to 75 years inclusive, weight > 45 kg and with BMI > 18kg/m² at screening
    9. Man and woman of child bearing potential, (entering the study after a menstrual period and who have a negative pregnancy test) must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake.
    10. Patient able and willing to comply with study procedures as per protocol.
    11. Patient able to understand, sign, and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures.
    12. Patient affiliated to a social security system.
    E.4Principal exclusion criteria
    1. Pregnant, or nursing female patient
    2. Patient experiencing COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to the screening visit.
    3. Patient with lower respiratory tract infection not resolved 4 weeks prior to the screening visit.
    4. Patient with asthma and/or other relevant lung disease (e.g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease [e.g. fibrosis, silicosis, sarcoidosis], and active tuberculosis).
    5. Patient currently participating in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the screening visit.
    6. Patients with known alpha-1-antitrypsin deficiency.
    7. Patient with clinically significant cardiopulmonary abnormalities (diagnosed clinically or by X-ray / CT-scan / ECG) that are not related to COPD and that require further evaluation.
    8. Patient who had major surgery within 2 weeks prior to screening visit
    9. Patient having cardiac disorders defined by at least one of the following conditions:
    a. Ischemic heart disease, defined by at least one of the following condition:
    i. Medical history of ischemic heart disease
    ii. Clinical symptoms of ischemic heart disease
    iii. Q wave > 3 mm on the electrocardiogram
    iv. ST elevation or depression > 2 mm on the electrocardiogram
    v. Negative T wave in at least 2 leads of the electrocardiogram
    b. Cardiac failure, defined by at least one of the following condition:
    i. Medical history of cardiac failure defined by a previous left ventricular ejection fraction ≤ 50% or a current treatment for cardiac failure
    ii. Clinical symptoms of cardiac failure
    iii. NT proBNP ≥ 300 pg/mL or BNP ≥ 75 pg/mL or troponin T > 0.1 ng/mL or troponin I > 0.35 ng/mL
    c. Conduction disorders or arrhythmia, defined by at least one of the following and confirmed by electrocardiogram :
    i. Severe ventricular arrhythmia (frequent premature ventricular beats)
    ii. Atrioventricular block at second or third level
    iii. Left bundle branch block
    10. Patient with:
    Life expectancy < 6 months
    < 5 years free of malignancy, except treated basal cell skin cancer or cervical carcinoma in situ
    Any severe and/or uncontrolled medical condition
    Known diagnosis of human immunodeficiency virus (HIV) infection
    11. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
    12. Treatment with any investigational agent within 4 weeks prior baseline
    RANDOMISATION:
    To be randomised into the double-blind treatment period the following criteria must be fulfilled at baseline [W0]:
    1. No moderate or severe COPD exacerbations between screening visit and baseline or W0 visit
    2. Tablet compliance ≥ 80%
    E.5 End points
    E.5.1Primary end point(s)
    -minutes walking distance. The test is performed on subjects free of diseases, which could interfere with performance in a walking test. Tests must be performed in a quiet 50-m long hospital corridor. Patients must be encouraged every 30 s to continue walking as quickly as possible.
    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 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) 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.8.3 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 concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    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 months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state45
    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 Decision2010-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-21
    P. End of Trial
    P.End of Trial StatusProhibited by CA
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