Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43850   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-020803-63
    Sponsor's Protocol Code Number:AB07015
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-01-20
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2010-020803-63
    A.3Full title of the trial
    A prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, study to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroid
    A.4.1Sponsor's protocol code numberAB07015
    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 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 supportAB Science
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAB Science
    B.5.2Functional name of contact pointOleg Vustenko
    B.5.3 Address:
    B.5.3.1Street Address3 avenue George V
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number+33147201 261
    B.5.5Fax number+33147202 411
    B.5.6E-mailOleg.VUSTENKO@ab-science.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 namemasitinib
    D.3.2Product code AB1010
    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 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 milligram(s)
    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 milligram(s)
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe Persistent Asthma
    E.1.1.1Medical condition in easily understood language
    Severe asthma with oral streroids need
    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 19.0
    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
    The study 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 Asthma uncontrolled with oral corticosteroids
    Primary endpoint:
    • Severe Asthma exacerbation rate adjusted on the available person-time (time to end of treatment) on full exposure (main period + extension/weaning period).
    E.2.2Secondary objectives of the trial
    • Overall asthma exacerbation rate (severe and moderate exacerbations) adjusted on the available person-time (time to end of treatment) on full exposure (main period + extension/weaning period).
    • Asthma Control Questionnaire (ACQ) Score at 12, 20, 28 and 36 weeks
    • Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow between 25-75% of FVC (FEF25-75) at 12, 20, 28 and 36 weeks
    • Moderate and severe asthma exacerbation rate at 12, 20, 28 and 36 weeks
    • Severe asthma exacerbation rate at 12, 20, 28 and 36 weeks
    • Time to first asthma exacerbation (severe or moderate)
    • Percentage of patient experiencing at least one exacerbation at 12, 20, 28 and 36 weeks
    • Asthma symptom score at all time points
    • Morning and evening Peak Expiratory Flow Rate (PEFR) at 12, 20, 28 and 36 weeks
    • Use of rescue medication for asthma at 12, 20, 28 and 36 weeks
    • Quality of Life assessment: AQLQ score at each visit at 12, 20, 28 and 36 weeks
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient with Severe Asthma and already treated with oral corticosteroids at a minimal daily dose of 7.5 mg prednisone or equivalent for at least 3 months prior to screening visit
    2. Patient treated during at least one period of 21 days with oral corticosteroids from one year prior to screening to 3 months before screening.
    3. Patient with history of asthma ≥ 1 year prior to screening visit who also meet the following criteria:
    o baseline FEV1  35 to < 80% of the predicted normal value, demonstrated at least 6 hours after short-acting -2-agonist or 12 hours after long-acting -2-agonist
    o at least 2 asthma exacerbations within one year prior to screening visit including one severe asthma exacerbation as per protocol definition
    o uncontrolled asthma as defined as two or more of the following features within the week prior to screening visit (ACQ items)

    Daytime symptoms More than twice/week
    Limitations of activities symptoms Any
    Nocturnal symptoms/awakening Any
    Need for reliever/rescue treatment More than twice/week

    4. Patient with no significant change in the regular asthma medication, no severe asthma exacerbation for at least 4 weeks prior to screening visit
    5. Non-smoker patient for at least one year and with a prior tobacco consumption < 10 packs/year
    6. Patient with normal organ function defined as:
    • Absolute neutrophil count (ANC) ≥ 2.0 x 109/L
    • Haemoglobin ≥ 10 g/dL
    • Platelets (PTL) ≥ 100 x 109/L
    • AST and ALT ≤ 3 x ULN
    • Bilirubin ≤ 1.5x ULN
    • Creatinine clearance ≥ 60 mL/min (Cockcroft and Gault formula)
    • Albumin > 1 x LLN
    • Proteinuria < 30 mg/dL (1+) on the dipstick. In case of proteinuria ≥ 30 mg/dL, 24 hours proteinuria must be < 1.5 g/24 hours
    7. Male or female patient aged 18 to 75 years
    8. Patient weight > 50 kg and Body Mass Index (BMI) between 18 and 35 kg/m²
    9. Female patient of childbearing potential (entering the study after a menstrual period and who has a negative pregnancy test), who agrees to use a highly effective method of contraception and an acceptable method of contraception by her male partner during the study and for 3 months after the last treatment intake.

    • Male patient with a female partner of childbearing potential who agrees to use a highly effective method of contraception and an acceptable method of contraception by his female partner during the study and for 3 months after the last treatment intake OR who agrees to use an acceptable method of contraception and a highly effective method of contraception by his female partner during the study and for 3 months after the last treatment intake.

    • Highly effective methods of contraception include:
    1) Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
    2) Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable
    4) Intrauterine device (IUD)
    3) Intrauterine hormone-releasing system (IUS)
    4) Bilateral tubal occlusion
    5) Vasectomized male (azoospermia assessed medically)
    6) Sexual abstinence (Its reliability should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)

    Acceptable methods of contraception include:
    1) Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
    2) Male or female condom with or without spermicide
    10. 3) Cap, diaphragm or sponge with spermicidePatient able and willing to comply with study procedures as per protocol
    11. Patient able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe skin toxicity.
    12. Patient able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
    E.4Principal exclusion criteria
    1. Female patient who is pregnant or lactating
    2. Asthmatic patient still exposed to allergens or to triggering factors influencing asthma control
    3. Patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening visit
    4. Patient presenting with cardiac disorders defined by at least one of the following conditions will be excluded:
    a. Patient with recent cardiac history (within 6 months) of:
    i. Acute coronary syndrome
    ii. Acute heart failure (class III or IV of the NYHA classification)
    iii. Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
    b. Patient with cardiac failure class III or IV of the NYHA classification
    c. Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
    d. Syncope without known aetiology within 3 months
    e. Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension
    5. Patient with active lung disease other than asthma (e.g. chronic bronchitis)
    6. Patient who had a major surgery within 2 weeks prior to screening visit
    7. Patient with life expectancy < 6 months
    8. Patient with history of primary malignancy < 5 years, except treated basal cell skin cancer or cervical carcinoma in situ
    9. Patient with any severe and/or uncontrolled medical condition
    10. Patient with a 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. Patient with inadequate wash-out time at the screening visit:
    Wash-out time for prohibited concomitant asthma medications:
    Treatment with the following non-steroidal controllers has to be stopped about 24 h prior to screening visit: sustained-release theophylline, leukotriene antagonists, lipoxygenase inhibitors, inhaled anticholinergics, oral beta2-agonists, inhaled disodium cromoglycate, inhaled nedocromil.
    Wash-out time for allowed concomitant asthma medications
    • Long acting Beta agonists (12h prior to screening visit)
    • Short acting agonists (6h prior to screening visit)
    13. Patient treated with prohibited medications

    RANDOMISATION CRITERIA (to be checked at W0):
    1. Good study treatment (i.e. placebo) compliance (≥80%) during the 2-week run-in period
    2. Daily mean symptom score ≥ 2 during the 2-week run in period
    3. No asthma exacerbation (moderate or severe) during the 2-week run in period
    E.5 End points
    E.5.1Primary end point(s)
    Severe Asthma exacerbation rate
    E.5.1.1Timepoint(s) of evaluation of this end point
    Adjusted on the available person-time (time to end of treatment) on full exposure (main period + extension/weaning period).
    E.5.2Secondary end point(s)
    • Overall asthma exacerbation rate (severe and moderate exacerbations) adjusted on the available person-time (time to end of treatment) on full exposure (main period + extension/weaning period).
    • Asthma Control Questionnaire (ACQ) Score at 12, 20, 28 and 36 weeks
    • Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow between 25-75% of FVC (FEF25-75) at 12, 20, 28 and 36 weeks
    • Moderate and severe asthma exacerbation rate at 12, 20, 28 and 36 weeks
    • Severe asthma exacerbation rate at 12, 20, 28 and 36 weeks
    • Time to first asthma exacerbation (severe or moderate)
    • Percentage of patient experiencing at least one exacerbation at 12, 20, 28 and 36 weeks
    • Asthma symptom score at all time points
    • Morning and evening Peak Expiratory Flow Rate (PEFR) at 12, 20, 28 and 36 weeks
    • Use of rescue medication for asthma at 12, 20, 28 and 36 weeks
    • Quality of Life assessment: AQLQ score at each visit at 12, 20, 28 and 36 weeks
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Overall asthma exacerbation rate (severe and moderate exacerbations) adjusted on the available person-time (time to end of treatment) on full exposure (main period + extension/weaning period).
    • Other end points at 12, 20, 28 and 36 weeks
    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 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 trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    Bulgaria
    Czech Republic
    Germany
    India
    Morocco
    Poland
    Romania
    Slovakia
    South Africa
    Spain
    Tunisia
    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
    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 months6
    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 months6
    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.1.2.1Number of subjects for this age range: 280
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 59
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 339
    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
    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 Decision2011-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-06
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 19:35:49 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA