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    Summary
    EudraCT Number:2016-001447-39
    Sponsor's Protocol Code Number:AB15003
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-20
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2016-001447-39
    A.3Full title of the trial
    A 24-week with possible extension, prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, phase 3 study to compare efficacy and safety of masitinib to placebo in treatment of patients with Smouldering or Indolent Severe Systemic mastocytosis with handicap, unresponsive to optimal symptomatic treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 24-week with possible extension study to compare efficacy and safety of masitinib to placebo in treatment of patients with Smouldering or Indolent Severe Systemic mastocytosis
    A.4.1Sponsor's protocol code numberAB15003
    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 pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street Address3 avenue Georges V
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number+33610641954
    B.5.5Fax number+33147202411
    B.5.6E-mailinna.ivanina@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 nameAB1010 Tablets
    D.3.2Product code AB1010 Tablets
    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 790299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.9.3Other descriptive nameMasitinib mesylate
    D.3.9.4EV Substance CodeSUB32266
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 nameAB1010 Tablets
    D.3.2Product code AB1010 Tablets
    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 790299-79-5
    D.3.9.3Other descriptive nameMasitinib mesylate
    D.3.9.4EV Substance CodeSUB32266
    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
    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
    Smouldering or Indolent Severe Systemic Mastocytosis with handicap
    E.1.1.1Medical condition in easily understood language
    Systemic Mastocytosis
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10042949
    E.1.2Term Systemic mastocytosis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10026891
    E.1.2Term Mastocytosis
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10056452
    E.1.2Term Indolent systemic mastocytosis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective: to compare the efficacy and safety of oral masitinib versus placebo in the treatment of patients suffering from documented Smouldering or Indolent Severe Systemic mastocytosis with handicap after failure of symptomatic treatment.
    Primary endpoint:
    - Response on 3 handicaps: cumulative response by patient*handicap (pruritus and/or flushes and/or depression) from Week 8 to Week 24.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    - Response on 4 handicaps: cumulative response by patient*handicap (pruritus and/or flushes and/or depression and/or FSS) from W8 to W24.
    - Response on 4 handicaps: response by patient*handicap (pruritus and/or flushes and/or depression and/or FIS) from W8 to W24.
    - Response on 2 handicaps: response by patient*handicap (pruritus and/or flushes) from W8 to W24.
    - Long-term response on 3 handicaps: response by patient*handicap (pruritus and/or flushes and/or depression) from W8 to W96.
    - Long-term response on 4 handicaps: response by patient*handicap (pruritus and/or flushes and/or depression and/or FSS) from W8 to W96.
    - Long-term response on 4 handicaps: response by patient*handicap (pruritus and/or flushes and/or depression and/or FIS) from 8 to W96 .
    - Long-term response on 2 handicaps: response by patients*handicap (pruritus and/or flushes) from W8 to W96.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    1. Patients with one of the following documented mastocytosis:
     Smouldering Systemic Mastocytosis
     Indolent Systemic Mastocytosis
    The retained classification of systemic mastocytosis is based on an excess of mast cells or a presence of abnormal mast cells in at least two organs.
    The criteria used will be as follows:
    i. Bone marrow biopsy and/or aspirate associated with at least a sign of abnormality of mast cells:
    Signs of abnormality of mast cells are:
    a) Abnormal aggregates of mast cells in a sample in bone marrow:
    The criteria is deemed satisfied if the aggregate i) is quantified and is strictly above 15 mast cells per aggregated (corresponding to WHO major criterion), or ii) is not quantified but is described as nodule, seat, cluster, focus, or granuloma and therefore pathological
    b) ≥25% atypical mast cells in a sample of bone marrow (corresponding to WHO minor criterion)
    c) c-Kit point mutation at codon 816 in bone marrow (corresponding to WHO minor criterion)
    d) Abnormal mast cells in the sample of bone marrow while microscopic testing that can be described by the following words: Spindled; Abnormal; Atypical; Fusiform; Dystrophic; Pathologic; Dysmorphic (corresponding to WHO minor criterion)
    e) Abnormal immunohistochemistry signs: mast cells in bone marrow express CD2 or/and CD25 present (corresponding to WHO minor criterion)
    f) Abnormal infiltration of mast cells in the bone marrow
    The criteria is deemed satisfied if the infiltration i) is quantified and is strictly above 3% in the biopsy, or ii) is not quantified but is abnormal as described with infiltration, contingent of mast cells, or proliferation and therefore pathological.
    ii. Detection of c-kit 816 in the bone marrow without evidence of mast cells in bone marrow but with evidence of c-Kit 816 in skin, justifying clonality
    iii. Excess of mast cells in digestive organs

    2. Patient with documented treatment failure of his/her handicap(s) with at least one of the following therapy used at optimized dose (Table S1):
     Anti H1
     Anti H2
     Proton pump inhibitor
     Osteoclast inhibitor
     Cromoglycate Sodium
     Antileukotriene
    3. Handicapped status defined as at least one of the following handicaps:
    Pruritus score ≥ 9
    Number of flushes per week ≥ 8
    Hamilton rating scale for depression(HAMD-17) score ≥ 19
    4. Patients with adequate organ function:
    - Absolute neutrophils count (ANC) ≥ 2.0 x 109/L,
    - Haemoglobin ≥ 10 g/dL
    - Platelets (PLT) ≥ 100 x 109/L
    - AST and ALT ≤ 3x ULN
    - Bilirubin ≤ 1.5x ULN
    - Creatinine clearance > 60mL/min (Cockcroft and Gault formula)
    - Albuminemia >1 x LLN
    - Proteinuria at screening < 30 mg/mL (1+) on the dipstick. If proteinuria is > 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours
    5. Male or female patient aged 18 to 75 years, weight > 41 kg and BMI between 18 and 35 kg/m2
    6. Contraception:
    • 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.
    7. Female patient of childbearing potential must have a negative serum pregnancy test at screening and baseline
    8. Patient must be able and willing to comply with study visits and procedures per protocol
    9. Patient must understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed
    10. Patient must understand the patient card and follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity
    E.4Principal exclusion criteria
    Exclusion criteria:
    1. Previous treatment with any Tyrosine Kinase Inhibitor.
    2. Patient presenting with cardiac disorders defined by at least one of the following conditions:
    • Patient with recent cardiac history (within 6 months) of:
    - Acute coronary syndrome
    - Acute heart failure (class III or IV of the NYHA classification)
    - Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
    • Patient with cardiac failure class III or IV of the NYHA classification
    • Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
    • Syncope without known aetiology within 3 months
    • Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension
    3. Patient who had major surgery within 2 weeks prior to screening visit
    4. Patient presenting with edema of cardiac origin and left ventricular ejection fraction ≤ 50%
    5. Patient with chronic diarrhea defined as an episode that lasts longer than 14 days.
    6. Vulnerable population defined as:
    • Life expectancy < 6 months
    • Patient with < 5 years free of malignancy, except treated basal cell skin cancer or cervical carcinoma in situ
    • Patient with any severe and/or uncontrolled medical condition
    • Patient with known diagnosis of human immunodeficiency virus (HIV) infection
    7. 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 according to the judgment of the investigator , or institutionalized by court decision
    8. Patient with any condition that the physician judges could be detrimental to patients participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical events
    Previous treatment
    9. Change in the symptomatic treatment of systemic mastocytosis, including the systemic corticosteroids,or administration of any new treatment for systemic mastocytosis (including any Tyrosine Kinase Inhibitor) within 4 weeks prior to baseline
    10. Treatment with any investigational agent within 4 weeks prior to baseline
    E.5 End points
    E.5.1Primary end point(s)
    Primary objective:
    Primary endpoint:
    - Response on 3 handicaps: cumulative response by patient*handicap (pruritus and/or flushes and/or depression) from Week 8 to Week 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    W8 to W24
    E.5.2Secondary end point(s)
    Secondary objectives:
    Secondary endpoints:

    Mast cells activation symptoms:

    - Response on 4 handicaps: cumulative response by patient*handicap (pruritus and/or flushes and/or depression and/or FSS) from Week 8 to Week 24 (version 1).
    - Response on 4 handicaps: cumulative response by patient*handicap (pruritus and/or flushes and/or depression and/or FIS) from Week 8 to Week 24 (version 2).
    - Response on 2 handicaps: cumulative response by patient*handicap (pruritus and/or flushes) from Week 8 to Week 24.
    - Long-term response on 3 handicaps: cumulative response by patient*handicap (pruritus and/or flushes and/or depression) from Week 8 to Week 96.
    - Long-term response on 4 handicaps: cumulative response by patient*handicap (pruritus and/or flushes and/or depression and/or FSS) from Week 8 to Week 96 (version 1).
    - Long-term response on 4 handicaps: cumulative response by patient*handicap (pruritus and/or flushes and/or depression and/or FIS) from Week 8 to Week 96 (version 2).
    - Long-term response on 2 handicaps: cumulative response by patients*handicap (pruritus and/or flushes) from Week 8 to Week 96.

    Biological and skin parameters:

    - Tryptase response –change from baseline at week 12, 24 and then every 12 weeks
    - Urticaria Pigmentosa (UP) evaluation:
    o percentage of patients with improvement Darrier sign among UP patients at week 8, 12, 24 and then every 12 weeks
    o change from baseline in the Body Surface Area (BSA) covered by UP

    Other symptomatic endpoints:
    - Cumulative response on pruritus from Week 8 to Week 24 among patients with the handicap at Baseline.
    - Cumulative response on flushes from Week 8 to Week 24 among patients with the handicap at Baseline.
    - Cumulative response on depression from Week 8 to Week 24 among patients with the handicap at Baseline (Hamilton rating scale for depression (HAMD-17) score ≥ 19)
    - Cumulative response on Fatigue Severity Scale (FSS) from Week 8 to Week 24 among patients with the handicap at Baseline (FSS score ≥ 36)
    - Cumulative response on Fatigue Impact Scale (FIS) from Week 8 to Week 24 among patients with the handicap at Baseline (FIS score ≥ 75)
    - In addition, long-term response (Week 8 to Week 96) for each endpoint in this section

    Quality of Life (QOL) – valid for the sites for which questionnaire is validated in local language:
    - Change from baseline to week 24 and every 24 weeks in MC-QoL questionnaire; in addition, long-term response (W8 to W96)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 8 to Week 96
    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 Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Poland
    Romania
    Russian Federation
    Slovakia
    Spain
    Switzerland
    Ukraine
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 50
    F.4.2.2In the whole clinical trial 140
    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 Decision2020-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-18
    P. End of Trial
    P.End of Trial StatusOngoing
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