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    Summary
    EudraCT Number:2016-001447-39
    Sponsor's Protocol Code Number:AB15003
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-11-20
    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 ConcernedPoland - Office for Medicinal Products
    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 oral masitinib to placebo in treatment of patients with Smouldering or Indolent Severe Systemic mastocytosis with handicap, unresponsive to optimal symptomatic treatment
    24-tygodniowe z możliwością przedłużenia, prospektywne, wieloośrodkowe, randomizowane, podwójnie ślepe, kontrolowane placebo, z dwoma równoległymi grupami z randomizacją 1:1, badanie fazy trzeciej, porównujące skuteczność i bezpieczeństwo masytinibu z placebo podawanych doustnie w leczeniu pacjentów z tlącą się lub ciężką układową mastocytozą o powolnym przebiegu z uciążliwymi objawami upośledzającymi jakość życia, nieodpowiadających na optymalne leczenie objawowe
    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 oral masitinib to placebo in treatment of patients with Smouldering or Indolent Severe Systemic mastocytosis
    24-tygodniowe z możliwością przedłużenia badanie porównujące skuteczność i bezpieczeństwo masytinibu z placebo w leczeniu pacjentów z tlącą się lub ciężką układową mastocytozą
    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 pointChief executive officer
    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 number33147202311
    B.5.5Fax number33147202411
    B.5.6E-maila.moussy@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.3.9.2Current 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 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 placeboCoated 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 unresponsive to optimal sympomatic treatment
    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
    Cumulative response on 3 handicaps (Pruritus, Flush, Depression) from week 8 to week 24.
    • Handicaps are defined as: Pruritus score ≥ 9, number of Flushes per week ≥ 8, Depression HAMD score ≥ 19.
    • Response on a handicap is defined as an improvement ≥ 75% for Pruritus, Flushes and Depression (HAMD Score).
    For all the patients, the response at each study visit (5 visits from week 8 to week 24) will be calculated on each handicap present at Baseline (among pruritus, flushes, depression) as defined above.
    Sensitivity analysis will be performed from week 8 to week 48.
    In case of rescue medication to manage a handicap, all subsequent measures will be considered as “fail”.
    E.2.2Secondary objectives of the trial
    • Cumulative response on 4 handicaps (Pruritus, Flushes, Depression, FSS) from w 8 to w 24. • Cumulative response on 4 handicaps (Pruritus, Flushes, Depression, FIS) from w 8 to w24.
    • Cumulative response on 2 handicaps (Pruritus, Flush) from w 8 to w24.
    • Cumulative response on each of the individual handicaps from w 8 to w 24:
    - Response on above mentioned handicaps is defined as an improvement ≥75%.

    2. Biological and Skin Parameters:
    • Tryptase Level:
    - Change from baseline at week 24 in serum tryptase level;
    • Urticaria Pigmentosa:
    - “Darier Sign” disappearance (Yes/No) (week 12 to week 24);
    - Body Surface Area (BSA) (week 12 to week 24).

    3. Quality of Life
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient with one of the following documented mastocytosis:
    • Smouldering Systemic Mastocytosis (SSM)
    • Indolent Systemic Mastocytosis (ISM)
    2. An excess of mast cells or a presence of abnormal mast cells in at least two organs (among skin, bone-marrow and GI Tract)
    3. Patients meet the retained classification of systematic mastocytosis (SM) based on the presence of one of the three criteria:
    • Bone marrow biopsy and/or aspirate associated with at least a sign of abnormality of mast cells:
    - Abnormal aggregates of mast cells in a sample in bone marrow:
    The criterion 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;
    - ≥25% atypical mast cells in a sample of bone marrow (corresponding to WHO minor criterion);
    - c-Kit point mutation at codon 816 in bone marrow (corresponding to WHO minor criterion);
    - 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);
    - Abnormal immunohistochemistry signs: mast cells in bone marrow express CD2 or/and CD25 present (corresponding to WHO minor criterion);
    - Abnormal infiltration of mast cells in the bone marrow:
    The criterion 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.
    • 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;
    • Excess of mast cells in digestive organs.
    4. Patient with severe symptoms of mastocytosis over the 14-day run-in period defined as at least one of the following:
    • Pruritus score ≥ 9
    • Number of flushes per week ≥ 8
    • Hamilton rating scale for depression (HAMD-17) score ≥ 19
    5. Patient with documented treatment failures of his/her symptom (s) (within last two years) with at least two of the symptomatic treatments used at optimized dose (Minimal duration of each treatment should be at least 8 weeks):
    • Anti-H1
    • Anti-H2
    • Proton pump inhibitor
    • Antidepressants
    • Cromoglycate Sodium
    • Antileukotriene
    6. Patients must be on a stable dose of Anti-H1 for a minimum of 4 weeks before screening and should remain at a stable dose throughout the study period. For other symptomatic treatments, if the patient takes Corticosteroids, Anti-H2 or PPI or Antidepressants or Cromoglycate Sodium or Antileukotriene, the treatment must have started at least 4 weeks before Screening and must be stable throughout the study.
    7. Age between 18 to 75 years (inclusive).
    8. Weight > 45 kg and BMI between 18 and 35 kg/m2
    9. Contraception:
    • The patient and his/her partner must use a highly effective method during the study and for 3 months and 1 week after the last treatment intake.
    • Highly effective methods of contraception include:
    - Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
    - Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable
    - Intrauterine device (IUD)
    - Intrauterine hormone-releasing system (IUS)
    - Bilateral tubal occlusion
    - Vasectomized male (azoospermia assessed medically)
    - 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)
    10. Patient must be able and willing to comply with study visits and procedures.
    11. Patient able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures.
    12. Patient able to 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
    1. Cutaneous mastocytosis, SM associated with hematological neoplasm, Mast Cell Leukemia and Aggressive SM.
    2. Previous treatment with any Tyrosine Kinase Inhibitor.
    3. Any change in the symptomatic treatment of SM, including the systemic corticosteroids, or administration of any new treatment for SM within 4 weeks prior to screening.
    4. Treatment with any investigational agent within 8 weeks prior to screening.
    5. Recent history of severe cardiovascular disease including acute myocardial infarction, unstable angina pectoris, coronary revascularization procedure, congestive heart failure of NYHA Class III or IV, stroke, including a transient ischemic attack, edema of cardiac origin and left ventricular ejection fraction ≤ 50%.
    6. Patient who had major surgery within 2 weeks prior to screening visit.
    7. Known hypersensitivity to masitinib or to any of its excipients.
    8. Patient with concomitant treatment or therapies associated with severe drug-induced skin toxicity.
    9. Pregnancy and lactation.
    10. Patient with following laboratory results out of the ranges detailed below at screening:
    • Absolute neutrophil count (ANC) ≤ 1.5 x 109/L
    • Haemoglobin ≤ 10 g/dL
    • Platelets (PLT) ≤ 100 x 109/L
    • Albuminemia ≤ 1 x LLN
    11. Patient with history of hepatic disorders, recent alcohol abuse or recent history of hepatic impairment defined as hepatic transaminase levels >3 x ULN or total bilirubin level > 1.5 x ULN
    12. Patient with severe pre-existing renal impairment, or with abnormal laboratory results from local laboratory assessments at screening:
    • Creatinine clearance < 60 mL/min (Cockcroft and Gault formula)
    • Proteinuria > 30 mg/dL (1+) on dipstick; in case of the proteinuria ≥ 1+ on the dipstick, 24 hours proteinuria must be > 1.5g/24 hours
    13. Vulnerable population defined as:
    • Life expectancy < 6 months
    • Patient with < 5 years free of malignancy.
    • Patient with known diagnosis of human immunodeficiency virus (HIV) infection.
    14. Patient with history of poor compliance, or current or past psychiatric disease that might interfere with the ability to comply with the study procedures or give informed consent according to the judgment of the investigator or institutionalized by court decision.
    15. Patient with any condition that the physician judges could be detrimental to patient participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical conditions.
    E.5 End points
    E.5.1Primary end point(s)
    Cumulative response on 3 handicaps (Pruritus, Flush, Depression) from week 8 to week 24.
    • Handicaps are defined as: Pruritus score ≥ 9, number of Flushes per week ≥ 8, Depression HAMD score ≥ 19.
    • Response on a handicap is defined as an improvement ≥ 75% for Pruritus, Flushes and Depression (HAMD Score).
    For all the patients, the response at each study visit (5 visits from week 8 to week 24) will be calculated on each handicap present at Baseline (among pruritus, flushes, depression) as defined above.
    Sensitivity analysis will be performed from week 8 to week 48.
    In case of rescue medication to manage a handicap, all subsequent measures will be considered as “fail”.
    E.5.1.1Timepoint(s) of evaluation of this end point
    W8 to W24
    E.5.2Secondary end point(s)
    1. Handicap:
    • Cumulative response on 4 handicaps (Pruritus, Flushes, Depression, FSS) from week 8 to week 24. Handicaps for this cumulative response are defined as: Pruritus score ≥ 9, number of Flushes per week ≥ 8, Depression HAMD score ≥ 19, FSS ≥ 36.
    • Cumulative response on 4 handicaps (Pruritus, Flushes, Depression, FIS) from week 8 to week 24. Handicaps for this cumulative response are defined as: Pruritus score ≥ 9, number of Flushes per week ≥ 8, Depression HAMD score ≥ 19, FIS ≥ 75.
    • Cumulative response on 2 handicaps (Pruritus, Flush) from week 8 to week 24. Handicaps for this cumulative response are defined as: Pruritus score ≥ 9 and number of Flushes per week ≥ 8.
    • Cumulative response on each of the individual handicaps from week 8 to week 24:
    - Pruritus (Handicap defined as Pruritus Score ≥ 9);
    - Flushes (Handicap defined as Flushes ≥ 8);
    - Depression (Handicap defined as HAMD ≥ 19);
    - Fatigue Severity Scale (FSS) (Handicap defined as FSS ≥ 36);
    - Fatigue Impact Scale (FIS) (Handicap defined as FIS ≥ 75).
    Response on above mentioned handicaps is defined as an improvement ≥75%.
    Sensitivity analysis will be performed from week 8 to week 48.
    2. Biological and Skin Parameters:
    • Tryptase Level:
    - Change from baseline at week 24 in serum tryptase level;
    - Response: Defined as a diminution of at least 25% in tryptase level at week 24.
    • Urticaria Pigmentosa:
    - “Darier Sign” disappearance (Yes/No) (week 12 to week 24);
    - Body Surface Area (BSA) (week 12 to week 24).
    Sensitivity analysis for “Darier Sign” disappearance (Yes/No) and Body Surface Area (BSA) will be performed from week 12 to week 48.
    3. Quality of Life:
    • MC-QoL Questionnaire (27 questions)
    • MC-QoL questionnaire must be completed by patient for quality of his/her life for past two (2) weeks.
    Sensitivity analysis will be performed from week 8 to week 48.
    Additional analysis will be elaborated in the Statistical Analysis Plan which will be approved before the Data Base Lock.

    Criteria for Safety Occurrence of IMP-related and unrelated Adverse Events (AEs)/Serious Adverse Events (SAEs).
    Changes in physical examination including vital signs (blood pressure, pulse rate), weight and ECG.
    Changes in clinical laboratory tests (biochemistry, haematology, urinalysis).
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    Canada
    France
    Germany
    Italy
    Lithuania
    Netherlands
    Poland
    Romania
    Russian Federation
    Spain
    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 years3
    E.8.9.1In the Member State concerned months11
    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 state15
    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 Decision2018-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-11
    P. End of Trial
    P.End of Trial StatusOngoing
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