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    Summary
    EudraCT Number:2017-005028-11
    Sponsor's Protocol Code Number:I4V-MC-JAIM
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-02
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2017-005028-11
    A.3Full title of the trial
    A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)
    3. fázisú, kettős-vak, multicentrikus vizsgálat a baricitinib hosszú távú biztonságosságának és hatásosságának értékelésére szisztémás lupus erythematosusban (SLE) szenvedő betegeknél
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Baricitinib in patients with Lupus
    A.4.1Sponsor's protocol code numberI4V-MC-JAIM
    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 SponsorEli Lilly and Company
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 Yes
    D.2.1.1.1Trade name Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V, Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBaricitinib
    D.3.2Product code LY3009104
    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 INNBaricitinib
    D.3.9.2Current sponsor codeLY3009104
    D.3.9.3Other descriptive nameBARICITINIB
    D.3.9.4EV Substance CodeSUB31583
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Yes
    D.2.1.1.1Trade name Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V, Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBaricitinib
    D.3.2Product code LY3009104
    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 INNBaricitinib
    D.3.9.2Current sponsor codeLY3009104
    D.3.9.3Other descriptive nameBARICITINIB
    D.3.9.4EV Substance CodeSUB31583
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Systemic Lupus Erythematosus (SLE)
    E.1.1.1Medical condition in easily understood language
    Systemic Lupus Erythematosus ( SLE) also known as Lupus
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025139
    E.1.2Term Lupus erythematosus systemic
    E.1.2System Organ Class 100000004859
    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 long-term safety and tolerability of baricitinib in patients with SLE.
    E.2.2Secondary objectives of the trial
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD and background standard-of-care therapy on SLE disease activity
    - To evaluate the long-term corticosteroid sparing effect of baricitinib 4-mg or 2-mg QD
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on SLE flares
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on mucocutaneous manifestations of SLE
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on musculoskeletal manifestations of SLE
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on individual organ system disease activity.
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on damage.
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on patient-reported outcomes (PROs)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [ [1] Are at least 18 years of age.
    [2] Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
    [3] Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 ACR criteria for classification of SLE (Tan et al. 1982; Hochberg et al. 1997) prior to randomization.
    [4] Have 1 or more of the following as assessed by the central lab during screening: a positive antinuclear antibody (ANA; titer ≥1:80), and/or a positive anti-dsDNA, and/or a positive anti-Smith (anti Sm). Patients with an ANA <1:80 at screening with documentation of a historical ANA ≥1:80 may be eligible, as assessed by the eligibility review committee.
    [5] Have a total SLEDAI-2K score ≥6 during screening, with at least 4 points attributed to clinical items (not including items requiring laboratory value assessment). SLEDAI-2K items requiring laboratory values should be assessed based on the results from the labs drawn during the screening period.
    [6] Have a clinical SLEDAI-2K score ≥4 at baseline (Visit 2); not including any items requiring laboratory value assessment.
    [7] Have at least 1 BILAG A score or 2 BILAG B scores during the screening period. BILAG items requiring laboratory values should be assessed based on the results from the labs drawn during the screening period.
    [8] Are receiving at least one of the following SoC medications for SLE:
    - A single antimalarial (such as hydroxychloroquine, chloroquine, quinacrine) at a stable therapeutic dose for at least 8 weeks prior to screening (Visit 1).
    - A single immunosuppressant (such as methotrexate [MTX], azathioprine, mycophenolate, tacrolimus, leflunomide, cyclosporine) at a stable therapeutic dose for at least 8 weeks prior to screening (Visit 1).
    - An oral corticosteroid, initiated at least 4 weeks prior to screening (Visit 1), at a stable dose ≤40 mg/day prednisone (or equivalent) for at least 2 weeks prior to screening (Visit 1) and through baseline (Visit 2). If the patient is not receiving an antimalarial or immunosuppressant, the dose of corticosteroid must be ≥7.5 mg/day prednisone (or equivalent).
    [9] Male or nonpregnant, nonbreastfeeding female patient
    - Patients of child-bearing potential who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle) or in a same-sex relationship (as part of their preferred and usual lifestyle) must agree to either remain abstinent or stay in a same-sex relationship without sexual relationships with the opposite sex.
    - Total abstinence is defined as refraining from intercourse during the entirety of the study and for at least 1 week following the last dose of investigational product.
    - Otherwise, patients of child-bearing potential must agree to use 2 effective methods of contraception, where at least 1 form is highly effective, for the entirety of the study and for at least 1 week following the last dose of investigational product.
    - The following contraception methods are considered acceptable (the patient should choose 2, and 1 must be highly effective [defined as less than 1% failure rate per year when used consistently and correctly]):
    • Highly effective birth control methods:
     Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
     Progestogen-only containing hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
     intrauterine device (IUD)/intrauterine hormone-releasing system (IUS)
     vasectomized male (with appropriate postvasectomy documentation of the absence of sperm in the ejaculate).
    • Effective birth control methods:
     Male or female condom with spermicide. It should be noted that the use of male and female condoms as a double barrier method is not considered acceptable due to the high failure rate when these methods are combined.
     Diaphragm with spermicide
     Cervical sponge
     Cervical cap with spermicide
    Patients of non‒child-bearing potential are not required to use birth control and they are defined as:
    • Women who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation)
    • Post-menopausal – defined either as
     A woman at least 50 years of age with an intact uterus
    • Women aged 55 years or older who are not on hormone therapy, and who have had at least 6 months of spontaneous amenorrhea
    • Women aged 55 years or older who have a diagnosis of menopause
    [10] Must read and understand the informed consent approved by Eli Lilly and Company (Lilly), or its designee, and the institutional review board (IRB)/ethics review board (ERB) governing the site, and provide written informed consent.
    E.4Principal exclusion criteria
    [11] Have severe active lupus nephritis defined clinically and/or by histologic evidence of proliferative glomerulonephritis on renal biopsy (if available) within the 24 weeks prior to screening, or urine protein/creatinine ratio >200 mg/mmol (as an estimate of approximate proteinuria >2 g/day) or eGFR (Modification of Diet in Renal Disease [MDRD]) <40 mL/min/1.73 m 2 at screening, or as determined by the eligibility review committee.
    [12] Have active CNS lupus as defined by ACR nomenclature for neuropsychiatric lupus syndromes and as captured by SLEDAI-2K (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, and cerebrovascular accident).
    [13] Have active fibromyalgia that, in the investigator’s opinion, would make it difficult to appropriately assess SLE activity for the purposes of this study.
    [14] Have been treated for or had an active occurrence of a systemic inflammatory condition other than SLE.
    [15] Have had any major surgery within 8 weeks prior to screening or will require major surgery during the study that, in the opinion of the investigator in consultation with Lilly or its designee, would pose an unacceptable risk to the patient.
    [16] Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the investigator, are clinically significant and indicate an unacceptable risk for the patient’s participation in the study.
    [17] Have experienced any of the following within 12 weeks of screening: VTE (DVT/pulmonary embolism [PE]), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
    [18] Have a history of recurrent (≥2) VTE (DVT/PE).
    [19] Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness.
    [20] Have a history of lymphoproliferative disease
    [21] Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection or any other active or recent infection.
    [22] Have symptomatic herpes simplex at the time of randomization.
    [23] Have had symptomatic herpes zoster infection within 12 weeks prior to randomization.
    [24] Have a history of disseminated/complicated herpes zoster (for example, ophthalmic zoster or CNS involvement).
    [25] Have a positive test for hepatitis B virus (HBV)
    [26] Have hepatitis C virus (HCV) infection (hepatitis C antibody-positive and HCV ribonucleic acid [RNA]-positive).
    [27] Have evidence of HIV infection and/or positive HIV antibodies.
    [28] Have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB.
    [29] Have evidence of active TB or latent TB
    [20] Have a history of lymphoproliferative disease;
    [21] Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection or any other active or recent infection.
    [22] Have symptomatic herpes simplex at the time of randomization.
    [23] Have had symptomatic herpes zoster infection within 12 weeks prior to randomization.
    [24] Have a history of disseminated/complicated herpes zoster (for example, ophthalmic zoster or CNS involvement).
    [25] Have a positive test for hepatitis B virus (HBV)
    [26] Have hepatitis C virus (HCV) infection (hepatitis C antibody-positive and HCV ribonucleic acid [RNA]-positive).
    [27] Have evidence of HIV infection and/or positive HIV antibodies.
    [28] Have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB.
    [29] Have evidence of active TB or latent TB
    [30] Have received parenteral corticosteroids within 6 weeks of screening (Visit 1), or are expected to require parenteral corticosteroids during the study.
    [31] Have received any of the following medications (please refer to protocol).
    [32] Have received a JAK inhibitor.
    [33] Have been treated with probenecid that cannot be discontinued for the duration of the study.
    [34] Have received plasmapheresis within 12 weeks of screening.
    [35] Have been exposed to a live vaccine within 12 weeks of randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination).
    [36] Are currently enrolled in or have discontinued within 4 weeks of screening from, any other clinical trial.
    [37] Have previously completed or been randomized and withdrawn from this study or have received baricitinib in any other study.
    [38] Have screening laboratory test values, in the opinion of the investigator, pose an unacceptable risk for the patient’s participation in the study.
    [39] Have any of the following specific abnormalities on screening laboratory tests from the central laboratory (please refer to the protocol)
    Other Exclusions (please refer to the protocol)


    E.5 End points
    E.5.1Primary end point(s)
     Proportion of patients with treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs).
     Proportion of patients with temporary investigational product interruptions and permanent discontinuations.

    E.5.1.1Timepoint(s) of evaluation of this end point
    The change will be evaluated from the baseline time point to the study week 156 time point
    E.5.2Secondary end point(s)
    Proportion of patients achieving SRI-4 response through Week 156, defined as:
    - Reduction of ≥4 points from baseline in SLEDAI-2K score; and
    - No new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity score; and
    - No worsening (defined as an increase of ≥0.3 points [10 mm] from baseline) in the Physician’s
    Global Assessment of Disease Activity.

    Proportion of patients achieving an SRI-5, -6, -7, or -8 response through Week 156.

    Proportion of patients achieving an LLDAS response through Week 156.

    Change from baseline in mean total SLEDAI-2Kscores through Week 156.

    Change from baseline in Physician’s Global Disease Activity score through Week 156.

    Proportion of patients receiving >7.5 mg prednisone (or equivalent) at baseline able to decrease dose by ≥25% to a prednisone equivalent dose of ≤7.5 mg/day maintained for at least 12 weeks through Week 156.

    Change from baseline in prednisone dose through Week 156.

    Proportion of patients taking corticosteroids at baseline able to discontinue use through Week 156.

    Annualized mild/moderate flare rate

    Annualized severe flare rate

    Annualized flare rate (any severity).

    Proportion of patients with CLASI total activity score ≥ 10 at baseline with ≥50% reduction in CLASI total activity score through Week 156.

    Change from baseline in tender joint count through Week 156.

    Change from baseline in swollen joint count through Week 156.

    Proportion of patients with improvement in each SLEDAI-2K organ system versus baseline through Week 156.

    Proportion of patients with worsening in each SLEDAI-2K organ system versus baseline through Week 156.

    Change from baseline in SLICC/ACR damage index total score through Week 156.

    Change from baseline in Worst Pain NRS through Week 156.

    Change from baseline in Worst Joint Pain NRS through Week 156.

    Change from baseline in Worst Fatigue NRS through Week 156.

    Change from baseline in Patient Global Impression of Severity through Week 156.

    Change from baseline in mental component score (MCS), physical component score (PCS), and domain scores in the Short-Form 36-item health
    survey version 2 (SF- 36v2) acute through Week 156.

    Change from baseline in FACIT-F total score through Week 156.

    Change from baseline in the EQ-5D-5L through Week 156.

    Change from baseline in the WPAI-Lupus through Week 156.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The change will be evaluated from the baseline time point to the study week 156 time point
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    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 EEA98
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Chile
    China
    Colombia
    Czech Republic
    France
    Germany
    Hungary
    India
    Italy
    Japan
    Korea, Republic of
    Mexico
    Philippines
    Poland
    Romania
    Russian Federation
    Serbia
    South Africa
    Spain
    Switzerland
    Taiwan
    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
    End of the trial is the date of the last visit, last scheduled procedure shown in the Schedule of Activities, or date of discontinued participation for the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    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: 990
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 state78
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 302
    F.4.2.2In the whole clinical trial 1100
    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 Decision2019-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-09
    P. End of Trial
    P.End of Trial StatusOngoing
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