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    Summary
    EudraCT Number:2019-000720-17
    Sponsor's Protocol Code Number:MOM-M281-006
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-09-05
    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 ConcernedGermany - PEI
    A.2EudraCT number2019-000720-17
    A.3Full title of the trial
    Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia
    A.4.1Sponsor's protocol code numberMOM-M281-006
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Research & Development, LLC
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street Address920 US-202
    B.5.3.2Town/ cityRaritan
    B.5.3.3Post codeNJ 08869
    B.5.3.4CountryUnited States
    B.5.6E-mailJCI-Office@its.jnj.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 nameNipocalimab
    D.3.2Product code M281
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 2211985-36-1
    D.3.9.2Current sponsor codeM281
    D.3.9.3Other descriptive nameNipocalimab
    D.3.9.4EV Substance CodeSUB182674
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 nameNipocalimab
    D.3.2Product code M281
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 2211985-36-1
    D.3.9.2Current sponsor codeM281
    D.3.9.3Other descriptive nameNipocalimab
    D.3.9.4EV Substance CodeSUB182674
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adults with Warm Autoimmune Hemolytic Anemia
    E.1.1.1Medical condition in easily understood language
    Autoimmune Hemolytic Anemia
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10002285
    E.1.2Term Anemia hemolytic autoimmune (NOS)
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of M281 in patients with warm autoimmune hemolytic anemia (wAIHA).
    E.2.2Secondary objectives of the trial
    to evaluate the:
    - Impact of nipocalimab treatment on fatigue
    - Effects of nipocalimab on normalization of hemolytic markers
    - Impact of nipocalimab on corticosteroid use
    -Association between immunoglobulin G (IgG) reduction and
    Hgb/hemolysis parameters
    -Effects of nipocalimab on normalization of hematologic and hemolytic
    parameters
    -Effects of nipocalimab on the time to, and the duration of, Hgb response
    -Effects of nipocalimab on quality of life and clinical status
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    DBP
    1. Male or female ≥18 years of age.
    2. Diagnosed with active primary or secondary wAIHA, defined as:
    a.Hemoglobin concentration <9 g/dL or <10 g/dL if symptomatic or on corticosteroids/immunosuppressants AND
    b.Signs of hemolysis, defined as: lactate dehydrogenase (LDH) levels above upper limit of normal (ULN), or haptoglobin below lower limit of normal, or indirect bilirubin above ULN AND
    c.Serological evidence of anti-erythrocyte antibodies associated with a DAT that is either positive for IgG only or is positive for IgG+C3d at screening. DAT: negative, can be repeated once. If negative, patient not eligible.
    3.Diagnosed with wAIHA for at least 3 months, and currently receiving or previously received treatment for wAIHA (treatment naive patients not eligible)
    4.If on corticosteroids, the dose must be stable during screening or for at least 14 d prior randomization.
    5. If receiving immunosuppressants, following drugs allowed: concomitant immunosuppressants are azathioprine, mycophenolate mofetil/mycophenolic acid, methotrexate, cyclosporine, tacrolimus, danazol, and cyclophosphamide. Patient on stable dose of these drugs for ≥12 weeks prior screening and during the screening period. If stopped, for at least 8 weeks prior to screening.
    6.Have a platelet count ≥30 × 10E9/L.
    7.Patients who have undergone splenectomy must be at least 3 months post resection prior screening and must be vaccinated as per the US Center for Disease Control and Prevention annual Recommended Immunization Schedule for Adults Aged 19 Years or Older, US
    8.Patients with other autoimmune disease or lymphoproliferative disorders may be eligible if they are stable (no changes in concomitant disease-related medications and severity of disease for at least 3 months prior to screening). Patients with lymphoproliferative disease must have a low grade, be stable and be, unlikely to require chemotherapy or
    monoclonal antibody therapy during the double blind period of the study. Patients requiring change of treatment or new treatment (but not rescue therapy for wAIHA) during the DBP will be terminated from the study
    9.Have sufficient venous access to allow drug administration by IV infusion and blood sampling as per the protocol.
    10.Women of childbearing potential, defined as women physiologically capable of becoming pregnant, must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Baseline. Menopausal women must have an elevated serum FSH level at Screening; if the FSH is not elevated, they are considered to be of childbearing potential and must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Baseline to be eligible.
    11.Women of childbearing potential (including menopausal women who do not have elevated FSH) must agree to remain totally abstinent or to consistently use a reliable and highly effective method of contraception during the study and for 30 days after the last study treatment.
    12.Male patients must agree to remain totally abstinent (ie, refrain from sexual intercourse during the study) or to consistently use a reliable and highly effective method of contraception (eg, condom plus diaphragm, condom plus spermicide, diaphragm plus spermicide, or intrauterine device or oral/injectable/implanted hormonal contraceptive used in combination with an additional barrier method) to avoid pregnancy of the patient's partner(s) during the study and for 100 days following the last study treatment, unless the patient provides documentation of a vasectomy at least 6 months prior to Screening. Male patients must also abstain from sperm donation during the study and for 100 days following the last treatment.
    13. Patients who use herbal, naturopathic, traditional Chinese remedies, ayurvedic and nutritional supplements, or medical marijuana (with a doctor's prescription) are eligible if the use of these medications is acceptable to the Investigator. These remedies must be at a stable dose and regimen using the same preparation for ≥2 months prior to Screening.
    14.Are able to understand and voluntarily provide written informed consent to participate in the study and comply with all study procedures. Patients who initially provide consent and subsequently withdraw it prior to randomization, will be deemed as having failed this inclusion criterion.
    15.Vaccinations prior to screening as per routine local guidelines (including COVID-19).

    Open-Label
    1.Have completed the double-blind period (through Week 24), or have required rescue therapy after Week 4 of the double-blind period, or failed to demonstrate an increase from baseline in Hgb of at least 1 g/dL at or after Week 16 of the double-blind period.
    2.Are able to understand and voluntarily provide written informed consent to participate in the OLE period and comply with all study procedures.
    Inclusion Criteria #6, #8, #10, #11, and #12 from the Double-blind Period also apply to enrollment in the OLE
    E.4Principal exclusion criteria
    Double blind period
    1.Are currently taking IgG Fc-related protein therapeutics.
    2.Have received a transfusion within 30 days prior to randomization.
    3.Have any other associated cause of hereditary or acquired hemolytic anemia.
    4.Have received rituximab within 3 months prior to screening.
    5.Have received IVIg within 6 weeks prior to screening.
    6.Have cold antibody AIHA, cold agglutinin syndrome, mixed type (ie, warm and cold) AIHA, or paroxysmal cold hemoglobinuria.
    7.Have a severe infection that requires parenteral anti-infectives and/or hospitalization, and/or is assessed as serious/clinically significant by the Investigator, within 8 weeks prior to screening. Any patient with an infection requiring oral antiinfectives within 4 weeks prior to screening will be excluded.
    8.Have a chronic infection or require chronic treatment with antiinfectives (eg, antibiotics, antivirals).
    9.Have received a live vaccine within 3 months prior to screening, or have a known need to receive a live vaccine during the study or within at least 3 months after the last dose of study drug.
    10.Have any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her wAIHA, or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the patient.
    11.Have any of the following viral testing outcomes: A history of HIV infection or positive test result for HIV-1 and HIV 2 antibodies; A positive test for hepatitis B virus surface antigen (HBsAg). For patients with a negative test for HBsAg along with a positive test for antihepatitis B core antibodies and a positive or negative test for anti-HBs antibodies, hepatitis B viral DNA detection will be performed. Patients with a positive hepatitis B viral DNA detection will be excluded; A positive test for hepatitis C virus (HCV) antibodies along with a positive detection for HCV ribonucleic acid (RNA).
    12.Are currently breastfeeding, pregnant, intend to become pregnant during the study, or are planning egg donation during the study or within 30 days after the last dose of study drug.
    13.Have current alcohol/substance abuse/dependence, a history of alcohol/substance abuse/dependence within the 12 months prior to screening, or, in the Investigator's opinion, show evidence of ongoing alcohol/substance abuse/dependence.
    14.Are currently participating in another interventional clinical trial or have received any investigational drug within the past 3 months prior to screening.
    15.Have had any major surgery within 3 months prior to screening or have plans for or have been scheduled for any elective surgery or major dental procedure during the study.
    16.Have a history of a major organ transplant, or hematopoietic stem cell/marrow transplant.
    17.Have a history of severe and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological, or musculoskeletal disorder, hypertension, or any other
    medical or uncontrolled autoimmune disorder that, in the opinion of the Investigator, might interfere with the patient's full participation in the study, or might jeopardize the safety of the patient or the validity of the study results.
    18.Received treatment for non-lymphoid malignancy within 1 year prior to screening, with the exceptions of properly treated basal or squamous cell carcinoma of the skin or properly treated carcinoma in situ of the cervix.
    19.Have any other medical condition(s) likely to require treatment with oral or parenteral glucocorticosteroids, or have required oral or parenteral glucocorticosteroids (inhalational, intra-articular, topical, or ocular glucocorticosteroids are not exclusionary) for other than wAIHA in the 14 d prior to randomization, or other medical condition(s) likely to require treatment with any immunosuppressive agents not being used to treat wAIHA, or have required any immunosuppressive agents for other than wAIHA for 6 months prior to screening.
    20.Have previously received nipocalimab (M281).
    21.Have a hypersensitivity to nipocalimab or any constituent of the study drug solution.
    22.Have had a prior severe therapeutic drug reaction that included shock or severe hypersensitivity to injectable biologics.

    Exclusion Criteria - Opel Label Extension
    1.Met any of the stopping criteria (see Section 6.4.1 of the protocol) or discontinued study drug during the double-blind period due to treatment-related AE.
    2.Currently have a serious or clinically significant infection requiring parenteral anti-infectives and/or hospitalization.
    The following exclusion criteria from the Double-blind Period (Protocol Section 4.2.2) also apply to enrollment in the OLE: Exclusion Criteria #8 and #21.
    Exception: The patient who was previously enrolled in this study and was unable to complete the double-blind period due to the Sponsor suspending dosing due to the COVID-19 pandemic can be enrolled in the OLE after meeting all the double-blind eligibility criteria.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is durable response in improvement of
    Hgb, defined as the attainment of the following at 3 consecutive visits, where at least the first is at or before Week 16, without the need of rescue therapy:
    • Hgb concentration
    • Hgb level ≥10 g/dL AND
    • An increase from baseline in Hgb ≥2 g/dL
    The first of the three consecutive visits must be at or before week 16 in order to qualify for success in the primary efficacy endpoint. For
    example, if a patient attained the above criteria at weeks 18, 20, and 22 and not before, this patient would not be considered a success. If the patient attained the criteria at weeks 16, 18, and 20, the patient would be considered a success.
    In case 1 of the 3 consecutive Hgb observations is missing and the other 2 met the above criteria, the next non-missing Hgb observation must also meet the criteria in order for the patient to qualify as a success in the primary efficacy endpoint. No more than 1 missing observations is allowed. For example, if a patient met the criteria at weeks 14, 16, and 20, and with a missing value at week 18, this patient would be considered a success in the primary efficacy endpoint. If the patient met the criteria at weeks 14, 18, and 22, but with missing data at weeks 16 and 20, the patient would not be considered a success.
    Patients who took rescue therapy before reaching the criteria will be
    treated as having failed the primary efficacy outcome.
    If a patient has missing Hgb at both baseline and screening but is
    randomized by mistake, the patient will be excluded from the ITT
    analysis. This situation is unlikely to happen because the IVRS system
    requires screening Hgb for randomization to occur.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The first of the three consecutive visits must be at or before week 16 in order to qualify for success in the primary efficacy endpoint. In case 1 of the 3 consecutive Hgb observations is missing and the other 2 met the above criteria, the next non-missing Hgb observation must also meet the criteria in order for the patient to qualify as a success in the primary efficacy endpoint. No more than 1 missing observations is allowed. For example, if a patient met the criteria at weeks 14, 16, and 20, and with a missing value at week 18, this patient would be considered a success in the primary efficacy endpoint. If the patient met the criteria at weeks 14, 18, and 22, but with missing data at weeks 16 and 20, the patient would not be considered a success.
    E.5.2Secondary end point(s)
    Key secondary endpoints:
    -Change in the level of patient fatigue. Change from baseline in the total
    score from the FACIT-Fatigue Scale at the end of the double-blind period.
    -Simultaneous attainment of normal LDH (below the ULN), AND
    haptoglobin (above the LLN), AND indirect bilirubin levels (below the
    ULN) at a minimum of 3 consecutive visits after baseline.
    -Percent reduction from baseline in daily dose of prednisone
    or equivalent at week 24 among patients on prednisone or
    equivalent at baseline.
    Other Secondary Endpoints:
    Other Secondary Endpoints:
    -Association between IgG reduction and Hgb/hemolysis parameters: Hgb
    range at steady state (estimated using a model-based longitudinal
    analysis of Hgb/hemolysis parameters in relationship to IgG level and
    dose regimen)
    -Normalization of hematologic and hemolytic parameters:
    Hgb concentration, reticulocyte count, and hemolytic markers, and
    change from baseline in these parameters through Week 16 of the
    double-blind period
    Hgb concentration, reticulocyte count, and hemolytic markers, and
    change from baseline throughout the study
    -Normalization of hemolytic markers
    1. Attainment of a 2 g/dL Hgb increase from baseline AND normal LDH,
    and haptoglobin, and indirect bilirubin levels at any time during the
    study
    2. Attainment of a 2 g/dL Hgb increase from baseline AND normal LDH
    and, haptoglobin, and indirect bilirubin levels at 3 consecutive visits
    -Time to and duration of Hgb response
    1.Time to response defined as the first time point at which the durable
    response criteria for the primary efficacy endpoint is met
    2.Duration from the first time point at which the durable Hgb response
    criteria for the primary efficacy endpoint is met until the time point at
    which it is no longer met
    -Change in the level of patient fatigue:
    1.Change from baseline in the total score from the FACIT-Fatigue Scale
    at the time of durable response;
    2.Change from baseline in the total score and item scores from the
    FACIT-Fatigue Scale during the double-blind period and open-label
    extension (OLE)
    -Changes in quality of life parameters based on EQ-5D-5L, SF-36, PGIS,
    PGIC, and FACIT-Fatigue Scale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The first of the three consecutive visits must be at or before week 16 in order to qualify for success in the primary efficacy endpoint. In case 1 of the 3 consecutive Hgb observations is missing and the other 2 met the above criteria, the next non-missing Hgb observation must also meet the criteria in order for the patient to qualify as a success in the primary efficacy endpoint. No more than 1 missing observations is allowed. For example, if a patient met the criteria at weeks 14, 16, and 20, and with a missing value at week 18, this patient would be considered a success in the primary efficacy endpoint. If the patient met the criteria at weeks 14, 18, and 22, but with missing data at weeks 16 and 20, the patient would not be considered a success.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability and Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) 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 No
    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 trial3
    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 EEA73
    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
    Czechia
    France
    Germany
    Greece
    Hungary
    Israel
    Italy
    Netherlands
    Poland
    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
    LPLV
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months11
    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: 124
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 98
    F.4.2.2In the whole clinical trial 148
    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)
    Standard of care treatment is expected
    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 Decision2019-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-14
    P. End of Trial
    P.End of Trial StatusOngoing
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