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    Summary
    EudraCT Number:2019-000720-17
    Sponsor's Protocol Code Number:MOM-M281-006
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2019-10-08
    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 ConcernedGreece - EOF
    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
    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 nipocalimab in participants with warm
    autoimmune hemolytic anemia (wAIHA).
    E.2.2Secondary objectives of the trial
    The key secondary objectives of this study are to evaluate the:
    •impact of nipocalimab treatment on fatigue
    •impact of nipocalimab on corticosteroid use
    Other secondary objectives of this study are to evaluate the:
    •effects of nipocalimab on normalization of hemolytic markers
    •effects of nipocalimab on maintaining response in Hgb
    •effects of nipocalimab on normalization of hematologic and hemolytic
    parameters
    •effects of nipocalimab on the time to, and duration of, Hgb response
    •impact of nipocalimab treatment on fatigue improvement
    •effect of nipocalimab on health-related quality of life and health status
    •association between IgG reduction and Hgb/hemolysis parameters
    •impact of nipocalimab on the reduction of corticosteroid dose
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Double blind period
    1.Participants ≥18 years of age.2. Diagnosed with active primary or secondary wAIHA, defined as:
    a. Hgb value<10 g/dL 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, participant not eligible.3.Diagnosed with wAIHA for at least 3 months, and currently receiving or previously received treatment for wAIHA (treatment naive participants not eligible) 4.If on corticosteroids, participants must have been on treatment for at least 4 weeks with a stable dose during the screening period or for at least 14 days prior to randomization, whichever is longer. Note:Investigators can optimize the above background medications prior to randomization if they are following the above rules for stable dose duration.5. If receiving immunosuppressants, following drugs allowed:concomitant immunosuppressants are azathioprine, mycophenolate
    mofetil/mycophenolic acid, methotrexate, cyclosporine, tacrolimus,danazol, and cyclophosphamide. Participants 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. Note: Investigators can optimize the above background medications prior to randomization if they are following the above rules for stable dose duration. 6.Have a platelet count ≥30 × 10E9/L.
    7.Participants 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.Participants 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). Participants 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.
    Participants requiring change of treatment or new treatment for
    autoimmune or lymphoproliferative diseases (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 (i.e.,
    refrain from sexual intercourse during the study) or to consistently use a
    reliable and highly effective method of contraception during the study
    and for 30 days after the last dose of
    drug.
    study
    12. Male participants must wear a condom when engaging in any activity
    that allows for passage of ejaculate to another person during the study
    and for at least 90 days after receiving the last dose of study drug. In
    addition, male participants with partners who are a woman of
    childbearing potential are to be highly encouraged to inform their
    partner to use highly effective contraception methods that result in a low
    failure rate (less than 1% per year)
    13. Participants 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.
    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 at/or after Week 4 of the double-blind period, or
    failed to demonstrate an increase from baseline in Hgb of at least 1 g/dL
    and are symptomatic 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.
    E.4Principal exclusion criteria
    Double blind period
    1. Are currently taking IgG Fc-related protein therapeutics.
    2.Have received 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 been diagnosed with 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 participant
    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 anti-
    infectives.
    9.Have received a live viral or bacterial vaccine within 4 weeks prior to
    first dose of study drug, or have a known need to receive a live viral or
    bacterial vaccine during the study or within at least 8 weeks after the
    last dose of study drug. For information regarding the Bacille CalmetteGuérin (BCG) vaccine, please see Exclusion Criterion
    25.
    10. Have any confirmed or suspected clinical immunodeficiency

    syndrome not related to treatment of their wAIHA, or has a family

    history of congenital or hereditary immunodeficiency unless confirmed

    absent in the
    participant.
    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; positive

    test for hepatitis B virus surface antigen. For participants with a

    negative test for HBsAg along with a positive test for anti-hepatitis B

    core antibodies and a positive or negative test for anti-HBs antibodies,

    hepatitis B viral DNA detection will be performed. Participants with a

    positive hepatitis B viral DNA detection will be excluded. If HBV DNA

    testing cannot be performed, or there is evidence of chronic liver

    disease, the participant is not eligible for the protocol; A positive test
    for
    hepatitis C virus (HCV) unless 1 of the following conditions are met: (a)

    Has a history of successful treatment, defined as being negative for HCV

    RNA at least 24 weeks after completing antiviral treatment, and has a

    negative HCV RNA test result at screening, OR (b) -Has a negative HCV

    RNA test result at least 24 weeks prior to screening and a negative HCV

    RNA test at the
    screening.
    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.
    Further exclusion criteria listed in the protocol not listed here due to
    character restriction.
    Open Label Extension
    1. Met any of the stopping criteria 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 criterion from the Double-blind Period also
    applies to enrollment in the OLE: Exclusion Criteria #8 and #21.
    Exception: Participants who were previously enrolled in this study and
    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 of the double-blind eligibility criteria. Participants
    who completed the 28-week OLE before Amendment 6 can be re-enrolled
    in the OLE per investigator's discretion if the participants continue meet
    the eligibility criteria for the OLE. Participants will resume study
    treatment calculated from the baseline visit once they have reconsented
    to the study.
    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
    (minimum duration 28 days), where at least the first is at or before
    Week 16, without the need of rescue therapy:
    • Hgb concentration ≥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 of
    the double-blind period in order to qualify for success in the primary
    efficacy endpoint. For example, if a participant attained the above
    criteria at weeks 18, 20, and 22 and not before, this participant would
    not be considered a success. If the participant attained the criteria at
    weeks 16, 18, and 20, the patient would be considered a success.
    Participants who took rescue therapy before reaching the criteria will be
    treated as having failed the primary efficacy outcome.
    If a participant has missing Hgb at both screening and baseline but is
    randomized by mistake, the participant 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.
    E.5.2Secondary end point(s)
    Key secondary endpoints:
    -Change in the level of participant fatigue. Change from baseline in the
    total score from the FACIT-Fatigue Scale at the time of durable response.
    -Change from baseline in the total score from the FACIT-Fatigue Scale at
    the end of the double-blind period (Week 24)
    -Percent reduction from baseline in average daily dose of prednisone or
    equivalent at Week 24 of the double-blind period among participants on
    prednisone or equivalent at baseline.
    Other Secondary Endpoints:
    -Normalization of hemolytic markers
    1. Proportion of participants who simultaneously attain normal lactate
    dehydrogenase (LDH), AND normal haptoglobin, AND normal indirect
    bilirubin levels at 3 consecutive visits
    2. 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
    3. Attainment of a 2 g/dL Hgb increase from baseline AND normal LDH
    and, haptoglobin, and indirect bilirubin levels at 3 consecutive visits
    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, reticulocyte count, and hemolytic markers, and change from
    baseline in these parameters through the study
    Effect of nipocalimab on maintaining response in Hgb
    -Proportion of participants who achieve the durable response in
    improvement of Hgb and maintain that response for up to 24 weeks
    throughout the study without the need of rescue therapy.
    -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 participant fatigue:
    Change from baseline in the total score, item scores and impact and
    experience domains from the FACIT-Fatigue Scale through Week 24 of
    the double-blind period
    -Changes in health-related quality of life parameters based on EQ -5D5L, SF -36, PGIS, and
    PGIC
    -Impact of nipocalimab on corticosteroid
    use
    Absolute reduction from baseline in average daily dose of prednisone or

    equivalent at Week 24 of the double-blind period among all
    participants
    The proportion of participants who achieve corticosteroid reduction to

    7.5 mg/day of oral prednisone (or equivalent) at Week 24 of
    doubleblind period among participants on prednisone or equivalent >7.5

    mg/day at
    baseline
    The proportion of participants who achieve the durable response in
    improvement of Hgb during the double-blind period and maintain that
    response for up to 24 weeks throughout the study without the need of
    rescue therapy will be summarized descriptively.
    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 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 concerned5
    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
    Ukraine
    Czechia
    France
    Germany
    Greece
    Hungary
    Israel
    Italy
    Netherlands
    Poland
    Spain
    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 years4
    E.8.9.1In the Member State concerned months9
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 98
    F.4.2.2In the whole clinical trial 148
    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 Decision2019-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-11
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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