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    Clinical Trial Results:
    A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of MEDI9929 in Adolescents with Mild to Moderate Asthma

    Summary
    EudraCT number
    2014-005450-19
    Trial protocol
    PL  
    Global end of trial date
    02 May 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Jan 2017
    First version publication date
    20 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D5180C00002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02512900
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    MedImmune, LLC
    Sponsor organisation address
    One MedImmune Way, Gaithersburg, United States,
    Public contact
    Rene van der Merwe, Senior Director, Clinical Development, Respiratory, and Inflammation, MedImmune, LLC, 011 3013980000 x, information.center@astrazeneca.com
    Scientific contact
    Rene van der Merwe, Senior Director, Clinical Development, Respiratory, and Inflammation, MedImmune, LLC, 011 3013980000 x, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-001613-PIP01-14
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    02 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the PK profile of a single-dose administration of MEDI9929 in adolescent subjects with mild to moderate asthma
    Protection of trial subjects
    The conduct of this clinical study met all local and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and are consistent with International Conference on Harmonization guideline: Good Clinical Practice, and applicable regulatory requirements. Participants signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    Participants in this study continued to receive asthma controller medications consistent with those described at Step 2 to Step 4 of GINA guidelines (GINA, 2014) as prescribed by their physician.
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Sep 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 21
    Worldwide total number of subjects
    21
    EEA total number of subjects
    21
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    21
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Adolescent participants (12 to 17 years, inclusive) with mild to moderate asthma were recruited in an open-label fashion to receive a single-dose of MEDI9929 (also known as tezepelumab or AMG 157) at two study centers in Poland from Sep 2015 to May 2016.

    Pre-assignment
    Screening details
    A total of 26 participants were screened in this study. Of which 21 participants completed the study. Additional 5 participants signed the informed consent but were not enrolled in the study as they were screen failures. The reason for screen failures were not meeting the inclusion/exclusion criteria, lost to follow-up, and/or consent withdrawal.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    This is an Open-label study

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cohort 1
    Arm description
    On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
    Arm type
    Experimental

    Investigational medicinal product name
    MEDI9929
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single-dose subcutaneous

    Arm title
    Cohort 2
    Arm description
    On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
    Arm type
    Experimental

    Investigational medicinal product name
    MEDI9929
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single-dose subcutaneous

    Number of subjects in period 1
    Cohort 1 Cohort 2
    Started
    11
    10
    Completed
    11
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.

    Reporting group title
    Cohort 2
    Reporting group description
    On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.

    Reporting group values
    Cohort 1 Cohort 2 Total
    Number of subjects
    11 10 21
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    11 10 21
        Adults (18-64 years)
    0 0 0
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    13.5 ± 0.8 15.9 ± 0.7 -
    Gender, Male/Female
    Units: Participants
        Male
    10 5 15
        Female
    1 5 6
    Subject analysis sets

    Subject analysis set title
    MEDI9929
    Subject analysis set type
    Per protocol
    Subject analysis set description
    On Day 1, a single dose of MEDI9929 was administered subcutaneously to participants, aged 12 to 17 years, inclusive.

    Subject analysis sets values
    MEDI9929
    Number of subjects
    21
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    21
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    14.7 ± 1.4
    Gender, Male/Female
    Units: Participants
        Male
    15
        Female
    6

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.

    Reporting group title
    Cohort 2
    Reporting group description
    On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.

    Subject analysis set title
    MEDI9929
    Subject analysis set type
    Per protocol
    Subject analysis set description
    On Day 1, a single dose of MEDI9929 was administered subcutaneously to participants, aged 12 to 17 years, inclusive.

    Primary: Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity])

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    End point title
    Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity]) [1]
    End point description
    The pharmacokinetic (PK) parameter AUC (0 to infinity) was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
    End point type
    Primary
    End point timeframe
    Day 1 (predose) and postdose.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable since there was no formal statistical testing or modeling performed.
    End point values
    Cohort 1 Cohort 2
    Number of subjects analysed
    11
    10
    Units: μg•day/mL
        arithmetic mean (standard deviation)
    1020 ± 355
    881 ± 185
    No statistical analyses for this end point

    Primary: Area Under the Concentration-Time Curve From Zero to Last Observation (AUC [0-t])

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    End point title
    Area Under the Concentration-Time Curve From Zero to Last Observation (AUC [0-t]) [2]
    End point description
    The PK parameter AUC (0-t) was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
    End point type
    Primary
    End point timeframe
    Day 1 (predose) and postdose.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable since there was no formal statistical testing or modeling performed.
    End point values
    Cohort 1 Cohort 2
    Number of subjects analysed
    11
    10
    Units: μg•day/mL
        arithmetic mean (standard deviation)
    906 ± 284
    780 ± 171
    No statistical analyses for this end point

    Primary: Dose-normalized AUC (0-infinity) (AUC [0 infinity]/D)

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    End point title
    Dose-normalized AUC (0-infinity) (AUC [0 infinity]/D) [3]
    End point description
    The AUC (0-infinity)/D is the area under concentration-time curve extrapolated to infinity postdose normalized by MEDI9929 dose. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
    End point type
    Primary
    End point timeframe
    Day 1 (predose) and postdose.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable since there was no formal statistical testing or modeling performed.
    End point values
    Cohort 1 Cohort 2
    Number of subjects analysed
    11
    10
    Units: μg•day/mL/mg
        arithmetic mean (standard deviation)
    7.27 ± 2.54
    6.29 ± 1.32
    No statistical analyses for this end point

    Primary: Maximum Observed Serum Concentration (Cmax)

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    End point title
    Maximum Observed Serum Concentration (Cmax) [4]
    End point description
    The PK parameter Cmax was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
    End point type
    Primary
    End point timeframe
    Day 1 (predose) and postdose.
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable since there was no formal statistical testing or modeling performed.
    End point values
    Cohort 1 Cohort 2
    Number of subjects analysed
    11
    10
    Units: μg/mL
        arithmetic mean (standard deviation)
    24.6 ± 6.65
    23.4 ± 6.82
    No statistical analyses for this end point

    Primary: Dose-normalized Cmax (Cmax/D)

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    End point title
    Dose-normalized Cmax (Cmax/D) [5]
    End point description
    The Cmax/D is the maximum observed concentration post dose normalized by MEDI9929 dose. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
    End point type
    Primary
    End point timeframe
    Day 1 (predose) and postdose.
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable since there was no formal statistical testing or modeling performed.
    End point values
    Cohort 1 Cohort 2
    Number of subjects analysed
    11
    10
    Units: μg/mL/mg
        arithmetic mean (standard deviation)
    0.176 ± 0.0475
    0.167 ± 0.0487
    No statistical analyses for this end point

    Primary: Time to Reach Cmax (Tmax)

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    End point title
    Time to Reach Cmax (Tmax) [6]
    End point description
    The Tmax is the time to maximum observed serum concentration of MEDI9929. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
    End point type
    Primary
    End point timeframe
    Day 1 (predose) and postdose.
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable since there was no formal statistical testing or modeling performed.
    End point values
    Cohort 1 Cohort 2
    Number of subjects analysed
    11
    10
    Units: Day
        median (full range (min-max))
    5.98 (0.99 to 9.97)
    4.44 (1.4 to 19.9)
    No statistical analyses for this end point

    Primary: Terminal Phase Elimination Half Life (t1/2,z)

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    End point title
    Terminal Phase Elimination Half Life (t1/2,z) [7]
    End point description
    The t½,z is the time measured for the serum drug concentration of MEDI9929 to decrease by one half. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
    End point type
    Primary
    End point timeframe
    Day 1 (predose) and postdose.
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable since there was no formal statistical testing or modeling performed.
    End point values
    Cohort 1 Cohort 2
    Number of subjects analysed
    11
    10
    Units: Day
        arithmetic mean (standard deviation)
    24 ± 4.09
    26.7 ± 5.13
    No statistical analyses for this end point

    Primary: Apparent Clearance (CL/F)

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    End point title
    Apparent Clearance (CL/F) [8]
    End point description
    The PK parameter CL/F was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
    End point type
    Primary
    End point timeframe
    Day 1 (predose) and postdose.
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable since there was no formal statistical testing or modeling performed.
    End point values
    Cohort 1 Cohort 2
    Number of subjects analysed
    11
    10
    Units: Liter/day
        arithmetic mean (standard deviation)
    0.153 ± 0.0507
    0.166 ± 0.0376
    No statistical analyses for this end point

    Primary: Apparent steady-state volume of distribution (Vss/F)

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    End point title
    Apparent steady-state volume of distribution (Vss/F) [9]
    End point description
    The PK parameter Vss/F was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.
    End point type
    Primary
    End point timeframe
    Day 1 (predose) and postdose.
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable since there was no formal statistical testing or modeling performed.
    End point values
    Cohort 1 Cohort 2
    Number of subjects analysed
    11
    10
    Units: Liter
        arithmetic mean (standard deviation)
    5.65 ± 1.6
    6.55 ± 2.19
    No statistical analyses for this end point

    Secondary: Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events

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    End point title
    Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events
    End point description
    An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is any AE resulting in any of the following outcomes such as death; initial or prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly or birth defect, or is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. A TEAE is defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0
    End point type
    Secondary
    End point timeframe
    From the start of study drug administration up to end of follow-up period
    End point values
    Cohort 1 Cohort 2
    Number of subjects analysed
    11
    10
    Units: Participants
        Participants with TEAEs
    4
    4
        Participants with treatment-emergent SAEs
    0
    0
    No statistical analyses for this end point

    Secondary: Treatment-emergent Adverse Events Related to Vital Sign Parameters and Physical Findings

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    End point title
    Treatment-emergent Adverse Events Related to Vital Sign Parameters and Physical Findings
    End point description
    Vital signs (blood pressure, temperature, pulse, and respiratory rate) were performed throughout the study. The TEAEs related to vital signs in participants were reported.
    End point type
    Secondary
    End point timeframe
    From the start of study drug administration up to end of follow-up period
    End point values
    Cohort 1 Cohort 2
    Number of subjects analysed
    11
    10
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Treatment-emergent Adverse Events Related to Laboratory Parameters

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    End point title
    Treatment-emergent Adverse Events Related to Laboratory Parameters
    End point description
    Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell count with differential, red blood cell count, hematocrit, hemoglobin and platelet count); serum chemistry: calcium, chloride, potassium, sodium, bicarbonate, aspartate transaminase, alanine transaminase, albumin, uric acid, creatinine, total bilirubin, glucose, alkaline phosphatase, blood urea nitrogen, total protein, and gamma glutamyl transferase; and urinalysis (nitrites, protein, glucose, ketones, urine drug screen, blood, and bilirubin). Number of participants with TEAEs related to laboratory evaluations were reported.
    End point type
    Secondary
    End point timeframe
    From the start of study drug administration up to end of follow-up period
    End point values
    Cohort 1 Cohort 2
    Number of subjects analysed
    11
    10
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Treatment-emergent Adverse Events Related to Electrocardiogram Evaluations

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    End point title
    Treatment-emergent Adverse Events Related to Electrocardiogram Evaluations
    End point description
    Computerized triplicate 12-lead ECGs as well as Qualitative 12-lead ECGs were obtained during the study. ECG parameters included heart rate, PR, QRS, QT, and corrected QT (QTc) intervals. Number of participants with TEAEs related to ECG after the start of study drug were to be reported.
    End point type
    Secondary
    End point timeframe
    From the start of study drug administration up to end of followup period
    End point values
    Cohort 1 Cohort 2
    Number of subjects analysed
    11
    10
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants Positive for Anti-drug Antibodies and With Neutralizing Antibodies for MEDI9929 at any Visit

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    End point title
    Number of Participants Positive for Anti-drug Antibodies and With Neutralizing Antibodies for MEDI9929 at any Visit
    End point description
    Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9929. The incidence rate of positive serum antibodies to MEDI9929 were presented. Neutralizing antibody was tested only for the positive ADA samples. Combined immunogenicity data are presented for Cohort 1 and Cohort 2, i.e., for all participants.
    End point type
    Secondary
    End point timeframe
    Day 1 (predose), and postdose.
    End point values
    MEDI9929
    Number of subjects analysed
    21
    Units: Participants
        Baseline: ADA positive, n=21
    1
        Baseline: Positive neutralizing antibody, n=1
    0
        Post-baseline: ADA positive, n=21
    1
        Post-baseline: Positive neutralizing antibody, n=1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the start of study drug administration up to end of followup period.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.

    Reporting group title
    Cohort 2
    Reporting group description
    On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.

    Serious adverse events
    Cohort 1 Cohort 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Cohort 1 Cohort 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 11 (36.36%)
    4 / 10 (40.00%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Ligament sprain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    2
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Bronchitis
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 10 (10.00%)
         occurrences all number
    3
    1
    Pharyngitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jun 2015
    Protocol Amendment 1: The major changes were made in response to feedback from the Polish regulatory authorities Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products regarding the period of contraception following administration of investigational product. Minor editing and correction of typographical errors were also addressed.
    10 Feb 2016
    Protocol Amendment 2: The purpose of this amendment was to change the Medical Monitor of the study.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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