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

    Summary
    EudraCT number
    2011-005503-33
    Trial protocol
    PL  
    Global end of trial date
    09 Jan 2013

    Results information
    Results version number
    v2(current)
    This version publication date
    07 May 2016
    First version publication date
    05 Aug 2015
    Other versions
    v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    CD-RI-CAT-354-1054
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01592396
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    MedImmune, LLC
    Sponsor organisation address
    Milstein Building, Grant Park, Cambridge, United Kingdom, CB21 6GH
    Public contact
    Meena Jain, MB BChir/Associate Medical Director, MedImmune, LLC, jainm@medimmune.com
    Scientific contact
    Meena Jain, MB BChir/Associate Medical Director, MedImmune, LLC, jainm@medimmune.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000782-PIP01-09
    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
    09 Jan 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jan 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the pharmacokinetic (PK) profile of a single 300 milligram (mg) of subcutaneous (SC) dose of tralokinumab in adolescent subjects with asthma.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Participating participant 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
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 Jun 2012
    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: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    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
    Twenty (20) participants enrolled and completed the study as planned. An additional 10 participants signed informed consent but were not enrolled in the study. The reasons for screen failures were not meeting the inclusion/exclusion criteria, and/or consent withdrawal.

    Pre-assignment
    Screening details
    Screening Details: A total of 20 participants participated in the study at 3 investigative sites in Poland.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Tralokinumab 300 mg (Participants aged 12-14 years) - Cohort 1
    Arm description
    Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    Tralokinumab
    Investigational medicinal product code
    CAT-354
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg and Subcutaneous use

    Arm title
    Tralokinumab 300 mg (Participants aged 15-17 years) - Cohort 2
    Arm description
    Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    Tralokinumab
    Investigational medicinal product code
    CAT-354
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg and Subcutaneous use

    Number of subjects in period 1
    Tralokinumab 300 mg (Participants aged 12-14 years) - Cohort 1 Tralokinumab 300 mg (Participants aged 15-17 years) - Cohort 2
    Started
    10
    10
    Completed
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tralokinumab 300 mg (Participants aged 12-14 years) - Cohort 1
    Reporting group description
    Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.

    Reporting group title
    Tralokinumab 300 mg (Participants aged 15-17 years) - Cohort 2
    Reporting group description
    Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.

    Reporting group values
    Tralokinumab 300 mg (Participants aged 12-14 years) - Cohort 1 Tralokinumab 300 mg (Participants aged 15-17 years) - Cohort 2 Total
    Number of subjects
    10 10 20
    Age categorical
    Units: Subjects
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    12.6 ± 0.7 15.8 ± 0.9 -
    Gender, Male/Female
    Units: Participants
        Female
    3 3 6
        Male
    7 7 14
    Subject analysis sets

    Subject analysis set title
    Tralokinumab 300 mg (Participants aged 12-14 years) - Cohort 1
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.

    Subject analysis set title
    Tralokinumab 300mg (Participants aged 15-17 years) - Cohort 2
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.

    Subject analysis set title
    Tralokinumab 300 mg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.

    Subject analysis sets values
    Tralokinumab 300 mg (Participants aged 12-14 years) - Cohort 1 Tralokinumab 300mg (Participants aged 15-17 years) - Cohort 2 Tralokinumab 300 mg
    Number of subjects
    10
    10
    20
    Age categorical
    Units: Subjects
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    12.6 ± 0.7
    15.8 ± 0.9
    14.2 ± 1.8
    Gender, Male/Female
    Units: Participants
        Female
    3
    3
    6
        Male
    7
    7
    14

    End points

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    End points reporting groups
    Reporting group title
    Tralokinumab 300 mg (Participants aged 12-14 years) - Cohort 1
    Reporting group description
    Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.

    Reporting group title
    Tralokinumab 300 mg (Participants aged 15-17 years) - Cohort 2
    Reporting group description
    Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.

    Subject analysis set title
    Tralokinumab 300 mg (Participants aged 12-14 years) - Cohort 1
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.

    Subject analysis set title
    Tralokinumab 300mg (Participants aged 15-17 years) - Cohort 2
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.

    Subject analysis set title
    Tralokinumab 300 mg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.

    Primary: Time to Reach Maximum Observed Serum Concentration (Tmax)

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    End point title
    Time to Reach Maximum Observed Serum Concentration (Tmax) [1] [2]
    End point description
    End point type
    Primary
    End point timeframe
    0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
    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 data was not planned to be reported for this endpoint.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical data was not planned to be reported for this endpoint.
    End point values
    Tralokinumab 300 mg (Participants aged 12-14 years) - Cohort 1 Tralokinumab 300mg (Participants aged 15-17 years) - Cohort 2
    Number of subjects analysed
    10
    10
    Units: days
        median (full range (min-max))
    5.2 (3 to 9.1)
    6.1 (2.9 to 9)
    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) [3] [4]
    End point description
    End point type
    Primary
    End point timeframe
    0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
    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 data was not planned to be reported for this endpoint.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical data was not planned to be reported for this endpoint.
    End point values
    Tralokinumab 300 mg (Participants aged 12-14 years) - Cohort 1 Tralokinumab 300mg (Participants aged 15-17 years) - Cohort 2
    Number of subjects analysed
    10
    10
    Units: microgram per milliliter (mcg/mL)
        arithmetic mean (standard deviation)
    57 ± 21.7
    50.6 ± 16.2
    No statistical analyses for this end point

    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]) [5] [6]
    End point description
    AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
    End point type
    Primary
    End point timeframe
    0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
    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 data was not planned to be reported for this endpoint.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical data was not planned to be reported for this endpoint.
    End point values
    Tralokinumab 300 mg (Participants aged 12-14 years) - Cohort 1 Tralokinumab 300mg (Participants aged 15-17 years) - Cohort 2
    Number of subjects analysed
    10
    10
    Units: (microgram*day)/milliliter (mcg*day/mL)
        arithmetic mean (standard deviation)
    1916 ± 806.3
    1721.1 ± 568.5
    No statistical analyses for this end point

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

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    End point title
    Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t]) [7] [8]
    End point description
    End point type
    Primary
    End point timeframe
    0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
    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 data was not planned to be reported for this endpoint.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical data was not planned to be reported for this endpoint.
    End point values
    Tralokinumab 300 mg (Participants aged 12-14 years) - Cohort 1 Tralokinumab 300mg (Participants aged 15-17 years) - Cohort 2
    Number of subjects analysed
    10
    10
    Units: mcg*day/mL
        arithmetic mean (standard deviation)
    1561.4 ± 614.9
    1384.6 ± 421.6
    No statistical analyses for this end point

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

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    End point title
    Terminal Phase Elimination Half Life (t1/2) [9] [10]
    End point description
    Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.
    End point type
    Primary
    End point timeframe
    0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
    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 data was not planned to be reported for this endpoint.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical data was not planned to be reported for this endpoint.
    End point values
    Tralokinumab 300 mg (Participants aged 12-14 years) - Cohort 1 Tralokinumab 300mg (Participants aged 15-17 years) - Cohort 2
    Number of subjects analysed
    10
    10
    Units: days
        arithmetic mean (standard deviation)
    21.4 ± 5.5
    22.1 ± 3.5
    No statistical analyses for this end point

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

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    End point title
    Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state. Adverse events were summarized together for all participants.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 57
    End point values
    Tralokinumab 300 mg
    Number of subjects analysed
    20
    Units: participants
        TEAEs
    6
        TESAEs
    0
    No statistical analyses for this end point

    Secondary: Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at any Visit

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    End point title
    Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at any Visit
    End point description
    Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples. Immunogenicity results were summarized together for all participants.
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 57
    End point values
    Tralokinumab 300 mg (Participants aged 12-14 years) - Cohort 1
    Number of subjects analysed
    20
    Units: participants
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to Day 57
    Adverse event reporting additional description
    Adverse events were summarized together for all participants.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Tralokinumab 300 mg
    Reporting group description
    Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.

    Serious adverse events
    Tralokinumab 300 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Tralokinumab 300 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 20 (30.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    General disorders and administration site conditions
    Injection site pruritus
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    4
    Pharyngitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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.
    Dose-normalized AUC(0-infinity) and dose-normalized Cmax were not evaluated as they were not relevant for single-dose study. Apparent volume of distribution at steady state (Vss/F) was replaced by Vz/F as it was more relevant for subcutaneous dose.
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