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    Clinical Trial Results:
    A Multicentre, Randomised, Open-label, Parallel-group, Functionality, and Performance Study of an Accessorised Pre-filled Syringe and Autoinjector with Home-administered Subcutaneous Tezepelumab in Adolescent and Adult Subjects with Severe Asthma (PATH-HOME)

    Summary
    EudraCT number
    2018-004588-30
    Trial protocol
    PL  
    Global end of trial date
    05 Jun 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    18 Dec 2020
    First version publication date
    18 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D5180C00011
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03968978
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    151 85, Södertälje, Sweden,
    Public contact
    Global Clinical Head, AstraZeneca, +1 8772409479, information.center@astrazeneca.com
    Scientific contact
    AstraZeneca Clinical Study Information, AstraZeneca, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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
    22 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Jun 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jun 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study is to assess the successful administration, performance, and functionality of a single-use accessorized pre-filled syringe (APFS) and autoinjector (AI) with a fixed 210 mg dose of tezepelumab administered subcutaneously (SC) in clinic and an at-home setting.
    Protection of trial subjects
    Data safety monitoring board is not utilized for this study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    21 May 2019
    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
    Canada: 37
    Country: Number of subjects enrolled
    Japan: 17
    Country: Number of subjects enrolled
    Poland: 78
    Country: Number of subjects enrolled
    United States: 84
    Worldwide total number of subjects
    216
    EEA total number of subjects
    78
    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)
    24
    Adults (18-64 years)
    152
    From 65 to 84 years
    40
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    266 subjects enrolled in the study. 50 subjects were screen failure, and 216 randomized.

    Pre-assignment
    Screening details
    216 subjects randomized to tezepelumab 210 mg Q4W via APFS and tezepelumab 210 mg Q4W via AI. All randomized subjects were treated. 111 (51.4%) were randomized to tezepelumab 210 mg Q4W via APFS and 105 (48.6%) were randomized to tezepelumab 210 mg Q4W via AI.

    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
    Teze 210 mg Q4W via APFS
    Arm description
    Accessorized pre-filled syringe every 4 weeks administered subcutaneously
    Arm type
    Experimental

    Investigational medicinal product name
    Tezepelumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    210 mg

    Arm title
    Teze 210 mg Q4W via AI
    Arm description
    Autoinjector every 4 weeks administered subcutaneously
    Arm type
    Experimental

    Investigational medicinal product name
    Tezepelumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    210 mg

    Number of subjects in period 1
    Teze 210 mg Q4W via APFS Teze 210 mg Q4W via AI
    Started
    111
    105
    Completed
    110
    105
    Not completed
    1
    0
         Adverse event, non-fatal
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Teze 210 mg Q4W via APFS
    Reporting group description
    Accessorized pre-filled syringe every 4 weeks administered subcutaneously

    Reporting group title
    Teze 210 mg Q4W via AI
    Reporting group description
    Autoinjector every 4 weeks administered subcutaneously

    Reporting group values
    Teze 210 mg Q4W via APFS Teze 210 mg Q4W via AI Total
    Number of subjects
    111 105 216
    Age Categorical
    Units: Participants
        Adolescents (>=12 to <18 years)
    13 11 24
        Adults (>=18 to <65 years)
    79 73 152
        Adults (>=65 years)
    19 21 40
    Age Continuous
    Measure analysis population description for: Full Analysis Set
    Units: Years
        arithmetic mean (standard deviation)
    48.5 ± 18.1 45.8 ± 18.3 -
    Sex: Female, Male
    Units: Participants
        Female
    56 52 108
        Male
    55 53 108
    Race/Ethnicity, Customized
    Units: Subjects
        White
    87 82 169
        Black or African American
    8 8 16
        Asian
    16 15 31
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    12 13 25
        Not Hispanic or Latino
    99 92 191

    End points

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    End points reporting groups
    Reporting group title
    Teze 210 mg Q4W via APFS
    Reporting group description
    Accessorized pre-filled syringe every 4 weeks administered subcutaneously

    Reporting group title
    Teze 210 mg Q4W via AI
    Reporting group description
    Autoinjector every 4 weeks administered subcutaneously

    Primary: Proportions of HCPs and subjects/caregivers who successfully administered tezepelumab in clinic or at home by device type

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    End point title
    Proportions of HCPs and subjects/caregivers who successfully administered tezepelumab in clinic or at home by device type [1]
    End point description
    Successful administration is defined as an injection completed, based on a used/returned (HCP or subject/caregiver) answer of YES to all 5 questions in the administration questionnaire, and satisfactory in vitro evaluation of returned/evaluated devices.
    End point type
    Primary
    End point timeframe
    Week 0, Week 4, Week 8, Week 12, Week 16, Week 20
    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: According to the protocol the primary analysis in this study was not a comparison between treatments, it was to assess the functionality in each treatment arm separately. Therefore no statistical analysis is included in this form. The proportions and confidence intervals within treatment arms are however provided.
    End point values
    Teze 210 mg Q4W via APFS Teze 210 mg Q4W via AI
    Number of subjects analysed
    111
    105
    Units: Proportion of Participants
    number (confidence interval 95%)
        Week 0 (in clinic)
    98.2 (93.7 to 99.5)
    100.0 (96.5 to 100.0)
        Week 4 (in clinic)
    100.0 (96.6 to 100.0)
    97.1 (91.9 to 99.0)
        Week 8 (in clinic)
    100.0 (96.6 to 100.0)
    98.1 (93.3 to 99.5)
        Week 12 (at home)
    100.0 (96.6 to 100.0)
    99.0 (94.8 to 99.8)
        Week 16 (at home)
    95.4 (89.7 to 98.0)
    97.1 (91.9 to 99.0)
        Week 20 (in clinic)
    96.3 (90.9 to 98.6)
    97.1 (91.9 to 99.0)
    No statistical analyses for this end point

    Secondary: Proportions of used/returned devices that pass functional tests and visual inspection and showed no evidence of malfunction

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    End point title
    Proportions of used/returned devices that pass functional tests and visual inspection and showed no evidence of malfunction
    End point description
    Devices that passed functional tests and visual inspection and showed no evidence of malfunction will be evaluated as functional. Percentages have been calculated by using the number of used and returned devices at specified visit as denominator.
    End point type
    Secondary
    End point timeframe
    Week 0, Week 4, Week 8, Week 12, Week 16, Week 20
    End point values
    Teze 210 mg Q4W via APFS Teze 210 mg Q4W via AI
    Number of subjects analysed
    111
    105
    Units: Proportion of Devices
    number (confidence interval 95%)
        Week 0 (in clinic)|
    98.2 (93.7 to 99.5)
    100.0 (96.5 to 100.0)
        Week 4 (in clinic)
    100.0 (96.6 to 100.0)
    97.2 (93.4 to 99.5)
        Week 8 (in clinic)
    100.0 (96.6 to 100.0)
    98.1 (93.3 to 99.5)
        Week 12 (at home)|
    100.0 (96.6 to 100.0)
    100.0 (96.4 to 100.0)
        Week 16 (at home)
    97.2 (92.1 to 99.0)
    100.0 (96.4 to 100.0)
        Week 20 (in clinic)
    99.1 (94.8 to 99.8)
    100.0 (96.4 to 100.0)
    No statistical analyses for this end point

    Secondary: Proportions of devices that have been reported as malfunctioning (Product Complaints)

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    End point title
    Proportions of devices that have been reported as malfunctioning (Product Complaints)
    End point description
    Performance is measured by the proportion of APFS or AI devices that have been reported as malfunctioning (i.e. via Product Complaints). Percentages have been calculated by using the number of used and returned devices at specified visit as denominator.
    End point type
    Secondary
    End point timeframe
    Week 0, Week 4, Week 8, Week 12, Week 16, Week 20
    End point values
    Teze 210 mg Q4W via APFS Teze 210 mg Q4W via AI
    Number of subjects analysed
    111
    105
    Units: Proportion of Devices
    number (confidence interval 95%)
        Week 0 (in clinic)
    1.8 (0.5 to 6.3)
    0.0 (0.0 to 3.5)
        Week 4 (in clinic)
    0.0 (0.0 to 3.3)
    2.8 (1.0 to 8.0)
        Week 8 (in clinic)
    0.0 (0.0 to 3.4)
    1.9 (0.5 to 6.7)
        Week 12 (at home)|
    0.0 (0.0 to 3.4)
    0.0 (0.0 to 3.6)
        Week 16 (at home)|
    2.8 (1.0 to 7.9)
    0.0 (0.0 to 3.6)
        Week 20 (in clinic)
    0.9 (0.2 to 5.1)
    0.0 (0.0 to 3.6)
    No statistical analyses for this end point

    Secondary: Change from baseline in Asthma Control Questionnaire-6 (ACQ-6) score

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    End point title
    Change from baseline in Asthma Control Questionnaire-6 (ACQ-6) score
    End point description
    The ACQ-6 captures asthma symptoms and short-acting β2-agonist use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24
    End point values
    Teze 210 mg Q4W via APFS Teze 210 mg Q4W via AI
    Number of subjects analysed
    111
    105
    Units: Score
    arithmetic mean (standard deviation)
        ACQ-6 score at Baseline (Week 0)
    2.227 ± 0.732
    2.081 ± 0.625
        ACQ-6 score at Week 4
    1.629 ± 0.791
    1.492 ± 0.715
        Change from Baseline of ACQ-6 score at Week 4
    -0.598 ± 0.702
    -0.589 ± 0.694
        ACQ-6 score at Week 8
    1.401 ± 0.859
    1.316 ± 0.744
        Change from Baseline of ACQ-6 score at Week 8
    -0.826 ± 0.833
    -0.765 ± 0.793
        ACQ-6 score at Week 12
    1.197 ± 0.751
    1.143 ± 0.745
        Change from Baseline of ACQ-6 score at Week 12
    -1.011 ± 0.805
    -0.938 ± 0.805
        ACQ-6 score at Week 16
    1.226 ± 0.845
    1.171 ± 0.782
        Change from Baseline of ACQ-6 score at Week 16
    -0.986 ± 0.893
    -0.910 ± 0.867
        ACQ-6 score at Week 20
    1.230 ± 0.832
    1.238 ± 0.795
        Change from Baseline of ACQ-6 score at Week 20
    -0.978 ± 0.866
    -0.843 ± 0.910
        ACQ-6 score at Week 24
    1.072 ± 0.755
    1.140 ± 0.765
        Change from Baseline of ACQ-6 score at Week 24
    -1.141 ± 0.845
    -0.941 ± 0.775
    No statistical analyses for this end point

    Secondary: Serum trough concentrations

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    End point title
    Serum trough concentrations
    End point description
    PK serum samples were collected pre-dose on dosing visits
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Week 4, Week 20 and Week 24 (EOT)
    End point values
    Teze 210 mg Q4W via APFS Teze 210 mg Q4W via AI
    Number of subjects analysed
    111
    105
    Units: µg/mL
    geometric mean (geometric coefficient of variation)
        Baseline (Week 0)
    0 ± 0
    0 ± 0
        Week 4
    10.9764 ± 48.3948
    10.5690 ± 57.0076
        Week 20
    18.9653 ± 69.0785
    20.3206 ± 56.5858
        Week 24 (EOT)
    19.6274 ± 58.2660
    19.9264 ± 54.3198
    No statistical analyses for this end point

    Secondary: Anti-drug antibodies (ADA)

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    End point title
    Anti-drug antibodies (ADA)
    End point description
    Anti-drug antibodies (ADA) responses at baseline and/or post baseline. Treatment-induced ADA positive is defined as ADA negative at baseline and post-baseline ADA positive. Treatment-boosted ADA positive is defined as baseline positive ADA titre that was boosted to a 4-fold or higher-level following IP administration. Treatment-emergent ADA (TE-ADA) positive is defined as either treatment-induced ADA positive or treatment-boosted ADA positive. ADA incidence is the proportion of TE-ADA positive subjects in a population. Persistently positive is defined as ADA positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or ADA positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive
    End point type
    Secondary
    End point timeframe
    Pre-treatment on dosing days until end of follow-up (Week 36) per protocol
    End point values
    Teze 210 mg Q4W via APFS Teze 210 mg Q4W via AI
    Number of subjects analysed
    111
    105
    Units: Participants
        ADA prevalence
    2
    11
        TE-ADA positive (ADA incidence)
    2
    8
        Treatment-induced ADA positive
    2
    8
        Treatment-boosted ADA positive
    0
    0
        ADA persistently positive
    1
    7
        ADA transiently positive
    1
    3
        Only baseline ADA positive
    0
    1
        Both baseline and at least one post-baseline ADA +
    0
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose till end of study (Week 36)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Teze 210 mg Q4W via APFS
    Reporting group description
    Accessorized pre-filled syringe every 4 weeks administered subcutaneously

    Reporting group title
    Teze 210 mg Q4W via AI
    Reporting group description
    Autoinjector every 4 weeks administered subcutaneously

    Serious adverse events
    Teze 210 mg Q4W via APFS Teze 210 mg Q4W via AI
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 111 (4.50%)
    4 / 105 (3.81%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 111 (0.00%)
    3 / 105 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Psychogenic seizure
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    2 / 111 (1.80%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genitourinary tract infection
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia escherichia
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    Teze 210 mg Q4W via APFS Teze 210 mg Q4W via AI
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 111 (26.13%)
    29 / 105 (27.62%)
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    6 / 111 (5.41%)
    5 / 105 (4.76%)
         occurrences all number
    9
    5
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    12 / 111 (10.81%)
    15 / 105 (14.29%)
         occurrences all number
    13
    15
    Pharyngitis
         subjects affected / exposed
    4 / 111 (3.60%)
    4 / 105 (3.81%)
         occurrences all number
    4
    6
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 111 (8.11%)
    8 / 105 (7.62%)
         occurrences all number
    11
    9

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Jul 2019
    Added exclusion criterion of non-leukocyte depleted whole blood transfusion in 120 days prior to Visit 1
    03 Jul 2019
    Language was updated from “Prior to the date of randomisation, a history of continuous treatment with medium or high dose ICS plus a second controller medication for at least six months prior to Visit 1 should be documented in source documents and recorded in the eCRF.” to “Prior to the date of randomisation, a history of continuous treatment with medium or high dose ICS for at least six months prior to Visit 1 plus a second controller medication for at least three months prior to Visit 1 should be documented in source documents and recorded in the eCRF.”

    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
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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