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    Clinical Trial Results:
    An open-label, single-arm, multi-centre, long-term extension trial to evaluate the safety and efficacy of tralokinumab in subjects with atopic dermatitis who participated in previous tralokinumab clinical trials

    Summary
    EudraCT number
    2018-000746-19
    Trial protocol
    ES   GB   DE   PL   BE   CZ   IT  
    Global end of trial date
    03 Jul 2024

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Jan 2025
    First version publication date
    05 Jan 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LP0162-1337
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03587805
    WHO universal trial number (UTN)
    U1111-1282-4519
    Sponsors
    Sponsor organisation name
    LEO Pharma A/S
    Sponsor organisation address
    Industriparken 55, Ballerup, Denmark, 2750
    Public contact
    Clinical disclosure, Leo Pharma A/S, +45 4494 5888, disclosure@leo-pharma.com
    Scientific contact
    Clinical disclosure, Leo Pharma A/S, +45 4494 5888, disclosure@leo-pharma.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
    16 Jul 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Jul 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jul 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the long-term safety of tralokinumab
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH GCP), including archiving of essential documents.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    20 Aug 2018
    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: 237
    Country: Number of subjects enrolled
    Japan: 181
    Country: Number of subjects enrolled
    United States: 384
    Country: Number of subjects enrolled
    Italy: 15
    Country: Number of subjects enrolled
    Poland: 228
    Country: Number of subjects enrolled
    Spain: 127
    Country: Number of subjects enrolled
    United Kingdom: 70
    Country: Number of subjects enrolled
    Belgium: 69
    Country: Number of subjects enrolled
    Czechia: 20
    Country: Number of subjects enrolled
    France: 73
    Country: Number of subjects enrolled
    Germany: 268
    Worldwide total number of subjects
    1672
    EEA total number of subjects
    870
    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)
    103
    Adults (18-64 years)
    1498
    From 65 to 84 years
    70
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    This trial was conducted at 309 sites that screened subjects in 11 countries.

    Pre-assignment
    Screening details
    1706 subjects screened for this trial, 34 subjects were excluded prior to treatment assignment.

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

    Arms
    Arm title
    tralokinumab
    Arm description
    Week 0: subcutaneous (SC) injection of tralokinumab loading dose. From Week 2 up to Week 266*: SC injection of tralokinumab maintenance dose. *The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from. Tralokinumab: Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.
    Arm type
    Experimental

    Investigational medicinal product name
    Tralokinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dose for adult subjects from all parent trials, except the parent trial LP0162-1334: 600 mg initial loading dose, then 300 mg every second week. Dose for subjects from the parent trial LP0162-1334: 300 mg every second week.

    Number of subjects in period 1
    tralokinumab
    Started
    1672
    Completed
    1143
    Not completed
    529
         Adverse event, serious fatal
    1
         COVID-19 pandemic
    4
         Consent withdrawn by subject
    105
         Adverse event, non-fatal
    72
         Reason unknown
    26
         Various reasons
    121
         Lost to follow-up
    78
         Withdrawal by parent/guardian
    3
         Lack of efficacy
    119

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    -

    Reporting group values
    Overall study Total
    Number of subjects
    1672 1672
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    103 103
        Adults (18-64 years)
    1498 1498
        From 65-84 years
    70 70
        85 years and over
    1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    37.5 ( 14.8 ) -
    Gender categorical
    Units: Subjects
        Female
    709 709
        Male
    963 963
    Race
    Units: Subjects
        White
    1194 1194
        Black or African American
    120 120
        Asian
    312 312
        American Indian or Alaska Native
    2 2
        Native Hawaiian or other Pacific Islander
    4 4
        Other
    38 38
        Missing
    2 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    112 112
        Not Hispanic or Latino
    1558 1558
        Unknown or Not Reported
    2 2
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    77.1 ( 19.1 ) -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    170.3 ( 10.1 ) -
    BMI
    Units: kg/m^2
        arithmetic mean (standard deviation)
    26.52 ( 6.04 ) -

    End points

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    End points reporting groups
    Reporting group title
    tralokinumab
    Reporting group description
    Week 0: subcutaneous (SC) injection of tralokinumab loading dose. From Week 2 up to Week 266*: SC injection of tralokinumab maintenance dose. *The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from. Tralokinumab: Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.

    Primary: Number of adverse events from baseline through the last treatment visit (up to Week 268)

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    End point title
    Number of adverse events from baseline through the last treatment visit (up to Week 268) [1]
    End point description
    End point type
    Primary
    End point timeframe
    From Week 0 up to Week 268
    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: No statistical analysis as the primary endpoint is investigating safety.
    End point values
    tralokinumab
    Number of subjects analysed
    1672
    Units: events
    8119
    No statistical analyses for this end point

    Secondary: Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248

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    End point title
    Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
    End point description
    The IGA is an instrument used in clinical trials to rate the severity of the subject's global atopic dermatitis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
    End point type
    Secondary
    End point timeframe
    From Week 16 up to Week 248
    End point values
    tralokinumab
    Number of subjects analysed
    1647
    Units: percentage of responders
    number (confidence interval 95%)
        IGA 0/1 at Week 16
    47.3 (44.9 to 49.8)
        IGA 0/1 at Week 56
    48.5 (45.9 to 51.1)
        IGA 0/1 at Week 88
    48.6 (46.1 to 51.1)
        IGA 0/1 at Week 104
    47.1 (44.6 to 49.6)
        IGA 0/1 at Week 136
    48.7 (46.2 to 51.3)
        IGA 0/1 at Week 152
    46.8 (44.1 to 49.4)
        IGA 0/1 at Week 184
    46.7 (44.1 to 49.3)
        IGA 0/1 at Week 216
    47.2 (44.4 to 50.0)
        IGA 0/1 at Week 248
    46.9 (44.1 to 49.7)
    No statistical analyses for this end point

    Secondary: At least 75% reduction in Eczema Area and Severity Index (EASI75) relative to baseline in parent trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248

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    End point title
    At least 75% reduction in Eczema Area and Severity Index (EASI75) relative to baseline in parent trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
    End point description
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe or more extensive condition.
    End point type
    Secondary
    End point timeframe
    From Week 16 up to Week 248
    End point values
    tralokinumab
    Number of subjects analysed
    1639
    Units: percentage of responders
    number (confidence interval 95%)
        EASI75 at Week 16
    77.0 (74.9 to 79.0)
        EASI75 at Week 56
    75.2 (72.9 to 77.4)
        EASI75 at Week 88
    75.1 (72.9 to 77.3)
        EASI75 at Week 104
    74.6 (72.3 to 76.8)
        EASI75 at Week 136
    74.1 (71.7 to 76.3)
        EASI75 at Week 152
    73.0 (70.6 to 75.2)
        EASI75 at Week 184
    72.3 (69.7 to 74.6)
        EASI75 at Week 216
    72.1 (69.7 to 74.5)
        EASI75 at Week 248
    71.7 (69.2 to 74.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline up to week 268
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    27
    Reporting groups
    Reporting group title
    tralokinumab
    Reporting group description
    Week 0: subcutaneous (SC) injection of tralokinumab loading dose. From Week 2 up to Week 266: SC injection of tralokinumab maintenance dose. The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from. Tralokinumab: Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.

    Serious adverse events
    tralokinumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    151 / 1672 (9.03%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenoid cystic carcinoma
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Breast cancer
         subjects affected / exposed
    2 / 1672 (0.12%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Cutaneous T-cell lymphoma
         subjects affected / exposed
    2 / 1672 (0.12%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    Invasive breast carcinoma
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    2 / 1672 (0.12%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Alcohol detoxication
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac resynchronisation therapy
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Ruptured ectopic pregnancy
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    4 / 1672 (0.24%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Corneal graft rejection
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Endometriosis
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    3 / 1672 (0.18%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Obstructive sleep apnoea syndrome
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Depression
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Irritability
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Schizophrenia
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Suicide attempt
         subjects affected / exposed
    2 / 1672 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Product issues
    Device dislocation
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ankle fracture
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cartilage injury
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    3 / 1672 (0.18%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Fall
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural complication
         subjects affected / exposed
    2 / 1672 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post-traumatic neck syndrome
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Seroma
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Corneal dystrophy
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Angina pectoris
         subjects affected / exposed
    2 / 1672 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 1672 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    3 / 1672 (0.18%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pericarditis
         subjects affected / exposed
    2 / 1672 (0.12%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Encephalopathy
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    2 / 1672 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Migraine with aura
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Multiple sclerosis
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Radiculopathy
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Atopic cataract
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cataract
         subjects affected / exposed
    3 / 1672 (0.18%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Cataract nuclear
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Corneal disorder
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Glaucoma
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Retinal detachment
         subjects affected / exposed
    2 / 1672 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ulcerative keratitis
         subjects affected / exposed
    2 / 1672 (0.12%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vogt-Koyanagi-Harada disease
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Crohn disease
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemoperitoneum
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Proctitis ulcerative
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Atopic dermatitis
         subjects affected / exposed
    12 / 1672 (0.72%)
         occurrences causally related to treatment / all
    1 / 12
         deaths causally related to treatment / all
    0 / 0
    Cutaneous vasculitis
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dermatitis psoriasiform
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Bladder metaplasia
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    2 / 1672 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Proteinuria
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Foot deformity
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    intervertebral disc protusion
         subjects affected / exposed
    3 / 1672 (0.18%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Jaw cyst
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Arthritis infective
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Colonic abscess
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    COVID-19
         subjects affected / exposed
    5 / 1672 (0.30%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Dermatitis infected
         subjects affected / exposed
    2 / 1672 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eczema herpeticum
         subjects affected / exposed
    3 / 1672 (0.18%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Encephalitis herpes
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Giardiasis
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster pharyngitis
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Localised infection
         subjects affected / exposed
    2 / 1672 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Medical device site joint infection
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural infection
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tonsilitis
         subjects affected / exposed
    2 / 1672 (0.12%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Tooth abscess
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 1672 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    tralokinumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    924 / 1672 (55.26%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    114 / 1672 (6.82%)
         occurrences all number
    143
    Skin and subcutaneous tissue disorders
    Atopic dermatitis
         subjects affected / exposed
    351 / 1672 (20.99%)
         occurrences all number
    620
    Infections and infestations
    Conjuctivitis
         subjects affected / exposed
    103 / 1672 (6.16%)
         occurrences all number
    131
    Covid-19
         subjects affected / exposed
    295 / 1672 (17.64%)
         occurrences all number
    317
    Nasopharyngitis
         subjects affected / exposed
    372 / 1672 (22.25%)
         occurrences all number
    599
    Upper respiratory tract infection
         subjects affected / exposed
    147 / 1672 (8.79%)
         occurrences all number
    233

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jun 2018
    The main reason for this amendment is to change an inclusion criterion that will enable all eligible subjects to enter this trial directly after completing the treatment period(s) in their parent trial.
    31 Aug 2018
    The main reason for this amendment is to change an inclusion criterion to also allow eligible subjects from trial LP0162-1346 to enter the extension trial.
    13 Dec 2018
    The main reason for this amendment is to change exclusion criterion to reflect that a wash-out period is not considered necessary because subjects are allowed to resume investigational medicinal product following 5 half-lives after the last administration of systemic immunosuppressive or immunomodulating drugs and/or systemic corticosteroids. Clarifications on how to handle duplicate assessments (i.e. assessments performed on the same day) between parent trial and trial LP0162-1337 have been added.
    28 May 2019
    The main reason for this amendment is to introduce the option to take skin biopsy samples at selected sites in the subgroup of subjects who had skin biopsy samples in the parent trial LP0162-1325 and to consolidate the 2 screening visits to 1 visit.
    17 Feb 2020
    The main reason for the amendment is to introduce the possibility for eligible subjects in selected countries of trial LP0162-1334 with adolescent subjects to continue in this long-term extension trial (LP0162-1337, ECZTEND). The purpose is to obtain long-term safety data for adolescent subjects with atopic dermatitis (AD) treated with tralokinumab.
    25 Nov 2020
    The main reason for this amendment is to extend the collection of long-term safety data for tralokinumab up to 5 years, and at the same time provide subjects the possibility to continue treatment until treatment with tralokinumab is also available to patients outside the clinical trial setting. Subjects from the parent trial LP0162-1334 will have the opportunity to continue for an additional 1-year extension, providing an additional year of safety data for adolescents/young adults. To reduce the burden of frequent site visits for subjects, the amendment will introduce a visit schedule more similar to standard practice for home use. The modified design reduces the number of site visits and instead introduces a mandatory telephone visit in between site visits to ensure close safety monitoring of the subjects. This amendment also introduces the possibility for eligible subjects from 2 new parent trials, LP0162-1343 and TRA-WEI-0015-I, to participate in this long-term extension trial.
    08 Feb 2022
    The main reason for amendment 9 is to shorten the safety follow-up period from 16 weeks to 4 weeks for subjects transferred from the adolescent parent trial LP0162-1334. Furthermore, changes that were made for the local protocol versions for Japan and Germany have been implemented in the protocol, and the definition of treatment completers has been updated.

    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/35863467
    http://www.ncbi.nlm.nih.gov/pubmed/38563683
    http://www.ncbi.nlm.nih.gov/pubmed/36223087
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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