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    Clinical Trial Results:
    Efficacy of brodalumab in patients with psoriasis with failure of other anti-IL-17 treatments

    Summary
    EudraCT number
    		 2018-000097-30
    Trial protocol
    		 DK  
    Global end of trial date
    20 Apr 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Oct 2021
    First version publication date
    27 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2018-PSO-IL17R
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gentofte Hospital
    Sponsor organisation address
    Gentofte Hospitalsvej 15, 1., Hellerup, Denmark, 2900
    Public contact
    Dept of Dermatology and Allergy, Herlev and Gentofte Hospital, 0045 38673204, nikolai.dyrberg.loft@regionh.dk
    Scientific contact
    Dept of Dermatology and Allergy, Herlev and Gentofte Hospital, 0045 38673204, nikolai.dyrberg.loft@regionh.dk
    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
    10 May 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Apr 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will evaluate brodalumab treatment in patients with moderate-to-severe psoriasis previously treated with anti-IL-17A with primary or secondary failure of treatment. 1. Percentage of patients achieving PASI75 or an absolute PASI ≤2 after 3 months. 2. Percentage of patients achieving PASI90 after 3 months.
    Protection of trial subjects
    Screening for infections prior to drug initiation, monitoring of infections and biomarkers.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Apr 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 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)
    0
    Adults (18-64 years)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 20
    Number of subjects completed
    		 20

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Brodalumab
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Kyntheum
    Investigational medicinal product code
    Other name
    Brodalumab
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    210mg

    Number of subjects in period 1
    		Brodalumab
    Started
    20
    Completed
    20
    Period 2
    Period 2 title
    4 weeks
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Brodalumab
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Kyntheum
    Investigational medicinal product code
    Other name
    Brodalumab
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    210mg

    Number of subjects in period 2
    		Brodalumab
    Started
    20
    Completed
    20
    Period 3
    Period 3 title
    12 weeks
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Brodalumab
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Kyntheum
    Investigational medicinal product code
    Other name
    Brodalumab
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    210mg

    Number of subjects in period 3
    		Brodalumab
    Started
    20
    Completed
    19
    Not completed
    1
         Lack of efficacy
    1
    Period 4
    Period 4 title
    26 weeks
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Brodalumab
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Kyntheum
    Investigational medicinal product code
    Other name
    Brodalumab
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    210mg

    Number of subjects in period 4
    		Brodalumab
    Started
    19
    Completed
    14
    Not completed
    5
         Lack of efficacy
    5
    Period 5
    Period 5 title
    52 weeks
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Brodalumab
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Kyntheum
    Investigational medicinal product code
    Other name
    Brodalumab
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    210mg

    Number of subjects in period 5
    		Brodalumab
    Started
    14
    Completed
    9
    Not completed
    5
         Adverse event, non-fatal
    2
         Lack of efficacy
    3

    Baseline characteristics

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

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 20 20
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    50 (30-59)
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 50 (30 to 59) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 13 13
    Subject analysis sets

    Subject analysis set title
    Full
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    20

    Subject analysis sets values
    		 Full
    Number of subjects
    20
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    50 (30-59)
    Units: years
        median (inter-quartile range (Q1-Q3))
    50 (30 to 59)
    Gender categorical
    Units: Subjects
        Female
    7
        Male
    13

    End points

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    End points reporting groups
    Reporting group title
    Brodalumab
    Reporting group description
    		 -
    Reporting group title
    Brodalumab
    Reporting group description
    		 -
    Reporting group title
    Brodalumab
    Reporting group description
    		 -
    Reporting group title
    Brodalumab
    Reporting group description
    		 -
    Reporting group title
    Brodalumab
    Reporting group description
    		 -

    Subject analysis set title
    Full
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    20

    Primary: Proportion of patients with PASI75 and/or PASI<=2 after 3 months

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    End point title
    		 Proportion of patients with PASI75 and/or PASI<=2 after 3 months [1]
    End point description
    End point type
    Primary
    End point timeframe
    3 months
    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: One arm, no statistical analysis
    End point values
    		 Full
    Number of subjects analysed
    20
    Units: 14
    14
    No statistical analyses for this end point

    Primary: Proportion of patients with PASI90 after 3 months

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    End point title
    		 Proportion of patients with PASI90 after 3 months [2]
    End point description
    End point type
    Primary
    End point timeframe
    3 months
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: One arm, no statistical analysis
    End point values
    		 Full
    Number of subjects analysed
    20
    Units: 8
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse events
    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: 5%
    Non-serious adverse events
    		 Adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 20 (65.00%)
    Nervous system disorders
    Fatigue
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Restlessness
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Social circumstances
    Traffic accident
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    COVID-19
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 20 (30.00%)
         occurrences all number
    6
    Skin and subcutaneous tissue disorders
    Blisters
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Candidiasis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Hair loss
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Hyperkeratotic hand eczema
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Psoriasis flare
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Skin infections
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Endocrine disorders
    Hashimotos
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Back pain
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    PsA flare
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Spondylitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Tendonitis
         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.
    None reported
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    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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