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    Clinical Trial Results:
    Efficacy and safety comparison of brodalumab versus guselkumab in adult subjects with moderate-to-severe plaque psoriasis and inadequate response to ustekinumab.

    Summary
    EudraCT number
    		 2019-004099-20
    Trial protocol
    		 DE   GB   BE   AT   FR   NL   GR   DK   CZ   IT  
    Global end of trial date
    07 Dec 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Dec 2023
    First version publication date
    23 Dec 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LP0160-1510
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04533737
    WHO universal trial number (UTN)
    		 U1111-1283-7584
    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 44945888, disclosure@leo-pharma.com
    Scientific contact
    Global Regulatory Affairs, LEO Pharma A/S, +45 44945888, raleodk@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
    23 Jun 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Sep 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Dec 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the efficacy of brodalumab with guselkumab in adult subjects with moderate-to-severe plaque psoriasis and prior inadequate response to ustekinumab.
    Protection of trial subjects
    This clinical trial was conducted to conform to the principles of the Declaration of Helsinki, the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, in compliance with the approved protocol, and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Dec 2020
    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
    Netherlands: 1
    Country: Number of subjects enrolled
    Sweden: 3
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Denmark: 1
    Country: Number of subjects enrolled
    France: 26
    Country: Number of subjects enrolled
    Germany: 40
    Country: Number of subjects enrolled
    Greece: 8
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    Switzerland: 4
    Worldwide total number of subjects
    113
    EEA total number of subjects
    104
    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)
    101
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at 62 sites that screened subjects in 12 European countries: Austria, Belgium, Denmark, France, Germany, Greece, Italy, the Netherlands, Spain, Sweden, Switzerland, and the United Kingdom.

    Pre-assignment
    Screening details
    		 141 subjects were screened and 113 subjects were randomized 1:1 (stratified by body weight [≤100 kg or >100 kg]) into the 2 treatment groups brodalumab and guselkumab.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Subject, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Brodalumab 210 mg Q2W
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brodalumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Brodalumab 210 mg (1.5 mL) subcutaneously at Weeks 0, 1, 2, and then Q2W until the end of trial (last administration of brodalumab at Week 26).

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo 1.0 mL subcutaneously at Weeks 0, 4, and then every 8 weeks (Q8W) until the end of trial (last administration of placebo at Week 20).

    Arm title
    		 Guselkumab 100 mg Q8W
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Guselkumab 100 mg (1.0 mL) subcutaneously at Weeks 0, 4, and then Q8W until the end of trial (last administration of guselkumab at Week 20).

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo 1.5 mL subcutaneously at Weeks 0, 1, 2, and then Q2W until the end of trial (last administration of placebo at Week 26).

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: Only the assessor evaluating the efficacy was blinded. The assessor could be someone other than the investigator.
    Number of subjects in period 1
    		Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Started
    56
    57
    Completed
    50
    50
    Not completed
    6
    7
         Consent withdrawn by subject
    1
    3
         Adverse event, non-fatal
    3
    1
         Randomised in error
    -
    3
         Lack of efficacy
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Brodalumab 210 mg Q2W
    Reporting group description
    		 -

    Reporting group title
    Guselkumab 100 mg Q8W
    Reporting group description
    		 -

    Reporting group values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W Total
    Number of subjects
    		 56 57 113
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 53 48 101
        From 65-84 years
    		 3 9 12
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.5 ( 10.7 ) 51.1 ( 13.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 16 16 32
        Male
    		 40 41 81

    End points

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    End points reporting groups
    Reporting group title
    Brodalumab 210 mg Q2W
    Reporting group description
    		 -

    Reporting group title
    Guselkumab 100 mg Q8W
    Reporting group description
    		 -

    Primary: Having PASI 100 response at Week 16

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    End point title
    		 Having PASI 100 response at Week 16
    End point description
    FAS
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: % of subjects
        least squares mean (confidence interval 95%)
    53.4 (40.0 to 66.8)
    35.9 (23.0 to 48.7)
    Statistical analysis title
    		 Primary endpoint analysis
    Statistical analysis description
    The primary endpoint was analyzed based on a logistic regression model, adjusted for baseline body weight (≤100 kg, >100 kg) and baseline PASI score. Missing data were imputed using multiple imputation based on a missing at random assumption within treatment groups. The primary endpoint was tested based on the odds ratio between the two treatment groups.
    Comparison groups
    Guselkumab 100 mg Q8W v Brodalumab 210 mg Q2W
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.069
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 4.44

    Secondary: Having PASI 100 response at Week 4

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    End point title
    		 Having PASI 100 response at Week 4
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: % of subjects
        least squares mean (confidence interval 95%)
    23.3 (12.0 to 34.6)
    1.9 (-1.8 to 5.6)
    No statistical analyses for this end point

    Secondary: Having PASI 100 response at Week 8

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    End point title
    		 Having PASI 100 response at Week 8
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: % of subjects
        least squares mean (confidence interval 95%)
    40.8 (27.5 to 54.1)
    16.5 (6.5 to 26.4)
    No statistical analyses for this end point

    Secondary: Having PASI 100 response at Week 28

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    End point title
    		 Having PASI 100 response at Week 28
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 28
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: % of subjects
        least squares mean (confidence interval 95%)
    61.4 (48.3 to 74.5)
    36.8 (23.9 to 49.8)
    No statistical analyses for this end point

    Secondary: Having PASI 90 response at Week 16

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    End point title
    		 Having PASI 90 response at Week 16
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: % of subjects
        least squares mean (confidence interval 95%)
    69.1 (56.7 to 81.5)
    45.2 (31.8 to 58.6)
    No statistical analyses for this end point

    Secondary: Having PASI 90 response at Week 4

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    End point title
    		 Having PASI 90 response at Week 4
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: % of subjects
        least squares mean (confidence interval 95%)
    28.7 (16.7 to 40.8)
    9.2 (1.4 to 16.9)
    No statistical analyses for this end point

    Secondary: Having PASI 90 response at Week 8

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    End point title
    		 Having PASI 90 response at Week 8
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: % of subjects
        least squares mean (confidence interval 95%)
    60.2 (46.8 to 73.7)
    24.9 (13.1 to 36.7)
    No statistical analyses for this end point

    Secondary: Having PASI 90 response at Week 28

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    End point title
    		 Having PASI 90 response at Week 28
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 28
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: % of subjects
        least squares mean (confidence interval 95%)
    69.8 (57.4 to 82.2)
    44.7 (31.2 to 58.2)
    No statistical analyses for this end point

    Secondary: Having IGA of 0 at Week 16

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    End point title
    		 Having IGA of 0 at Week 16
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: % of subjects
        least squares mean (confidence interval 95%)
    55.5 (42.3 to 68.7)
    35.6 (22.8 to 48.3)
    No statistical analyses for this end point

    Secondary: Having IGA of 0 at Week 28

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    End point title
    		 Having IGA of 0 at Week 28
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 28
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: % of subjects
        least squares mean (confidence interval 95%)
    62.4 (49.5 to 75.3)
    41.2 (28.1 to 54.3)
    No statistical analyses for this end point

    Secondary: Having IGA of 0 or 1 at Week 16

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    End point title
    		 Having IGA of 0 or 1 at Week 16
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: % of subjects
        least squares mean (confidence interval 95%)
    78.5 (67.5 to 89.5)
    52.5 (39.1 to 66.0)
    No statistical analyses for this end point

    Secondary: Having IGA of 0 or 1 at Week 28

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    End point title
    		 Having IGA of 0 or 1 at Week 28
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 28
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: % of subjects
        least squares mean (confidence interval 95%)
    82.1 (71.8 to 92.4)
    65.4 (52.7 to 78.2)
    No statistical analyses for this end point

    Secondary: Having DLQI total score of 0 or 1 at Week 4

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    End point title
    		 Having DLQI total score of 0 or 1 at Week 4
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: % of subjects
        least squares mean (confidence interval 95%)
    67.8 (54.9 to 80.8)
    34.3 (21.1 to 47.6)
    No statistical analyses for this end point

    Secondary: Having DLQI total score of 0 or 1 at Week 8

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    End point title
    		 Having DLQI total score of 0 or 1 at Week 8
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: % of subjects
        least squares mean (confidence interval 95%)
    68.8 (56.2 to 81.3)
    66.8 (53.7 to 79.8)
    No statistical analyses for this end point

    Secondary: Having DLQI total score of 0 or 1 at Week 12

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    End point title
    		 Having DLQI total score of 0 or 1 at Week 12
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: % of subjects
        least squares mean (confidence interval 95%)
    78.4 (66.8 to 89.9)
    66.0 (52.7 to 79.2)
    No statistical analyses for this end point

    Secondary: Having DLQI total score of 0 or 1 at Week 16

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    End point title
    		 Having DLQI total score of 0 or 1 at Week 16
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: % of subjects
        least squares mean (confidence interval 95%)
    80.2 (69.7 to 90.8)
    71.6 (59.7 to 83.4)
    No statistical analyses for this end point

    Secondary: Having DLQI total score of 0 or 1 at Week 20

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    End point title
    		 Having DLQI total score of 0 or 1 at Week 20
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 20
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: % of subjects
        least squares mean (confidence interval 95%)
    80.0 (69.0 to 90.9)
    68.9 (56.3 to 81.4)
    No statistical analyses for this end point

    Secondary: Having DLQI total score of 0 or 1 at Week 24

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    End point title
    		 Having DLQI total score of 0 or 1 at Week 24
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: % of subjects
        least squares mean (confidence interval 95%)
    75.7 (64.0 to 87.3)
    70.6 (58.3 to 82.9)
    No statistical analyses for this end point

    Secondary: Having DLQI total score of 0 or 1 at Week 28

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    End point title
    		 Having DLQI total score of 0 or 1 at Week 28
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 28
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: % of subjects
        least squares mean (confidence interval 95%)
    79.3 (68.3 to 90.3)
    66.6 (53.9 to 79.3)
    No statistical analyses for this end point

    Secondary: Change in SF-36v2 Physical component summary measure at Week 4

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    End point title
    		 Change in SF-36v2 Physical component summary measure at Week 4
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: Score
        least squares mean (confidence interval 95%)
    3.3 (1.9 to 4.7)
    1.9 (0.4 to 3.3)
    No statistical analyses for this end point

    Secondary: Change in SF-36v2 Physical component summary measure at Week 8

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    End point title
    		 Change in SF-36v2 Physical component summary measure at Week 8
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: Score
        least squares mean (confidence interval 95%)
    3.8 (2.5 to 5.1)
    3.0 (1.6 to 4.4)
    No statistical analyses for this end point

    Secondary: Change in SF-36v2 Physical component summary measure at Week 16

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    End point title
    		 Change in SF-36v2 Physical component summary measure at Week 16
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: Score
        least squares mean (confidence interval 95%)
    4.2 (2.7 to 5.6)
    3.7 (2.2 to 5.1)
    No statistical analyses for this end point

    Secondary: Change in SF-36v2 Physical component summary measure at Week 28

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    End point title
    		 Change in SF-36v2 Physical component summary measure at Week 28
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 28
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: Score
        least squares mean (confidence interval 95%)
    3.9 (2.5 to 5.3)
    3.9 (2.5 to 5.3)
    No statistical analyses for this end point

    Secondary: Change in SF-36v2 Mental component summary measure at Week 4

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    End point title
    		 Change in SF-36v2 Mental component summary measure at Week 4
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: Score
        least squares mean (confidence interval 95%)
    2.7 (1.3 to 4.1)
    2.6 (1.2 to 4.0)
    No statistical analyses for this end point

    Secondary: Change in SF-36v2 Mental component summary measure at Week 8

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    End point title
    		 Change in SF-36v2 Mental component summary measure at Week 8
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: Score
        least squares mean (confidence interval 95%)
    3.8 (2.3 to 5.2)
    3.7 (2.2 to 5.2)
    No statistical analyses for this end point

    Secondary: Change in SF-36v2 Mental component summary measure at Week 16

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    End point title
    		 Change in SF-36v2 Mental component summary measure at Week 16
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: Score
        least squares mean (confidence interval 95%)
    3.0 (1.5 to 4.4)
    3.6 (2.1 to 5.1)
    No statistical analyses for this end point

    Secondary: Change in SF-36v2 Mental component summary measure at Week 28

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    End point title
    		 Change in SF-36v2 Mental component summary measure at Week 28
    End point description
    FAS
    End point type
    Secondary
    End point timeframe
    Week 28
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: Score
        least squares mean (confidence interval 95%)
    3.1 (1.3 to 4.9)
    4.0 (2.2 to 5.8)
    No statistical analyses for this end point

    Secondary: Occurrence of TEAEs

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    End point title
    		 Occurrence of TEAEs
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to Week 28
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: subjects
    42
    31
    No statistical analyses for this end point

    Secondary: Time to PASI 100 response

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    End point title
    		 Time to PASI 100 response
    End point description
    The outcome measure is summarized using the cumulative percentage of subjects with PASI 100 response (stratified by weight) at each timepoint.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 28
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: Percentage of subjects
    number (confidence interval 95%)
        <=100 kg Week 1
    0 (0 to 0)
    0 (0 to 0)
        <=100 kg Week 2
    4.5 (0.8 to 13.7)
    0 (0 to 0)
        <=100 kg Week 4
    22.7 (11.7 to 36.0)
    2.3 (0.2 to 10.7)
        <=100 kg Week 6
    34.1 (20.5 to 48.1)
    14.0 (5.6 to 26.1)
        <=100 kg Week 8
    40.9 (26.3 to 55.0)
    23.3 (11.9 to 36.8)
        <=100 kg Week 10
    45.5 (30.2 to 59.5)
    27.9 (15.4 to 41.8)
        <=100 kg Week 12
    61.4 (45.1 to 74.1)
    27.9 (15.4 to 41.8)
        <=100 kg Week 14
    61.4 (45.1 to 74.1)
    30.2 (17.2 to 44.3)
        <=100 kg Week 16
    63.6 (47.4 to 76.1)
    39.5 (24.9 to 53.8)
        <=100 kg Week 18
    63.6 (47.4 to 76.1)
    46.5 (31.0 to 60.6)
        <=100 kg Week 20
    65.9 (49.6 to 78.0)
    46.5 (31.0 to 60.6)
        <=100 kg Week 22
    65.9 (49.6 to 78.0)
    46.5 (31.0 to 60.6)
        <=100 kg Week 24
    68.2 (51.9 to 80.0)
    46.5 (31.0 to 60.6)
        <=100 kg Week 26
    68.2 (51.9 to 80.0)
    46.5 (31.0 to 60.6)
        <=100 kg Week 28
    70.5 (54.2 to 81.9)
    48.8 (33.1 to 62.8)
        >100 kg Week 1
    0 (0 to 0)
    0 (0 to 0)
        >100 kg Week 2
    8.3 (0.4 to 32.3)
    0 (0 to 0)
        >100 kg Week 4
    25.0 (5.5 to 51.6)
    0 (0 to 0)
        >100 kg Week 6
    25.0 (5.5 to 51.6)
    7.7 (0.4 to 30.3)
        >100 kg Week 8
    41.7 (14.1 to 67.6)
    7.7 (0.4 to 30.3)
        >100 kg Week 10
    50.0 (19.2 to 74.7)
    15.4 (2.2 to 39.8)
        >100 kg Week 12
    50.0 (19.2 to 74.7)
    15.4 (2.2 to 39.8)
        >100 kg Week 14
    58.3 (24.8 to 81.2)
    23.1 (5.1 to 48.5)
        >100 kg Week 16
    58.3 (24.8 to 81.2)
    30.8 (8.8 to 56.5)
        >100 kg Week 18
    58.3 (24.8 to 81.2)
    30.8 (8.8 to 56.5)
        >100 kg Week 20
    58.3 (24.8 to 81.2)
    30.8 (8.8 to 56.5)
        >100 kg Week 22
    58.3 (24.8 to 81.2)
    30.8 (8.8 to 56.5)
        >100 kg Week 24
    66.7 (30.2 to 87.2)
    30.8 (8.8 to 56.5)
        >100 kg Week 26
    66.7 (30.2 to 87.2)
    30.8 (8.8 to 56.5)
        >100 kg Week 28
    66.7 (30.2 to 87.2)
    30.8 (8.8 to 56.5)
    No statistical analyses for this end point

    Secondary: Time to PASI 90 response

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    End point title
    		 Time to PASI 90 response
    End point description
    The outcome measure is summarized using the cumulative percentage of subjects with PASI 100 response (stratified by weight) at each timepoint.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 28
    End point values
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Number of subjects analysed
    56
    56
    Units: Percentage of subjects
    number (confidence interval 95%)
        <=100 kg Week 1
    0 (0 to 0)
    0 (0 to 0)
        <=100 kg Week 2
    6.8 (1.7 to 16.9)
    0 (0 to 0)
        <=100 kg Week 4
    27.3 (15.1 to 41.0)
    9.3 (2.9 to 20.3)
        <=100 kg Week 6
    56.8 (40.8 to 70.0)
    23.3 (11.9 to 36.8)
        <=100 kg Week 8
    65.9 (49.6 to 78.0)
    34.9 (21.0 to 49.1)
        <=100 kg Week 10
    68.2 (51.9 to 79.9)
    39.5 (24.9 to 53.8)
        <=100 kg Week 12
    72.7 (56.6 to 83.7)
    41.9 (26.9 to 56.1)
        <=100 kg Week 14
    72.7 (56.6 to 83.7)
    44.2 (29.0 to 58.4)
        <=100 kg Week 16
    75.0 (59.0 to 85.5)
    48.8 (33.1 to 62.8)
        <=100 kg Week 18
    75.0 (59.0 to 85.5)
    51.2 (35.3 to 65.0)
        <=100 kg Week 20
    81.8 (66.2 to 90.7)
    55.8 (39.6 to 69.3)
        <=100 kg Week 22
    81.8 (66.2 to 90.7)
    55.8 (39.6 to 69.3)
        <=100 kg Week 24
    81.8 (66.2 to 90.7)
    55.8 (39.6 to 69.3)
        <=100 kg Week 26
    81.8 (66.2 to 90.7)
    55.8 (39.6 to 69.3)
        <=100 kg Week 28
    81.8 (66.2 to 90.7)
    55.8 (39.6 to 69.3)
        >100 kg Week 1
    0 (0 to 0)
    0 (0 to 0)
        >100 kg Week 2
    16.7 (2.4 to 42.4)
    7.7 (0.4 to 30.3)
        >100 kg Week 4
    33.3 (9.4 to 60.0)
    15.4 (2.2 to 39.8)
        >100 kg Week 6
    58.3 (25.1 to 81.1)
    23.1 (5.1 to 48.5)
        >100 kg Week 8
    58.3 (25.1 to 81.1)
    23.1 (5.1 to 48.5)
        >100 kg Week 10
    58.3 (25.1 to 81.1)
    23.1 (5.1 to 48.5)
        >100 kg Week 12
    58.3 (25.1 to 81.1)
    23.1 (5.1 to 48.5)
        >100 kg Week 14
    66.7 (30.8 to 87.0)
    30.8 (8.8 to 56.5)
        >100 kg Week 16
    66.7 (30.8 to 87.0)
    46.2 (17.9 to 70.7)
        >100 kg Week 18
    66.7 (30.8 to 87.0)
    46.2 (17.9 to 70.7)
        >100 kg Week 20
    66.7 (30.8 to 87.0)
    46.2 (17.9 to 70.7)
        >100 kg Week 22
    75.0 (35.5 to 92.3)
    46.2 (17.9 to 70.7)
        >100 kg Week 24
    75.0 (35.5 to 92.3)
    53.8 (23.1 to 77.0)
        >100 kg Week 26
    75.0 (35.5 to 92.3)
    53.8 (23.1 to 77.0)
        >100 kg Week 28
    75.0 (35.5 to 92.3)
    53.8 (23.1 to 77.0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    28 Weeks
    Adverse event reporting additional description
    Treatment-emergent adverse events
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Brodalumab 210 mg Q2W
    Reporting group description
    		 -

    Reporting group title
    Guselkumab 100 mg Q8W
    Reporting group description
    		 -

    Serious adverse events
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 56 (7.14%)
    4 / 56 (7.14%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Arterial stenosis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic mass
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol abuse
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Brodalumab 210 mg Q2W Guselkumab 100 mg Q8W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 56 (66.07%)
    25 / 56 (44.64%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 56 (8.93%)
    2 / 56 (3.57%)
         occurrences all number
    5
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 56 (8.93%)
    3 / 56 (5.36%)
         occurrences all number
    10
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 56 (3.57%)
    3 / 56 (5.36%)
         occurrences all number
    2
    3
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 56 (0.00%)
         occurrences all number
    3
    0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 56 (0.00%)
         occurrences all number
    3
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    3 / 56 (5.36%)
    5 / 56 (8.93%)
         occurrences all number
    3
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    10 / 56 (17.86%)
    2 / 56 (3.57%)
         occurrences all number
    14
    4
    Back pain
         subjects affected / exposed
    5 / 56 (8.93%)
    1 / 56 (1.79%)
         occurrences all number
    5
    1
    Pain in extremity
         subjects affected / exposed
    4 / 56 (7.14%)
    0 / 56 (0.00%)
         occurrences all number
    4
    0
    Myalgia
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 56 (0.00%)
         occurrences all number
    4
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    8 / 56 (14.29%)
    6 / 56 (10.71%)
         occurrences all number
    8
    6
    Nasopharyngitis
         subjects affected / exposed
    7 / 56 (12.50%)
    4 / 56 (7.14%)
         occurrences all number
    7
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Aug 2020
    The main reasons for this amendment, based on input provided during the Voluntary Harmonisation Procedure in EU, are: • to add the discontinuation criterion for subjects who show no response after 16 weeks of treatment. • to add an evaluation by a specialist in case of a positive QuantiFERON® test. • to add an additional sensitivity analysis to assess the robustness of the results of the primary analysis with respect to the use of prohibited medication and procedures among subjects not discontinuing IMP. Furthermore, capturing of ‘lack of efficacy’ in case of aggravation/exacerbation/worsening of the trial disease has been clarified, and albumin-to-creatinine test at screening was changed to only be performed in case of abnormal urine dipstick test.
    22 Jan 2021
    The main reason for this amendment is to provide a possibility to perform minimum safety and efficacy assessments via the use of electronic communications followed by delivery of IMP to subjects for self-injections in case of emergency COVID-19 pandemic restrictions.
    10 Mar 2022
    The main reason for this amendment is to reduce the sample size and amend the eligibility criteria to ease recruitment.

    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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    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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