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    Clinical Trial Results:
    A Randomized, Controlled, Multicenter, Open Label Study with Blinded Assessment of the Efficacy of the Humanized Anti-IL-23p19 Risankizumab Compared to FUMADERM® in Subjects with Moderate to Severe Plaque Psoriasis Who are Naïve to and Candidates for Systemic Therapy

    Summary
    EudraCT number
    2016-003718-28
    Trial protocol
    DE  
    Global end of trial date
    06 Jul 2018

    Results information
    Results version number
    v2(current)
    This version publication date
    18 Dec 2019
    First version publication date
    13 Jul 2019
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    number discrepancy

    Trial information

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    Trial identification
    Sponsor protocol code
    M16-178
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03255382
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB
    Public contact
    Global Medical Services, AbbVie , 001 800-633-9110,
    Scientific contact
    David Williams, MD, MPH, AbbVie, david.a.williams@abbvie.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
    06 Jul 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to compare the efficacy and safety of subcutaneous (SC) risankizumab and oral FUMADERM® provided as study medication in subjects with moderate to severe plaque psoriasis who are naïve to and candidates for systemic therapy.
    Protection of trial subjects
    Subject and/or parent or legal guardian read and understood the information provided about the study and gave written permission.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    22 Aug 2017
    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
    Germany: 120
    Worldwide total number of subjects
    120
    EEA total number of subjects
    120
    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)
    113
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Intent-to-treat (ITT) analysis set included all participants enrolled in the study (N = 120). Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 117).

    Pre-assignment
    Screening details
    A total of 120 participants were enrolled and included in the ITT population; 3 randomized participants discontinued prior to receiving any study drug and were excluded from the safety population.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Fumaderm
    Arm description
    Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.
    Arm type
    Active comparator

    Investigational medicinal product name
    Fumaderm
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Fumaderm tablet administered orally

    Arm title
    Risankizumab
    Arm description
    Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.
    Arm type
    Experimental

    Investigational medicinal product name
    Risankizumab
    Investigational medicinal product code
    Other name
    ABBV-066, BI 655066
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Risankizumab administered by subcutaneous (SC) injection

    Number of subjects in period 1
    Fumaderm Risankizumab
    Started
    60
    60
    Completed
    47
    60
    Not completed
    13
    0
         Not specified
    6
    -
         Adverse event
    3
    -
         Withdrawal by Subject
    2
    -
         Lost to follow-up
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fumaderm
    Reporting group description
    Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.

    Reporting group title
    Risankizumab
    Reporting group description
    Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.

    Reporting group values
    Fumaderm Risankizumab Total
    Number of subjects
    60 60 120
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    42.5 ± 12.71 42.0 ± 13.75 -
    Gender categorical
    Units: Subjects
        Female
    22 27 49
        Male
    38 33 71
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    1 0 1
        Not Hispanic or Latino
    59 60 119
        Unknown or Not Reported
    0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0
        Asian
    0 1 1
        Native Hawaiian or Other Pacific Islander
    0 0 0
        Black or African American
    0 0 0
        White
    60 59 119
        More than one race
    0 0 0
        Unknown or Not Reported
    0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Fumaderm
    Reporting group description
    Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.

    Reporting group title
    Risankizumab
    Reporting group description
    Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.

    Primary: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24

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    End point title
    Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24
    End point description
    The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data.
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [1]
    60 [2]
    Units: Percentage of Participants
        number (not applicable)
    10.0
    83.3
    Notes
    [1] - Intent to Treat (ITT) analysis set: all participants who were randomized.
    [2] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the Cochran-Mantel-Haenszel (CMH) test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    73.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    61.3
         upper limit
    85.3

    Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 4

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    End point title
    Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 4
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) I PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [3]
    60 [4]
    Units: Percentage of Participants
        number (not applicable)
    6.7
    53.3
    Notes
    [3] - ITT analysis set
    [4] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Risankizumab v Fumaderm
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    46.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    32.8
         upper limit
    60.8

    Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 8

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    End point title
    Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 8
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [5]
    60 [6]
    Units: Percentage of Participants
        number (not applicable)
    28.3
    91.7
    Notes
    [5] - ITT analysis set
    [6] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    63.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    50.2
         upper limit
    76.6

    Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 12

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    End point title
    Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 12
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [7]
    60 [8]
    Units: Percentage of Participants
        number (not applicable)
    46.7
    100
    Notes
    [7] - ITT analysis set
    [8] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    53.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    40.4
         upper limit
    65.7

    Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 16

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    End point title
    Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 16
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PAS150 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) I PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [9]
    60 [10]
    Units: Percentage of Participants
        number (not applicable)
    60.0
    100
    Notes
    [9] - ITT analysis set
    [10] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    39.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    27.3
         upper limit
    51.9

    Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 20

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    End point title
    Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 20
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 20
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [11]
    60 [12]
    Units: Percentage of Participants
        number (not applicable)
    63.3
    100
    Notes
    [11] - ITT analysis set
    [12] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    36.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    24.1
         upper limit
    48.5

    Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 24

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    End point title
    Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 24
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [13]
    60 [14]
    Units: Percentage of Participants
        number (not applicable)
    53.3
    100
    Notes
    [13] - ITT analysis set
    [14] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    46.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    33.7
         upper limit
    59

    Secondary: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 4

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    End point title
    Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 4
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [15]
    60 [16]
    Units: Percentage of Participants
        number (not applicable)
    3.3
    13.3
    Notes
    [15] - ITT analysis set
    [16] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.047
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    9.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.1
         upper limit
    19.7

    Secondary: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 8

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    End point title
    Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 8
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PAS175 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) I PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [17]
    60 [18]
    Units: Percentage of Participants
        number (not applicable)
    8.3
    75.0
    Notes
    [17] - ITT analysis set
    [18] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    66.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    53.8
         upper limit
    79.5

    Secondary: Percentage of Participants Achieving 75% Improvement in PAST Score (PAS175) at Week 12

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    End point title
    Percentage of Participants Achieving 75% Improvement in PAST Score (PAS175) at Week 12
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PAST score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [19]
    60 [20]
    Units: Percentage of Participants
        number (not applicable)
    20.0
    86.7
    Notes
    [19] - ITT analysis set
    [20] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    66.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    53.3
         upper limit
    79.9

    Secondary: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16

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    End point title
    Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [21]
    60 [22]
    Units: Percentage of Participants
        number (not applicable)
    26.7
    93.3
    Notes
    [21] - ITT analysis set
    [22] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    66.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    53.8
         upper limit
    79.5

    Secondary: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 20

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    End point title
    Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 20
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 20
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [23]
    60 [24]
    Units: Percentage of Participants
        number (not applicable)
    38.3
    95.0
    Notes
    [23] - ITT analysis set
    [24] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    56.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    43
         upper limit
    70

    Secondary: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 24

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    End point title
    Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 24
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PAS175 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [25]
    60 [26]
    Units: Percentage of Participants
        number (not applicable)
    33.3
    98.3
    Notes
    [25] - ITT analysis set
    [26] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other [27]
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    64.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    52.5
         upper limit
    77.2
    Notes
    [27] - P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

    Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 4

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    End point title
    Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 4
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [28]
    60 [29]
    Units: Percentage of Participants
        number (not applicable)
    0
    1.7
    Notes
    [28] - ITT analysis set
    [29] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.392
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    1.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.1
         upper limit
    5.4

    Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 8

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    End point title
    Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 8
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [30]
    60 [31]
    Units: Percentage of Participants
        number (not applicable)
    1.7
    38.3
    Notes
    [30] - ITT analysis set
    [31] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    36.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    23.8
         upper limit
    49.3

    Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 12

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    End point title
    Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 12
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [32]
    60 [33]
    Units: Percentage of Participants
        number (not applicable)
    5.0
    61.7
    Notes
    [32] - ITT analysis set
    [33] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    56.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    43.2
         upper limit
    70

    Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 16

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    End point title
    Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 16
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PAS190 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [34]
    60 [35]
    Units: Percentage of Participants
        number (not applicable)
    11.7
    76.7
    Notes
    [34] - ITT analysis set
    [35] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    64.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    51.5
         upper limit
    78.3

    Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 20

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    End point title
    Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 20
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 20
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [36]
    60 [37]
    Units: Percentage of Participants
        number (not applicable)
    16.7
    83.3
    Notes
    [36] - ITT analysis set
    [37] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    66.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    53.3
         upper limit
    79.8

    Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 4

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    End point title
    Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 4
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) I PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [38]
    60 [39]
    Units: Percentage of Participants
        number (not applicable)
    0
    0
    Notes
    [38] - ITT analysis set
    [39] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.991
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2
         upper limit
    2.1

    Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 8

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    End point title
    Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 8
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [40]
    60 [41]
    Units: Percentage of Participants
        number (not applicable)
    1.7
    5.0
    Notes
    [40] - ITT analysis set
    [41] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.323
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    3.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.2
         upper limit
    9.8

    Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 12

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    End point title
    Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 12
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [42]
    60 [43]
    Units: Percentage of Participants
        number (not applicable)
    1.7
    23.3
    Notes
    [42] - ITT analysis set
    [43] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    21.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    10.4
         upper limit
    32.6

    Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 16

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    End point title
    Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 16
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [44]
    60 [45]
    Units: Percentage of Participants
        number (not applicable)
    1.7
    35.0
    Notes
    [44] - ITT analysis set
    [45] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    33.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    20.7
         upper limit
    45.5

    Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 20

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    End point title
    Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 20
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 20
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [46]
    60 [47]
    Units: Percentage of Participants
        number (not applicable)
    6.7
    48.3
    Notes
    [46] - ITT analysis set
    [47] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    41.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    27.3
         upper limit
    55.3

    Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 24

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    End point title
    Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 24
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [48]
    60 [49]
    Units: Percentage of Participants
        number (not applicable)
    5.0
    50.0
    Notes
    [48] - ITT analysis set
    [49] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no])
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    44.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    30.9
         upper limit
    58.5

    Secondary: The Psoriasis Area and Severity Index (PASI): Change From Baseline to Week 4

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    End point title
    The Psoriasis Area and Severity Index (PASI): Change From Baseline to Week 4
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. Last observation carried forward (LOCF) imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    58 [50]
    60 [51]
    Units: units on a scale
        least squares mean (standard error)
    -2.37 ± 0.669
    -9.56 ± 0.673
    Notes
    [50] - ITT analysis set
    [51] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -7.19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.82
         upper limit
    -5.56
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.825

    Secondary: PASI: Change From Baseline to Week 8

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    End point title
    PASI: Change From Baseline to Week 8
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    58 [52]
    60 [53]
    Units: units on a scale
        least squares mean (standard error)
    -5.61 ± 0.759
    -15.18 ± 0.763
    Notes
    [52] - ITT analysis set
    [53] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -9.58
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -11.43
         upper limit
    -7.72
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.936

    Secondary: PASI: Change From Baseline to Week 12

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    End point title
    PASI: Change From Baseline to Week 12
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    58 [54]
    60 [55]
    Units: units on a scale
        least squares mean (standard error)
    -7.69 ± 0.788
    -16.49 ± 0.793
    Notes
    [54] - ITT analysis set
    [55] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -8.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.72
         upper limit
    -6.87
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.972

    Secondary: PASI: Change From Baseline to Week 16

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    End point title
    PASI: Change From Baseline to Week 16
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    58 [56]
    60 [57]
    Units: units on a scale
        least squares mean (standard error)
    -9.11 ± 0.777
    -16.89 ± 0.782
    Notes
    [56] - ITT analysis set
    [57] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -7.78
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.68
         upper limit
    -5.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.958

    Secondary: PASI: Change From Baseline to Week 20

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    End point title
    PASI: Change From Baseline to Week 20
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 20
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    58 [58]
    60 [59]
    Units: units on a scale
        least squares mean (standard error)
    -9.46 ± 0.894
    -17.35 ± 0.899
    Notes
    [58] - ITT analysis set
    [59] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -7.89
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.07
         upper limit
    -5.71
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.101

    Secondary: PASI: Change From Baseline to Week 24

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    End point title
    PASI: Change From Baseline to Week 24
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    58 [60]
    60 [61]
    Units: units on a scale
        least squares mean (standard error)
    -9.31 ± 0.953
    -17.69 ± 0.959
    Notes
    [60] - ITT analysis set
    [61] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -8.39
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.71
         upper limit
    -6.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.175

    Secondary: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 4

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    End point title
    Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 4
    End point description
    The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [62]
    60 [63]
    Units: Percentage of Participants
        number (not applicable)
    3.3
    33.3
    Notes
    [62] - ITT analysis set
    [63] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    29.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    17.1
         upper limit
    42.4

    Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 8

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    End point title
    Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 8
    End point description
    The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [64]
    60 [65]
    Units: Percentage of Participants
        number (not applicable)
    15.0
    81.7
    Notes
    [64] - ITT analysis set
    [65] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    66.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    53.4
         upper limit
    80

    Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12

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    End point title
    Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12
    End point description
    The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [66]
    60 [67]
    Units: Percentage of Participants
        number (not applicable)
    33.3
    90.0
    Notes
    [66] - ITT analysis set
    [67] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    56.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    42.7
         upper limit
    70.8

    Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16

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    End point title
    Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16
    End point description
    The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [68]
    60 [69]
    Units: Percentage of Participants
        number (not applicable)
    31.7
    91.7
    Notes
    [68] - ITT analysis set
    [69] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    59.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    46.3
         upper limit
    73.6

    Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 20

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    End point title
    Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 20
    End point description
    The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 20
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [70]
    60 [71]
    Units: Percentage of Participants
        number (not applicable)
    48.3
    93.3
    Notes
    [70] - ITT analysis set
    [71] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    44.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    30.8
         upper limit
    59.1

    Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 24

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    End point title
    Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 24
    End point description
    The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    58 [72]
    60 [73]
    Units: Percentage of Participants
        number (not applicable)
    38.3
    93.3
    Notes
    [72] - ITT Analysis Set
    [73] - ITT Analysis Set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    41.2
         upper limit
    68.8

    Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 4

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    End point title
    Percentage of Participants Achieving sPGA Score of Clear at Week 4
    End point description
    The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [74]
    60 [75]
    Units: Percentage of Participants
        number (not applicable)
    0
    1.7
    Notes
    [74] - ITT analysis set
    [75] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Risankizumab v Fumaderm
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.392
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    1.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.1
         upper limit
    5.4

    Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 8

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    End point title
    Percentage of Participants Achieving sPGA Score of Clear at Week 8
    End point description
    The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [76]
    60 [77]
    Units: Percentage of Participants
        number (not applicable)
    1.7
    10.0
    Notes
    [76] - ITT analysis set
    [77] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.048
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    8.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.1
         upper limit
    16.7

    Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 12

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    End point title
    Percentage of Participants Achieving sPGA Score of Clear at Week 12
    End point description
    The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [78]
    60 [79]
    Units: Percentage of Participants
        number (not applicable)
    3.3
    21.7
    Notes
    [78] - ITT analysis set
    [79] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    18.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    7.1
         upper limit
    29.5

    Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 16

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    End point title
    Percentage of Participants Achieving sPGA Score of Clear at Week 16
    End point description
    The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [80]
    60 [81]
    Units: Percentage of Participants
        number (not applicable)
    3.3
    36.7
    Notes
    [80] - ITT analysis set
    [81] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    20.2
         upper limit
    45.9

    Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 20

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    End point title
    Percentage of Participants Achieving sPGA Score of Clear at Week 20
    End point description
    The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 20
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [82]
    60 [83]
    Units: Percentage of Participants
        number (not applicable)
    6.7
    48.3
    Notes
    [82] - ITT analysis set
    [83] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    41.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    27.3
         upper limit
    55.3

    Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 24

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    End point title
    Percentage of Participants Achieving sPGA Score of Clear at Week 24
    End point description
    The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [84]
    60 [85]
    Units: Percentage of Participants
        number (not applicable)
    5.0
    51.7
    Notes
    [84] - ITT analysis set
    [85] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    46.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    32.6
         upper limit
    60.1

    Secondary: Percentage of Participants With Psoriasis Symptoms Scale (PSS) Score of 0 at Week 16

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    End point title
    Percentage of Participants With Psoriasis Symptoms Scale (PSS) Score of 0 at Week 16
    End point description
    The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [86]
    60 [87]
    Units: Percentage of Participants
        number (not applicable)
    5.0
    25.0
    Notes
    [86] - ITT analysis set
    [87] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    19.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    7.6
         upper limit
    31.9

    Secondary: Percentage of Participants With PSS Score of 0 at Week 24

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    End point title
    Percentage of Participants With PSS Score of 0 at Week 24
    End point description
    The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [88]
    60 [89]
    Units: Percentage of Participants
        number (not applicable)
    3.3
    41.7
    Notes
    [88] - ITT analysis set
    [89] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    38.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    25
         upper limit
    51.5

    Secondary: PSS Total Score: Change From Baseline to Week 16

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    End point title
    PSS Total Score: Change From Baseline to Week 16
    End point description
    The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    55 [90]
    59 [91]
    Units: units on a scale
        least squares mean (standard error)
    -5.5 ± 0.52
    -8.7 ± 0.51
    Notes
    [90] - ITT analysis set
    [91] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated by stratified van Elteren test.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    van Elteren test
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -3.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.5
         upper limit
    -2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.63

    Secondary: PSS Total Score: Change From Baseline to Week 24

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    End point title
    PSS Total Score: Change From Baseline to Week 24
    End point description
    The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    55 [92]
    60 [93]
    Units: units on a scale
        least squares mean (standard error)
    -5.6 ± 0.49
    -9.5 ± 0.48
    Notes
    [92] - ITT analysis set
    [93] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated by stratified van Elteren test.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    van Elteren test
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -3.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.1
         upper limit
    -2.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.59

    Secondary: Summary of Patient Benefit Index (PBI) at Week 16

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    End point title
    Summary of Patient Benefit Index (PBI) at Week 16
    End point description
    The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment.The PBI assessment consists of 2 steps: before treatment, every participant defines his/her treatment needs according to a standardized list (Patient Needs Questionnaire [PNQ]). After treatment, the participant rates the degree of benefits achieved (Patient Benefits Questionnaire [PBQ]). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for "did not apply to me" (5) and missing. For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score. An increase in PBI indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    54 [94]
    59 [95]
    Units: units on a scale
        arithmetic mean (standard deviation)
    1.970 ± 1.1971
    3.118 ± 0.8246
    Notes
    [94] - ITT analysis set
    [95] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    1.146
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.764
         upper limit
    1.528

    Secondary: Summary of PBI at Week 24

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    End point title
    Summary of PBI at Week 24
    End point description
    The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment. The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment. The PBI assessment consists of 2 steps: before treatment, every participant defines his/her treatment needs according to a standardized list (PNQ). After treatment, the participant rates the degree of benefits achieved (PBQ). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for "did not apply to me" (5) and missing. For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score. An increase in PBI indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    54 [96]
    60 [97]
    Units: units on a scale
        arithmetic mean (standard deviation)
    1.997 ± 1.2710
    3.316 ± 0.7487
    Notes
    [96] - ITT analysis set
    [97] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    1.32
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.936
         upper limit
    1.704

    Secondary: Clinical Severity of Nail Psoriasis (NAPPA-CLIN) Total Score: Change From Baseline to Week 16

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    End point title
    Clinical Severity of Nail Psoriasis (NAPPA-CLIN) Total Score: Change From Baseline to Week 16
    End point description
    The NAPPA-CLIN is an investigator assessment used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis). NAPPA-CLIN has been developed from the Nail Psoriasis Severity Index (NAPSI) score, a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 2 criteria for each nail. The NAPPA-CLIN is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands or both feet respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16. A higher score indicates a worse involvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    56 [98]
    58 [99]
    Units: units on a scale
        arithmetic mean (standard error)
    -0.4 ± 0.51
    -2.7 ± 0.51
    Notes
    [98] - ITT analysis set
    [99] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -2.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.6
         upper limit
    -1.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.63

    Secondary: NAPPA-CLIN Total Score: Change From Baseline to Week 24

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    End point title
    NAPPA-CLIN Total Score: Change From Baseline to Week 24
    End point description
    The NAPPA-CLIN is an investigator assessment used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis). NAPPA-CLIN has been developed from the NAPSI score, a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 2 criteria for each nail. The NAPPA-CLIN is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands or both feet respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16. A higher score indicates a worse involvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    56 [100]
    58 [101]
    Units: units on a scale
        arithmetic mean (standard error)
    -0.7 ± 0.53
    -3.7 ± 0.54
    Notes
    [100] - ITT analysis set
    [101] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.3
         upper limit
    -1.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.66

    Secondary: Palmoplantar Psoriasis Severity Index (PPASI): Change From Baseline to Week 16

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    End point title
    Palmoplantar Psoriasis Severity Index (PPASI): Change From Baseline to Week 16
    End point description
    The PPASI is an assessment by the investigator that provides a numeric scoring for psoriasis affecting the hands and feet with scores ranging from 0 to 72. It is a linear combination of percent of surface area of palms and soles that are affected and the severity of erythema, induration, and desquamation. The higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    56 [102]
    60 [103]
    Units: units on a scale
        arithmetic mean (standard error)
    -0.76 ± 0.251
    -1.04 ± 0.249
    Notes
    [102] - ITT analysis set
    [103] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.352
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -0.29
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.9
         upper limit
    0.32
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.307

    Secondary: PPASI: Change From Baseline to Week 24

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    End point title
    PPASI: Change From Baseline to Week 24
    End point description
    The PPASI is an assessment by the investigator that provides a numeric scoring for psoriasis affecting the hands and feet with scores ranging from 0 to 72. It is a linear combination of percent of surface area of palms and soles that are affected and the severity of erythema, induration, and desquamation. The higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    56 [104]
    60 [105]
    Units: units on a scale
        arithmetic mean (standard error)
    -0.87 ± 0.242
    -1.17 ± 0.240
    Notes
    [104] - ITT analysis set
    [105] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.315
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.88
         upper limit
    0.29
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.296

    Secondary: Body Surface Area (BSA) Affected by Psoriasis: Change From Baseline to Week 4

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    End point title
    Body Surface Area (BSA) Affected by Psoriasis: Change From Baseline to Week 4
    End point description
    BSA affected by psoriasis was measured by the physician selecting the participants right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    58 [106]
    60 [107]
    Units: percentage estimated body surface area
        least squares mean (standard error)
    -0.3 ± 0.86
    -5.2 ± 0.86
    Notes
    [106] - ITT Analysis Set
    [107] - ITT Analysis Set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -4.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.9
         upper limit
    -2.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.06

    Secondary: BSA Affected by Psoriasis: Change From Baseline to Week 8

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    End point title
    BSA Affected by Psoriasis: Change From Baseline to Week 8
    End point description
    BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    58 [108]
    60 [109]
    Units: percentage estimated body surface area
        least squares mean (standard error)
    -3.5 ± 1.33
    -12.8 ± 1.33
    Notes
    [108] - ITT Analysis Set
    [109] - ITT Analysis Set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -9.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.6
         upper limit
    -6.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.64

    Secondary: BSA Affected by Psoriasis: Change From Baseline to Week 12

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    End point title
    BSA Affected by Psoriasis: Change From Baseline to Week 12
    End point description
    BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    58 [110]
    60 [111]
    Units: percentage estimated body surface area
        least squares mean (standard error)
    -6.0 ± 1.22
    -16.2 ± 1.23
    Notes
    [110] - ITT Analysis Set
    [111] - ITT Analysis Set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -10.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -13.2
         upper limit
    -7.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.51

    Secondary: BSA Affected by Psoriasis: Change From Baseline to Week 16

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    End point title
    BSA Affected by Psoriasis: Change From Baseline to Week 16
    End point description
    BSA affected by psoriasis was measured by the physician selecting the participants right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    58 [112]
    60 [113]
    Units: percentage estimated body surface area
        least squares mean (standard error)
    -8.2 ± 1.22
    -18.0 ± 1.22
    Notes
    [112] - ITT Analysis Set
    [113] - ITT Analysis Set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -9.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.8
         upper limit
    -6.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.51

    Secondary: BSA Affected by Psoriasis: Change From Baseline to Week 20

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    End point title
    BSA Affected by Psoriasis: Change From Baseline to Week 20
    End point description
    BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 20
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    58 [114]
    60 [115]
    Units: percentage estimated body surface area
        least squares mean (standard error)
    -9.7 ± 1.13
    -19.3 ± 1.13
    Notes
    [114] - ITT Analysis Set
    [115] - ITT Analysis Set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -9.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.4
         upper limit
    -6.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.39

    Secondary: BSA Affected by Psoriasis: Change From Baseline to Week 24

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    End point title
    BSA Affected by Psoriasis: Change From Baseline to Week 24
    End point description
    BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    58 [116]
    60 [117]
    Units: percentage estimated body surface area
        least squares mean (standard error)
    -9.8 ± 1.19
    -19.8 ± 1.19
    Notes
    [116] - ITT Analysis Set
    [117] - ITT Analysis Set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -10
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.9
         upper limit
    -7.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.47

    Secondary: Short Form Health Survey 36, Version 2 (SF-36 V2) Physical Component Summary (PCS) Score: Change From Baseline to Week 16

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    End point title
    Short Form Health Survey 36, Version 2 (SF-36 V2) Physical Component Summary (PCS) Score: Change From Baseline to Week 16
    End point description
    The SF-36 V2 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    55 [118]
    59 [119]
    Units: units on a scale
        least squares mean (standard error)
    2.87 ± 1.153
    7.36 ± 1.135
    Notes
    [118] - ITT analysis set
    [119] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.002
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    4.49
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.74
         upper limit
    7.23
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.385

    Secondary: SF-36 V2 PCS Score: Change From Baseline to Week 24

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    End point title
    SF-36 V2 PCS Score: Change From Baseline to Week 24
    End point description
    The SF-36 V2 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    55 [120]
    60 [121]
    Units: units on a scale
        least squares mean (standard error)
    3.68 ± 1.104
    8.31 ± 1.083
    Notes
    [120] - ITT analysis set
    [121] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    4.63
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.01
         upper limit
    7.25
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.322

    Secondary: SF-36 V2 Mental Component Summary (MCS) Score: Change From Baseline: to Week 16

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    End point title
    SF-36 V2 Mental Component Summary (MCS) Score: Change From Baseline: to Week 16
    End point description
    The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    55 [122]
    59 [123]
    Units: units on a scale
        least squares mean (standard error)
    4.20 ± 1.493
    10.86 ± 1.472
    Notes
    [122] - ITT analysis set
    [123] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    6.66
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.11
         upper limit
    10.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.787

    Secondary: SF-36 V2 MCS Score: Change From Baseline to Week 24

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    End point title
    SF-36 V2 MCS Score: Change From Baseline to Week 24
    End point description
    The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    55 [124]
    60 [125]
    Units: units on a scale
        least squares mean (standard error)
    3.56 ± 1.494
    11.41 ± 1.470
    Notes
    [124] - ITT analysis set
    [125] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    7.85
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.31
         upper limit
    11.38
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.784

    Secondary: Patient's Global Assessment (PtGA): Change From Baseline to Week 16

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    End point title
    Patient's Global Assessment (PtGA): Change From Baseline to Week 16
    End point description
    The PtGA is a patient-reported outcome instrument to assess the patient's assessment of disease severity. This self-reported measure is used to assess disease activity using a 4-point scale where a higher score indicates a higher level of disease activity. Disease activity is assessed from 0 ("complete disease control") to 3 ("uncontrolled disease"). LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    56 [126]
    59 [127]
    Units: units on a scale
        least squares mean (standard error)
    -1.0 ± 0.11
    -1.9 ± 0.11
    Notes
    [126] - ITT analysis set
    [127] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.2
         upper limit
    -0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13

    Secondary: PtGA: Change From Baseline to Week 24

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    End point title
    PtGA: Change From Baseline to Week 24
    End point description
    The PtGA is a patient-reported outcome instrument to assess the patient's assessment of disease severity. This self-reported measure is used to assess disease activity using a 4-point scale where a higher score indicates a higher level of disease activity. Disease activity is assessed from 0 ("complete disease control") to 3 ("uncontrolled disease"). LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    56 [128]
    60 [129]
    Units: units on a scale
        least squares mean (standard error)
    -1.0 ± 0.11
    -2.0 ± 0.11
    Notes
    [128] - ITT analysis set
    [129] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.3
         upper limit
    -0.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13

    Secondary: Hospital Anxiety and Depression Scale (HADS) Total Score-Anxiety: Change From Baseline to Week 16

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    End point title
    Hospital Anxiety and Depression Scale (HADS) Total Score-Anxiety: Change From Baseline to Week 16
    End point description
    The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the selling of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    55 [130]
    59 [131]
    Units: units on a scale
        least squares mean (standard error)
    -2.2 ± 0.48
    -4.3 ± 0.47
    Notes
    [130] - ITT analysis set
    [131] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.2
         upper limit
    -0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.57

    Secondary: HADS Total Score-Anxiety: Change From Baseline to Week 24

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    End point title
    HADS Total Score-Anxiety: Change From Baseline to Week 24
    End point description
    The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    55 [132]
    60 [133]
    Units: units on a scale
        least squares mean (standard error)
    -1.8 ± 0.49
    -4.0 ± 0.48
    Notes
    [132] - ITT analysis set
    [133] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -2.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.5
         upper limit
    -1.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.59

    Secondary: HADS Total Score-Depression: Change From Baseline to Week 16

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    End point title
    HADS Total Score-Depression: Change From Baseline to Week 16
    End point description
    The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    55 [134]
    59 [135]
    Units: units on a scale
        least squares mean (standard error)
    -1.8 ± 0.50
    -4.9 ± 0.50
    Notes
    [134] - ITT analysis set
    [135] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -3.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.3
         upper limit
    -1.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.61

    Secondary: HADS Total Score-Depression: Change From Baseline to Week 24

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    End point title
    HADS Total Score-Depression: Change From Baseline to Week 24
    End point description
    The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively.. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    55 [136]
    60 [137]
    Units: units on a scale
        least squares mean (standard error)
    -1.7 ± 0.54
    -4.8 ± 0.53
    Notes
    [136] - ITT analysis set
    [137] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -3.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.4
         upper limit
    -1.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.65

    Secondary: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16

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    End point title
    Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
    End point description
    The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [138]
    60 [139]
    Units: Percentage of Participants
        number (not applicable)
    10.0
    48.3
    Notes
    [138] - ITT analysis set
    [139] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    38.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    23.6
         upper limit
    53.1

    Secondary: Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 24

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    End point title
    Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 24
    End point description
    The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    60 [140]
    60 [141]
    Units: Percentage of Participants
        number (not applicable)
    10.0
    66.7
    Notes
    [140] - ITT analysis set
    [141] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    56.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    42.7
         upper limit
    70.9

    Secondary: DLQI Total Score: Change From Baseline to Week 16

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    End point title
    DLQI Total Score: Change From Baseline to Week 16
    End point description
    The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    56 [142]
    59 [143]
    Units: units on a scale
        least squares mean (standard error)
    -9.7 ± 0.94
    -17.0 ± 0.94
    Notes
    [142] - ITT analysis set
    [143] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with prior phototherapy (yes/no), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -7.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.6
         upper limit
    -5.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.15

    Secondary: DLQI: Change From Baseline to Week 24

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    End point title
    DLQI: Change From Baseline to Week 24
    End point description
    The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    56 [144]
    60 [145]
    Units: units on a scale
        least squares mean (standard error)
    -11.2 ± 0.87
    -18.8 ± 0.87
    Notes
    [144] - ITT analysis set
    [145] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -7.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.7
         upper limit
    -5.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.06

    Secondary: Psoriasis Scalp Severity Index (PSSI): Change From Baseline at Week 16

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    End point title
    Psoriasis Scalp Severity Index (PSSI): Change From Baseline at Week 16
    End point description
    The physician assessed the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved). The composite score is calculated as the sum of symptom scores multiplied by the score for the area of scalp involved. The PSSI ranges from 0 (best) to 72 (worst). A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    56 [146]
    60 [147]
    Units: units on a scale
        least squares mean (standard error)
    -14.6 ± 1.01
    -21.2 ± 1.01
    Notes
    [146] - ITT analysis set
    [147] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -6.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9
         upper limit
    -4.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.23

    Secondary: PSSI: Change From Baseline at Week 24

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    End point title
    PSSI: Change From Baseline at Week 24
    End point description
    The physician assessed the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved). The composite score is calculated as the sum of symptom scores multiplied by the score for the area of scalp involved. The PSSI ranges from 0 (best) to 72 (worst). A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    56 [148]
    60 [149]
    Units: units on a scale
        least squares mean (standard error)
    -13.9 ± 1.25
    -22.0 ± 1.25
    Notes
    [148] - ITT analysis set
    [149] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -8.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -11.1
         upper limit
    -5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.53

    Secondary: European Quality of Life 5 Dimensions (EQ-5D-5L) Total Score: Change From Baseline to Week 16

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    End point title
    European Quality of Life 5 Dimensions (EQ-5D-5L) Total Score: Change From Baseline to Week 16
    End point description
    The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-50-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    55 [150]
    58 [151]
    Units: units on a scale
        least squares mean (standard error)
    0.083 ± 0.0179
    0.171 ± 0.0176
    Notes
    [150] - ITT analysis set
    [151] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    0.087
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.045
         upper limit
    0.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0215

    Secondary: EQ-5D-5L Total Score: Change From Baseline to Week 24

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    End point title
    EQ-5D-5L Total Score: Change From Baseline to Week 24
    End point description
    The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    55 [152]
    60 [153]
    Units: units on a scale
        least squares mean (standard error)
    0.106 ± 0.0155
    0.165 ± 0.0152
    Notes
    [152] - ITT analysis set
    [153] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.002
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    0.059
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.022
         upper limit
    0.096
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0186

    Secondary: EQ-5D-5L Visual Analog Scale (VAS): Change From Baseline to Week 16

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    End point title
    EQ-5D-5L Visual Analog Scale (VAS): Change From Baseline to Week 16
    End point description
    The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale numbered from 100 (best health imagined) to 0 (worst health imagined). The VAS score from the scale is then entered as a number by the participant. This can be used as a quantitative measure of health outcome that reflects the participant's own judgement. An increase in the EQ-5D-5L VAS score indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    55 [154]
    58 [155]
    Units: units on a scale
        least squares mean (standard error)
    11.0 ± 2.32
    26.0 ± 2.28
    Notes
    [154] - ITT analysis set
    [155] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    14.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    9.4
         upper limit
    20.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.8

    Secondary: EQ-5D-5L VAS: Change From Baseline to Week 24

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    End point title
    EQ-5D-5L VAS: Change From Baseline to Week 24
    End point description
    The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale numbered from 100 (best health imagined) to 0 (worst health imagined). The VAS score from the scale is then entered as a number by the participant. This can be used as a quantitative measure of health outcome that reflects the participant's own judgement. An increase in the EQ-5D-5L VAS score indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    55 [156]
    60 [157]
    Units: units on a scale
        least squares mean (standard error)
    11.6 ± 2.29
    28.4 ± 2.23
    Notes
    [156] - ITT analysis set
    [157] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    16.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    11.4
         upper limit
    22.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.73

    Secondary: Nail Psoriasis Severity Index (NAPSI): Change From Baseline to Week 16

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    End point title
    Nail Psoriasis Severity Index (NAPSI): Change From Baseline to Week 16
    End point description
    The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    56 [158]
    58 [159]
    Units: units on a scale
        least squares mean (standard error)
    -2.2 ± 2.13
    -13.6 ± 2.14
    Notes
    [158] - ITT analysis set
    [159] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -11.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -16.6
         upper limit
    -6.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.64

    Secondary: NAPSI: Change From Baseline to Week 24

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    End point title
    NAPSI: Change From Baseline to Week 24
    End point description
    The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    56 [160]
    58 [161]
    Units: units on a scale
        least squares mean (standard error)
    -4.4 ± 2.18
    -18.1 ± 2.19
    Notes
    [160] - ITT analysis set
    [161] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -13.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -19.1
         upper limit
    -8.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.7

    Secondary: Participants With Baseline NAPSI >0: Change From Baseline to Week 16

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    End point title
    Participants With Baseline NAPSI >0: Change From Baseline to Week 16
    End point description
    The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    33 [162]
    42 [163]
    Units: units on a scale
        least squares mean (standard error)
    -4.2 ± 3.11
    -21.4 ± 2.86
    Notes
    [162] - ITT analysis set
    [163] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -17.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -24.8
         upper limit
    -9.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.75

    Secondary: Participants With Baseline NAPSI >0: Change From Baseline to Week 24

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    End point title
    Participants With Baseline NAPSI >0: Change From Baseline to Week 24
    End point description
    The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Fumaderm Risankizumab
    Number of subjects analysed
    33 [164]
    42 [165]
    Units: units on a scale
        least squares mean (standard error)
    -6.0 ± 3.03
    -27.5 ± 2.79
    Notes
    [164] - ITT analysis set
    [165] - ITT analysis set
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.
    Comparison groups
    Fumaderm v Risankizumab
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Least Squares Mean Difference
    Point estimate
    -21.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -28.8
         upper limit
    -14.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.66

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of risankizumab (up to 31 weeks) or until 1 week after the last dose of Fumaderm (up to 25 weeks)
    Adverse event reporting additional description
    Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 117).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Fumaderm
    Reporting group description
    Participants randomized to receive open-label Fumaderm Initial once daily from Week 0 to Week 2 and Fumaderm once daily from Week 3 to Week 24.

    Reporting group title
    Risankizumab
    Reporting group description
    Participants randomized to receive open-label risankizumab 150 mg at Weeks 0, 4, and 16.

    Serious adverse events
    Fumaderm Risankizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 57 (3.51%)
    1 / 60 (1.67%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Obesity
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (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
    Fumaderm Risankizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    54 / 57 (94.74%)
    45 / 60 (75.00%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    23 / 57 (40.35%)
    0 / 60 (0.00%)
         occurrences all number
    28
    0
    Hypertension
         subjects affected / exposed
    2 / 57 (3.51%)
    4 / 60 (6.67%)
         occurrences all number
    2
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 57 (7.02%)
    0 / 60 (0.00%)
         occurrences all number
    4
    0
    Headache
         subjects affected / exposed
    7 / 57 (12.28%)
    5 / 60 (8.33%)
         occurrences all number
    15
    6
    Migraine
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 60 (0.00%)
         occurrences all number
    3
    0
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    8 / 57 (14.04%)
    0 / 60 (0.00%)
         occurrences all number
    9
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    11 / 57 (19.30%)
    0 / 60 (0.00%)
         occurrences all number
    13
    0
    Abdominal pain upper
         subjects affected / exposed
    26 / 57 (45.61%)
    1 / 60 (1.67%)
         occurrences all number
    34
    1
    Diarrhoea
         subjects affected / exposed
    32 / 57 (56.14%)
    4 / 60 (6.67%)
         occurrences all number
    57
    4
    Nausea
         subjects affected / exposed
    9 / 57 (15.79%)
    0 / 60 (0.00%)
         occurrences all number
    12
    0
    Toothache
         subjects affected / exposed
    0 / 57 (0.00%)
    3 / 60 (5.00%)
         occurrences all number
    0
    4
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    2 / 57 (3.51%)
    5 / 60 (8.33%)
         occurrences all number
    2
    5
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    5 / 57 (8.77%)
    2 / 60 (3.33%)
         occurrences all number
    8
    2
    Skin burning sensation
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 60 (0.00%)
         occurrences all number
    3
    0
    Urticaria
         subjects affected / exposed
    4 / 57 (7.02%)
    0 / 60 (0.00%)
         occurrences all number
    4
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 57 (5.26%)
    2 / 60 (3.33%)
         occurrences all number
    3
    2
    Pain in extremity
         subjects affected / exposed
    3 / 57 (5.26%)
    2 / 60 (3.33%)
         occurrences all number
    3
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 57 (5.26%)
    3 / 60 (5.00%)
         occurrences all number
    3
    3
    Influenza
         subjects affected / exposed
    3 / 57 (5.26%)
    4 / 60 (6.67%)
         occurrences all number
    3
    4
    Nasopharyngitis
         subjects affected / exposed
    26 / 57 (45.61%)
    35 / 60 (58.33%)
         occurrences all number
    32
    47
    Rhinitis
         subjects affected / exposed
    3 / 57 (5.26%)
    3 / 60 (5.00%)
         occurrences all number
    4
    4

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Mar 2017
    Revisions included changing the pharmacokinetic and anti-drug antibody sample collection from plasma to serum as the bioanalysis method utilizes serum instead of plasma. The study schematic was updated to reflect timing of dosing of FUMADERM® INITIAL and FUMADERM®.
    05 Jul 2017
    Revisions included updating the number of study sites from approximately 20 to approximately 25 sites, clarifying that the duration of treatment is 16 weeks for risankizumab vs 24 weeks for FUMADERM®. Changes made to Exclusion Criteria included changing language of complete blood count and microalbuminuria and specifying that the relevant values are from Screening. Exclusion Criterion 14 was modified to make the language closer to medical practice and closely control blood pressure to prevent the risk of renal insufficiency associated with FUMADERM®. Prior phototherapy was modified, as UV-therapy and balneotherapy are considered systemic therapy when associated with UV-sensitizing agents and are not considered systemic therapy when they are not associated with UV-sensitizing agents. A cap for stratum of participants with prior phototherapy resulted in changes regarding stratification of randomization and corresponding analyses. Blood pressure measurement technique was provided to improve screening of the participants who will request a consultation to explore elevated blood pressure values at the Screening visit. Study Procedures clarification was made that differential white blood cell count should be transferred as absolute (not relative) values for consistency within the protocol. A slow increase in FUMADERM® INITIAL or FUMADERM® dose or a return to FUMADERM® INITIAL after initiation of FUMADERM® clarification was added in order to increase the retention of participants randomized to FUMADERM®. For NAPPA-CLIN: specifying that use of artificial nails and/or nail polish should be avoided for participants with nail psoriasis to optimize nail assessment and to record the severity of nail psoriasis for all fingers and toes in the e-CRF instead of only the worst affected one and the least affected one. The Rheumatology Common Toxicity Criteria v.2.0 was removed as this is no longer used in the risankizumab program.
    28 Nov 2017
    Revisions included a change to Prohibited Therapy: moving the time point from which phototherapy (e.g., UVA, UVB, any other UV-therapy or balneotherapy) not-associated with systemic UV-sensitizing agents, topical treatment for psoriasis or any other skin condition (e.g., corticosteroids,c vitamin D analogues, vitamin A analogues, pimecrolimus, retinoids, salicylvaseline, salicylic acid, lactic acid, tacrolimus, tar, urea, andanthralin, α-hydroxy acid, fruit acids) are prohibited from 14 days prior to Screening to 14 days prior to Baseline. The half-life of those therapies is short and no interaction with study medication is to be expected if they are discontinued 14 weeks before 1st dose of study medication, i.e., 14 days before Baseline (Day 1, Week 0). FUMADERM® INITIAL and FUMADERM® Subject Diary: Clarified that the subject diary dispensed at every visit, starting at the Week 0/Baseline Visit rather than at the Screening Visit, and training will occur at the Week 0/Baseline Visit. Discontinuation of Subjects on FUMADERM®: Restriction of the discontinuation of the participants on FUMADERM® for rash/flush to those with severe rash/flush to be consistent with clinical practice where only severe persistent rash/flush leads to discontinuation of patients from FUMADERM®. FUMADERM® label does not request discontinuation of FUMADERM® treatment for all adverse events of rash/flush, but says: "... severe forms (of rash/flush) may lead to (FUMADERM®) treatment discontinuation." Treatments Administered: "Additional dosing instructions will be provided separately from this protocol" was removed as risankizumab administered by site personnel only, so no additional instructions on administering SC injection required. Prohibition of artificial nail and/or nail polish to all participants instead of participants with nail psoriasis only changed as analysis of efficacy on nail psoriasis planned on all participants regardless of concomitant nail psoriasis.

    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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