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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Versus Placebo in Patients with Moderate-to-Severe Genital Psoriasis

    Summary
    EudraCT number
    2015-002628-14
    Trial protocol
    NL   AT   BE  
    Global end of trial date
    21 Feb 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Mar 2019
    First version publication date
    01 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I1F-MC-RHBQ
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02718898
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Eli lilly and Company: 16010
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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
    21 Feb 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of this study is to evaluate the efficacy and safety of the study drug ixekizumab compared to placebo in participants with moderate-to-severe genital psoriasis.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 May 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 29
    Country: Number of subjects enrolled
    Puerto Rico: 11
    Country: Number of subjects enrolled
    Austria: 8
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    Turkey: 7
    Country: Number of subjects enrolled
    Belgium: 7
    Country: Number of subjects enrolled
    United States: 62
    Country: Number of subjects enrolled
    Australia: 20
    Worldwide total number of subjects
    149
    EEA total number of subjects
    20
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    138
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    12 week Blinded Treatment period, followed by 40 week Open Label Treatment Period, followed by 12 week Post treatment follow-up period.

    Period 1
    Period 1 title
    Blinded Treatment period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo - Blinded Treatment
    Arm description
    Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was given by Subcutaneous injection during blinded treatment period.
    Arm type
    Placebo

    Investigational medicinal product name
    Ixekizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At week 12, subjects received 160 mg Ixekizumab by SC injection.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo at baseline and every 2 weeks from week 2 to 10 by subcutaneous injection.

    Arm title
    Ixekizumab 80mg Q2W - Blinded Treatment
    Arm description
    Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80mg Ixekizumab and placebo was given SC during blinded treatment period.
    Arm type
    Placebo

    Investigational medicinal product name
    Ixekizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80mg Ixekizumab and placebo was given SC during blinded treatment period.

    Number of subjects in period 1
    Placebo - Blinded Treatment Ixekizumab 80mg Q2W - Blinded Treatment
    Started
    74
    75
    Completed
    65
    74
    Not completed
    9
    1
         Physician decision
    1
    -
         Adverse event, non-fatal
    5
    1
         Lost to follow-up
    2
    -
         Lack of efficacy
    1
    -
    Period 2
    Period 2 title
    Open Label Treatment Period
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo/Ixekizumab 80mg Q4W - Open label treatment period
    Arm description
    Participants who received placebo in blinded treatment Period had received initial dose of 160mg Ixekizumab at week 12 followed by 80mg Ixekizumab Q4W by subcutaneous injection in open label treatment period. Participants had an option to step-up to Q2W dosing starting at week 24 through week 40.
    Arm type
    Experimental

    Investigational medicinal product name
    Ixekizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 160mg Ixekizumab at week 12 followed by 80mg Ixekizumab Q4W by subcutaneous injection.

    Arm title
    Ixekizumab 80mg Q2W/Ixekizumab 80mg Q4W - Open label treatment
    Arm description
    Participants who received Ixekizumab in blinded treatment Period had received initial dose of 80mg Ixekizumab & placebo at week 12 followed by 80mg Ixekizumab Q4W by subcutaneous injection in open label treatment period. Participants had an option to step-up to Q2W dosing starting at week 24 through week 40.
    Arm type
    Experimental

    Investigational medicinal product name
    Ixekizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80mg Ixekizumab & placebo at week 12 followed by 80mg Ixekizumab Q4W by subcutaneous injection.

    Number of subjects in period 2
    Placebo/Ixekizumab 80mg Q4W - Open label treatment period Ixekizumab 80mg Q2W/Ixekizumab 80mg Q4W - Open label treatment
    Started
    65
    74
    Completed
    62
    64
    Not completed
    3
    10
         Consent withdrawn by subject
    1
    3
         Subject discontinued in OLTP
    -
    1
         Adverse event, non-fatal
    1
    1
         Treatment of undisclosed addiction-Pt withdrew
    -
    1
         Lost to follow-up
    -
    2
         Lack of efficacy
    1
    2
    Period 3
    Period 3 title
    Post treatment follow-up period
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Placebo - Post treatment follow-up
    Arm description
    Participants did not receive any study treatment during post treatment follow-up period.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    Ixekizumab 80mg Q4W - Post treatment follow-up period
    Arm description
    Participants did not receive any study treatment during post treatment follow-up period.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    Ixekizumab 80mg Q2W - Post treatment follow-up
    Arm description
    Participants did not receive any study treatment during post treatment follow-up period.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    Placebo - Post treatment follow-up Ixekizumab 80mg Q4W - Post treatment follow-up period Ixekizumab 80mg Q2W - Post treatment follow-up
    Started
    1
    78
    49
    Completed
    0
    67
    44
    Not completed
    1
    11
    5
         Consent withdrawn by subject
    -
    5
    3
         Adverse event, non-fatal
    -
    1
    1
         Lost to follow-up
    1
    5
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo - Blinded Treatment
    Reporting group description
    Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was given by Subcutaneous injection during blinded treatment period.

    Reporting group title
    Ixekizumab 80mg Q2W - Blinded Treatment
    Reporting group description
    Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80mg Ixekizumab and placebo was given SC during blinded treatment period.

    Reporting group values
    Placebo - Blinded Treatment Ixekizumab 80mg Q2W - Blinded Treatment Total
    Number of subjects
    74 75 149
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    44.4 ± 12.55 43.1 ± 12.95 -
    Gender categorical
    Units: Subjects
        Female
    17 19 36
        Male
    57 56 113
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    14 13 27
        Not Hispanic or Latino
    57 60 117
        Unknown or Not Reported
    3 2 5
    Race
    Units: Subjects
        American Indian or Alaska Native
    0 1 1
        Asian
    7 3 10
        Native Hawaiian or Other Pacific Islander
    0 0 0
        Black or African American
    2 0 2
        White
    64 67 131
        More than one race
    1 4 5
        Unknown or Not Reported
    0 0 0
    sPGA of Genitalia
    The Static Physician Global Assessment (sPGA) of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale). For the analysis of responses, the participant's psoriasis is assessed as follows: 0 = clear,1 = minimal,2 = mild,3 = moderate,4 = severe,5 = very severe.
    Units: units on a scale
        arithmetic mean (standard deviation)
    3.5 ± 0.53 3.4 ± 0.61 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo - Blinded Treatment
    Reporting group description
    Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab was given by Subcutaneous injection during blinded treatment period.

    Reporting group title
    Ixekizumab 80mg Q2W - Blinded Treatment
    Reporting group description
    Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80mg Ixekizumab and placebo was given SC during blinded treatment period.
    Reporting group title
    Placebo/Ixekizumab 80mg Q4W - Open label treatment period
    Reporting group description
    Participants who received placebo in blinded treatment Period had received initial dose of 160mg Ixekizumab at week 12 followed by 80mg Ixekizumab Q4W by subcutaneous injection in open label treatment period. Participants had an option to step-up to Q2W dosing starting at week 24 through week 40.

    Reporting group title
    Ixekizumab 80mg Q2W/Ixekizumab 80mg Q4W - Open label treatment
    Reporting group description
    Participants who received Ixekizumab in blinded treatment Period had received initial dose of 80mg Ixekizumab & placebo at week 12 followed by 80mg Ixekizumab Q4W by subcutaneous injection in open label treatment period. Participants had an option to step-up to Q2W dosing starting at week 24 through week 40.
    Reporting group title
    Placebo - Post treatment follow-up
    Reporting group description
    Participants did not receive any study treatment during post treatment follow-up period.

    Reporting group title
    Ixekizumab 80mg Q4W - Post treatment follow-up period
    Reporting group description
    Participants did not receive any study treatment during post treatment follow-up period.

    Reporting group title
    Ixekizumab 80mg Q2W - Post treatment follow-up
    Reporting group description
    Participants did not receive any study treatment during post treatment follow-up period.

    Primary: Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1)

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    End point title
    Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1)
    End point description
    sPGA of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale) in genital area. For the analysis of responses, the participant's psoriasis was assessed as follows: 0 = clear,1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe. sPGA of Genitalia (0,1) : A sPGA of Genitalia assessed as either 0 or 1. APD:All randomized participants.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    Placebo - Blinded Treatment Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects analysed
    74
    75
    Units: participants
    6
    55
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo - Blinded Treatment v Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    33.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    12.39
         upper limit
    92.23

    Secondary: Number of Participants Achieving Overall sPGA (0,1)

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    End point title
    Number of Participants Achieving Overall sPGA (0,1)
    End point description
    The overall sPGA is the physician’s global assessment of the participant's psoriasis (Ps) lesions at a given time point. Plaques were assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity was given using the anchors of 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe. Overall sPGA (0,1) : An overall sPGA assessed as either 0 or 1. APD:All randomized participants.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo - Blinded Treatment Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects analysed
    74
    75
    Units: participants
    2
    55
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo - Blinded Treatment v Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    102.55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    22.79
         upper limit
    461.43

    Secondary: Number of Participants with at Least a 3 Point Improvement in Genital Psoriasis Itch Numeric Rating Scale (NRS) Item within the Genital Psoriasis Symptom Scale (GPSS)

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    End point title
    Number of Participants with at Least a 3 Point Improvement in Genital Psoriasis Itch Numeric Rating Scale (NRS) Item within the Genital Psoriasis Symptom Scale (GPSS)
    End point description
    GPSS is a participant-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent was asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an Numeric Rating Scale (NRS) of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, where 0 (= no severity) and 10 (worst imaginable severity). APD:All randomized participants with baseline GPSS Itch NRS Score >= 3.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo - Blinded Treatment Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects analysed
    60
    62
    Units: participants
    5
    37
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo - Blinded Treatment v Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    16.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    5.71
         upper limit
    46.4

    Secondary: Number of Participants Whose Frequency of Sexual Activity is Never or Rarely Limited by Genital Psoriasis, Utilizing the Genital Psoriasis Sexual Frequency Questionnaire (SFQ) Item 2

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    End point title
    Number of Participants Whose Frequency of Sexual Activity is Never or Rarely Limited by Genital Psoriasis, Utilizing the Genital Psoriasis Sexual Frequency Questionnaire (SFQ) Item 2
    End point description
    The SFQ is a participant reported outcome measure to evaluate the impact of genital psoriasis symptoms on sexual frequency. It consists of 2 items that assess the impact of genital psoriasis symptoms on the frequency of sexual activity. Respondents were asked to answer the questions based on their psoriasis symptoms in the genital area. Item 2 assesses how often genital psoriasis symptoms limited the frequency of sexual activity with the following response options: 0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always. *The SFQ is also referred to as the GenPs-SFQ (genital psoriasis sexual frequency questionnaire). APD:All randomized participants with baseline GenPs-SFQ Item 2 Score >= 2.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo - Blinded Treatment Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects analysed
    42
    37
    Units: participants
    9
    29
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo - Blinded Treatment v Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    13.57
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.57
         upper limit
    40.29

    Secondary: Number of Participants whose Frequency of Avoiding Sexual Activity is Either Never or Rarely Limited by Genital Psoriasis in the Sexual Activity Avoidance Subscale Score of the Genital Psoriasis Sexual Impact Scale (GPSIS)

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    End point title
    Number of Participants whose Frequency of Avoiding Sexual Activity is Either Never or Rarely Limited by Genital Psoriasis in the Sexual Activity Avoidance Subscale Score of the Genital Psoriasis Sexual Impact Scale (GPSIS)
    End point description
    GPSIS is a participant reported outcome measure to evaluate the impact of genital psoriasis symptoms on sexual activity. The GPSIS Sexual Activity Avoidance Subscale includes 2 items: Item 1 asks whether the participant has been sexually active in the past week. (No due to other reasons = 1, No due to genital Ps = 5) Item 2 asks how often the participant avoided sexual activity in the past week due to Genital Psoriasis. (Never = 1, rarely = 2, Sometimes = 3, Often = 4). APD:All randomized participants with baseline GPSIS sexual activity avoidance subscale score >= 3.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo - Blinded Treatment Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects analysed
    35
    30
    Units: participants
    9
    23
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo - Blinded Treatment v Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    9.84
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.08
         upper limit
    31.4

    Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score

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    End point title
    Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score
    End point description
    DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: 1) Symptoms and feelings 2) Daily activities 3) Leisure 4) Work and school 5) Personal relationships 6) Treatment. Response categories include: 0 = not at all; 1 = a little; 2 = a lot; 3 = very much; “not relevant” responses scored as “0” and total score range of 0 to 30; higher scores indicate poor quality of life. Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, baseline body surface area (BSA) category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects. APD:All randomized participants with baseline and post baseline observation for DLQI.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo - Blinded Treatment Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects analysed
    70
    74
    Units: units on a scale
        least squares mean (standard error)
    -1.4 ± 0.62
    -9.7 ± 0.59
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo - Blinded Treatment v Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -8.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.1
         upper limit
    -6.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.86

    Secondary: Change from Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score

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    End point title
    Change from Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score
    End point description
    mGPASI determines participants psoriasis severity in the genital region at a given time point yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. scoring index incorporates the degree of erythema (or redness), induration (or thickness), and scaling) of the genital plaques as well as erosion, fissure, and/or ulcer as a product of the genital area involved. LS Mean was calculated using MMRM model with treatment, baseline BSA category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects. APD:All randomized participants with baseline and post baseline observation for mGPASI.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo - Blinded Treatment Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects analysed
    73
    74
    Units: units on a scale
        least squares mean (standard error)
    -3.9 ± 1.56
    -23.9 ± 1.48
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo - Blinded Treatment v Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -20
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -24.3
         upper limit
    -15.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.15

    Secondary: Number of Participants with at least a 2-Point Change in Patient’s Global Assessment of Genital Psoriasis (PatGA-Genital)

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    End point title
    Number of Participants with at least a 2-Point Change in Patient’s Global Assessment of Genital Psoriasis (PatGA-Genital)
    End point description
    Patient’s Global Assessment of Genital Psoriasis (PatGA-Genital) is a participant-administered, single-item scale on which participants are asked to rank the severity of their genital psoriasis “today” by circling a number on a 0 to 5 NRS, as follows: from 0 (clear), no genital psoriasis; to 5 (severe). APD: All randomized participants with baseline PatGA-Genital score >= 2.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo - Blinded Treatment Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects analysed
    73
    72
    Units: participants
    11
    51
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo - Blinded Treatment v Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    13.95
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.12
         upper limit
    31.8

    Secondary: Change from Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)

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    End point title
    Change from Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
    End point description
    SF-36 is a participant-reported outcome measure evaluating a participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS Mean was calculated using ANCOVA model with treatment, baseline BSA category, & baseline value and mBOCF imputation method. All randomized participants with baseline and post baseline measurement for SF-36 PCS. mBOCF: Participants with or without post baseline measurement who discontinued treatment due to Adverse Event (AE) or death were imputed by their baseline observation , Participants who discontinued due to other reasons were imputed by their last observation.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo - Blinded Treatment Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects analysed
    71
    72
    Units: units on a scale
        least squares mean (standard error)
    0.687 ± 0.7998
    5.193 ± 0.7942
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo - Blinded Treatment v Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    4.506
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.264
         upper limit
    6.748
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.1339

    Secondary: Change from Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS)

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    End point title
    Change from Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS)
    End point description
    SF-36 is a participant-reported outcome measure evaluating a participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the MCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS Mean was calculated using ANCOVA model with treatment, baseline BSA category, & baseline value and modified baseline observation carried forward (mBOCF) imputation method. All randomized participants with baseline and post baseline measurement for SF-36 MCS. mBOCF: Participants with or without post baseline measurement who discontinued treatment due to AE or death were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo - Blinded Treatment Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects analysed
    71
    72
    Units: units on a scale
        least squares mean (standard error)
    2.186 ± 0.7333
    3.982 ± 0.7281
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo - Blinded Treatment v Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.085
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    1.797
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.253
         upper limit
    3.847
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.0367

    Secondary: Change from Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items

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    End point title
    Change from Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items
    End point description
    GPSS is a participant's-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent was asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an Numeric Rating Scale (NRS) of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, where 0 (no severity) and 10 (worst imaginable severity). total score ranges from 0 (no severity) - 80 (worst imaginable severity) LS Mean was calculated using MMRM model with treatment, baseline BSA category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects. APD:All randomized participants with baseline and post baseline observation for GPSS total or individual item scores.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo - Blinded Treatment Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects analysed
    66
    69
    Units: units on a scale
    least squares mean (standard error)
        Total Score
    -2.82 ± 2.190
    -31.57 ± 2.070
        Itch
    -0.21 ± 0.290
    -4.02 ± 0.274
        Pain
    -0.34 ± 0.294
    -3.84 ± 0.278
        Discomfort
    -0.42 ± 0.298
    -4.27 ± 0.282
        Stinging
    -0.51 ± 0.298
    -3.74 ± 0.281
        Burning
    -0.53 ± 0.289
    -3.73 ± 0.273
        Redness
    -0.63 ± 0.287
    -4.45 ± 0.272
        Scaling
    -0.02 ± 0.273
    -3.80 ± 0.259
        Cracking
    -0.19 ± 0.280
    -3.74 ± 0.264
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Total Score
    Comparison groups
    Ixekizumab 80mg Q2W - Blinded Treatment v Placebo - Blinded Treatment
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -28.75
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -34.72
         upper limit
    -22.78
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.015
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Itch
    Comparison groups
    Placebo - Blinded Treatment v Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.81
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.6
         upper limit
    -3.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.399
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    Pain
    Comparison groups
    Placebo - Blinded Treatment v Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.3
         upper limit
    -2.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.405
    Statistical analysis title
    Statistical Analysis 4
    Statistical analysis description
    Discomfort
    Comparison groups
    Placebo - Blinded Treatment v Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.85
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.66
         upper limit
    -3.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.41
    Statistical analysis title
    Statistical Analysis 5
    Statistical analysis description
    Stinging
    Comparison groups
    Placebo - Blinded Treatment v Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.23
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.04
         upper limit
    -2.42
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.41
    Statistical analysis title
    Statistical Analysis 6
    Statistical analysis description
    Burning
    Comparison groups
    Placebo - Blinded Treatment v Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.99
         upper limit
    -2.41
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.397
    Statistical analysis title
    Statistical Analysis 7
    Statistical analysis description
    Redness
    Comparison groups
    Placebo - Blinded Treatment v Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.81
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.59
         upper limit
    -3.03
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.395
    Statistical analysis title
    Statistical Analysis 8
    Statistical analysis description
    Scaling
    Comparison groups
    Placebo - Blinded Treatment v Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.78
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.53
         upper limit
    -3.03
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.377
    Statistical analysis title
    Statistical Analysis 9
    Statistical analysis description
    Cracking
    Comparison groups
    Placebo - Blinded Treatment v Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.31
         upper limit
    -2.79
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.385

    Secondary: Number of Participants achieving sPGA of Genitalia (0,1) at Week 12 by Treatment-Emergent Anti-Drug Antibody (TE-ADA) status and by Neutralizing Antibody (NAb) status

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    End point title
    Number of Participants achieving sPGA of Genitalia (0,1) at Week 12 by Treatment-Emergent Anti-Drug Antibody (TE-ADA) status and by Neutralizing Antibody (NAb) status
    End point description
    sPGA of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale). For the analysis of responses, the participant's psoriasis was assessed as follows: 0 = clear,1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe. sPGA of Genitalia (0,1) : A sPGA of Genitalia assessed as either 0 or 1. Analysis Population Description (APD): All randomized participants who received at least one dose of study drug and either had baseline and at least 1 post-baseline evaluable samples or had no evaluable baseline and all negative post-baseline anti-drug antibody negative samples.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo - Blinded Treatment Ixekizumab 80mg Q2W - Blinded Treatment
    Number of subjects analysed
    73 [1]
    75 [2]
    Units: participants
        TE-ADA positive
    0
    5
        TE-ADA negative
    6
    50
        NAb positive
    0
    0
        NAb negative
    0
    0
        NAb inconclusive
    0
    5
    Notes
    [1] - Subjects analyzed (N): 0,73,0,0,0,0;
    [2] - Subjects analyzed (N): 6,69,0,0,0,6;
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    I1F-MC-RHBQ
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group title
    Ixekizumab 80Q2W
    Reporting group description
    -

    Reporting group title
    Placebo/Ixekizumab 80Q4W
    Reporting group description
    -

    Reporting group title
    Ixekizumab 80Q2W/Ixekizumab 80Q4W
    Reporting group description
    -

    Reporting group title
    Placebo Post-Treatment Follow-up
    Reporting group description
    -

    Reporting group title
    Ixekizumab 80Q2W Post-Treatment Follow-up
    Reporting group description
    -

    Reporting group title
    Ixekizumab 80Q4W Post-Treatment Follow-up
    Reporting group description
    -

    Serious adverse events
    Placebo Ixekizumab 80Q2W Placebo/Ixekizumab 80Q4W Ixekizumab 80Q2W/Ixekizumab 80Q4W Placebo Post-Treatment Follow-up Ixekizumab 80Q2W Post-Treatment Follow-up Ixekizumab 80Q4W Post-Treatment Follow-up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 75 (0.00%)
    2 / 65 (3.08%)
    5 / 74 (6.76%)
    0 / 1 (0.00%)
    2 / 49 (4.08%)
    1 / 78 (1.28%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    extradural haematoma
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    1 / 65 (1.54%)
    0 / 74 (0.00%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    peripheral ischaemia
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    0 / 65 (0.00%)
    1 / 74 (1.35%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    benign prostatic hyperplasia
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed [1]
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    0 / 49 (0.00%)
    1 / 56 (1.79%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    colitis
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    0 / 65 (0.00%)
    1 / 74 (1.35%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pancreatitis acute
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 75 (0.00%)
    0 / 65 (0.00%)
    0 / 74 (0.00%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cholelithiasis
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    0 / 65 (0.00%)
    1 / 74 (1.35%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    depression
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    0 / 65 (0.00%)
    0 / 74 (0.00%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    suicide attempt
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    0 / 65 (0.00%)
    1 / 74 (1.35%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    ureterolithiasis
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    0 / 65 (0.00%)
    1 / 74 (1.35%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    appendicitis
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    0 / 65 (0.00%)
    0 / 74 (0.00%)
    0 / 1 (0.00%)
    1 / 49 (2.04%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    1 / 65 (1.54%)
    0 / 74 (0.00%)
    0 / 1 (0.00%)
    1 / 49 (2.04%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    escherichia bacteraemia
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    0 / 65 (0.00%)
    1 / 74 (1.35%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sepsis
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    0 / 65 (0.00%)
    1 / 74 (1.35%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender based adverse event; Analyzed in female subjects.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Ixekizumab 80Q2W Placebo/Ixekizumab 80Q4W Ixekizumab 80Q2W/Ixekizumab 80Q4W Placebo Post-Treatment Follow-up Ixekizumab 80Q2W Post-Treatment Follow-up Ixekizumab 80Q4W Post-Treatment Follow-up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 74 (25.68%)
    21 / 75 (28.00%)
    28 / 65 (43.08%)
    27 / 74 (36.49%)
    0 / 1 (0.00%)
    1 / 49 (2.04%)
    0 / 78 (0.00%)
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    4 / 74 (5.41%)
    3 / 75 (4.00%)
    2 / 65 (3.08%)
    6 / 74 (8.11%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    6
    3
    2
    6
    0
    0
    0
    General disorders and administration site conditions
    injection site reaction
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 74 (0.00%)
    5 / 75 (6.67%)
    10 / 65 (15.38%)
    3 / 74 (4.05%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    7
    24
    6
    0
    0
    0
    Gastrointestinal disorders
    diarrhoea
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    4 / 74 (5.41%)
    1 / 75 (1.33%)
    0 / 65 (0.00%)
    0 / 74 (0.00%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    4
    2
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    dysmenorrhoea
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed [2]
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    vaginal haemorrhage
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed [3]
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    vulvovaginal discomfort
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed [4]
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    0 / 65 (0.00%)
    0 / 74 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    psoriasis
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    4 / 74 (5.41%)
    1 / 75 (1.33%)
    0 / 65 (0.00%)
    0 / 74 (0.00%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    4
    1
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    0 / 65 (0.00%)
    5 / 74 (6.76%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    5
    0
    0
    0
    Infections and infestations
    bacterial vaginosis
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed [5]
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    nasopharyngitis
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    4 / 74 (5.41%)
    2 / 75 (2.67%)
    9 / 65 (13.85%)
    7 / 74 (9.46%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    4
    2
    13
    8
    0
    0
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    5 / 74 (6.76%)
    12 / 75 (16.00%)
    10 / 65 (15.38%)
    6 / 74 (8.11%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    5
    12
    12
    6
    0
    0
    0
    urinary tract infection
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    2 / 65 (3.08%)
    4 / 74 (5.41%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    2
    4
    0
    0
    0
    vulvovaginal candidiasis
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed [6]
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    1 / 16 (6.25%)
    0 / 18 (0.00%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    vulvovaginal mycotic infection
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed [7]
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    0 / 16 (0.00%)
    1 / 18 (5.56%)
    0 / 1 (0.00%)
    0 / 49 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Notes
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender based adverse event; Analyzed in female subjects.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender based adverse event; Analyzed in female subjects.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender based adverse event; Analyzed in female subjects.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender based adverse event; Analyzed in female subjects.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender based adverse event; Analyzed in female subjects.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender based adverse event; Analyzed in female subjects.

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jan 2016
    Columbia–Suicide Severity Rating Scale definition was added.
    22 Nov 2016
    SFQ Item 2 was added into the “Major Secondary Endpoint. GPSS Individual items modified to include itch. Addition of sentence “For patients who have entered Period 4, psoriasis therapy is allowed, as determined appropriate by the investigator.” in post treatment follow-up phase. Genital Psoriasis Symptoms Scale, text to define the GPSS total and item scores at Week 12 (Visit 7) was added. Genital Psoriasis Sexual Impact Scale, the Sexual Activity Avoidance Subscale scoring of the GPSIS was updated. Sexual Frequency Questionnaire, text was added to define SFQ Item 2 score at Week 12. Adverse Events of Special interest, text was added to include inflammatory bowel disease (IBD).

    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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