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    Clinical Trial Results:
    A 52-Week Multicenter, Randomized, Blinded,Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis.

    Summary
    EudraCT number
    		 2015-000892-28
    Trial protocol
    		 DE   GB   SE   HU   NL   ES   AT   BE   PL   IT  
    Global end of trial date
    05 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Oct 2018
    First version publication date
    14 Oct 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    I1F-MC-RHBS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02561806
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 16012
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, United States, 46285
    Public contact
    1-877-CTLILLY (1-877-285-4559) or, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, 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
    05 Oct 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Oct 2017
    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 of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque 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
    06 Oct 2015
    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
    Hungary: 23
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Switzerland: 11
    Country: Number of subjects enrolled
    Spain: 25
    Country: Number of subjects enrolled
    Canada: 52
    Country: Number of subjects enrolled
    Austria: 12
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Sweden: 6
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Poland: 38
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    France: 48
    Country: Number of subjects enrolled
    Germany: 66
    Worldwide total number of subjects
    302
    EEA total number of subjects
    239
    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)
    286
    From 65 to 84 years
    16
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Induction period occurring from week 0 to week 12 followed by maintenance period occurring week 12 to week 52 followed by post-treatment follow-up period occurring from last treatment period visit (week 52) or Early termination visit, for a minimum of 12 weeks following that visit.

    Pre-assignment
    Screening details
    		 Screening occurred approximately 4 to 35 days before induction period, Screening procedures (including complete medical history and demographics) were performed.

    Period 1
    Period 1 title
    Induction 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
    		 Ustekinumab
    Arm description
    		 45 milligram (mg) ustekinumab given as subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Stelara
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    45 milligram (mg) Ustekinumab given as subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo administered subcutaneously.

    Arm title
    		 Ixekizumab
    Arm description
    		 160 mg ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ixekizumab
    Investigational medicinal product code
    Other name
    LY2439821
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    160 mg Ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg Ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg Ixekizumab every 4 weeks through week 52.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo administered subcutaneously.

    Number of subjects in period 1
    		Ustekinumab Ixekizumab
    Started
    166
    136
    Received At least one dose of study drug
    166
    135
    Completed
    164
    131
    Not completed
    2
    5
         Consent withdrawn by subject
    -
    2
         Adverse event, non-fatal
    -
    2
         Randomized but not treated
    -
    1
         Site staff became unblinded
    1
    -
         Lack of efficacy
    1
    -
    Period 2
    Period 2 title
    Maintenance 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
    		 Ustekinumab
    Arm description
    		 45 milligram (mg) ustekinumab given as subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Stelara
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    45 milligram (mg) Ustekinumab given as subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo administered subcutaneously.

    Arm title
    		 Ixekizumab
    Arm description
    		 160 mg ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ixekizumab
    Investigational medicinal product code
    Other name
    LY2439821
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    160 mg Ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg Ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg Ixekizumab every 4 weeks through week 52.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo administered subcutaneously.

    Number of subjects in period 2
    		Ustekinumab Ixekizumab
    Started
    164
    131
    Completed
    151
    123
    Not completed
    13
    8
         Consent withdrawn by subject
    5
    3
         Adverse event, non-fatal
    2
    1
         Site staff became unblinded
    -
    1
         Lost to follow-up
    2
    2
         Lack of efficacy
    3
    1
         Protocol deviation
    1
    -
    Period 3
    Period 3 title
    Post-Treatment Follow-up
    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
    		 Ustekinumab
    Arm description
    		 Participants were allowed to continue the treatment administered during the blinded period or any other psoriasis treatment.
    Arm type
    		 Allowed to continue any other psoriasis treatment

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Ixekizumab
    Arm description
    		 Participants were allowed to continue the treatment administered during the blinded period or any other psoriasis treatment.
    Arm type
    		 Allowed to continue any other psoriasis treatment

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3 [1]
    		Ustekinumab Ixekizumab
    Started
    157
    60
    Completed
    155
    59
    Not completed
    2
    1
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    1
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Participants who discontinued previous periods had option to enter post treatment follow-up period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ustekinumab
    Reporting group description
    		 45 milligram (mg) ustekinumab given as subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.

    Reporting group title
    Ixekizumab
    Reporting group description
    		 160 mg ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.

    Reporting group values
    		 Ustekinumab Ixekizumab Total
    Number of subjects
    		 166 136 302
    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 ± 13.25 42.7 ± 12.67 -
    Gender categorical
    Units: Subjects
        Female
    		 54 46 100
        Male
    		 112 90 202
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 5 4 9
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 1 3 4
        White
    		 157 125 282
        More than one race
    		 1 2 3
        Unknown or Not Reported
    		 2 2 4
    Region of Enrollment
    Units: Subjects
        Hungary
    		 12 11 23
        United Kingdom
    		 4 2 6
        Switzerland
    		 6 5 11
        Spain
    		 13 12 25
        Canada
    		 27 25 52
        Austria
    		 6 6 12
        Netherlands
    		 0 1 1
        Sweden
    		 4 2 6
        Belgium
    		 4 2 6
        Poland
    		 21 17 38
        Italy
    		 4 4 8
        France
    		 25 23 48
        Germany
    		 40 26 66
    Age group at psoriasis onset
    Units: Subjects
        <40 years (Type 1 psoriasis)
    		 134 113 247
        >=40 years (Type 2 psoriasis)
    		 32 23 55
    Weight
    Units: Kilogram
        arithmetic mean (standard deviation)
    		 89.4 ± 24.5 85.8 ± 20.30 -
    BMI
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 29.7 ± 6.97 28.8 ± 5.55 -
    Duration of psoriasis
    Units: years
        arithmetic mean (standard deviation)
    		 18.2 ± 12.0 18.0 ± 11.14 -
    Psoriasis Area & Severity Index (PASI)
    PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, & legs). For each region the % area of skin involved was estimated from 0(0%) to 6(90%-100%) & severity was estimated by clinical signs of erythema, induration & scaling with scores range from 0 to 4 ("no" to "severe" involvement). Each area is scored & scores were combined for final PASI (sum of severity parameters for each region * area score * weighing factor [head(0.1), upper limbs(0.2), trunk(0.3), lower limbs(0.4)]. Overall scores range from 0 (no Ps) to 72 (most severe disease).
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 19.8 ± 9.02 19.9 ± 8.15 -

    End points

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    End points reporting groups
    Reporting group title
    Ustekinumab
    Reporting group description
    		 45 milligram (mg) ustekinumab given as subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.

    Reporting group title
    Ixekizumab
    Reporting group description
    		 160 mg ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
    Reporting group title
    Ustekinumab
    Reporting group description
    		 45 milligram (mg) ustekinumab given as subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.

    Reporting group title
    Ixekizumab
    Reporting group description
    		 160 mg ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
    Reporting group title
    Ustekinumab
    Reporting group description
    		 Participants were allowed to continue the treatment administered during the blinded period or any other psoriasis treatment.

    Reporting group title
    Ixekizumab
    Reporting group description
    		 Participants were allowed to continue the treatment administered during the blinded period or any other psoriasis treatment.

    Primary: Percentage of Participants with a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) from Baseline

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    End point title
    		 Percentage of Participants with a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) from Baseline
    End point description
    The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Analysis Population Description: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for PASI 90. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    166
    136
    Units: percentage of participants
        number (not applicable)
    42.2
    72.8
    Statistical analysis title
    		 STATISTICAL ANALYSIS 1
    Comparison groups
    Ustekinumab v Ixekizumab
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.321
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.198
         upper limit
    		 0.445
    Notes
    [1] - Non-inferiority margin was -12.6% for 97.5% confidence interval

    Secondary: Percentage of Participants with a ≥75% Improvement in PASI (PASI 75) from Baseline

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    End point title
    		 Percentage of Participants with a ≥75% Improvement in PASI (PASI 75) from Baseline
    End point description
    The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Analysis Population Description: All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for PASI 75. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    166
    136
    Units: percentage of participants
        number (not applicable)
    68.7
    88.2
    Statistical analysis title
    		 STATISTICAL ANALYSIS 1
    Comparison groups
    Ustekinumab v Ixekizumab
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.285
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.13
         upper limit
    		 1.439

    Secondary: Percentage of Participants with a 100% Improvement of PASI (PASI 100) from Baseline

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    End point title
    		 Percentage of Participants with a 100% Improvement of PASI (PASI 100) from Baseline
    End point description
    The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Analysis Population Description: All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for PASI 100. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    166
    136
    Units: percentage of participants
        number (not applicable)
    14.5
    36
    Statistical analysis title
    		 STATISTICAL ANALYSIS 1
    Comparison groups
    Ustekinumab v Ixekizumab
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.009
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    2.699
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.423
         upper limit
    		 3.975

    Secondary: Percentage of Participants with a Static Physician Global Assessment (sPGA) (0,1) with at Least a 2-Point Improvement from Baseline

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    End point title
    		 Percentage of Participants with a Static Physician Global Assessment (sPGA) (0,1) with at Least a 2-Point Improvement from Baseline
    End point description
    The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Analysis Population Description: All randomized participants with baseline sPGA >=3 & received at least 1 dose of study drug and had a post-baseline measurement for sPGA. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    166
    134
    Units: percentage of participants
        number (not applicable)
    57.2
    83.6
    Statistical analysis title
    		 STATISTICAL ANALYSIS 1
    Comparison groups
    Ustekinumab v Ixekizumab
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.469
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.244
         upper limit
    		 1.695

    Secondary: Percentage of Participants with a sPGA (0) Remission

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    End point title
    		 Percentage of Participants with a sPGA (0) Remission
    End point description
    The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA assessed as 0, indicates complete resolution of plaque Ps. Analysis Population Description: All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for sPGA (0). Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    166
    136
    Units: percentage of participants
        number (not applicable)
    18.1
    41.9
    Statistical analysis title
    		 STATISTICAL ANALYSIS 1
    Comparison groups
    Ustekinumab v Ixekizumab
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.021
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    3.421
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.353
         upper limit
    		 5.488

    Secondary: Change from Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis

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    End point title
    		 Change from Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis
    End point description
    The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb. ANCOVA model with modified baseline observation carried forward (mBOCF) was used to produce Least Square (LS) mean with baseline, treatment group, region weight group as fixed effects. All randomized participants who received at least 1 dose of study drug & had a baseline & post-baseline measurement for BSA affected by Ps. mBOCF: Participants who discontinued treatment due to Adverse Event (AE) 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
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    164
    135
    Units: Percent Body Surface Affected
        least squares mean (confidence interval 95%)
    -16.92 (-18.50 to -15.34)
    -22.55 (-24.34 to -20.76)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score

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    End point title
    		 Change from Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score
    End point description
    The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no Ps) to 72. (the most severe disease) The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. Analysis Population Description: All randomized participants who had psoriasis in palmoplantar regions at baseline & received at least 1 dose of study drug & had baseline & post-baseline PPASI data. mBOCF: Participants who discontinued treatment due to AE 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
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    28
    35
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -8.34 (-9.64 to -7.03)
    -10.31 (-11.63 to -8.99)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score

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    End point title
    		 Change from Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score
    End point description
    The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered. The composite score is derived from the sum of scores for erythema, induration, and desquamation with a scores range from 0 (none) to 4 (very severe) multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. Analysis Population Description: All randomized participants who had psoriasis in scalp region at baseline & received at least 1 dose of study drug & had baseline & post-baseline PSSI data. mBOCF: Participants who discontinued treatment due to AE 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
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    152
    119
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -16.00 (-17.24 to -14.77)
    -19.29 (-20.67 to -17.92)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score

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    End point title
    		 Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score
    End point description
    NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail(fn) Ps. This scale is used to evaluate severity of fn bed Ps & fn matrix Ps by area of involvement in the fn unit. fn is divided with imaginary horizontal & longitudinal lines into quadrants. Each fn is given a score for fn bed Ps 0(none) to 4(Ps in 4 quadrants of the fn) & fn matrix Ps 0(none) to 4(Ps in 4 quadrants in matrix), depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed or matrix Ps in each quadrant.NAPSI score of a fn is sum of scores in fn bed & fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from range 0 to 80. Higher scores indicate more severe ps. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 Analysis Population Description: All randomized participants who had nail psoriasis at baseline & received at least 1 dose of study drug and had baseline & post-baseline NAPSI measurement.
    End point values
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    103
    84
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -5.02 (-7.19 to -2.84)
    -12.24 (-14.72 to -9.77)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Itch Numeric Rating Scale (NRS)

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    End point title
    		 Change from Baseline in Itch Numeric Rating Scale (NRS)
    End point description
    The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. Analysis Population Description: All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for Itch NRS. mBOCF: Participants who discontinued treatment due to AE 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
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    165
    135
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -4.12 (-4.51 to -3.74)
    -4.56 (-4.98 to -4.14)
    No statistical analyses for this end point

    Secondary: Change from Baseline on the Skin Pain Visual Analog Scale (VAS) (0,100)

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    End point title
    		 Change from Baseline on the Skin Pain Visual Analog Scale (VAS) (0,100)
    End point description
    Skin Pain VAS is a participant administered scale designed to measure skin pain from psoriasis using a 100-millimeter (mm) horizontal VAS. Overall severity of a participant's skin pain from psoriasis at the present time is indicated by placing a single mark on the horizontal scale (0 = no skin pain; 100 = severe skin pain). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. Analysis Population Description: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for skin pain VAS. mBOCF: Participants who discontinued treatment due to AE 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
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    165
    135
    Units: mm
        least squares mean (confidence interval 95%)
    -29.92 (-32.81 to -27.04)
    -33.32 (-36.44 to -30.20)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Dermatology Life Quality Index (DLQI) (0,1)

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    End point title
    		 Percentage of Participants with Dermatology Life Quality Index (DLQI) (0,1)
    End point description
    The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment). A score of 0 or 1 indicates no impact of disease on a participants quality of life. Analysis Population Description: All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for DLQI. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    166
    136
    Units: percentage of participants
        number (not applicable)
    44.6
    61.0
    Statistical analysis title
    		 STATISTICA ANALYSIS 1
    Comparison groups
    Ustekinumab v Ixekizumab
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.012
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.391
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.085
         upper limit
    		 1.698

    Secondary: Change from Baseline on the Hospital Anxiety and Depression Scale (HADS) Depression Subscale

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    End point title
    		 Change from Baseline on the Hospital Anxiety and Depression Scale (HADS) Depression Subscale
    End point description
    The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 items questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. Analysis Population Description: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for HADS depression subscale. mBOCF: Participants who discontinued treatment due to AE 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
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    162
    134
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -0.96 (-1.38 to -0.54)
    -1.20 (-1.65 to -0.74)
    No statistical analyses for this end point

    Secondary: Change from Baseline on the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale.

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    End point title
    		 Change from Baseline on the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale.
    End point description
    The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 items questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. Analysis Population Description: All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for HADS anxiety subscale. mBOCF: Participants who discontinued treatment due to AE 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
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    162
    134
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -0.90 (-1.37 to -0.43)
    -1.27 (-1.80 to -0.73)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score;

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    End point title
    		 Change from Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score;
    End point description
    The SF-36 is a participant-reported outcome measure evaluating 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. SF-36 acute version was used, which has a 1 week recall period. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. Analysis Population Description: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for SF-36 PCS score. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    164
    133
    Units: units on a scale
        least squares mean (confidence interval 95%)
    3.10 (1.97 to 4.23)
    5.03 (3.80 to 6.26)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Score

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    End point title
    		 Change from Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Score
    End point description
    The SF-36 is a participant-reported outcome measure evaluating 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. SF-36 acute version was used, which has a 1 week recall period. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. Analysis Population Description: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for SF36 MCS score.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    164
    133
    Units: units on a scale
        least squares mean (confidence interval 95%)
    2.36 (0.87 to 3.86)
    2.96 (1.33 to 4.59)
    No statistical analyses for this end point

    Secondary: Change from Baseline on Patient Global Assessment of Disease Severity (PatGA)

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    End point title
    		 Change from Baseline on Patient Global Assessment of Disease Severity (PatGA)
    End point description
    The Patient Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. Analysis Population Description: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for PatGA. mBOCF: Participants who discontinued treatment due to AE 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
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    164
    135
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -2.60 (-2.78 to -2.42)
    -3.07 (-3.26 to -2.88)
    No statistical analyses for this end point

    Secondary: Change from Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) "Bolt On" Psoriasis (PSO) -Index

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    End point title
    		 Change from Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) "Bolt On" Psoriasis (PSO) -Index
    End point description
    The European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of a descriptive system of the respondent's health which comprises the following 5 dimensions: 1) mobility 2) self-care 3) usual activities 4) pain/discomfort 5) anxiety/depression. The Bolt On PSO is an addition to the EQ-5D-5L that consists of 2 dimensions specific to psoriatic disease: 6) skin irritation (itching) and 7) self-confidence. Index scores for the Bolt On PSO range from 0.0042 to 1.0 (worse to better health). ANCOVA model was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. Analysis Population Description: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for EQ-5D 5L "Bolt On" PSO-Index.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    165
    134
    Units: units on a scale
        least squares mean (confidence interval 95%)
    0.11 (0.09 to 0.13)
    0.15 (0.13 to 0.17)
    No statistical analyses for this end point

    Secondary: Change from Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) VAS

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    End point title
    		 Change from Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) VAS
    End point description
    The EQ-5D 5L is a standardized measure of health status that includes a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (worst health imaginable)- to 100 (best health imaginable)-millimeter (mm) Visual Analog Scale (VAS). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. Analysis population Description: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for EQ-5D 5L VAS. mBOCF: Participants who discontinued treatment due to AE 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
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    163
    134
    Units: mm
        least squares mean (confidence interval 95%)
    8.75 (5.77 to 11.74)
    12.24 (9.01 to 15.46)
    No statistical analyses for this end point

    Secondary: Change from Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) United Kingdom(UK) population-based index score

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    End point title
    		 Change from Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) United Kingdom(UK) population-based index score
    End point description
    The EQ-5D-5L descriptive system comprises 5 dimensions, each with 5 levels. The EQ-5D-5L health states were converted into a single summary index by applying a crosswalk using a UK Population value set to each of the levels in each dimension. This produced patient-level index scores between -0.594 and 1.0 (worse to better health). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. Analysis Population Description: All randomized participants who received at least 1 dose of study drug & had baseline & post-baseline EQ-5D 5L UK population-based index score measurement. mBOCF: Participants who discontinued treatment due to AE 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
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    165
    134
    Units: units on a scale
        least squares mean (confidence interval 95%)
    0.12 (0.09 to 0.15)
    0.15 (0.12 to 0.18)
    No statistical analyses for this end point

    Secondary: Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) absenteeism

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    End point title
    		 Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) absenteeism
    End point description
    The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO absenteeism score is derived from these questions. Each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. Analysis Population Description: All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for WPAI-PSO absenteeism score.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    90
    87
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -1.42 (-4.55 to 1.72)
    -0.46 (-3.51 to 2.60)
    No statistical analyses for this end point

    Secondary: Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) presenteeism

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    End point title
    		 Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) presenteeism
    End point description
    The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO Presenteeism score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. Analysis Population Description: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for WPAI-PSO presenteeism score.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    98
    92
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -15.53 (-18.33 to -12.72)
    -16.91 (-19.71 to -14.11)
    No statistical analyses for this end point

    Secondary: Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) work impairment score.

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    End point title
    		 Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) work impairment score.
    End point description
    The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO work impairment score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. Analysis Population Description: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for WPAI-PSO work impairment score.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    90
    87
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -15.05 (-19.25 to -10.85)
    -16.27 (-20.39 to -12.16)
    No statistical analyses for this end point

    Secondary: Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) impairment in activities performed outside of work

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    End point title
    		 Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) impairment in activities performed outside of work
    End point description
    The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO impairment in activities performed outside of work score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects. Analysis Population Description: All randomized participants who received at least 1 dose of study drug & had baseline & post-baseline data for WPAI-PSO impairment in activities performed outside work.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Ustekinumab Ixekizumab
    Number of subjects analysed
    154
    127
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -19.14 (-21.79 to -16.48)
    -23.06 (-26.04 to -20.09)
    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
    All randomized participants.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Ustekinumab - Induction period
    Reporting group description
    		 45 milligram (mg) Ustekinumab given as subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg. Placebo for Ixekizumab injection was used for blinding.

    Reporting group title
    Ixekizumab - Induction period
    Reporting group description
    		 160 mg Ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg Ixekizumab given as a single SC injection once every 2 weeks. Placebo for Ustekinumab injection was used for blinding.

    Reporting group title
    Ustekinumab - Maintenance period
    Reporting group description
    		 45 milligram (mg) Ustekinumab given as Subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants >100 kg. Placebo for Ixekizumab injection was used for blinding.

    Reporting group title
    Ixekizumab - Maintenance period
    Reporting group description
    		 80 mg Ixekizumab given as a single SC injection once every 4 weeks. Placebo for Ustekinumab injection was used for blinding.

    Reporting group title
    Ixekizumab/Ustekinumab - Post Treatment Follow-up
    Reporting group description
    		 Participants were allowed to continue the treatment administered during the blinded period or any other psoriasis treatment.

    Serious adverse events
    		 Ustekinumab - Induction period Ixekizumab - Induction period Ustekinumab - Maintenance period Ixekizumab - Maintenance period Ixekizumab/Ustekinumab - Post Treatment Follow-up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 166 (0.00%)
    2 / 135 (1.48%)
    6 / 164 (3.66%)
    7 / 131 (5.34%)
    2 / 217 (0.92%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    ankle fracture
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 135 (0.00%)
    1 / 164 (0.61%)
    0 / 131 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    angina unstable
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 135 (0.74%)
    0 / 164 (0.00%)
    0 / 131 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    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
    myocardial infarction
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 135 (0.00%)
    1 / 164 (0.61%)
    0 / 131 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    rectal haemorrhage
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 135 (0.00%)
    0 / 164 (0.00%)
    1 / 131 (0.76%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    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
    Hepatobiliary disorders
    cholecystitis acute
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 135 (0.00%)
    1 / 164 (0.61%)
    0 / 131 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cholelithiasis
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 135 (0.00%)
    1 / 164 (0.61%)
    1 / 131 (0.76%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 135 (0.00%)
    1 / 164 (0.61%)
    0 / 131 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    eczema
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 135 (0.00%)
    0 / 164 (0.00%)
    1 / 131 (0.76%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    depression
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 135 (0.00%)
    0 / 164 (0.00%)
    1 / 131 (0.76%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    arthritis
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 135 (0.00%)
    0 / 164 (0.00%)
    1 / 131 (0.76%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    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
    pseudarthrosis
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 135 (0.00%)
    0 / 164 (0.00%)
    1 / 131 (0.76%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    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
    psoriatic arthropathy
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 135 (0.00%)
    0 / 164 (0.00%)
    0 / 131 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    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
    rotator cuff syndrome
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 135 (0.00%)
    0 / 164 (0.00%)
    1 / 131 (0.76%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    erysipelas
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 135 (0.00%)
    0 / 164 (0.00%)
    0 / 131 (0.00%)
    1 / 217 (0.46%)
         occurrences causally related to treatment / all
    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
    gastroenteritis bacterial
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 135 (0.74%)
    0 / 164 (0.00%)
    0 / 131 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    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
    Metabolism and nutrition disorders
    obesity
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 135 (0.00%)
    1 / 164 (0.61%)
    0 / 131 (0.00%)
    0 / 217 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ustekinumab - Induction period Ixekizumab - Induction period Ustekinumab - Maintenance period Ixekizumab - Maintenance period Ixekizumab/Ustekinumab - Post Treatment Follow-up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    55 / 166 (33.13%)
    40 / 135 (29.63%)
    65 / 164 (39.63%)
    50 / 131 (38.17%)
    0 / 217 (0.00%)
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    4 / 166 (2.41%)
    2 / 135 (1.48%)
    11 / 164 (6.71%)
    4 / 131 (3.05%)
    0 / 217 (0.00%)
         occurrences all number
    4
    2
    11
    5
    0
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    12 / 166 (7.23%)
    7 / 135 (5.19%)
    12 / 164 (7.32%)
    10 / 131 (7.63%)
    0 / 217 (0.00%)
         occurrences all number
    17
    9
    19
    17
    0
    General disorders and administration site conditions
    injection site erythema
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    0 / 166 (0.00%)
    10 / 135 (7.41%)
    0 / 164 (0.00%)
    2 / 131 (1.53%)
    0 / 217 (0.00%)
         occurrences all number
    0
    15
    0
    4
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    8 / 166 (4.82%)
    3 / 135 (2.22%)
    11 / 164 (6.71%)
    8 / 131 (6.11%)
    0 / 217 (0.00%)
         occurrences all number
    8
    3
    16
    8
    0
    back pain
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    4 / 166 (2.41%)
    2 / 135 (1.48%)
    9 / 164 (5.49%)
    5 / 131 (3.82%)
    0 / 217 (0.00%)
         occurrences all number
    5
    2
    11
    5
    0
    Infections and infestations
    nasopharyngitis
    alternative dictionary used: MedDRA 19.1
         subjects affected / exposed
    34 / 166 (20.48%)
    23 / 135 (17.04%)
    40 / 164 (24.39%)
    36 / 131 (27.48%)
    0 / 217 (0.00%)
         occurrences all number
    39
    27
    52
    47
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Feb 2016
    Reworded the note on one of the exclusion criterion. Modified one of the exclusion criterion. Clarified the unblinding process. Clarified key secondary analysis for sPGA. Corrected the Study Schedule. Clarification of the testing parameters of the hepatitis B monitoring. Recalculated blood volumes to remove retest sample collections. immunogenicity blood sample collection was added.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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