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    Clinical Trial Results:
    A Phase 3 Multicenter, Randomized, Double-blind, Placebocontrolled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2009-014368-20
    Trial protocol
    		 DE   NL   SE   PT   FR   BE   HU   GB   Outside EU/EEA  
    Global end of trial date
    03 Jan 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    15 Jul 2016
    First version publication date
    13 Aug 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO1275PSO3006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01090427
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International N.V.
    Sponsor organisation address
    Archimedesweg 29, Leiden, Netherlands, 2333 CM
    Public contact
    Clinical Registry Group, Janssen-Cilag International N.V., clinicaltrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International N.V., clinicaltrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000311-PIP01-08
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Jan 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study was to evaluate the efficacy and safety of 2 Subcutaneous (SC) dosing tiers of ustekinumab in the treatment of adolescent patients greater than equal to (≥) 12 to less than (<) 18 years of age with moderate to severe chronic plaque psoriasis.
    Protection of trial subjects
    Safety evaluation in this study included the assessment of adverse events (AEs), vital signs, routine laboratories, C-Reactive Protein (CRP) and cholesterol.
    Background therapy
    		 None
    Evidence for comparator
    		 Placebo
    Actual start date of recruitment
    30 Mar 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 11
    Country: Number of subjects enrolled
    Canada: 41
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Hungary: 7
    Country: Number of subjects enrolled
    Portugal: 8
    Country: Number of subjects enrolled
    Russian Federation: 19
    Country: Number of subjects enrolled
    Sweden: 3
    Country: Number of subjects enrolled
    Ukraine: 8
    Worldwide total number of subjects
    110
    EEA total number of subjects
    42
    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)
    110
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 110 participants from 10 countries were randomized and treated in this study.

    Pre-assignment
    Screening details
    		 A total of 110 participants were randomized into three groups, i.e 37 participants to placebo, 37 participants to ustekinumab half-standard dosage and 36 participants to ustekinumab standard dosage.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo - Controlled Period (CP)
    Arm description
    		 Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4.

    Arm title
    		 Ustekinumab Half-Standard Dosage Controlled period (CP)
    Arm description
    		 Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 milligram per kilogram (mg/kg) for participants with weight less than equal to (<=) 60 kilogram (kg), 22.5 milligram (mg) for participants with weight greater than (>) 60 to less than equal to (<=) 100 kg, and 45 mg for participants with weight greater than (>) 100 kg at Week 0 and Week 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 milligram per kilogram (mg/kg) for participants with weight less than equal to (<=) 60 kilogram (kg), 22.5 milligram (mg) for participants with weight greater than (>) 60 to less than equal to (<=) 100 kg, and 45 mg for participants with weight greater than (>) 100 kg at Week 0 and Week 4.

    Arm title
    		 Ustekinumab Standard Dosage Controlled Period (CP)
    Arm description
    		 Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 milligram per kilogram (mg/kg) for participants with weight less than equal to (<=) 60 kilogram (kg), 45 milligram (mg) for participants with weight greater than (>) 60 to less than equal to (<=) 100 kg, and 90 mg for participants with weight > 100 kg at Week 0 and Week 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 milligram per kilogram (mg/kg) for participants with weight less than equal to (<=) 60 kilogram (kg), 45 milligram (mg) for participants with weight greater than (>) 60 to 100kg, and 90 mg for participants with weight > 100 kg at Week 0 and Week 4.

    Number of subjects in period 1
    		Placebo - Controlled Period (CP) Ustekinumab Half-Standard Dosage Controlled period (CP) Ustekinumab Standard Dosage Controlled Period (CP)
    Started
    37
    37
    36
    Completed
    37
    37
    36
    Period 2
    Period 2 title
    After Controlled Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo -> Ustekinumab Half-Standard Dosage (after CP)
    Arm description
    		 After Controlled period (Week 12-60) - patients receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then every 12 week with the last dose at Week 40.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received ustekinumab subcutaneous (SC) injections [0.375 milligram per kilogram (mg/kg), 22.5 milligram (mg), or 45 mg based on body weight] at Weeks 12, 16, 28, and 40.

    Arm title
    		 Placebo -> Ustekinumab Standard Dosage (after CP)
    Arm description
    		 After Controlled period (Week 12-60) - patients receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received ustekinumab [0.75 milligram per kilogram (mg/kg), 45 mg, or 90 mg based on body weight] subcutaneous (SC) injections at Weeks 12, 16, 28, and 40.

    Arm title
    		 Ustekinumab Half-Standard Dosage (after CP)
    Arm description
    		 After Controlled period (Week 12-60) - patients receiving Ustekinumab Half-Standard Dosage at Weeks 16, 28 and every 12 weeks with the last dose at Week 40.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received ustekinumab subcutaneous (SC) injections [0.375 milligram per kilogram (mg/kg), 22.5 milligram (mg), or 45 mg based on body weight] at Weeks 16, 28, and 40.

    Arm title
    		 Ustekinumab Standard Dosage (after CP)
    Arm description
    		 After Controlled period (Week 12-60) - patients receiving Ustekinumab Standard Dosage at Weeks 16, 28 and every 12 weeks with last dose at Week 40.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received ustekinumab [0.75 milligram per kilogram (mg/kg), 45 milligram (mg), or 90 mg based on body weight] subcutaneous (SC) injections at Weeks 16, 28, and 40.

    Number of subjects in period 2
    		Placebo -> Ustekinumab Half-Standard Dosage (after CP) Placebo -> Ustekinumab Standard Dosage (after CP) Ustekinumab Half-Standard Dosage (after CP) Ustekinumab Standard Dosage (after CP)
    Started
    19
    18
    37
    36
    Completed
    17
    18
    32
    34
    Not completed
    2
    0
    5
    2
         Adverse event, serious fatal
    -
    -
    1
    -
         Adverse event, non-fatal
    2
    -
    1
    -
         Lack of efficacy
    -
    -
    3
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo - Controlled Period (CP)
    Reporting group description
    		 Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.

    Reporting group title
    Ustekinumab Half-Standard Dosage Controlled period (CP)
    Reporting group description
    		 Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 milligram per kilogram (mg/kg) for participants with weight less than equal to (<=) 60 kilogram (kg), 22.5 milligram (mg) for participants with weight greater than (>) 60 to less than equal to (<=) 100 kg, and 45 mg for participants with weight greater than (>) 100 kg at Week 0 and Week 4.

    Reporting group title
    Ustekinumab Standard Dosage Controlled Period (CP)
    Reporting group description
    		 Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 milligram per kilogram (mg/kg) for participants with weight less than equal to (<=) 60 kilogram (kg), 45 milligram (mg) for participants with weight greater than (>) 60 to less than equal to (<=) 100 kg, and 90 mg for participants with weight > 100 kg at Week 0 and Week 4.

    Reporting group values
    		 Placebo - Controlled Period (CP) Ustekinumab Half-Standard Dosage Controlled period (CP) Ustekinumab Standard Dosage Controlled Period (CP) Total
    Number of subjects
    		 37 37 36 110
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 37 37 36 110
        Adults (18-64 years)
    		 0 0 0 0
        From 65 to 84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 15.6 ( 1.46 ) 15.1 ( 1.7 ) 14.8 ( 1.73 ) -
    Title for Gender
    Units: subjects
        Female
    		 17 19 20 56
        Male
    		 20 18 16 54

    End points

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    End points reporting groups
    Reporting group title
    Placebo - Controlled Period (CP)
    Reporting group description
    		 Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.

    Reporting group title
    Ustekinumab Half-Standard Dosage Controlled period (CP)
    Reporting group description
    		 Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 milligram per kilogram (mg/kg) for participants with weight less than equal to (<=) 60 kilogram (kg), 22.5 milligram (mg) for participants with weight greater than (>) 60 to less than equal to (<=) 100 kg, and 45 mg for participants with weight greater than (>) 100 kg at Week 0 and Week 4.

    Reporting group title
    Ustekinumab Standard Dosage Controlled Period (CP)
    Reporting group description
    		 Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 milligram per kilogram (mg/kg) for participants with weight less than equal to (<=) 60 kilogram (kg), 45 milligram (mg) for participants with weight greater than (>) 60 to less than equal to (<=) 100 kg, and 90 mg for participants with weight > 100 kg at Week 0 and Week 4.
    Reporting group title
    Placebo -> Ustekinumab Half-Standard Dosage (after CP)
    Reporting group description
    		 After Controlled period (Week 12-60) - patients receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then every 12 week with the last dose at Week 40.

    Reporting group title
    Placebo -> Ustekinumab Standard Dosage (after CP)
    Reporting group description
    		 After Controlled period (Week 12-60) - patients receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.

    Reporting group title
    Ustekinumab Half-Standard Dosage (after CP)
    Reporting group description
    		 After Controlled period (Week 12-60) - patients receiving Ustekinumab Half-Standard Dosage at Weeks 16, 28 and every 12 weeks with the last dose at Week 40.

    Reporting group title
    Ustekinumab Standard Dosage (after CP)
    Reporting group description
    		 After Controlled period (Week 12-60) - patients receiving Ustekinumab Standard Dosage at Weeks 16, 28 and every 12 weeks with last dose at Week 40.

    Primary: The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12

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    End point title
    		 The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12
    End point description
    The PGA documents the physician’s assessment of the participant’s psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 6-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), marked (4), or severe (5); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 or 1 at Week 12 in each treatment group.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Placebo - Controlled Period (CP) Ustekinumab Half-Standard Dosage Controlled period (CP) Ustekinumab Standard Dosage Controlled Period (CP)
    Number of subjects analysed
    37
    37
    36
    Units: Percentage of Participants
        number (not applicable)
    5.4
    67.6
    69.4
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12.
    Comparison groups
    Ustekinumab Half-Standard Dosage Controlled period (CP) v Placebo - Controlled Period (CP)
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Standard Dosage Controlled Period (CP)
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12

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    End point title
    		 The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12
    End point description
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. A PASI 75 response is defined as a equal to or greater than (=>) 75% improvement in PASI score from baseline. The table below shows the percentage of participants who achieved a PASI 75 response at Week 12 in each treatment group.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo - Controlled Period (CP) Ustekinumab Half-Standard Dosage Controlled period (CP) Ustekinumab Standard Dosage Controlled Period (CP)
    Number of subjects analysed
    37
    37
    36
    Units: Percentage of Participants
        number (not applicable)
    10.8
    78.4
    80.6
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The Percentage of Participants Achieving a Psoria Area and Severity Index (PASI) 75 Response at Week 12.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Half-Standard Dosage Controlled period (CP)
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Standard Dosage Controlled Period (CP)
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups

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    End point title
    		 Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups
    End point description
    The CDLQI is a dermatology-specific quality of life instrument designed to assess the impact of the disease on a child’s quality of life. The CDLQI, a 10-item questionnaire has 4 items response options and a recall period of 1 week. In addition to evaluating overall quality of life, the CDLQI can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, leisure, School or holidays, personal relationships, sleep, and treatment. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater impairment in quality of life. The table below shows the mean change in CDLQI score from baseline at Week 12 for each treatment group.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 12
    End point values
    		 Placebo - Controlled Period (CP) Ustekinumab Half-Standard Dosage Controlled period (CP) Ustekinumab Standard Dosage Controlled Period (CP)
    Number of subjects analysed
    32
    35
    32
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    -1.5 ( 3.18 )
    -5.6 ( 6.43 )
    -6.7 ( 5.63 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Half-Standard Dosage Controlled period (CP)
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 ANOVA on van der Waerden normal Score
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Standard Dosage Controlled Period (CP)
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA on van der Waerden normal Score
    Confidence interval

    Secondary: The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups

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    End point title
    		 The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups
    End point description
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. The table below shows the percentage of participants who achieved a PASI 90 response defined as achieving a greater than or equal to (≥) 90% improvement in PASI score from baseline.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo - Controlled Period (CP) Ustekinumab Half-Standard Dosage Controlled period (CP) Ustekinumab Standard Dosage Controlled Period (CP)
    Number of subjects analysed
    37
    37
    36
    Units: Percentage of Participants
        number (not applicable)
    5.4
    54.1
    61.1
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Half-Standard Dosage Controlled period (CP)
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Standard Dosage Controlled Period (CP)
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12

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    End point title
    		 The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12
    End point description
    The PGA documents the physician’s assessment of the participant’s psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 and the percentage of participants who achieved a PGA score of 0, 1, or 2 at Week 12 in each treatment group.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo - Controlled Period (CP) Ustekinumab Half-Standard Dosage Controlled period (CP) Ustekinumab Standard Dosage Controlled Period (CP)
    Number of subjects analysed
    37
    37
    36
    Units: Percentage of participants
    number (not applicable)
        PGA of 0
    2.7
    32.4
    47.2
        PGA of 0, 1, or 2
    32.4
    81.1
    83.3
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) at Week 12.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Half-Standard Dosage Controlled period (CP)
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) at Week 12.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Half-Standard Dosage Controlled period (CP)
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Mild or Better (<=2) at Week 12.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Half-Standard Dosage Controlled period (CP)
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    The Percentage of Participants Achieving a Physician's Global Assessment (PGA)Score of Mild or Better (<=2) at Week 12.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Standard Dosage Controlled Period (CP)
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12

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    End point title
    		 The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12
    End point description
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). The table below shows the percentage of participants in each treatment group who were PASI 50 responders at Week 12 defined as participants who achieved a greater than or equal to (>=) 50% improvement in PASI score from baseline as well as the percentage of participants with a PASI score of 0.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo - Controlled Period (CP) Ustekinumab Half-Standard Dosage Controlled period (CP) Ustekinumab Standard Dosage Controlled Period (CP)
    Number of subjects analysed
    37
    37
    36
    Units: Percentage of participants
    number (not applicable)
        PASI 50 responders
    29.7
    81.1
    88.9
        Participants with PASI score of 0
    2.7
    21.6
    38.9
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The Percentage of Participants Who Were PASI 50 Responders.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Half-Standard Dosage Controlled period (CP)
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The Percentage of Participants Who Were PASI 50 Responders at Week 12.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Standard Dosage Controlled Period (CP)
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    The Percentage of Participants With a PASI Score of 0 at Week 12.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Half-Standard Dosage Controlled period (CP)
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.014
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    The Percentage of Participants With a PASI Score of 0 at Week 12.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Standard Dosage Controlled Period (CP)
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12

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    End point title
    		 The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12
    End point description
    The PedsQL is a general health-related quality of life measure developed for use in children and adolescent populations. The Generic Core Scale contains 23 items and is comprised of 4 domains: physical, social, emotional, and school functioning. Each domain can be scored independently. Additionally, a Psychosocial Health and Physical Health Summary Score can be calculated as well as a total score. The measure distinguishes between healthy children and children with acute and chronic health conditions and disease severity within a chronic health condition. The measure is applicable for healthy school and community populations, as well as with pediatric populations with acute and chronic health conditions and has versions for both parent and teen report. Scores range from 0 to 100, and higher scores indicate better health related quality of life.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo - Controlled Period (CP) Ustekinumab Half-Standard Dosage Controlled period (CP) Ustekinumab Standard Dosage Controlled Period (CP)
    Number of subjects analysed
    36
    36
    36
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        PedsQL Total scale score
    3.35 ( 10.044 )
    10.81 ( 12.882 )
    8.03 ( 10.436 )
        PedsQL Psychosocial health summary score
    3.66 ( 9.61 )
    12.13 ( 15.153 )
    8.43 ( 11.812 )
        PedsQL Physical health summary score
    2.86 ( 12.86 )
    8.33 ( 11.378 )
    7.29 ( 13.446 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Half-Standard Dosage Controlled period (CP)
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 ANOVA on van der Waerden normal Score
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Standard Dosage Controlled Period (CP)
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.028
    Method
    		 ANOVA on van der Waerden normal Score
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Psychosocial Health Summary Score.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Half-Standard Dosage Controlled period (CP)
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 ANOVA on van der Waerden normal Score
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Psychosocial Health Summary Score.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Standard Dosage Controlled Period (CP)
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.063
    Method
    		 ANOVA on van der Waerden normal Score
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 5
    Statistical analysis description
    Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Physical Health Summary Score at Week 12.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Half-Standard Dosage Controlled period (CP)
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 ANOVA on van der Waerden normal Score
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 6
    Statistical analysis description
    Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Physical Health Summary Score at Week 12.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Standard Dosage Controlled Period (CP)
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02
    Method
    		 ANOVA on van der Waerden normal Score
    Confidence interval

    Secondary: The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1

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    End point title
    		 The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1
    End point description
    Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements. In addition, this analysis was limited to participants with a CDLQI of > 1 at baseline
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo - Controlled Period (CP) Ustekinumab Half-Standard Dosage Controlled period (CP) Ustekinumab Standard Dosage Controlled Period (CP)
    Number of subjects analysed
    30
    31
    30
    Units: Percentage of participants
        number (not applicable)
    13.3
    38.7
    56.7
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Half-Standard Dosage Controlled period (CP)
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.027
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1.
    Comparison groups
    Placebo - Controlled Period (CP) v Ustekinumab Standard Dosage Controlled Period (CP)
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Through Week 60
    Adverse event reporting additional description
    Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Ustekinumab Half-Standard Dosage (CP)
    Reporting group description
    		 Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 milligram per kilogram (mg/kg) for patients with weight less than equal to (<=) 60 kg, 22.5 milligram (mg) for patients with weight greater than (>) 60 to <= 100 kg, and 45 mg for patients with weight > 100 kg at Week 0 and 4.

    Reporting group title
    Placebo (CP)
    Reporting group description
    		 Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.

    Reporting group title
    Ustekinumab Standard Dosage (CP)
    Reporting group description
    		 Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 milligram per kilogram (mg/kg) for patients with weight less than equal to (<=) 60 kg, 45 milligram (mg) for patients with weight greater than (>) 60 to <= 100 kg, and 90 mg for patients with weight > 100 kg at Week 0 and 4.

    Reporting group title
    Placebo -> Ustekinumab Half-Standard Dosage (after CP)
    Reporting group description
    		 After Controlled period (Week 12-60) - patients receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40.

    Reporting group title
    Ustekinumab Standard Dosage (after CP)
    Reporting group description
    		 After Controlled period (Week 12-60) - patients receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.

    Reporting group title
    Ustekinumab Half-Standard Dosage (after CP)
    Reporting group description
    		 After Controlled period (Week 12-60) - patients receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40.

    Reporting group title
    Placebo -> Ustekinumab Standard Dosage (after CP)
    Reporting group description
    		 After Controlled period (Week 12-60) - patients receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.

    Serious adverse events
    		 Ustekinumab Half-Standard Dosage (CP) Placebo (CP) Ustekinumab Standard Dosage (CP) Placebo -> Ustekinumab Half-Standard Dosage (after CP) Ustekinumab Standard Dosage (after CP) Ustekinumab Half-Standard Dosage (after CP) Placebo -> Ustekinumab Standard Dosage (after CP)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    5 / 37 (13.51%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    1
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Injury
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
    0 / 18 (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 / 1
    0 / 0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    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
    0 / 0
    0 / 0
    Dermatitis Contact
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
    0 / 18 (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
    Infections and infestations
    Ear Infection
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ustekinumab Half-Standard Dosage (CP) Placebo (CP) Ustekinumab Standard Dosage (CP) Placebo -> Ustekinumab Half-Standard Dosage (after CP) Ustekinumab Standard Dosage (after CP) Ustekinumab Half-Standard Dosage (after CP) Placebo -> Ustekinumab Standard Dosage (after CP)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 37 (40.54%)
    17 / 37 (45.95%)
    13 / 36 (36.11%)
    15 / 19 (78.95%)
    23 / 36 (63.89%)
    28 / 37 (75.68%)
    13 / 18 (72.22%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin Papilloma
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
    2 / 18 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    2
    Vascular disorders
    Orthostatic Hypotension
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 37 (2.70%)
    2 / 37 (5.41%)
    1 / 36 (2.78%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    2
    1
    1
    0
    0
    0
    Oedema Peripheral
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    1
    Pyrexia
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    1 / 36 (2.78%)
    1 / 37 (2.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    1
    0
    Reproductive system and breast disorders
    Gynaecomastia
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Dysmenorrhoea
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    2 / 36 (5.56%)
    1 / 19 (5.26%)
    3 / 36 (8.33%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    3
    1
    8
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    3 / 37 (8.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    4
    0
    Dyspnoea Exertional
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Epistaxis
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    Rhinitis Allergic
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    Oropharyngeal Pain
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
    3 / 19 (15.79%)
    0 / 36 (0.00%)
    3 / 37 (8.11%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    3
    0
    5
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    2 / 19 (10.53%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    Upper-Airway Cough Syndrome
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Depression
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Investigations
    Haematocrit Decreased
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Lymph Node Palpable
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Haemoglobin Decreased
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Weight Increased
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Arthropod Bite
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    Joint Injury
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Muscle Strain
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    1
    Skin Injury
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Sunburn
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Thermal Burn
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    1 / 36 (2.78%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Headache
         subjects affected / exposed
    4 / 37 (10.81%)
    2 / 37 (5.41%)
    3 / 36 (8.33%)
    2 / 19 (10.53%)
    2 / 36 (5.56%)
    9 / 37 (24.32%)
    3 / 18 (16.67%)
         occurrences all number
    6
    2
    3
    2
    2
    19
    6
    Migraine
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 37 (0.00%)
    2 / 37 (5.41%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
    1 / 18 (5.56%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    1
    Monocytosis
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Eye disorders
    Blepharitis
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Eye Pruritus
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    Abdominal Pain
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    2 / 36 (5.56%)
    3 / 37 (8.11%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    2
    5
    0
    Abdominal Pain Lower
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Dental Caries
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    3
    0
    Abdominal Pain Upper
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    2
    0
    Food Poisoning
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    2 / 36 (5.56%)
    0 / 19 (0.00%)
    2 / 36 (5.56%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    2
    0
    2
    0
    0
    Lip Oedema
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Odynophagia
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    3 / 37 (8.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    3
    0
    Tooth Deposit
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Tooth Impacted
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    1
    Erythema Multiforme
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    Night Sweats
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    2 / 37 (5.41%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    2
    0
    Psoriasis
         subjects affected / exposed
    0 / 37 (0.00%)
    2 / 37 (5.41%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    1 / 36 (2.78%)
    3 / 37 (8.11%)
    1 / 18 (5.56%)
         occurrences all number
    0
    2
    0
    1
    1
    4
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
    2 / 18 (11.11%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    2
    Musculoskeletal Pain
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Back Pain
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    2 / 36 (5.56%)
    2 / 37 (5.41%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    0
    0
    2
    3
    1
    Tendonitis
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    2 / 37 (5.41%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    1
    Psoriatic Arthropathy
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    4
    Infections and infestations
    Bacterial Rhinitis
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    1 / 36 (2.78%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    1
    Body Tinea
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    Gastroenteritis
         subjects affected / exposed
    1 / 37 (2.70%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    1 / 36 (2.78%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    1
    0
    1
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 37 (2.70%)
    1 / 36 (2.78%)
    1 / 19 (5.26%)
    1 / 36 (2.78%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    2
    2
    2
    0
    0
    Gingivitis
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    Herpes Simplex
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Herpes Zoster
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    1
    Laryngitis
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    1 / 36 (2.78%)
    0 / 37 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    5 / 37 (13.51%)
    10 / 37 (27.03%)
    1 / 36 (2.78%)
    5 / 19 (26.32%)
    11 / 36 (30.56%)
    11 / 37 (29.73%)
    10 / 18 (55.56%)
         occurrences all number
    5
    14
    1
    9
    12
    22
    16
    Oral Herpes
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    1 / 37 (2.70%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    5
    0
    Otitis Externa
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 37 (2.70%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    3 / 37 (8.11%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
    1 / 19 (5.26%)
    2 / 36 (5.56%)
    2 / 37 (5.41%)
    1 / 18 (5.56%)
         occurrences all number
    3
    0
    1
    2
    4
    2
    1
    Pharyngitis Streptococcal
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    1 / 36 (2.78%)
    0 / 19 (0.00%)
    2 / 36 (5.56%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    2
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    2 / 36 (5.56%)
    2 / 37 (5.41%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    2
    2
    1
    Tooth Abscess
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    0 / 19 (0.00%)
    2 / 36 (5.56%)
    1 / 37 (2.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    0
    Tooth Infection
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Toxoplasmosis
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 36 (0.00%)
    1 / 19 (5.26%)
    0 / 36 (0.00%)
    0 / 37 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 37 (2.70%)
    2 / 37 (5.41%)
    3 / 36 (8.33%)
    2 / 19 (10.53%)
    3 / 36 (8.33%)
    4 / 37 (10.81%)
    3 / 18 (16.67%)
         occurrences all number
    1
    2
    4
    3
    6
    6
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Dec 2010
    The overall reason for the amendment was to include changes : Clarification of topical medications/treatments that could affect psoriasis or PASI evaluation: Picrolimus and tacrolimus are topical therapies that may be used in the treatment of psoriasis and concomitant use of these therapies could affect PASI evaluations and present potential safety concerns. Both of these medications were added to the list of medication/treatments that were not permitted within 2 weeks of the first administration of study agent and through Week 60. In addition, the exception clause of allowing subjects to enter the study if they had used low potency corticosteroids on the face and/or groin was removed to allow for a full evaluation of psoriasis on all affected body areas and to avoid any potential confounding of efficacy by previous topical use.It also included other clarifications in the conduct of the study and some minor editorial changes.
    06 Jan 2011
    The overall reason for the amendment was to include changes in inclusion criterion regarding previous psoriasis treatments for participants in Germany: The German Central Ethics Committee indicated that local law requires that study participants must have received previous treatment with at least one systemic therapy prior to being enrolled in this study. Therefore, inclusion criterion #3 regarding prior treatments received for psoriasis was changed to comply with local regulations.
    27 Oct 2011
    The overall reason for the amendment was to include changes: Removal of collection of whole blood sample for messenger ribonucleic acid (RNA) profiling: As requested per the Hungarian Ethics Committee, differential gene expression (messenger RNA) profiling was not performed for subjects recruited in Hungary.
    16 Feb 2012
    The overall reason for the amendment was to include changes: The name of the sponsor for this protocol was changed to Janssen Research & Development: This change was necessary due to a change in the corporate identity of the sponsor. Centocor Research & Development, Inc. operates under the new sponsor identity of Janssen Research & Development and the legal identity of Janssen Research and Development, L.L.C.

    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
    For support, Contact us.
    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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