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    Clinical Trial Results:
    Multicenter, Double-Blind, Randomized, Active- and Placebo Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients from 6 to Less than 18 Years of Age with Moderate-to-Severe Plaque Psoriasis.

    Summary
    EudraCT number
    		 2016-003331-38
    Trial protocol
    		 NL   DE   ES   PL   HU   CZ   FR  
    Global end of trial date

    Results information
    Results version number
    		 v1
    This version publication date
    22 Feb 2020
    First version publication date
    22 Feb 2020
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    I1F-MC-RHCD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03073200
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 16367
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001050-PIP01-10
    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
    Interim
    Date of interim/final analysis
    07 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Feb 2019
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the safety and efficacy of ixekizumab in pediatric 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
    28 Mar 2017
    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
    Puerto Rico: 8
    Country: Number of subjects enrolled
    Argentina: 13
    Country: Number of subjects enrolled
    Hungary: 21
    Country: Number of subjects enrolled
    United States: 64
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    Russian Federation: 15
    Country: Number of subjects enrolled
    Canada: 7
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Poland: 25
    Country: Number of subjects enrolled
    Mexico: 7
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    Czech Republic: 12
    Worldwide total number of subjects
    201
    EEA total number of subjects
    87
    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)
    49
    Adolescents (12-17 years)
    152
    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
    		 -

    Pre-assignment
    Screening details
    		 Open-Label Etanercept group occurred only in Etanercept approved countries.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received matching placebo for Ixekizumab by subcutaneous injection.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received matching placebo for Ixekizumab by subcutaneous injection.

    Arm title
    		 Ixekizumab
    Arm description
    		 Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks (Q4W) from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ixekizumab
    Investigational medicinal product code
    Other name
    LY2439821
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks (Q4W) from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.

    Arm title
    		 Open-Label Etanercept
    Arm description
    		 Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Etanerccept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe, Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.

    Number of subjects in period 1
    		Placebo Ixekizumab Open-Label Etanercept
    Started
    56
    115
    30
    Subjects (Etanercept approved countries)
    19
    38
    30
    Completed
    1
    0
    0
    Not completed
    55
    115
    30
         Consent withdrawn by subject
    3
    3
    -
         Site closed by sponsor
    -
    -
    1
         Adverse event, non-fatal
    -
    2
    -
         Withdrawal by parent or guardian
    -
    1
    1
         Participant has Crohns disease
    -
    1
    -
         Continuing treatment (Ongoing)
    48
    106
    28
         Lost to follow-up
    1
    2
    -
         Lack of efficacy
    1
    -
    -
         Protocol deviation
    2
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo for Ixekizumab by subcutaneous injection.

    Reporting group title
    Ixekizumab
    Reporting group description
    		 Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks (Q4W) from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.

    Reporting group title
    Open-Label Etanercept
    Reporting group description
    		 Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.

    Reporting group values
    		 Placebo Ixekizumab Open-Label Etanercept Total
    Number of subjects
    		 56 115 30 201
    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)
    		 13.1 ( 2.79 ) 13.7 ( 3.14 ) 13.7 ( 2.95 ) -
    Gender categorical
    Units: Subjects
        Female
    		 36 63 18 117
        Male
    		 20 52 12 84
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 11 30 7 48
        Not Hispanic or Latino
    		 42 82 23 147
        Unknown or Not Reported
    		 3 3 0 6
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 2 1 3
        Asian
    		 2 4 0 6
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 3 3 0 6
        White
    		 45 95 25 165
        More than one race
    		 3 10 3 16
        Unknown or Not Reported
    		 3 1 1 5
    Region of Enrollment
    Units: Subjects
        Puerto Rico
    		 3 5 0 8
        Argentina
    		 3 7 3 13
        Hungary
    		 6 13 2 21
        United States
    		 22 42 0 64
        Czechia
    		 2 6 4 12
        Spain
    		 5 4 3 12
        Russia
    		 4 7 4 15
        Canada
    		 1 6 0 7
        Netherlands
    		 0 1 0 1
        Poland
    		 5 12 8 25
        Mexico
    		 1 4 2 7
        France
    		 1 1 1 3
        Germany
    		 3 7 3 13
    Psoriasis Area Severity Index (PASI)
    PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total body surface area affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement). Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
    Units: Score on a scale
        arithmetic mean (standard deviation)
    		 19.73 ( 8.010 ) 19.75 ( 7.509 ) 24.78 ( 7.448 ) -
    Static Physician Global Assessment (sPGA)
    Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5).
    Units: Score on a scale
        arithmetic mean (standard deviation)
    		 3.5 ( 0.63 ) 3.6 ( 0.61 ) 4.1 ( 0.31 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo for Ixekizumab by subcutaneous injection.

    Reporting group title
    Ixekizumab
    Reporting group description
    		 Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks (Q4W) from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.

    Reporting group title
    Open-Label Etanercept
    Reporting group description
    		 Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.

    Primary: Percentage of Participants with a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Placebo and Ixekizumab)

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    End point title
    		 Percentage of Participants with a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Placebo and Ixekizumab) [1]
    End point description
    PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease). APD: All randomized Pts in placebo and Ixekizumab. Missing values were imputed by Nonresponder imputation. Pts who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    End point type
    Primary
    End point timeframe
    Week 12
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, analysis was planned only for placebo & Ixekizumab arms.
    End point values
    		 Placebo Ixekizumab
    Number of subjects analysed
    56
    115
    Units: percentage of participants
        number (not applicable)
    25.0
    88.7
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Ixekizumab
    Number of subjects included in analysis
    171
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Parameter type
    		 Mean difference (final values)
    Point estimate
    63.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 51
         upper limit
    		 76.4

    Primary: Percentage of Participants with a Static Physician Global Assessment (sPGA) (0,1) (Placebo and Ixekizumab)

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    End point title
    		 Percentage of Participants with a Static Physician Global Assessment (sPGA) (0,1) (Placebo and Ixekizumab) [2]
    End point description
    Static Physician Global Assessment (sPGA): The physician’s global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis. Analysis Population Description (APD): All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation (NRI). Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    End point type
    Primary
    End point timeframe
    Week 12
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, analysis was planned only for placebo & Ixekizumab arms.
    End point values
    		 Placebo Ixekizumab
    Number of subjects analysed
    56
    115
    Units: percentage of participants
        number (not applicable)
    10.7
    80.9
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Ixekizumab
    Number of subjects included in analysis
    171
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Parameter type
    		 Mean difference (final values)
    Point estimate
    70.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 59.3
         upper limit
    		 81

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

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    End point title
    		 Percentage of Participants with a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) [3]
    End point description
    PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%.Overall score ranges from 0 (no psoriasis) to 72 (most severe disease). APD: All randomized pts in placebo and Ixekizumab. Missing values were imputed by Nonresponder imputation. Pts who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, analysis was planned only for placebo & Ixekizumab arms.
    End point values
    		 Placebo Ixekizumab
    Number of subjects analysed
    56
    115
    Units: percentage of participants
        number (not applicable)
    5.4
    78.3
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Ixekizumab
    Number of subjects included in analysis
    171
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Parameter type
    		 Mean difference (final values)
    Point estimate
    72.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 63.3
         upper limit
    		 82.5

    Secondary: Percentage of Participants with a sPGA (0)

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    End point title
    		 Percentage of Participants with a sPGA (0) [4]
    End point description
    Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis. An sPGA assessed as 0 represents a clinically important endpoint indicating complete resolution of plaque psoriasis. APD:All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation. Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, analysis was planned only for placebo & Ixekizumab arms.
    End point values
    		 Placebo Ixekizumab
    Number of subjects analysed
    56
    115
    Units: percentage of participants
        number (not applicable)
    1.8
    52.2
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Ixekizumab
    Number of subjects included in analysis
    171
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Parameter type
    		 Mean difference (final values)
    Point estimate
    50.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 40.6
         upper limit
    		 60.2

    Secondary: Percentage of Participants with a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)

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    End point title
    		 Percentage of Participants with a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) [5]
    End point description
    PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease). APD: All randomized pts in placebo and Ixekizumab.Missing values were imputed by Nonresponder imputation. Pts who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, analysis was planned only for placebo & Ixekizumab arms.
    End point values
    		 Placebo Ixekizumab
    Number of subjects analysed
    56
    115
    Units: percentage of participants
        number (not applicable)
    1.8
    49.6
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Ixekizumab
    Number of subjects included in analysis
    171
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    47.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 38
         upper limit
    		 57.6

    Secondary: Percentage of Participants with a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)

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    End point title
    		 Percentage of Participants with a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) [6]
    End point description
    PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease). APD: All randomized pts in placebo and Ixekizumab. Missing values were imputed by Nonresponder imputation. Pts who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    End point type
    Secondary
    End point timeframe
    Week 4
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, analysis was planned only for placebo & Ixekizumab arms.
    End point values
    		 Placebo Ixekizumab
    Number of subjects analysed
    56
    115
    Units: percentage of participants
        number (not applicable)
    14.3
    75.7
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Ixekizumab
    Number of subjects included in analysis
    171
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Parameter type
    		 Mean difference (final values)
    Point estimate
    45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 33.2
         upper limit
    		 56.8

    Secondary: Percentage of Participants with a Static Physician Global Assessment (sPGA) (0,1)

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    End point title
    		 Percentage of Participants with a Static Physician Global Assessment (sPGA) (0,1) [7]
    End point description
    Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis. APD: All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation. Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    End point type
    Secondary
    End point timeframe
    Week 4
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, analysis was planned only for placebo & Ixekizumab arms.
    End point values
    		 Placebo Ixekizumab
    Number of subjects analysed
    56
    115
    Units: percentage of participants
        number (not applicable)
    7.1
    47.8
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Ixekizumab
    Number of subjects included in analysis
    171
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Parameter type
    		 Mean difference (final values)
    Point estimate
    40.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 29.3
         upper limit
    		 52

    Secondary: Percentage of Participants with an Improvement of ≥4 in those who had a Baseline Itch Numeric Rating Scale (NRS) Score of ≥4

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    End point title
    		 Percentage of Participants with an Improvement of ≥4 in those who had a Baseline Itch Numeric Rating Scale (NRS) Score of ≥4 [8]
    End point description
    Itch Numeric Rating Scale (NRS): is a single-item, patient-reported outcome (PRO) measure designed to capture the overall severity of a participant's itching due to his/her psoriasis by having the patient circle the integer that describes the worst level of itching in the past 24 hours on an 11-point NRS anchored at 0 representing “no itching” and 10 representing “worst itch imaginable. APD: All randomized participants with baseline Itch NRS Score >=4 in placebo and Ixekizumab arms. Missing values were imputed by NRI. Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, analysis was planned only for placebo & Ixekizumab arms.
    End point values
    		 Placebo Ixekizumab
    Number of subjects analysed
    40
    83
    Units: percentage of participants
        number (not applicable)
    20.0
    71.1
    Statistical analysis title
    		 Statistical Anlaysis 1
    Comparison groups
    Placebo v Ixekizumab
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Parameter type
    		 Mean difference (final values)
    Point estimate
    51.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 35.3
         upper limit
    		 66.9

    Secondary: Percentage of Participants Achieving Children’s Dermatology Life Quality Index (CDLQI)/Dermatology Life Quality Index (DLQI) (0/1)

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    End point title
    		 Percentage of Participants Achieving Children’s Dermatology Life Quality Index (CDLQI)/Dermatology Life Quality Index (DLQI) (0/1) [9]
    End point description
    DLQI is a validated, dermatology-specific, patient reported measure that evaluates participant's health-related quality of life. It consists of 10 items that are grouped in 6 domains: symptoms & feelings, daily activities, leisure, work & school , personal relationships, & treatment. The recall period of this scale is over the "last week." Response categories and corresponding scores are: Very much = 3, A lot = 2, A little = 1, Not at all = 0, Not relevant = 0. A DLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment). CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. A CDLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment).
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, analysis was planned only for placebo & Ixekizumab arms.
    End point values
    		 Placebo Ixekizumab
    Number of subjects analysed
    56
    115
    Units: percentage of participants
        number (not applicable)
    23.2
    64.3
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Ixekizumab
    Number of subjects included in analysis
    171
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Parameter type
    		 Mean difference (final values)
    Point estimate
    41.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 27
         upper limit
    		 55.2

    Secondary: Change from Baseline on the Nail Psoriasis Severity Index (NAPSI)

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    End point title
    		 Change from Baseline on the Nail Psoriasis Severity Index (NAPSI) [10]
    End point description
    NAPSI is a numeric, reproducible, objective tool for evaluation of nail psoriasis. This scale was used to evaluate the severity of nail bed psoriasis and nail matrix psoriasis by area of involvement in the nail unit. Both fingernail and toenail involvement were assessed.The nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0 to 4) and nail matrix psoriasis (0 to 4), depending on the presence (score of 1) or absence (score of 0) of any of the features of nail bed and nail matrix psoriasis in each quadrant: 0 = None 1 = present in one quadrant of nail 2 = present in two quadrants of nail 3 = present in three quadrants of nail 4 = present in four quadrants of nail NAPSI score of a nail is the sum of scores in nail bed and nail matrix from each quadrant (maximum of 8). Each nail is evaluated, and the sum of all the fingernails and toenails is the total NAPSI score ranging from 0 (no nail Psoriasis).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 All randomized pts with baseline & post baseline NAPSI score.LSMean was calculated using treatment, region, baseline sPGA score,baseline weight category, baseline value, visit, treatment-by-visit, & baseline-by-visit as fixed factors.
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, analysis was planned only for placebo & Ixekizumab arms.
    End point values
    		 Placebo Ixekizumab
    Number of subjects analysed
    12
    34
    Units: score on a scale
        least squares mean (standard error)
    0.17 ( 5.331 )
    -16.87 ( 3.110 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Ixekizumab
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -17.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.7
         upper limit
    		 -5.38
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.747

    Secondary: Change from Baseline on the Psoriasis Scalp Severity Index (PSSI)

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    End point title
    		 Change from Baseline on the Psoriasis Scalp Severity Index (PSSI) [11]
    End point description
    The scalp was assessed for erythema (redness), induration (hardness), and desquamation (shedding of skin) and percentage of area affected as follows: Erythema, Induration and Desquamation: 0 = Absent 1 = Slight 2 = Moderate 3 = Severe 4 = Severest Possible Percent of Scalp Involved: 1 = <10% 2 = 10% – 29% 3 = 30% – 49% 4 = 50% – 69% 5 = 70% – 89% 6 = 90% – 100% The PSSI score is a composite score derived from the sum of the scores for erythema, induration and desquamation multiplied by the score for the extent of scalp area involved (percent of scalp involved). The range is 0 (no psoriasis) to 72 (Most severe Disease). LSMean was calculated using mixed model repeated measures (MMRM) model treatment, region, baseline sPGA score, baseline weight category, baseline value, visit, treatment-by-visit, and baseline-by-visit interactions as fixed factors.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 APD: All randomized pts with baseline & post-baseline PSSI score in placebo and Ixekizumab arms.
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, analysis was planned only for placebo & Ixekizumab arms.
    End point values
    		 Placebo Ixekizumab
    Number of subjects analysed
    50
    102
    Units: score on a scale
        least squares mean (standard error)
    -12.28 ( 2.572 )
    -27.64 ( 2.320 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Ixekizumab
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -15.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.69
         upper limit
    		 -12.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.682

    Secondary: Change from Baseline on the Palmoplantar Psoriasis Severity Index (PPASI)

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    End point title
    		 Change from Baseline on the Palmoplantar Psoriasis Severity Index (PPASI) [12]
    End point description
    PPASI was used if the participant has palmoplantar psoriasis at baseline. Both the palms & soles on each hand & foot was assessed for erythema, induration, desquamation & percentage of area affected as follows: Erythema (E), Induration (I), & Desquamation (D): 0 = None, 1 = Slight, 2 = Moderate, 3 = Severe, 4 = Very Severe Percent of Palm and Sole Area Covered: 0 = None, 1 = <10%, 2 = 10% – 29%, 3 = 30% – 49%, 4 = 50% – 69%, 5 = 70% – 89%, 6 = 90% – 100% PPASI score is a composite score derived from the sum scores for E, I, & D multiplied by a score for the extent of palm & sole area involvement. The range is 0 (no psoriasis) to 72 (most severe disease). APD: All randomized participants with baseline PPASI score in placebo and Ixekizumab arms. LSMean was calculated using MMRM with treatment, region, baseline sPGA score, baseline weight category, baseline value, visit, treatment-by-visit, and baseline-by-visit interactions as fixed factors.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, analysis was planned only for placebo & Ixekizumab arms.
    End point values
    		 Placebo Ixekizumab
    Number of subjects analysed
    9
    17
    Units: score on a scale
        least squares mean (standard error)
    6.89 ( 3.37 )
    -5.11 ( 2.148 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Ixekizumab
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.11
         upper limit
    		 -3.9
    Variability estimate
    Standard deviation
    Dispersion value
    3.853

    Secondary: Number of Participants with Anti-Ixekizumab Antibodies

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    End point title
    		 Number of Participants with Anti-Ixekizumab Antibodies
    End point description
    Number of participants with anti-ixekizumab antibodies
    End point type
    Secondary
    End point timeframe
    Baseline through Week 48
    End point values
    		 Placebo Ixekizumab Open-Label Etanercept
    Number of subjects analysed
    56 [13]
    115 [14]
    30 [15]
    Units: Number of Participants
        number (not applicable)
    99999
    99999
    99999
    Notes
    [13] - Results will be reported after LPV. 99999=NA
    [14] - Results will be reported after LPV. 99999=NA
    [15] - Results will be reported after LPV. 99999=NA
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss)

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    End point title
    		 Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss) [16]
    End point description
    Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss). APD: All randomized participants in Ixekizumab week 12 PK samples.
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Per protocol, analysis was planned only for placebo & Ixekizumab arms.
    End point values
    		 Ixekizumab
    Number of subjects analysed
    111
    Units: microgram per milliliter (μg/mL)
        geometric mean (geometric coefficient of variation)
    3.03 ( 106 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants with a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Etanercept approved countries)

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    End point title
    		 Percentage of Participants with a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Etanercept approved countries)
    End point description
    PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease). Missing values were imputed by Nonresponder imputation. Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    End point type
    Secondary
    End point timeframe
    Week 12 APD: All randomized participants in Etanercept approved countries per protocol addendum.
    End point values
    		 Placebo Ixekizumab Open-Label Etanercept
    Number of subjects analysed
    19
    38
    30
    Units: percentage of participants
        number (not applicable)
    26.3
    84.2
    63.3
    Statistical analysis title
    		 Statistical Anlaysis 1
    Comparison groups
    Open-Label Etanercept v Ixekizumab
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.089
    Method
    		 Fisher exact
    Parameter type
    		 Mean difference (final values)
    Point estimate
    20.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 41.7

    Secondary: Percentage of Participants with a Static Physician Global Assessment (sPGA) (0,1) (Etanercept approved countries)

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    End point title
    		 Percentage of Participants with a Static Physician Global Assessment (sPGA) (0,1) (Etanercept approved countries)
    End point description
    Static Physician Global Assessment (sPGA): The physician’s global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis. APD: All randomized participants in Etanercept approved countries per protocol addendum. Missing values were imputed by Nonresponder imputation. Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo Ixekizumab Open-Label Etanercept
    Number of subjects analysed
    19
    38
    30
    Units: percentage of participants
        number (not applicable)
    5.3
    76.3
    53.3
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Open-Label Etanercept v Ixekizumab
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.07
    Method
    		 Fisher exact
    Parameter type
    		 Mean difference (final values)
    Point estimate
    23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 45.4

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 12 weeks
    Adverse event reporting additional description
    All randomized participants.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo for Ixekizumab by subcutaneous injection.

    Reporting group title
    Open-Label Etanercept
    Reporting group description
    		 Participants with >50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks (Q4W) from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with >25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.

    Reporting group title
    Ixekizumab
    Reporting group description
    		 Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.

    Serious adverse events
    		 Placebo Open-Label Etanercept Ixekizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 30 (3.33%)
    1 / 115 (0.87%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    accidental overdose
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    overdose
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 30 (3.33%)
    0 / 115 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Open-Label Etanercept Ixekizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 56 (14.29%)
    5 / 30 (16.67%)
    38 / 115 (33.04%)
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 30 (3.33%)
    12 / 115 (10.43%)
         occurrences all number
    2
    1
    13
    General disorders and administration site conditions
    injection site reaction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    11 / 115 (9.57%)
         occurrences all number
    0
    0
    16
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    6 / 115 (5.22%)
         occurrences all number
    0
    0
    6
    nausea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 30 (0.00%)
    6 / 115 (5.22%)
         occurrences all number
    1
    0
    6
    Infections and infestations
    influenza
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 30 (6.67%)
    2 / 115 (1.74%)
         occurrences all number
    0
    2
    2
    nasopharyngitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 56 (7.14%)
    0 / 30 (0.00%)
    13 / 115 (11.30%)
         occurrences all number
    4
    0
    15
    pharyngitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 30 (6.67%)
    2 / 115 (1.74%)
         occurrences all number
    0
    2
    2
    upper respiratory tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 56 (7.14%)
    0 / 30 (0.00%)
    6 / 115 (5.22%)
         occurrences all number
    4
    0
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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