Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    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
    23 Mar 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    15 Sep 2021
    First version publication date
    22 Feb 2020
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    LPV results needs to be submitted.

    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
    Final
    Date of interim/final analysis
    23 Mar 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Mar 2021
    Was the trial ended prematurely?
    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
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 5 Months
    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

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Double-Blind Treatment Period (Week 0 to Week 12), Open-Label Maintenance Period (Week 12 to Week 60), Extension Period (Week 60 to Week 108) followed by post-treatment follow-up period occurring from last treatment visit (week 108), or Early Termination Visit (ETV) for up to 24 weeks following that visit.

    Pre-assignment
    Screening details
    		 The 48-Week Double-Blind, Randomized Withdrawal Period occurs from Week 60 to Week 108 for participants in the Europe who meet the response criterion at Week 60 (defined as sPGA [0,1]). Etanercept (ETN) is reference control group occurred only in Etanercept approved countries.

    Period 1
    Period 1 title
    Double Blind Treatment 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 (PBO) for Ixekizumab (IXE) 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
    		 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 Etanercept
    Started
    56
    115
    30
    Completed
    54
    114
    30
    Not completed
    2
    1
    0
         Consent withdrawn by subject
    1
    -
    -
         Withdrawal by Parent/Guardian
    -
    1
    -
         Protocol deviation
    1
    -
    -
    Period 2
    Period 2 title
    Open-Label Maintenance Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PBO/IXEQ4W-Maintenance Period
    Arm description
    		 Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 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 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.

    Arm title
    		 IXEQ4W/IXEQ4W-Maintenance Period
    Arm description
    		 Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 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 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.

    Arm title
    		 ETN/IXEQ4W-Maintenance Period
    Arm description
    		 Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 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 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.

    Number of subjects in period 2 [1]
    		PBO/IXEQ4W-Maintenance Period IXEQ4W/IXEQ4W-Maintenance Period ETN/IXEQ4W-Maintenance Period
    Started
    53
    113
    28
    Completed
    49
    109
    28
    Not completed
    4
    4
    0
         Participant moved to another city
    1
    -
    -
         Consent withdrawn by subject
    2
    1
    -
         Lost to follow-up
    1
    2
    -
         Lack of efficacy
    -
    1
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only Open-label maintenance period participants included.
    Period 3
    Period 3 title
    Extension Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PBO/IXEQ4W/IXEQ4W-Extension Period
    Arm description
    		 Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 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 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.

    Arm title
    		 IXEQ4W/IXEQ4W/IXEQ4W-Extension Period
    Arm description
    		 Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 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 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.

    Arm title
    		 ETN/IXEQ4W/IXEQ4W-Extension Period
    Arm description
    		 Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 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 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.

    Number of subjects in period 3 [2]
    		PBO/IXEQ4W/IXEQ4W-Extension Period IXEQ4W/IXEQ4W/IXEQ4W-Extension Period ETN/IXEQ4W/IXEQ4W-Extension Period
    Started
    34
    68
    9
    Completed
    31
    62
    7
    Not completed
    3
    6
    2
         Consent withdrawn by subject
    1
    2
    -
         Withdrawal by Parent/Guardian
    1
    3
    1
         Sponsor Decision
    -
    -
    1
         Lost to follow-up
    1
    1
    -
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only follow-up period participants were included.
    Period 4
    Period 4 title
    Randomized Withdrawal Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PBO-Randomized Withdrawal Period
    Arm description
    		 Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment [sPGA] [0,1]) at Week 60 were re-randomized to receive placebo during a 48-Week Double-Blind, Randomized Withdrawal Period.
    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
    		 IXEQ4W-Randomized Withdrawal Period
    Arm description
    		 Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment [sPGA] [0,1]) at Week 60 were re-randomized to ixekizumab 20, 40, or 80 mg every 4 weeks (Q4W) according to their weight at the time of rerandomization during a 48-Week Double-Blind, Randomized Withdrawal Period.
    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 received ixekizumab 20, 40, or 80 mg every 4 weeks (Q4W) according to their weight.

    Arm title
    		 IXEQ4W-Re-Treatment (Randomized Withdrawal) Period
    Arm description
    		 Participants from EU countries who do not meet the response criterion at Week 60 will continue with open-label treatment with ixekizumab.
    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 from EU countries who do not meet the response criterion at Week 60 will continue with open-label treatment with ixekizumab.

    Number of subjects in period 4
    		PBO-Randomized Withdrawal Period IXEQ4W-Randomized Withdrawal Period IXEQ4W-Re-Treatment (Randomized Withdrawal) Period
    Started
    33
    34
    33
    Completed
    33
    32
    30
    Not completed
    0
    2
    3
         Consent withdrawn by subject
    -
    1
    1
         Adverse event, non-fatal
    -
    1
    -
         Withdrawal by Parent/Guardian
    -
    -
    1
         Lost to follow-up
    -
    -
    1
    Period 5
    Period 5 title
    Post-Treatment Follow-Up Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 PBO-Post-Treatment Follow-Up
    Arm description
    		 Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 IXEQ4W-Post-Treatment Follow-Up
    Arm description
    		 Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 ETN-Post-Treatment Follow-Up
    Arm description
    		 Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 5
    		PBO-Post-Treatment Follow-Up IXEQ4W-Post-Treatment Follow-Up ETN-Post-Treatment Follow-Up
    Started
    6
    166
    2
    Completed
    6
    139
    1
    Not completed
    0
    27
    1
         Participant moved to another city
    -
    1
    -
         Consent withdrawn by subject
    -
    9
    -
         Adverse event, non-fatal
    -
    2
    -
         Site terminated by sponsor
    -
    -
    1
         Withdrawal by Parent/Guardian
    -
    11
    -
         Lost to follow-up
    -
    1
    -
         Other-determined by Investigator
    -
    2
    -
         Protocol deviation
    -
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo (PBO) for Ixekizumab (IXE) 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
    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 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

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo (PBO) for Ixekizumab (IXE) 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
    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 title
    PBO/IXEQ4W-Maintenance Period
    Reporting group description
    		 Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.

    Reporting group title
    IXEQ4W/IXEQ4W-Maintenance Period
    Reporting group description
    		 Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.

    Reporting group title
    ETN/IXEQ4W-Maintenance Period
    Reporting group description
    		 Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection
    Reporting group title
    PBO/IXEQ4W/IXEQ4W-Extension Period
    Reporting group description
    		 Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.

    Reporting group title
    IXEQ4W/IXEQ4W/IXEQ4W-Extension Period
    Reporting group description
    		 Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.

    Reporting group title
    ETN/IXEQ4W/IXEQ4W-Extension Period
    Reporting group description
    		 Participants with >50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with >25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.
    Reporting group title
    PBO-Randomized Withdrawal Period
    Reporting group description
    		 Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment [sPGA] [0,1]) at Week 60 were re-randomized to receive placebo during a 48-Week Double-Blind, Randomized Withdrawal Period.

    Reporting group title
    IXEQ4W-Randomized Withdrawal Period
    Reporting group description
    		 Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment [sPGA] [0,1]) at Week 60 were re-randomized to ixekizumab 20, 40, or 80 mg every 4 weeks (Q4W) according to their weight at the time of rerandomization during a 48-Week Double-Blind, Randomized Withdrawal Period.

    Reporting group title
    IXEQ4W-Re-Treatment (Randomized Withdrawal) Period
    Reporting group description
    		 Participants from EU countries who do not meet the response criterion at Week 60 will continue with open-label treatment with ixekizumab.
    Reporting group title
    PBO-Post-Treatment Follow-Up
    Reporting group description
    		 Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.

    Reporting group title
    IXEQ4W-Post-Treatment Follow-Up
    Reporting group description
    		 Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.

    Reporting group title
    ETN-Post-Treatment Follow-Up
    Reporting group description
    		 Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.

    Subject analysis set title
    Ixekizumab (Maintenance Period)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Open-Label Maintenance Period (Week 12 to Week 60) all participants received Ixekizumab.

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

    		 Close Top of page
    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)

    		 Close Top of page
    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)

    		 Close Top of page
    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)

    		 Close Top of page
    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)

    		 Close Top of page
    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)

    		 Close Top of page
    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)

    		 Close Top of page
    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

    		 Close Top of page
    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)

    		 Close Top of page
    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)

    		 Close Top of page
    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)

    		 Close Top of page
    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)

    		 Close Top of page
    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

    		 Close Top of page
    End point title
    		 Number of Participants with Anti-Ixekizumab Antibodies
    End point description
    A treatment emergent - antidrug antibody (TE-ADA) positive participant were defined as: 1) a participant with a >= 4-fold increase over a positive baseline antibody titer; or 2) for a negative baseline titer, a participant with an increase from the baseline to a level of >= 1:10. APD: All randomized participants from maintenance period (During maintenance period participants were on Ixekizumab treatment).
    End point type
    Secondary
    End point timeframe
    Baseline through Week 48
    End point values
    		 Ixekizumab (Maintenance Period)
    Number of subjects analysed
    194
    Units: Number of Participants
        number (not applicable)
    56
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss) [13]
    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
    [13] - 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)

    		 Close Top of page
    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 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
    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)

    		 Close Top of page
    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 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
    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

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to 132 Weeks
    Adverse event reporting additional description
    All randomized participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    IXEQ4W-Double-Blinded Treatment Period
    Reporting group description
    		 -

    Reporting group title
    PBO-Double-Blinded Treatment Period
    Reporting group description
    		 -

    Reporting group title
    ETN-Double-Blinded Treatment Period
    Reporting group description
    		 -

    Reporting group title
    IXEQ4W-Maintenance Period
    Reporting group description
    		 -

    Reporting group title
    IXEQ4W-Extension Period
    Reporting group description
    		 -

    Reporting group title
    IXEQ4W-Randomized Withdrawal Period
    Reporting group description
    		 -

    Reporting group title
    PBO-Randomized Withdrawal Period
    Reporting group description
    		 -

    Reporting group title
    IXEQ4W-Re-Treatment (Randomized Withdrawal) Period
    Reporting group description
    		 -

    Reporting group title
    IXEQ4W-Post-Treatment Follow-Up
    Reporting group description
    		 -

    Reporting group title
    PBO-Post-Treatment Follow-Up
    Reporting group description
    		 -

    Reporting group title
    ETN-Post-Treatment Follow-Up
    Reporting group description
    		 -

    Serious adverse events
    		 IXEQ4W-Double-Blinded Treatment Period PBO-Double-Blinded Treatment Period ETN-Double-Blinded Treatment Period IXEQ4W-Maintenance Period IXEQ4W-Extension Period IXEQ4W-Randomized Withdrawal Period PBO-Randomized Withdrawal Period IXEQ4W-Re-Treatment (Randomized Withdrawal) Period IXEQ4W-Post-Treatment Follow-Up PBO-Post-Treatment Follow-Up ETN-Post-Treatment Follow-Up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 56 (0.00%)
    1 / 30 (3.33%)
    11 / 194 (5.67%)
    2 / 111 (1.80%)
    3 / 34 (8.82%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    1 / 169 (0.59%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    astrocytoma
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    0 / 194 (0.00%)
    0 / 111 (0.00%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    glucose tolerance decreased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    1 / 194 (0.52%)
    0 / 111 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    accidental overdose
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    0 / 194 (0.00%)
    0 / 111 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ankle fracture
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    0 / 194 (0.00%)
    1 / 111 (0.90%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    overdose
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    1 / 30 (3.33%)
    0 / 194 (0.00%)
    0 / 111 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    postoperative ileus
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    1 / 194 (0.52%)
    0 / 111 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rib fracture
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    1 / 194 (0.52%)
    0 / 111 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    road traffic accident
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    0 / 194 (0.00%)
    1 / 111 (0.90%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    splenic rupture
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    1 / 194 (0.52%)
    1 / 111 (0.90%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    epilepsy
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    0 / 194 (0.00%)
    0 / 111 (0.00%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    pregnancy
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed [1]
    0 / 63 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 62 (0.00%)
    0 / 23 (0.00%)
    0 / 17 (0.00%)
    0 / 19 (0.00%)
    0 / 104 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    pyrexia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    1 / 194 (0.52%)
    0 / 111 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    crohn's disease
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    2 / 194 (1.03%)
    0 / 111 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    1 / 169 (0.59%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diarrhoea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    1 / 194 (0.52%)
    0 / 111 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    inflammatory bowel disease
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    1 / 194 (0.52%)
    0 / 111 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    1 / 194 (0.52%)
    0 / 111 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    ovarian cyst ruptured
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed [2]
    0 / 63 (0.00%)
    0 / 36 (0.00%)
    0 / 18 (0.00%)
    1 / 113 (0.88%)
    0 / 62 (0.00%)
    0 / 23 (0.00%)
    0 / 17 (0.00%)
    0 / 19 (0.00%)
    0 / 104 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    pneumothorax
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    1 / 194 (0.52%)
    0 / 111 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    renal haematoma
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    1 / 194 (0.52%)
    0 / 111 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    furuncle
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    0 / 194 (0.00%)
    0 / 111 (0.00%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    herpes zoster oticus
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    1 / 194 (0.52%)
    0 / 111 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    otitis media acute
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    1 / 194 (0.52%)
    0 / 111 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tonsillitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    1 / 194 (0.52%)
    0 / 111 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    dehydration
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    2 / 194 (1.03%)
    0 / 111 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IXEQ4W-Double-Blinded Treatment Period PBO-Double-Blinded Treatment Period ETN-Double-Blinded Treatment Period IXEQ4W-Maintenance Period IXEQ4W-Extension Period IXEQ4W-Randomized Withdrawal Period PBO-Randomized Withdrawal Period IXEQ4W-Re-Treatment (Randomized Withdrawal) Period IXEQ4W-Post-Treatment Follow-Up PBO-Post-Treatment Follow-Up ETN-Post-Treatment Follow-Up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 115 (39.13%)
    13 / 56 (23.21%)
    6 / 30 (20.00%)
    114 / 194 (58.76%)
    59 / 111 (53.15%)
    22 / 34 (64.71%)
    14 / 33 (42.42%)
    11 / 33 (33.33%)
    8 / 169 (4.73%)
    2 / 4 (50.00%)
    0 / 1 (0.00%)
    Investigations
    weight decreased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 56 (1.79%)
    0 / 30 (0.00%)
    7 / 194 (3.61%)
    1 / 111 (0.90%)
    0 / 34 (0.00%)
    2 / 33 (6.06%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    7
    1
    0
    2
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    fall
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    0 / 194 (0.00%)
    0 / 111 (0.00%)
    2 / 34 (5.88%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    12 / 115 (10.43%)
    1 / 56 (1.79%)
    1 / 30 (3.33%)
    15 / 194 (7.73%)
    8 / 111 (7.21%)
    2 / 34 (5.88%)
    1 / 33 (3.03%)
    1 / 33 (3.03%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    13
    2
    1
    18
    11
    4
    1
    1
    0
    0
    0
    General disorders and administration site conditions
    injection site reaction
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    11 / 115 (9.57%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    28 / 194 (14.43%)
    2 / 111 (1.80%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    1 / 33 (3.03%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    16
    0
    0
    63
    6
    0
    0
    3
    0
    0
    0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    6 / 115 (5.22%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    5 / 194 (2.58%)
    1 / 111 (0.90%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    6
    0
    0
    7
    1
    0
    1
    0
    0
    0
    0
    diarrhoea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    5 / 115 (4.35%)
    1 / 56 (1.79%)
    0 / 30 (0.00%)
    9 / 194 (4.64%)
    4 / 111 (3.60%)
    2 / 34 (5.88%)
    1 / 33 (3.03%)
    2 / 33 (6.06%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    7
    2
    0
    10
    8
    4
    1
    2
    0
    0
    0
    nausea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    6 / 115 (5.22%)
    1 / 56 (1.79%)
    0 / 30 (0.00%)
    11 / 194 (5.67%)
    0 / 111 (0.00%)
    1 / 34 (2.94%)
    1 / 33 (3.03%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    6
    1
    0
    12
    0
    1
    1
    0
    0
    0
    0
    vomiting
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    5 / 115 (4.35%)
    1 / 56 (1.79%)
    0 / 30 (0.00%)
    10 / 194 (5.15%)
    0 / 111 (0.00%)
    2 / 34 (5.88%)
    0 / 33 (0.00%)
    2 / 33 (6.06%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    5
    1
    0
    11
    0
    2
    0
    2
    0
    0
    0
    Skin and subcutaneous tissue disorders
    acne
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 56 (1.79%)
    0 / 30 (0.00%)
    5 / 194 (2.58%)
    3 / 111 (2.70%)
    2 / 34 (5.88%)
    0 / 33 (0.00%)
    1 / 33 (3.03%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    5
    3
    2
    0
    1
    0
    0
    0
    psoriasis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    1 / 194 (0.52%)
    3 / 111 (2.70%)
    0 / 34 (0.00%)
    3 / 33 (9.09%)
    0 / 33 (0.00%)
    4 / 169 (2.37%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    4
    0
    3
    0
    4
    0
    0
    urticaria
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 115 (1.74%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    2 / 194 (1.03%)
    0 / 111 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    2 / 33 (6.06%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    2
    0
    0
    0
    2
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 115 (1.74%)
    2 / 56 (3.57%)
    0 / 30 (0.00%)
    10 / 194 (5.15%)
    3 / 111 (2.70%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    1 / 33 (3.03%)
    1 / 169 (0.59%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    2
    0
    12
    3
    0
    0
    1
    1
    0
    0
    Infections and infestations
    bronchitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    1 / 30 (3.33%)
    2 / 194 (1.03%)
    4 / 111 (3.60%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    2
    2
    4
    0
    0
    0
    0
    1
    0
    cellulitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 56 (1.79%)
    0 / 30 (0.00%)
    0 / 194 (0.00%)
    0 / 111 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    conjunctivitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 115 (2.61%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    11 / 194 (5.67%)
    3 / 111 (2.70%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    1 / 33 (3.03%)
    1 / 169 (0.59%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    0
    14
    3
    0
    0
    1
    1
    0
    0
    gastroenteritis viral
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 115 (0.00%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    6 / 194 (3.09%)
    0 / 111 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    6
    0
    0
    0
    0
    0
    1
    0
    impetigo
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    11 / 194 (5.67%)
    1 / 111 (0.90%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    17
    1
    0
    0
    0
    0
    0
    0
    influenza
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 115 (1.74%)
    0 / 56 (0.00%)
    2 / 30 (6.67%)
    5 / 194 (2.58%)
    6 / 111 (5.41%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    1 / 169 (0.59%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    2
    6
    7
    1
    0
    0
    1
    0
    0
    nasopharyngitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    13 / 115 (11.30%)
    4 / 56 (7.14%)
    0 / 30 (0.00%)
    27 / 194 (13.92%)
    8 / 111 (7.21%)
    11 / 34 (32.35%)
    4 / 33 (12.12%)
    2 / 33 (6.06%)
    1 / 169 (0.59%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    15
    4
    0
    36
    10
    14
    4
    2
    1
    0
    0
    pharyngitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 115 (1.74%)
    0 / 56 (0.00%)
    2 / 30 (6.67%)
    14 / 194 (7.22%)
    6 / 111 (5.41%)
    1 / 34 (2.94%)
    2 / 33 (6.06%)
    2 / 33 (6.06%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    2
    19
    6
    1
    2
    2
    0
    0
    0
    tonsillitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 115 (0.87%)
    2 / 56 (3.57%)
    0 / 30 (0.00%)
    10 / 194 (5.15%)
    5 / 111 (4.50%)
    3 / 34 (8.82%)
    1 / 33 (3.03%)
    2 / 33 (6.06%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    2
    0
    15
    6
    3
    1
    3
    0
    0
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    6 / 115 (5.22%)
    4 / 56 (7.14%)
    0 / 30 (0.00%)
    20 / 194 (10.31%)
    21 / 111 (18.92%)
    1 / 34 (2.94%)
    3 / 33 (9.09%)
    2 / 33 (6.06%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    7
    4
    0
    30
    26
    1
    3
    2
    0
    0
    0
    viral upper respiratory tract infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 115 (1.74%)
    0 / 56 (0.00%)
    0 / 30 (0.00%)
    6 / 194 (3.09%)
    4 / 111 (3.60%)
    3 / 34 (8.82%)
    1 / 33 (3.03%)
    0 / 33 (0.00%)
    0 / 169 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    7
    5
    3
    1
    0
    0
    0
    0

    More information

    		 Close Top of page

    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.

    European Medicines Agency © 1995-Fri Apr 26 06:48:00 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA