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   44294   clinical trials with a EudraCT protocol, of which   7351   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:
    A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding and Proof of Concept Study, to Assess the Efficacy, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Namilumab/MT203 at 4 Different Subcutaneous Doses – together with an Open-Label, Dose-Escalated Extension to Assess Safety and Efficacy of One Year Treatment - in Subjects with Moderate to Severe Chronic Plaque Psoriasis

    Summary
    EudraCT number
    2013-002806-30
    Trial protocol
    DE   LV   DK   PL  
    Global end of trial date
    23 Feb 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    11 Mar 2017
    First version publication date
    11 Mar 2017
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    M1-1188_203
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    U1111-1146-1219
    Sponsors
    Sponsor organisation name
    Takeda
    Sponsor organisation address
    61 Aldwych, London, WC2B 4AE, United Kingdom,
    Public contact
    Program Manager, Takeda Development Centre Europe Ltd., + 18778253327, clinicaltrialregistry@tpna.com
    Scientific contact
    Program Manager, Takeda Development Centre Europe Ltd., +1 8778253327, clinicaltrialregistry@tpna.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Dec 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To establish proof of efficacy of namilumab in moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving a reduction in Psoriasis Area and Severity Index (PASI) scores greater than or equal to (>=) 75 percent (%) from Baseline (hereafter referred to as PASI75) response rate at Week 12.
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Jul 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy
    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
    Canada: 56
    Country: Number of subjects enrolled
    Denmark: 2
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Latvia: 17
    Country: Number of subjects enrolled
    Poland: 46
    Worldwide total number of subjects
    122
    EEA total number of subjects
    66
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    121
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    Subjects were enrolled into the double-blind treatment evaluation at 17 investigative sites in Canada, Denmark, Germany, Latvia, and Poland. Only those sites in Denmark, Latvia and Poland participated in the extension period which included open-label treatment with study medication.

    Pre-assignment
    Screening details
    Participants with diagnosis of moderate to severe plaque psoriasis without clinically significant lung/respiratory disorders were screened for enrollment into the study.To fulfill screening requirements,chest X-ray was carried out prior to Baseline visit which included assignment to the double-blind study treatment and first dosing with study drug.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Double-Blind Period: Placebo
    Arm description
    Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
    Arm type
    Placebo

    Investigational medicinal product name
    Namilumab placebo-matching injection
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.

    Arm title
    Double-Blind Period: Namilumab 20 mg
    Arm description
    Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
    Arm type
    Experimental

    Investigational medicinal product name
    Namilumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.

    Arm title
    Double-Blind Period: Namilumab 50 mg
    Arm description
    Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
    Arm type
    Experimental

    Investigational medicinal product name
    Namilumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.

    Arm title
    Double-Blind Period: Namilumab 80 mg
    Arm description
    Namilumab 160 mg injection (2 separate injections of 80 mg), subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
    Arm type
    Experimental

    Investigational medicinal product name
    Namilumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.

    Arm title
    Double-Blind Period: Namilumab 150 mg
    Arm description
    Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
    Arm type
    Experimental

    Investigational medicinal product name
    Namilumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.

    Number of subjects in period 1
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
    Started
    24
    24
    24
    25
    25
    Completed
    17
    16
    20
    18
    18
    Not completed
    7
    8
    4
    7
    7
         Consent withdrawn by subject
    2
    4
    3
    2
    3
         Adverse event, non-fatal
    -
    -
    -
    -
    1
         Other
    1
    2
    -
    -
    -
         Pregnancy
    -
    -
    -
    -
    1
         Lost to follow-up
    1
    1
    1
    2
    -
         Lack of efficacy
    3
    1
    -
    3
    2
    Period 2
    Period 2 title
    Open-Label Period
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Open-Label Period: Namilumab 80 mg
    Arm description
    Namilumab 80 mg, single injection, subcutaneously every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
    Arm type
    Experimental

    Investigational medicinal product name
    Namilumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Solution for injection, Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Namilumab 80 mg, injection, subcutaneously, every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.

    Arm title
    Open-Label Period: Namilumab 150 mg
    Arm description
    Namilumab 150 mg, single injection, subcutaneously from Week 8 and then every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
    Arm type
    Experimental

    Investigational medicinal product name
    Namilumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Solution for injection, Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Namilumab 150 mg, single injection, subcutaneously from Week 8 and then every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.

    Number of subjects in period 2 [1]
    Open-Label Period: Namilumab 80 mg Open-Label Period: Namilumab 150 mg
    Started
    12
    48
    Completed
    0
    0
    Not completed
    12
    48
         Consent withdrawn by subject
    1
    3
         Study Termination
    10
    39
         Lost to follow-up
    1
    1
         Lack of efficacy
    -
    5
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Participants were enrolled into the double-blind treatment evaluation at 17 investigative sites in Canada, Denmark, Germany, Latvia, and Poland. Only those sites in Denmark, Latvia and Poland participated in the extension period which included open-label treatment with study medication.

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Double-Blind Period: Placebo
    Reporting group description
    Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.

    Reporting group title
    Double-Blind Period: Namilumab 20 mg
    Reporting group description
    Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.

    Reporting group title
    Double-Blind Period: Namilumab 50 mg
    Reporting group description
    Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.

    Reporting group title
    Double-Blind Period: Namilumab 80 mg
    Reporting group description
    Namilumab 160 mg injection (2 separate injections of 80 mg), subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.

    Reporting group title
    Double-Blind Period: Namilumab 150 mg
    Reporting group description
    Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.

    Reporting group values
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg Total
    Number of subjects
    24 24 24 25 25 122
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0 0
        Adults (18-64 years)
    23 24 24 25 25 121
        From 65-84 years
    1 0 0 0 0 1
        85 years and over
    0 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    40.8 ( 15.2 ) 41.1 ( 11.28 ) 42.3 ( 10.92 ) 39 ( 12.04 ) 39.8 ( 9.62 ) -
    Gender, Male/Female
    Units: subjects
        Female
    9 4 5 7 13 38
        Male
    15 20 19 18 12 84
    Race/Ethnicity, Customized
    Units: Subjects
        Not Hispanic or Latino
    10 10 12 12 12 56
        Unknown or Not Reported
    14 14 12 13 13 66
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    2 1 2 2 4 11
        Black or African American
    0 0 1 0 0 1
        Native Hawaiian or Other Pacific Islander
    0 1 0 0 0 1
        White
    22 22 21 23 21 109
    Smoking Classification
    Units: Subjects
        Never Smoked
    7 11 9 13 12 52
        Current Smoker
    8 5 9 7 5 34
        Ex-Smoker
    9 8 6 5 8 36
    Region of Enrollment
    Units: Subjects
        Canada
    10 10 12 12 12 56
        Denmark
    0 1 0 0 1 2
        Germany
    0 0 0 0 1 1
        Latvia
    5 5 2 3 2 17
        Poland
    9 8 10 10 9 46
    Study Specific Characteristic | Height
    Units: centimeter
        arithmetic mean (standard deviation)
    172.3 ( 10.83 ) 176.1 ( 7.73 ) 176.5 ( 7.81 ) 176.8 ( 8.59 ) 168.1 ( 10.28 ) -
    Study Specific Characteristic | Weight
    Units: kilogram
        arithmetic mean (standard deviation)
    87.46 ( 22.864 ) 88.26 ( 22.033 ) 97.84 ( 33.643 ) 95.5 ( 25.056 ) 82.32 ( 24.634 ) -
    Study Specific Characteristic | Body Mass Index
    Units: kilogram per square meter (kg/m^2)
        arithmetic mean (standard deviation)
    29.16 ( 6.112 ) 28.25 ( 5.936 ) 31.26 ( 9.532 ) 30.53 ( 7.641 ) 29.01 ( 8.093 ) -

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Double-Blind Period: Placebo
    Reporting group description
    Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.

    Reporting group title
    Double-Blind Period: Namilumab 20 mg
    Reporting group description
    Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.

    Reporting group title
    Double-Blind Period: Namilumab 50 mg
    Reporting group description
    Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.

    Reporting group title
    Double-Blind Period: Namilumab 80 mg
    Reporting group description
    Namilumab 160 mg injection (2 separate injections of 80 mg), subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.

    Reporting group title
    Double-Blind Period: Namilumab 150 mg
    Reporting group description
    Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
    Reporting group title
    Open-Label Period: Namilumab 80 mg
    Reporting group description
    Namilumab 80 mg, single injection, subcutaneously every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.

    Reporting group title
    Open-Label Period: Namilumab 150 mg
    Reporting group description
    Namilumab 150 mg, single injection, subcutaneously from Week 8 and then every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.

    Primary: Percentage of Subjects Achieving 75 Percent Reduction From Baseline Psoriasis Area and Severity Index (PASI) Score (PASI75 Response) at Week 12

    Close Top of page
    End point title
    Percentage of Subjects Achieving 75 Percent Reduction From Baseline Psoriasis Area and Severity Index (PASI) Score (PASI75 Response) at Week 12
    End point description
    PASI is an assessment of psoriasis lesion severity and affected body area combined into single score.Body was divided into 4 sections:head(h),trunk(t),upper(u) and lower(l) extremities.Percent body surface area(A) involved was estimated: 0=No involvement to 6=90–100 percent(%).Severity was estimated by clinical signs:erythema(E),induration(I), and desquamation(D);scale:0=no symptoms to 4=very marked.Final PASI=0.1(Eh+Ih+Dh)Ah+0.3(Et+It+Dt)At+0.2(Eu+Iu+Du)Au+0.4(El+Il+Dl)Al where head:0.1,upper extremities(arms):0.2,trunk:0.3,lower extremities(legs):0.4(corresponding to 10%,20%,30% and 40% of body surface area, respectively);total possible score range:0=no disease to 72=maximal disease. Full analysis set(FAS) where baseline and Week 12 assessment were available.FAS included all randomized and treated subjects who had at least one valid post-baseline assessment of PASI in the double-blind period.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
    Number of subjects analysed
    23
    21
    22
    19
    20
    Units: percentage of subjects
        number (not applicable)
    8.7
    9.5
    0
    5.3
    0
    Statistical analysis title
    Week 12: Namilumab Placebo vs 20 mg
    Statistical analysis description
    Cochran-Mantel-Haenszel (CMH) P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit. Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 20 mg
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.925
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    0.008
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.162
         upper limit
    0.179
    Statistical analysis title
    Week 12: Namilumab Placebo vs 50 mg
    Statistical analysis description
    CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit. Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 50 mg
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.162
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.087
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.202
         upper limit
    0.028
    Statistical analysis title
    Week 12: Namilumab Placebo vs 80 mg
    Statistical analysis description
    CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit. Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 80 mg
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.671
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.034
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.187
         upper limit
    0.118
    Statistical analysis title
    Week 12: Namilumab Placebo vs 150 mg
    Statistical analysis description
    CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit. Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 150 mg
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.182
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.087
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.202
         upper limit
    0.028

    Secondary: Percentage of Subjects Achieving 75 Percent Reduction From Baseline PASI Score (PASI75 Response) at Weeks 2, 4, 6, and 10

    Close Top of page
    End point title
    Percentage of Subjects Achieving 75 Percent Reduction From Baseline PASI Score (PASI75 Response) at Weeks 2, 4, 6, and 10
    End point description
    PASI is an assessment of psoriasis lesion severity and affected body area combined into single score.Body was divided into 4 sections:head(h),trunk(t),upper(u) and lower(l) extremities.Percent body surface area(A) involved was estimated: 0=No involvement to 6=90–100 percent(%).Severity was estimated by clinical signs:erythema(E),induration(I), and desquamation(D);scale:0=no symptoms to 4=very marked.Final PASI=0.1(Eh+Ih+Dh)Ah+0.3(Et+It+Dt)At+0.2(Eu+Iu+Du)Au+0.4(El+Il+Dl)Al where head:0.1,upper extremities(arms):0.2,trunk:0.3,lower extremities(legs):0.4(corresponding to 10%,20%,30% and 40% of body surface area, respectively);total possible score range:0=no disease to 72=maximal disease. FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated subjects who had at least one valid post-baseline assessment of PASI in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6 and 10
    End point values
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
    Number of subjects analysed
    24
    24
    24
    25
    25
    Units: percentage of subjects
    number (not applicable)
        Week 2 (n= 24, 24, 24, 25, 25)
    0
    0
    0
    0
    0
        Week 4 (n= 24, 24, 23, 24, 24)
    0
    0
    4.3
    0
    0
        Week 6 (n= 23, 23, 24, 24, 23)
    4.3
    8.7
    4.2
    4.2
    0
        Week 10 (n= 22, 22, 24, 24, 22)
    9.1
    4.5
    0
    4.2
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in PASI Score at Weeks 2, 4, 6, 10, and 12

    Close Top of page
    End point title
    Change From Baseline in PASI Score at Weeks 2, 4, 6, 10, and 12
    End point description
    PASI is an assessment of psoriasis lesion severity and affected body area combined into single score.Body was divided into 4 sections:head(h),trunk(t),upper(u) and lower(l) extremities.Percent body surface area(A) involved was estimated: 0=No involvement to 6=90–100 percent(%).Severity was estimated by clinical signs:erythema(E),induration(I), and desquamation(D);scale:0=no symptoms to 4=very marked.Final PASI=0.1(Eh+Ih+Dh)Ah+0.3(Et+It+Dt)At+0.2(Eu+Iu+Du)Au+0.4(El+Il+Dl)Al where head:0.1,upper extremities(arms):0.2,trunk:0.3,lower extremities(legs):0.4(corresponding to 10%,20%,30% and 40% of body surface area, respectively);total possible score range:0=no disease to 72=maximal disease. FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated subjects who had at least one valid post-baseline assessment of PASI in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 6, 10, and 12
    End point values
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
    Number of subjects analysed
    24
    24
    24
    25
    25
    Units: units on a scale
    least squares mean (standard error)
        Baseline (n=24, 24, 24, 25, 25)
    18.6 ( 1.65 )
    19.1 ( 1.57 )
    20.9 ( 1.62 )
    17.4 ( 1.57 )
    17.3 ( 1.52 )
        Change at Week 2 (n=24, 24, 24, 25, 25)
    -2.2 ( 0.7 )
    -1.7 ( 0.67 )
    -1.2 ( 0.69 )
    -2.1 ( 0.67 )
    -1.4 ( 0.65 )
        Change at Week 4 (n=24, 24, 23, 24, 24)
    -3.6 ( 0.92 )
    -2.8 ( 0.9 )
    -1.9 ( 0.92 )
    -2.4 ( 0.9 )
    -2.2 ( 0.89 )
        Change at Week 6 (n=23, 23, 24, 24, 23)
    -5.1 ( 1.13 )
    -3.6 ( 1.1 )
    -1.4 ( 1.11 )
    -2.4 ( 1.1 )
    -2.4 ( 1.1 )
        Change at Week 10 (n=22, 22, 24, 24, 22)
    -6.4 ( 1.3 )
    -4.6 ( 1.29 )
    -3.2 ( 1.28 )
    -3.2 ( 1.27 )
    -3 ( 1.28 )
        Change at Week 12 (n=23, 21, 22, 19, 20)
    -6.3 ( 1.27 )
    -4.9 ( 1.26 )
    -4.4 ( 1.25 )
    -3.3 ( 1.26 )
    -3.4 ( 1.26 )
    Statistical analysis title
    Week 12: Namilumab Placebo vs 20 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 20 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.435
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    1.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.1
         upper limit
    4.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.75
    Statistical analysis title
    Week 12: Namilumab Placebo vs 50 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 50 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.279
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    1.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.6
         upper limit
    5.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.74
    Statistical analysis title
    Week 12: Namilumab Placebo vs 80 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 80 mg
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.085
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.4
         upper limit
    6.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.74
    Statistical analysis title
    Week 12: Namilumab Placebo vs 150 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 150 mg
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.11
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    2.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.7
         upper limit
    6.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.76

    Secondary: Percentage of Subjects Achieving 50 Percent Reduction From Baseline PASI Score (PASI50 Response) at Weeks 2, 4, 6, 10 and 12

    Close Top of page
    End point title
    Percentage of Subjects Achieving 50 Percent Reduction From Baseline PASI Score (PASI50 Response) at Weeks 2, 4, 6, 10 and 12
    End point description
    PASI is an assessment of psoriasis lesion severity and affected body area combined into single score.Body was divided into 4 sections:head(h),trunk(t),upper(u) and lower(l) extremities.Percent body surface area(A) involved was estimated: 0=No involvement to 6=90–100 percent(%).Severity was estimated by clinical signs:erythema(E),induration(I), and desquamation(D);scale:0=no symptoms to 4=very marked.Final PASI=0.1(Eh+Ih+Dh)Ah+0.3(Et+It+Dt)At+0.2(Eu+Iu+Du)Au+0.4(El+Il+Dl)Al where head:0.1,upper extremities(arms):0.2,trunk:0.3,lower extremities(legs):0.4(corresponding to 10%,20%,30% and 40% of body surface area, respectively);total possible score range:0=no disease to 72=maximal disease. FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated subjects who had at least one valid post-baseline assessment of PASI in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, 10 and 12
    End point values
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
    Number of subjects analysed
    24
    24
    24
    25
    25
    Units: percentage of subjects
    number (not applicable)
        Week 2 (n= 24, 24, 24, 25, 25)
    4.2
    0
    0
    0
    0
        Week 4 (n= 24, 24, 23, 24, 24)
    8.3
    4.2
    8.7
    4.2
    0
        Week 6 (n= 23, 23, 24, 24, 23)
    13
    13
    8.3
    4.2
    4.3
        Week 10 (n= 22, 22, 24, 24, 22)
    22.7
    18.2
    12.5
    8.3
    9.1
        Week 12 (n= 23, 21, 22, 19, 20)
    21.7
    19
    18.2
    10.5
    20
    Statistical analysis title
    Week 12: Namilumab Placebo vs 20 mg
    Statistical analysis description
    CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit. Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 20 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.827
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.027
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.265
         upper limit
    0.211
    Statistical analysis title
    Week 12: Namilumab Placebo vs 50 mg
    Statistical analysis description
    CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit. Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 50 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.768
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.036
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.269
         upper limit
    0.198
    Statistical analysis title
    Week 12: Namilumab Placebo vs 80 mg
    Statistical analysis description
    CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit. Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 80 mg
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.338
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.112
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.33
         upper limit
    0.106
    Statistical analysis title
    Week 12: Namilumab Placebo vs 150 mg
    Statistical analysis description
    CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit. Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 150 mg
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.89
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.017
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.261
         upper limit
    0.226

    Secondary: Percentage of Subjects Achieving 90 Percent Reduction From Baseline PASI Score (PASI90 Response) at Weeks 2, 4, 6, 10 and 12

    Close Top of page
    End point title
    Percentage of Subjects Achieving 90 Percent Reduction From Baseline PASI Score (PASI90 Response) at Weeks 2, 4, 6, 10 and 12
    End point description
    PASI is an assessment of psoriasis lesion severity and affected body area combined into single score.Body was divided into 4 sections:head(h),trunk(t),upper(u) and lower(l) extremities.Percent body surface area(A) involved was estimated: 0=No involvement to 6=90–100 percent(%).Severity was estimated by clinical signs:erythema(E),induration(I), and desquamation(D);scale:0=no symptoms to 4=very marked.Final PASI=0.1(Eh+Ih+Dh)Ah+0.3(Et+It+Dt)At+0.2(Eu+Iu+Du)Au+0.4(El+Il+Dl)Al where head:0.1,upper extremities(arms):0.2,trunk:0.3,lower extremities(legs):0.4(corresponding to 10%,20%,30% and 40% of body surface area, respectively);total possible score range:0=no disease to 72=maximal disease. FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated subjects who had at least one valid post-baseline assessment of PASI in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, 10 and 12
    End point values
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
    Number of subjects analysed
    24
    24
    24
    25
    25
    Units: percentage of subjects
    number (not applicable)
        Week 2 (n= 24, 24, 24, 25, 25)
    0
    0
    0
    0
    0
        Week 4 (n= 24, 24, 23, 24, 24)
    0
    0
    0
    0
    0
        Week 6 (n= 23, 23, 24, 24, 23)
    0
    4.3
    0
    0
    0
        Week 10 (n= 22, 22, 24, 24, 22)
    0
    4.5
    0
    0
    0
        Week 12 (n= 23, 21, 22, 19, 20)
    0
    4.8
    0
    0
    0
    Statistical analysis title
    Week 12: Namilumab Placebo vs 20 mg
    Statistical analysis description
    CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit. Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 20 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.295
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    0.048
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.043
         upper limit
    0.139

    Secondary: Percentage of Subjects Achieving Greater Than or Equal to (>=) 2 Point Improvement From Baseline in Static Physicians Global Assessment (sPGA) Score at Weeks 2, 4, 6, 10 and 12

    Close Top of page
    End point title
    Percentage of Subjects Achieving Greater Than or Equal to (>=) 2 Point Improvement From Baseline in Static Physicians Global Assessment (sPGA) Score at Weeks 2, 4, 6, 10 and 12
    End point description
    sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe). Subjects who had >=2 point improvement are reported. FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated subjects who had at least one valid post-baseline assessment of PASI in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, 10 and 12
    End point values
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
    Number of subjects analysed
    24
    24
    24
    25
    25
    Units: percentage of subjects
    number (not applicable)
        Week 2 (n= 24, 24, 24, 25, 25)
    0
    0
    0
    0
    0
        Week 4 (n= 24, 24, 23, 24, 24)
    0
    4.2
    4.3
    0
    0
        Week 6 (n= 23, 23, 24, 24, 23)
    0
    13
    4.2
    0
    0
        Week 10 (n= 22, 22, 24, 24, 22)
    13.6
    4.5
    4.2
    0
    4.5
        Week 12 (n= 23, 21, 22, 19, 20)
    13
    14.3
    9.1
    0
    5
    Statistical analysis title
    Week 12: Namilumab Placebo vs 20 mg
    Statistical analysis description
    CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and sPGA response category controlling for visit. Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 20 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.906
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    0.012
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.191
         upper limit
    0.216
    Statistical analysis title
    Week 12: Namilumab Placebo vs 50 mg
    Statistical analysis description
    CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and sPGA response category controlling for visit. Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 50 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.677
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.04
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.222
         upper limit
    0.143
    Statistical analysis title
    Week 12: Namilumab Placebo vs 80 mg
    Statistical analysis description
    CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and sPGA response category controlling for visit. Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 80 mg
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.107
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.13
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.268
         upper limit
    0.007
    Statistical analysis title
    Week 12: Namilumab Placebo vs 150 mg
    Statistical analysis description
    CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and sPGA response category controlling for visit. Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 150 mg
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.371
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.08
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.248
         upper limit
    0.087

    Secondary: Percentage of Subjects Achieving a sPGA Response of Clear (0) or Almost Clear (1) at Weeks 2, 4, 6, 10 and 12

    Close Top of page
    End point title
    Percentage of Subjects Achieving a sPGA Response of Clear (0) or Almost Clear (1) at Weeks 2, 4, 6, 10 and 12
    End point description
    sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe). ‘Clear’ and 'Almost clear’ included all subjects who had scored a 0 or 1. FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated subjects who had at least one valid post-baseline assessment of PASI in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, 10 and 12
    End point values
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
    Number of subjects analysed
    24
    24
    24
    25
    25
    Units: percentage of subjects
    number (not applicable)
        Week 2 (n= 24, 24, 24, 25, 25)
    0
    0
    0
    0
    0
        Week 4 (n= 24, 24, 23, 24, 24)
    0
    0
    0
    0
    0
        Week 6 (n= 23, 23, 24, 24, 23)
    0
    4.3
    0
    0
    0
        Week 10 (n= 22, 22, 24, 24, 22)
    0
    4.5
    0
    0
    0
        Week 12 (n= 23, 21, 22, 19, 20)
    0
    9.5
    0
    0
    0
    Statistical analysis title
    Week 12: Namilumab Placebo vs 20 mg
    Statistical analysis description
    CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and sPGA response category controlling for visit. Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 20 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.134
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    0.095
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.03
         upper limit
    0.221

    Secondary: Change From Baseline in sPGA Score at Weeks 2, 4, 6, 10, and 12

    Close Top of page
    End point title
    Change From Baseline in sPGA Score at Weeks 2, 4, 6, 10, and 12
    End point description
    sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe). FAS included all randomized and treated subjects who had at least one valid post-baseline assessment of PASI in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 6, 10, and 12
    End point values
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
    Number of subjects analysed
    24
    24
    24
    25
    25
    Units: units on a scale
    least squares mean (standard error)
        Baseline (n=24, 24, 24, 25, 25)
    3.5 ( 0.11 )
    3.5 ( 0.11 )
    3.6 ( 0.11 )
    3.3 ( 0.11 )
    3.6 ( 0.1 )
        Change at Week 2 (n=24, 24, 24, 25, 25)
    -0.1 ( 0.08 )
    -0.1 ( 0.08 )
    -0.2 ( 0.08 )
    -0.1 ( 0.08 )
    -0.1 ( 0.08 )
        Change at Week 4 (n=24, 24, 23, 24, 24)
    -0.1 ( 0.1 )
    -0.3 ( 0.1 )
    -0.2 ( 0.1 )
    -0.2 ( 0.1 )
    -0.3 ( 0.09 )
        Change at Week 6 (n=23, 23, 24, 24, 23)
    -0.3 ( 0.12 )
    -0.5 ( 0.12 )
    -0.3 ( 0.12 )
    -0.2 ( 0.12 )
    -0.2 ( 0.12 )
        Change at Week 10 (n=22, 22, 24, 24, 22)
    -0.4 ( 0.12 )
    -0.5 ( 0.12 )
    -0.4 ( 0.12 )
    -0.3 ( 0.12 )
    -0.5 ( 0.12 )
        Change at Week 12 (n=23, 21, 22, 19, 20)
    -0.4 ( 0.13 )
    -0.6 ( 0.13 )
    -0.6 ( 0.13 )
    -0.4 ( 0.13 )
    -0.5 ( 0.13 )
    Statistical analysis title
    Week 12: Namilumab Placebo vs 20 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported. Baseline least squares means and p-values were obtained using an analysis of variance (ANOVA) model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 20 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.258
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    -0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.6
         upper limit
    0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Statistical analysis title
    Week 12: Namilumab Placebo vs 50 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 50 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.365
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    -0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.5
         upper limit
    0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Statistical analysis title
    Week 12: Namilumab Placebo vs 80 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 80 mg
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.757
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.3
         upper limit
    0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Statistical analysis title
    Week 12: Namilumab Placebo vs 150 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 150 mg
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.825
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.4
         upper limit
    0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18

    Secondary: Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 6, 10, and 12

    Close Top of page
    End point title
    Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 6, 10, and 12
    End point description
    Assessment of BSA with psoriasis was performed by means of the palm method, where the palm of the subject's hand represented 1% of BSA. The affected areas were then calculated by their size compared to the subject's palm. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site. FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated subjects who had at least one valid post-baseline assessment of PASI in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 6, 10, and 12
    End point values
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
    Number of subjects analysed
    24
    24
    24
    25
    25
    Units: percentage of total body surface area
    least squares mean (standard error)
        Baseline (n=24, 24, 24, 25, 25)
    23.09 ( 3.674 )
    24.39 ( 3.485 )
    26.16 ( 3.596 )
    22.35 ( 3.497 )
    21.84 ( 3.385 )
        Change at Week 2 (n=24, 24, 24, 25, 25)
    -0.59 ( 0.624 )
    -0.22 ( 0.591 )
    0.21 ( 0.61 )
    -0.35 ( 0.594 )
    -0.26 ( 0.576 )
        Change at Week 4 (n=24, 24, 23, 24, 24)
    -0.86 ( 0.945 )
    -1.02 ( 0.923 )
    -0.24 ( 0.94 )
    -0.09 ( 0.923 )
    0.25 ( 0.911 )
        Change at Week 6 (n=23, 23, 24, 24, 23)
    -1.78 ( 1.366 )
    -3.65 ( 1.351 )
    0.43 ( 1.349 )
    0.36 ( 1.34 )
    0.12 ( 1.343 )
        Change at Week 10 (n=22, 22, 24, 24, 22)
    -3.24 ( 1.551 )
    -4.55 ( 1.542 )
    -0.63 ( 1.522 )
    0.45 ( 1.513 )
    -0.51 ( 1.535 )
        Change at Week 12 (n=23, 21, 22, 19, 20)
    -3.29 ( 1.537 )
    -3.48 ( 1.553 )
    -1.7 ( 1.527 )
    0.35 ( 1.559 )
    -0.51 ( 1.56 )
    Statistical analysis title
    Week 12: Namilumab Placebo vs 20 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 20 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.931
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    -0.19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.48
         upper limit
    4.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.163
    Statistical analysis title
    Week 12: Namilumab Placebo vs 50 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 50 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.459
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    1.59
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.65
         upper limit
    5.84
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.143
    Statistical analysis title
    Week 12: Namilumab Placebo vs 80 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 80 mg
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.094
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    3.65
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.63
         upper limit
    7.93
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.161
    Statistical analysis title
    Week 12: Namilumab Placebo vs 150 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 150 mg
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.203
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    2.78
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.52
         upper limit
    7.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.173

    Secondary: Change From Baseline in Visual Analogue Scale (VAS) Itching Score at Weeks 2, 4, 6, 10, and 12

    Close Top of page
    End point title
    Change From Baseline in Visual Analogue Scale (VAS) Itching Score at Weeks 2, 4, 6, 10, and 12
    End point description
    Assessments were performed using a portable electronic device, which was kept and used by the subject throughout the duration of the study. Subjects were asked to indicate their level of itching by marking a horizontal line with “No itch” at the left extreme and “Worst itch imaginable” at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of itching experienced during the previous 24 hours. FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated subjects who had at least one valid post-baseline assessment of PASI in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 6, 10, and 12
    End point values
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
    Number of subjects analysed
    24
    24
    24
    25
    25
    Units: units on a scale
    least squares mean (standard error)
        Baseline (n=23, 23, 24, 25, 25)
    5.35 ( 0.633 )
    5.28 ( 0.6 )
    5.67 ( 0.61 )
    6.08 ( 0.593 )
    5 ( 0.575 )
        Change at Week 2 (n=23, 23, 23, 25, 24)
    -1.34 ( 0.441 )
    -1.15 ( 0.418 )
    -1.92 ( 0.427 )
    -1.42 ( 0.417 )
    -1.36 ( 0.402 )
        Change at Week 4 (n=23, 23, 23, 23, 24)
    -1.38 ( 0.501 )
    -1.46 ( 0.48 )
    -2.1 ( 0.486 )
    -1.66 ( 0.477 )
    -1.48 ( 0.462 )
        Change at Week 6 (n=22, 22, 24, 22, 23)
    -1.08 ( 0.502 )
    -1.54 ( 0.482 )
    -2.01 ( 0.485 )
    -1.57 ( 0.479 )
    -1.33 ( 0.464 )
        Change at Week 10 (n=21, 21, 24, 22, 21)
    -1.12 ( 0.515 )
    -1.47 ( 0.497 )
    -2 ( 0.496 )
    -1.51 ( 0.492 )
    -1.68 ( 0.481 )
        Change at Week 12 (n=22, 20, 22, 17, 20)
    -0.95 ( 0.523 )
    -1.49 ( 0.508 )
    -2.11 ( 0.504 )
    -1.54 ( 0.508 )
    -2.11 ( 0.494 )
    Statistical analysis title
    Week 12: Namilumab Placebo vs 20 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 20 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.448
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    -0.53
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.92
         upper limit
    0.86
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.7
    Statistical analysis title
    Week 12: Namilumab Placebo vs 50 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 50 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.099
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    -1.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.53
         upper limit
    0.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.692
    Statistical analysis title
    Week 12: Namilumab Placebo vs 80 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 80 mg
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.396
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    -0.59
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.96
         upper limit
    0.78
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.69
    Statistical analysis title
    Week 12: Namilumab Placebo vs 150 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 150 mg
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.102
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    -1.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.54
         upper limit
    0.23
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.697

    Secondary: Change From Baseline in VAS Joint Pain Score at Weeks 2, 4, 6, 10, and 12

    Close Top of page
    End point title
    Change From Baseline in VAS Joint Pain Score at Weeks 2, 4, 6, 10, and 12
    End point description
    Assessments were performed using a portable electronic device, which was kept and used by the subject throughout the duration of the study. Subjects were asked to indicate their severity of joint pain by marking a horizontal line with “No pain” at the left extreme and “Worst pain imaginable” at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of pain experienced during the previous 24 hours. FAS included all randomized and treated subjects who had at least one valid post-baseline assessment of PASI in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 6, 10, and 12
    End point values
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
    Number of subjects analysed
    24
    24
    24
    25
    25
    Units: units on a scale
    least squares mean (standard error)
        Baseline (n=23, 23, 24, 25, 25)
    1.55 ( 0.618 )
    3.45 ( 0.585 )
    3.52 ( 0.595 )
    3.14 ( 0.579 )
    2.13 ( 0.56 )
        Change at Week 2 (n=23, 23, 23, 25, 24)
    -0.25 ( 0.334 )
    -0.89 ( 0.316 )
    -0.81 ( 0.323 )
    -0.68 ( 0.311 )
    -0.3 ( 0.301 )
        Change at Week 4 (n=23, 23, 23, 23, 24)
    -0.28 ( 0.378 )
    -1.06 ( 0.362 )
    -0.91 ( 0.366 )
    -0.89 ( 0.356 )
    -0.47 ( 0.346 )
        Change at Week 6 (n=22, 21, 24, 22, 23)
    -0.04 ( 0.405 )
    -0.84 ( 0.39 )
    -0.9 ( 0.391 )
    -0.63 ( 0.384 )
    -0.47 ( 0.374 )
        Change at Week 10 (n=21, 21, 24, 22, 21)
    -0.08 ( 0.417 )
    -0.6 ( 0.402 )
    -0.77 ( 0.401 )
    -0.56 ( 0.396 )
    -0.56 ( 0.387 )
        Change at Week 12 (n=22, 20, 22, 17, 20)
    0.51 ( 0.458 )
    -0.54 ( 0.449 )
    -0.75 ( 0.444 )
    -0.47 ( 0.452 )
    -0.72 ( 0.436 )
    Statistical analysis title
    Week 12: Namilumab Placebo vs 20 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 20 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.099
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    -1.04
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.29
         upper limit
    -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.626
    Statistical analysis title
    Week 12: Namilumab Placebo vs 50 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 50 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.045
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    -1.26
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.49
         upper limit
    -0.03
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.619
    Statistical analysis title
    Week 12: Namilumab Placebo vs 80 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 80 mg
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.118
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    -0.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.21
         upper limit
    0.25
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.62
    Statistical analysis title
    Week 12: Namilumab Placebo vs 150 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 150 mg
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.05
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    -1.22
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.44
         upper limit
    0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.616

    Secondary: Change From Baseline in VAS Morning Stiffness Score at Weeks 2, 4, 6, 10, and 12

    Close Top of page
    End point title
    Change From Baseline in VAS Morning Stiffness Score at Weeks 2, 4, 6, 10, and 12
    End point description
    Assessments were performed using a portable electronic device, which was kept and used by the subject throughout the duration of the study. Subjects were asked to indicate their level of morning stiffness by marking a horizontal line with “No stiffness” at the left extreme and “Very severe stiffness” at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of stiffness experienced by the subject since waking on that particular day. FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated subjects who had at least one valid post-baseline assessment of PASI in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 6, 10, and 12
    End point values
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
    Number of subjects analysed
    24
    24
    24
    25
    25
    Units: units on a scale
    least squares mean (standard error)
        Baseline (n=23, 23, 24, 25, 25)
    1.73 ( 0.592 )
    3.32 ( 0.561 )
    3.33 ( 0.571 )
    2.77 ( 0.555 )
    2.32 ( 0.537 )
        Change at Week 2 (n=23, 23, 23, 25, 24)
    -0.22 ( 0.276 )
    -0.87 ( 0.266 )
    -0.91 ( 0.271 )
    -0.67 ( 0.259 )
    -0.32 ( 0.25 )
        Change at Week 4 (n=23, 23, 23, 23, 24)
    -0.31 ( 0.316 )
    -0.95 ( 0.307 )
    -0.97 ( 0.31 )
    -0.8 ( 0.3 )
    -0.26 ( 0.291 )
        Change at Week 6 (n=22, 21, 24, 22, 23)
    -0.27 ( 0.351 )
    -0.84 ( 0.343 )
    -0.97 ( 0.342 )
    -0.61 ( 0.335 )
    -0.21 ( 0.327 )
        Change at Week 10 (n=21, 21, 24, 22, 21)
    -0.38 ( 0.372 )
    -0.74 ( 0.364 )
    -0.94 ( 0.362 )
    -0.46 ( 0.356 )
    -0.24 ( 0.349 )
        Change at Week 12 (n=22, 20, 22, 17, 20)
    -0.16 ( 0.368 )
    -0.79 ( 0.363 )
    -1.02 ( 0.359 )
    -0.43 ( 0.361 )
    -0.24 ( 0.35 )
    Statistical analysis title
    Week 12: Namilumab Placebo vs 20 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 20 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.211
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    -0.63
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.63
         upper limit
    0.36
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.503
    Statistical analysis title
    Week 12: Namilumab Placebo vs 50 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 50 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.087
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    -0.86
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.85
         upper limit
    0.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.497
    Statistical analysis title
    Week 12: Namilumab Placebo vs 80 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 80 mg
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.58
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    -0.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.26
         upper limit
    0.71
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.494
    Statistical analysis title
    Week 12: Namilumab Placebo vs 150 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 150 mg
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.873
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    -0.08
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.06
         upper limit
    0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.496

    Secondary: Change From Baseline in Duration of Morning Stiffness at Weeks 2, 4, 6, 10, and 12

    Close Top of page
    End point title
    Change From Baseline in Duration of Morning Stiffness at Weeks 2, 4, 6, 10, and 12
    End point description
    Assessments were performed using a portable electronic device, which was kept and used by the subject throughout the duration of the study. Duration of stiffness was elicited in response to a standard question included in the portable device. FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated subjects who had at least one valid post-baseline assessment of PASI in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 6, 10, and 12
    End point values
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
    Number of subjects analysed
    13
    17
    17
    18
    18
    Units: minutes
    least squares mean (standard error)
        Baseline (n=13, 17, 17, 18, 18)
    6.6 ( 5.65 )
    14.2 ( 4.49 )
    18.2 ( 4.84 )
    16.6 ( 4.58 )
    12.4 ( 4.91 )
        Change at Week 2 (n=13, 16, 17, 17, 17)
    1.2 ( 3.33 )
    -1.7 ( 2.67 )
    0.1 ( 2.85 )
    -5.3 ( 2.73 )
    -0.2 ( 2.88 )
        Change at Week 4 (n=13, 16, 16, 16, 17)
    -0.9 ( 3.49 )
    -3 ( 2.8 )
    2.4 ( 3.01 )
    -2.8 ( 2.88 )
    1 ( 3.03 )
        Change at Week 6 (n=13, 13, 17, 14, 16)
    -0.6 ( 4.06 )
    -2.4 ( 3.39 )
    4.1 ( 3.5 )
    -2 ( 3.44 )
    1.8 ( 3.55 )
        Change at Week 10 (n=11, 15, 17, 15, 13)
    -0.9 ( 4.3 )
    -2.3 ( 3.58 )
    5.2 ( 3.71 )
    -2 ( 3.64 )
    1.3 ( 3.77 )
        Change at Week 12 (n=13, 14, 16, 12, 12)
    -1.4 ( 5.12 )
    -3 ( 4.35 )
    6.5 ( 4.44 )
    -0.6 ( 4.42 )
    3 ( 4.56 )
    Statistical analysis title
    Week 12: Namilumab Placebo vs 20 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 20 mg
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.803
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    -1.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -15.2
         upper limit
    11.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.7
    Statistical analysis title
    Week 12: Namilumab Placebo vs 50 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 50 mg
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.248
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    7.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.7
         upper limit
    21.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.73
    Statistical analysis title
    Week 12: Namilumab Placebo vs 80 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 80 mg
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.914
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.7
         upper limit
    14.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.67
    Statistical analysis title
    Week 12: Namilumab Placebo vs 150 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 150 mg
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.523
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    4.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.2
         upper limit
    17.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.74

    Secondary: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12

    Close Top of page
    End point title
    Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12
    End point description
    The DLQI is a 10-point rating scale for determining the impact of dermatological conditions on the subject's quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Maximum total score is 30, where 0-1 represents “No effect at all on subject's life” and 21-30 “Extremely large effect on subject's life” - higher scores indicating poorer quality of life. FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated subjects who had at least one valid post-baseline assessment of PASI in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
    Number of subjects analysed
    21
    21
    22
    19
    19
    Units: units on a scale
    least squares mean (standard error)
        Baseline
    13.8 ( 1.95 )
    12.2 ( 1.85 )
    10.3 ( 1.83 )
    13.9 ( 1.95 )
    11.4 ( 1.89 )
        Change at Week 12
    -0.7 ( 1.06 )
    -0.7 ( 1.01 )
    -1.9 ( 1.01 )
    -2.1 ( 1.06 )
    -2.8 ( 1.03 )
    Statistical analysis title
    Week 12: Namilumab Placebo vs 20 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from an Analysis of covariance (ANCOVA) model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 20 mg
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.978
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.7
         upper limit
    2.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.37
    Statistical analysis title
    Week 12: Namilumab Placebo vs 50 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 50 mg
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.389
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -1.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.9
         upper limit
    1.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.36
    Statistical analysis title
    Week 12: Namilumab Placebo vs 80 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 80 mg
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.316
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -1.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.2
         upper limit
    1.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.39
    Statistical analysis title
    Week 12: Namilumab Placebo vs 150 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 150 mg
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.142
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -2.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.9
         upper limit
    0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.41

    Secondary: Change From Baseline in Short Form 36 Health Survey (SF-36) at Week 12

    Close Top of page
    End point title
    Change From Baseline in Short Form 36 Health Survey (SF-36) at Week 12
    End point description
    SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning). FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated subjects who had at least one valid post-baseline assessment of PASI in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
    Number of subjects analysed
    20
    20
    22
    19
    18
    Units: units on a scale
    least squares mean (standard error)
        Physical Health Summary Score: Baseline
    52.9 ( 2.08 )
    46.6 ( 1.97 )
    49 ( 1.92 )
    52.8 ( 2.04 )
    50.7 ( 2.05 )
        Physical Health Summary Score: Change at Week 12
    -0.5 ( 1.31 )
    -2.6 ( 1.24 )
    -0.8 ( 1.19 )
    0.9 ( 1.28 )
    0.4 ( 1.27 )
        Mental Health Summary Score: Baseline
    43.7 ( 2.67 )
    42.9 ( 2.53 )
    42.8 ( 2.46 )
    42.3 ( 2.61 )
    46 ( 2.63 )
        Mental Health Summary Score: Change at Week 12
    0.9 ( 1.78 )
    2.8 ( 1.69 )
    1.5 ( 1.64 )
    1.5 ( 1.75 )
    1.6 ( 1.76 )
    Statistical analysis title
    Physical Health Summary Score: Placebo vs 20 mg
    Statistical analysis description
    Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 20 mg
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.229
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -2.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.6
         upper limit
    1.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.73
    Statistical analysis title
    Physical Health Summary Score: Placebo vs 50 mg
    Statistical analysis description
    Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 50 mg
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.863
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.6
         upper limit
    3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.65
    Statistical analysis title
    Physical Health Summary Score: Placebo vs 80 mg
    Statistical analysis description
    Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 80 mg
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.403
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    1.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.9
         upper limit
    4.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.67
    Statistical analysis title
    Physical Health Summary Score: Placebo vs 150 mg
    Statistical analysis description
    Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 150 mg
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.597
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.5
         upper limit
    4.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.74
    Statistical analysis title
    Mental Health Summary Score: Placebo vs 20 mg
    Statistical analysis description
    Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 20 mg
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.416
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    1.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.7
         upper limit
    6.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.32
    Statistical analysis title
    Mental Health Summary Score: Placebo vs 50 mg
    Statistical analysis description
    Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 50 mg
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.77
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.8
         upper limit
    5.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.24
    Statistical analysis title
    Mental Health Summary Score: Placebo vs 80 mg
    Statistical analysis description
    Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 80 mg
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.798
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    0.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4
         upper limit
    5.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.31
    Statistical analysis title
    Week 12: Namilumab Placebo vs 150 mg
    Statistical analysis description
    Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 150 mg
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.767
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.1
         upper limit
    5.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.4

    Secondary: Change From Baseline in EuroQoL Health Questionnaire (EQ-5D)- Index Score at Week 12

    Close Top of page
    End point title
    Change From Baseline in EuroQoL Health Questionnaire (EQ-5D)- Index Score at Week 12
    End point description
    EQ-5D-Index score is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows subjects to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The score ranges from -0.594 to 1.000. The higher score indicates a better health state perceived by the subject. FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated subjects who had at least one valid post-baseline assessment of PASI in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
    Number of subjects analysed
    20
    20
    22
    19
    18
    Units: units on a scale
    least squares mean (standard error)
        Baseline
    0.86 ( 0.041 )
    0.8 ( 0.038 )
    0.84 ( 0.038 )
    0.81 ( 0.04 )
    0.87 ( 0.04 )
        Change at Week 12
    -0.02 ( 0.033 )
    -0.04 ( 0.031 )
    -0.04 ( 0.03 )
    0.01 ( 0.033 )
    0.01 ( 0.033 )
    Statistical analysis title
    Week 12: Namilumab Placebo vs 20 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 20 mg
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.57
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.11
         upper limit
    0.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.043
    Statistical analysis title
    Week 12: Namilumab Placebo vs 50 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 50 mg
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.619
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.1
         upper limit
    0.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.042
    Statistical analysis title
    Week 12: Namilumab Placebo vs 80 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 80 mg
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.597
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    0.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.06
         upper limit
    0.11
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.043
    Statistical analysis title
    Week 12: Namilumab Placebo vs 150 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 150 mg
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.509
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    0.03
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.06
         upper limit
    0.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.044

    Secondary: Change From Baseline in EQ-5D-VAS Score at Week 12

    Close Top of page
    End point title
    Change From Baseline in EQ-5D-VAS Score at Week 12
    End point description
    EQ-5D-VAS is a subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (“Worst imaginable health state”) to 100 mm (“Best imaginable health state”); higher scores indicate a better health state. FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated subjects who had at least one valid post-baseline assessment of PASI in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
    Number of subjects analysed
    16
    17
    20
    17
    16
    Units: millimeter (mm)
    least squares mean (standard error)
        Baseline
    76.8 ( 5.77 )
    58.9 ( 5.13 )
    67.2 ( 5.09 )
    75.3 ( 5.42 )
    74.3 ( 5.47 )
        Change at Week 12
    0.5 ( 3.99 )
    -0.5 ( 3.67 )
    5.3 ( 3.51 )
    -1.4 ( 3.74 )
    -1.9 ( 3.77 )
    Statistical analysis title
    Week 12: Namilumab Placebo vs 20 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 20 mg
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.845
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -11.7
         upper limit
    9.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.32
    Statistical analysis title
    Week 12: Namilumab Placebo vs 50 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 50 mg
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.323
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    4.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.8
         upper limit
    14.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.8
    Statistical analysis title
    Week 12: Namilumab Placebo vs 80 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 80 mg
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.697
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -1.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -11.7
         upper limit
    7.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.89
    Statistical analysis title
    Week 12: Namilumab Placebo vs 150 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 150 mg
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.633
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -2.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.6
         upper limit
    7.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.1

    Secondary: Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 6, 10, and 12

    Close Top of page
    End point title
    Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 6, 10, and 12
    End point description
    The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lunula, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated subjects who had at least one valid post-baseline assessment of PASI in the double-blind period.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 6, 10, and 12
    End point values
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg
    Number of subjects analysed
    24
    24
    24
    25
    25
    Units: units on a scale
    least squares mean (standard error)
        Baseline (n=24, 24, 24, 25, 25)
    14.5 ( 3.56 )
    9.6 ( 3.37 )
    15.6 ( 3.48 )
    12 ( 3.39 )
    12.5 ( 3.28 )
        Change at Week 2 (n=24, 24, 24, 25, 25)
    -0.8 ( 0.53 )
    0.1 ( 0.5 )
    0.8 ( 0.52 )
    0.4 ( 0.5 )
    0.1 ( 0.48 )
        Change at Week 4 (n=24, 24, 23, 24, 24)
    -1.5 ( 0.77 )
    0 ( 0.75 )
    1.4 ( 0.77 )
    0.6 ( 0.75 )
    0.1 ( 0.74 )
        Change at Week 6 (n=23, 23, 24, 24, 23)
    -1.5 ( 0.99 )
    -0.2 ( 0.98 )
    1.2 ( 0.98 )
    2.3 ( 0.97 )
    -0.7 ( 0.97 )
        Change at Week 10 (n=22, 22, 24, 24, 21)
    -2.4 ( 1.03 )
    -0.6 ( 1.02 )
    0.8 ( 1.01 )
    2 ( 1 )
    0.6 ( 1.02 )
        Change at Week 12 (n=23, 21, 22, 19, 20)
    -1.5 ( 1.17 )
    -0.5 ( 1.18 )
    0.9 ( 1.16 )
    2.5 ( 1.17 )
    1 ( 1.18 )
    Statistical analysis title
    Week 12: Namilumab Placebo vs 20 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 20 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.537
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.2
         upper limit
    4.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.64
    Statistical analysis title
    Week 12: Namilumab Placebo vs 50 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 50 mg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.142
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    2.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.8
         upper limit
    5.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.62
    Statistical analysis title
    Week 12: Namilumab Placebo vs 80 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 80 mg
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.015
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.8
         upper limit
    7.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.63
    Statistical analysis title
    Week 12: Namilumab Placebo vs 150 mg
    Statistical analysis description
    Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.
    Comparison groups
    Double-Blind Period: Placebo v Double-Blind Period: Namilumab 150 mg
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.121
    Method
    MMRM
    Parameter type
    LS Mean Difference
    Point estimate
    2.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.7
         upper limit
    5.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.64

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
    Adverse event reporting additional description
    At each clinic visit the investigator was required to document any occurrence of adverse events - including at specified visits abnormal laboratory, ECG and lung function test findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Double-Blind Period: Placebo
    Reporting group description
    Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection subcutaneously at Weeks 2, 6 and 10 during the double-blind period.

    Reporting group title
    Double-Blind Period: Namilumab 20 mg
    Reporting group description
    Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg), subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.

    Reporting group title
    Double-Blind Period: Namilumab 50 mg
    Reporting group description
    Namilumab 100 mg injection (2 separate injections of 50 mg), subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.

    Reporting group title
    Double-Blind Period: Namilumab 80 mg
    Reporting group description
    Namilumab 160 mg injection (2 separate injections of 80 mg), subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.

    Reporting group title
    Double-Blind Period: Namilumab 150 mg
    Reporting group description
    Namilumab 300 mg injection (2 separate injections of 150 mg), subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.

    Reporting group title
    Open-Label Period: Namilumab 80 mg
    Reporting group description
    Namilumab 80 mg, single injection, subcutaneously, every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.

    Reporting group title
    Open-Label Period: Namilumab 150 mg
    Reporting group description
    Namilumab 150 mg, single injection, subcutaneously from Week 8 and then every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.

    Reporting group title
    Follow-up Period: Placebo
    Reporting group description
    Subjects who received namilumab-matching placebo injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.

    Reporting group title
    Follow-up Period: Namilumab 20 mg
    Reporting group description
    Subjects who received namilumab 20 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.

    Reporting group title
    Follow-up Period: Namilumab 50 mg
    Reporting group description
    Subjects who received namilumab 50 mg injections during the double-blind treatment were to be followed-up after the last dose of study drug - whether administered in the double-blind period or open-label extension period.

    Reporting group title
    Follow-up Period: Namilumab 80 mg
    Reporting group description
    Subjects who received namilumab 80 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.

    Reporting group title
    Follow-up: Namilumab 150 mg
    Reporting group description
    Subjects who received namilumab 150 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.

    Serious adverse events
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg Open-Label Period: Namilumab 80 mg Open-Label Period: Namilumab 150 mg Follow-up Period: Placebo Follow-up Period: Namilumab 20 mg Follow-up Period: Namilumab 50 mg Follow-up Period: Namilumab 80 mg Follow-up: Namilumab 150 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 48 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
    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
    0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    0 / 48 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 25 (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
    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
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Double-Blind Period: Placebo Double-Blind Period: Namilumab 20 mg Double-Blind Period: Namilumab 50 mg Double-Blind Period: Namilumab 80 mg Double-Blind Period: Namilumab 150 mg Open-Label Period: Namilumab 80 mg Open-Label Period: Namilumab 150 mg Follow-up Period: Placebo Follow-up Period: Namilumab 20 mg Follow-up Period: Namilumab 50 mg Follow-up Period: Namilumab 80 mg Follow-up: Namilumab 150 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 24 (20.83%)
    0 / 24 (0.00%)
    2 / 24 (8.33%)
    3 / 25 (12.00%)
    2 / 25 (8.00%)
    1 / 12 (8.33%)
    2 / 48 (4.17%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 25 (4.00%)
    1 / 25 (4.00%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 48 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 48 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Wound
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 48 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Toothache
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 48 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 24 (12.50%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    3 / 25 (12.00%)
    1 / 25 (4.00%)
    0 / 12 (0.00%)
    2 / 48 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 25 (4.00%)
    1 / 25 (4.00%)
         occurrences all number
    3
    0
    2
    3
    1
    0
    3
    0
    0
    0
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    1 / 12 (8.33%)
    0 / 48 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    1
    0
    1
    1
    0
    1
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 48 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jul 2014
    The primary purpose of this amendment was to update the protocol regarding addition of the extension period - including open-label treatment and post-treatment follow-up.
    04 Nov 2014
    The primary purpose of this amendment was to increase the study population (sample size) to 120 subjects in total. This increase is needed to help accommodate the target number of subjects willing to provide tissue biopsy samples in the Biopsy sub-study.

    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 © 1995-2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA