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    Clinical Trial Results:
    A RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, PARALLEL-GROUP TRIAL TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF P-3073 FOR TOPICAL TREATMENT OF NAIL PSORIASIS

    Summary
    EudraCT number
    		 2015-002365-34
    Trial protocol
    		 LV   DE   CZ   PL   BG   GR  
    Global end of trial date
    08 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Feb 2018
    First version publication date
    20 Feb 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PM1434
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02606760
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Polichem S.A.
    Sponsor organisation address
    50, Val Fleuri Luxembourg, legally represented by branch in Lugano-Pazzallo, Switzerland, CH-6912
    Public contact
    Director, Clinical Development, Polichem S.A., +41 0919864024, maurizio.caserini@polichem.com
    Scientific contact
    Director, Clinical Development, Polichem S.A., +41 0919864024, maurizio.caserini@polichem.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
    08 Feb 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this Phase III study was to evaluate the efficacy of P-3073 in the treatment of nail psoriasis.
    Protection of trial subjects
    The clinical trial was conducted in compliance with globally accepted standards of good clinical practice (as defined in the ICH E6 guideline for good clinical practice, January 1997), in agreement with the Declaration of Helsinki for biomedical research in humans, revised version of Edinburgh (Scotland, 2000) including the Note of Clarification in paragraph 29, Washington (2002) and the announcements for the ‘Principles for Correct Implementation of Clinical Trials’.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Nov 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 124
    Country: Number of subjects enrolled
    Russian Federation: 27
    Country: Number of subjects enrolled
    Bulgaria: 64
    Country: Number of subjects enrolled
    Czech Republic: 67
    Country: Number of subjects enrolled
    Germany: 20
    Country: Number of subjects enrolled
    Latvia: 56
    Worldwide total number of subjects
    358
    EEA total number of subjects
    331
    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)
    315
    From 65 to 84 years
    43
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in Bulgaria, Czech Republic, Germany, Latvia, Poland and Russia between 23 November 2015 (first subject first visit) and 08 February 2017 (last subject last visit).

    Pre-assignment
    Screening details
    		 A total of 378 subjects were enrolled and 358 subjects were randomised in the study and of them, 352 subjects were treated.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 P-3073
    Arm description
    		 Subjects with mild to moderate psoriatic fingernail/s, were treated with P-3073 nail solution as a topical application once daily for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    P-3073
    Investigational medicinal product code
    Other name
    Calcipotriol
    Pharmaceutical forms
    Medicated nail lacquer
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects with mild to moderate psoriatic fingernail/s, were treated with P-3073 nail solution as a topical application once daily for 24 weeks.

    Arm title
    		 Vehicle
    Arm description
    		 Subjects with mild to moderate psoriatic fingernail/s, were treated with vehicle solution matched to P-3073 nail solution as a topical application once daily for 24 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Vehicle
    Pharmaceutical forms
    Medicated nail lacquer
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects with mild to moderate psoriatic fingernail/s, were treated with vehicle solution matched to P-3073 nail solution as a topical application once daily for 24 weeks.

    Number of subjects in period 1
    		P-3073 Vehicle
    Started
    181
    177
    Treated
    176
    176
    Completed
    158
    155
    Not completed
    23
    22
         Consent withdrawn by subject
    10
    13
         Adverse event, non-fatal
    1
    1
         Pregnancy
    1
    1
         Follow Up Visit Wrongly Not Performed
    1
    -
         Lost to follow-up
    7
    3
         Lack of efficacy
    1
    1
         Protocol deviation
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    P-3073
    Reporting group description
    		 Subjects with mild to moderate psoriatic fingernail/s, were treated with P-3073 nail solution as a topical application once daily for 24 weeks.

    Reporting group title
    Vehicle
    Reporting group description
    		 Subjects with mild to moderate psoriatic fingernail/s, were treated with vehicle solution matched to P-3073 nail solution as a topical application once daily for 24 weeks.

    Reporting group values
    		 P-3073 Vehicle Total
    Number of subjects
    		 181 177 358
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.54 ( 13.32 ) 47.94 ( 13.45 ) -
    Gender categorical
    Units: Subjects
        Female
    		 72 63 135
        Male
    		 109 114 223
    Nail Psoriasis Severity Index (NAPSI) Matrix Score
    Nail matrix psoriasis was assessed by the presence of any features including nail pitting, leukonychia, red spots in the lunula, and crumbling in each quadrant of the nail. The score was 0 if the findings were not present, 1 if they were present in 1 quadrant of the nail, 2 if present in 2 quadrants of a nail, 3 if present in 3 quadrants of a nail, and 4 if present in 4 quadrants of a nail. Thus each nail had a matrix score (0-4). The number of mild to moderate psoriasis fingernails analysed at the baseline visit are 1165 and 1166 for the reporting groups P-3073 and Vehicle respectively.
    Units: Score on a scale
        arithmetic mean (standard deviation)
    		 1.35 ( 1.04 ) 1.27 ( 1.06 ) -
    Nail Psoriasis Severity Index (NAPSI) Bed Score
    Nail bed psoriasis was assessed by the presence of any features including onycholysis, oil drop (salmon patch) dyschromia, splinter hemorrhages, and nail bed hyperkeratosis in each quadrant of nail. The score was 0 if the findings were not present, 1 if they were present in 1 quadrant of the nail, 2 if present in 2 quadrants of a nail, 3 if present in 3 quadrants of a nail, and 4 if present in 4 quadrants of a nail. Thus each nail had a nail bed score(0-4). The number of mild to moderate psoriasis fingernails analysed at the baseline are 1165 and 1166 for P-3073 and Vehicle group, respectively
    Units: Score on a scale
        arithmetic mean (standard deviation)
    		 1.55 ( 0.98 ) 1.54 ( 0.94 ) -

    End points

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    End points reporting groups
    Reporting group title
    P-3073
    Reporting group description
    		 Subjects with mild to moderate psoriatic fingernail/s, were treated with P-3073 nail solution as a topical application once daily for 24 weeks.

    Reporting group title
    Vehicle
    Reporting group description
    		 Subjects with mild to moderate psoriatic fingernail/s, were treated with vehicle solution matched to P-3073 nail solution as a topical application once daily for 24 weeks.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS consisted of all randomized subjects to whom the investigational drug was dispensed.

    Subject analysis set title
    Safety analysis set (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SAF consisted of all randomized subjects with at least one documented application of any study drug.

    Primary: Change From Baseline in Total Nail Psoriasis Severity Index (NAPSI) Score at Week 24

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    End point title
    		 Change From Baseline in Total Nail Psoriasis Severity Index (NAPSI) Score at Week 24
    End point description
    Nail psoriasis severity index (NAPSI) was used to asses nail psoriasis. The nail was assessed for nail matrix and bed psoriasis in each quadrant of the nail. The score was 0 if the findings were not present, 1 if they were present in 1 quadrant of the nail, 2 if present in 2 quadrants of a nail, 3 if present in 3 quadrants of a nail, and 4 if present in 4 quadrants of a nail. Thus each nail had a matrix score (0-4) and a nail bed score (0-4), and the total nail score was the sum of those two (0-8). The sum of the scores from all involved fingernails was 0-80 (total NAPSI score for that subject at that time). "n" signifies those subjects who were evaluable for this measure at given time point for each group.
    End point type
    Primary
    End point timeframe
    Baseline, Week 24
    End point values
    		 P-3073 Vehicle
    Number of subjects analysed
    181 [1]
    177 [2]
    Units: Score on the scale
    arithmetic mean (standard deviation)
        Change at week 24 (n=162, 157)
    -3.16 ( 7.72 )
    -2.87 ( 8.39 )
    Notes
    [1] - FAS
    [2] - FAS
    Statistical analysis title
    		 P-3073 vs Vehicle difference
    Statistical analysis description
    The linear effects model included the treatment group and the pooled site as dummy effects and the total NAPSI Score at screening as continuous covariate.
    Comparison groups
    P-3073 v Vehicle
    Number of subjects included in analysis
    358
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7333
    Method
    		 Linear effects model
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.99
         upper limit
    		 1.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.86

    Secondary: Nail Physician’s Global Assessment (PGA) Response Rate at Week 24

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    End point title
    		 Nail Physician’s Global Assessment (PGA) Response Rate at Week 24
    End point description
    Nail PGA score was used to assess the fingernail. For each affected fingernail, the proximal nail matrix, the distal nail matrix, and the nail bed were scored as 0-clear, 1-almost clear, 2-mild, 3-moderate or 4-severe. A responder fingernail was defined as a score of “clear” (0) or “almost clear” (1) and at least 2 points improvement from the baseline score. Nail PGA response rate is the proportion of subjects mild to moderate fingernails with nail PGA response which is the ratio of “number of subjects mild to moderate responder fingernails” by ”number of affected mild to moderate fingernails at baseline” for each subject. "n" signifies subjects who were evaluable for this measure at given time point for each group.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 P-3073 Vehicle
    Number of subjects analysed
    181 [3]
    177 [4]
    Units: Ratio of subject’s responder fingernails
    arithmetic mean (standard deviation)
        Response rate at Week 24 (n=162, 157)
    0.26 ( 0.31 )
    0.29 ( 0.32 )
    Notes
    [3] - FAS
    [4] - FAS
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A generalized linear mixed effects model for repeated measures (MMRM) was modelled to obtain an estimate of the probability to achieve a PGA response after 24 weeks of treatment. Only subjects with at least one mild to moderate fingernail were considered.
    Comparison groups
    P-3073 v Vehicle
    Number of subjects included in analysis
    358
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7913
    Method
    		 MMRM Model
    Parameter type
    		 Median difference (net)
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0.06

    Secondary: Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Matrix Score at Week 24

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    End point title
    		 Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Matrix Score at Week 24
    End point description
    NAPSI was used to asses nail psoriasis. The nail was assessed for nail matrix psoriasis in each quadrant of the nail. Nail matrix psoriasis was assessed by the presence of any features including nail pitting, leukonychia, red spots in the lunula, and crumbling in each quadrant of the nail. The score was 0 if the findings were not present, 1 if they were present in 1 quadrant of the nail, 2 if present in 2 quadrants of a nail, 3 if present in 3 quadrants of a nail, and 4 if present in 4 quadrants of a nail. Thus each nail had a matrix score (0-4). The number of mild to moderate psoriatic fingernails analysed at the baseline visit were 1165 and 1166 for the reporting groups P-3073 and Vehicle respectively. "n" signifies nails of subjects which were evaluable for this measure at given time point for each group.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 P-3073 Vehicle
    Number of subjects analysed
    181 [5]
    177 [6]
    Units: Score on the scale
    arithmetic mean (standard deviation)
        Change at Week 24 (n= 1038, 1040)
    -0.24 ( 1.21 )
    -0.26 ( 1.22 )
    Notes
    [5] - FAS
    [6] - FAS
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    P-3073 v Vehicle
    Number of subjects included in analysis
    358
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.382
    Method
    		 MMRM Model
    Parameter type
    		 Adjusted mean difference
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 0.14

    Secondary: Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Bed Score at Week 24

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    End point title
    		 Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Bed Score at Week 24
    End point description
    NAPSI was used to asses nail psoriasis. The nail was assessed for nail bed psoriasis in each quadrant of the nail. Nail bed psoriasis was assessed by the presence of any features including onycholysis, oil drop (salmon patch) dyschromia, splinter hemorrhages, and nail bed hyperkeratosis in each quadrant of the nail. The score was 0 if the findings were not present, 1 if they were present in 1 quadrant of the nail, 2 if present in 2 quadrants of a nail, 3 if present in 3 quadrants of a nail, and 4 if present in 4 quadrants of a nail. Thus each nail had a nail bed score (0-4). The improvement in NAPSI Bed Score was defined as the achievement of a value of NAPSI Bed Score equal to zero (i.e. completely clearance of psoriatic signs). The number of mild to moderate psoriatic fingernails analysed at the baseline visit were 1165 and 1166 for the reporting groups P-3073 and Vehicle respectively. "n" signifies nails of subjects which were evaluable for this measure at given time for each group
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 P-3073 Vehicle
    Number of subjects analysed
    181 [7]
    177 [8]
    Units: Score on the scale
    arithmetic mean (standard deviation)
        Change at Week 24 ( n= 1038, 1040)
    -0.24 ( 1.04 )
    -0.17 ( 1.10 )
    Notes
    [7] - FAS
    [8] - FAS
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    P-3073 v Vehicle
    Number of subjects included in analysis
    358
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0668
    Method
    		 MMRM Model
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 0.01

    Secondary: Change from Baseline in Subject’s Quality-Of-Life as Assessed by Dermatology Life Quality Index (DLQI) at Week 24

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    End point title
    		 Change from Baseline in Subject’s Quality-Of-Life as Assessed by Dermatology Life Quality Index (DLQI) at Week 24
    End point description
    Dermatology Life Quality Index (DLQI) score was used to evaluate the impact of nail psoriasis on subject’s quality-of-life. The DLQI Total score range from 0 (no effect) to 30 (extremely affected). The higher the score, the more quality of life is impaired. "n" signifies those subjects who were evaluable for this measure at given time point for each group.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 P-3073 Vehicle
    Number of subjects analysed
    181 [9]
    177 [10]
    Units: Score on the scale
    arithmetic mean (standard deviation)
        Change at week 24, n=162, 157
    -2.52 ( 5.54 )
    -2.64 ( 5.41 )
    Notes
    [9] - FAS
    [10] - FAS
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The linear mixed effects model for repeated measures included treatment, pooled site, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate. The unstructured variance-covariance matrix was used to take into account correlation among repeated measures within subject.
    Comparison groups
    P-3073 v Vehicle
    Number of subjects included in analysis
    358
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7885
    Method
    		 MMRM Model
    Parameter type
    		 Adjusted mean difference
    Point estimate
    0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.88
         upper limit
    		 1.16

    Secondary: Proportion of Subject's Mild to Moderate Fingernails With Improvement in Nail Psoriasis Severity Index (NAPSI) Score at Week 24

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    End point title
    		 Proportion of Subject's Mild to Moderate Fingernails With Improvement in Nail Psoriasis Severity Index (NAPSI) Score at Week 24
    End point description
    NAPSI was used to asses nail psoriasis. The nail was assessed for nail matrix and bed psoriasis in each quadrant of the nail. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any features of nail psoriasis in that quadrant. The score was 0 if no findings, and 4 if findings in 4 quadrants of a nail. The total nail score was the sum of those two (0-8). The sum of the scores from all involved fingernails was 0-80 (total NAPSI score for that subject at that time). The improvement in NAPSI score was defined as the achievement of a value of NAPSI score equal to zero. Proportion of subjects’ mild to moderate fingernails with improvement in NAPSI Score is the ratio of “number of improved mild to moderate fingernails in NAPSI Score” by ”number of affected mild to moderate fingernails at baseline” for each subject. "n" signifies the subjects who were evaluable for this measure at given time point for each group.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 P-3073 Vehicle
    Number of subjects analysed
    181 [11]
    177 [12]
    Units: Ratio of subject’s improved fingernails
    arithmetic mean (standard deviation)
        Week 24 (n=162, 158)
    0.20 ( 0.28 )
    0.22 ( 0.30 )
    Notes
    [11] - FAS
    [12] - FAS
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A generalized linear mixed effects model was modelled to obtain estimate of the probability to achieve an improvement after 24 weeks of treatment. Only subjects with at least one mild to moderate fingernail were considered.
    Comparison groups
    P-3073 v Vehicle
    Number of subjects included in analysis
    358
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7434
    Method
    		 MMRM Model
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0.05

    Secondary: Proportion of Subject's Mild to Moderate Fingernails With Improvement in Nail Psoriasis Severity Index (NAPSI) Matrix Score at Week 24

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    End point title
    		 Proportion of Subject's Mild to Moderate Fingernails With Improvement in Nail Psoriasis Severity Index (NAPSI) Matrix Score at Week 24
    End point description
    NAPSI was used to asses each nail psoriasis. The nail was assessed for nail matrix psoriasis in each quadrant of the nail. Nail matrix psoriasis was assessed by the presence of any features including nail pitting, leukonychia, red spots in the lunula, and crumbling in each quadrant of the nail. Each nail had a nail matrix score of 0-4 where was 0 if no findings, and 4 if findings in 4 quadrants of a nail. The improvement in NAPSI matrix score was defined as the achievement of a value of NAPSI matrix score equal to zero (i.e. completely clearance of psoriatic signs). Proportion of subjects’ mild to moderate fingernails with improvement in NAPSI matrix Score is the ratio of “number of improved mild to moderate fingernails in NAPSI matrix Score” by ”number of affected mild to moderate fingernails at baseline” for each subject. "n" signifies the subjects who were evaluable for this measure at given time point for each group.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 P-3073 Vehicle
    Number of subjects analysed
    181 [13]
    177 [14]
    Units: Ratio of subject’s improved fingernails
    arithmetic mean (standard deviation)
        Week 24 (n=162, 158)
    0.28 ( 0.32 )
    0.28 ( 0.32 )
    Notes
    [13] - FAS
    [14] - FAS
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A generalized linear mixed effects model was modelled to obtain estimate of the probability to achieve an improvement after 24 weeks of treatment. Only subjects with at least one mild to moderate fingernail were considered.
    Comparison groups
    P-3073 v Vehicle
    Number of subjects included in analysis
    358
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9753
    Method
    		 Linear mixed effects model
    Parameter type
    		 adjusted mean difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0.07

    Secondary: Proportion of Subject's Mild to Moderate Fingernails With Improvement in Nail Psoriasis Severity Index (NAPSI) Bed Score at Week 24

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    End point title
    		 Proportion of Subject's Mild to Moderate Fingernails With Improvement in Nail Psoriasis Severity Index (NAPSI) Bed Score at Week 24
    End point description
    NAPSI was used to asses each nail psoriasis. The nail was assessed for nail bed psoriasis in each quadrant of the nail. Nail bed psoriasis was assessed by the presence of any features including onycholysis, oil drop (salmon patch) dyschromia, splinter hemorrhages, and nail bed hyperkeratosis in each quadrant of the nail. Each nail had a nail bed score of 0-4 where was 0 if no findings, and 4 if findings in 4 quadrants of a nail. The improvement in NAPSI Bed Score was defined as the achievement of a value of NAPSI Bed Score equal to zero (i.e. completely clearance of psoriatic signs). Proportion of subjects’ mild to moderate fingernails with improvement in NAPSI Bed Score is the ratio of “number of improved mild to moderate fingernails in NAPSI Bed Score” by ”number of affected mild to moderate fingernails at baseline” for each subject. "n" signifies the subjects who were evaluable for this measure at given time point for each group.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 P-3073 Vehicle
    Number of subjects analysed
    181 [15]
    177 [16]
    Units: Ratio of subject’s improved fingernails
    arithmetic mean (standard deviation)
        Week 24 (n=162, 158)
    0.16 ( 0.24 )
    0.18 ( 0.26 )
    Notes
    [15] - FAS
    [16] - FAS
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    A generalized linear mixed effects model was modelled to obtain estimate of the probability to achieve an improvement after 24 weeks of treatment. Only subjects with at least one mild to moderate fingernail were considered.
    Comparison groups
    P-3073 v Vehicle
    Number of subjects included in analysis
    358
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9988
    Method
    		 Linear mixed effects model
    Parameter type
    		 Adjusted mean difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 0.05

    Secondary: Subject Acceptance of Study Therapy at Week 24

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    End point title
    		 Subject Acceptance of Study Therapy at Week 24
    End point description
    The subjects' acceptability of the study therapy was evaluated on the 4-point scale ranged from 1 = poor (very unpleasant and unsatisfactory), 2 = moderate (not fully satisfactory), 3 = good (satisfactory) to 4 = very good (fully satisfactory). "N" signifies those subjects who were evaluable for this measure for each group.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 P-3073 Vehicle
    Number of subjects analysed
    171 [17]
    167 [18]
    Units: Subject
        Poor
    26
    20
        Moderate
    34
    41
        Good
    64
    63
        Very Good
    39
    39
        Not Evaluated
    8
    4
    Notes
    [17] - FAS subjects evaluable for this end point.
    [18] - FAS subjects evaluable for this end point.
    No statistical analyses for this end point

    Secondary: Change in Discomfort Due to Fingernail Psoriasis as Measured on a Visual Analogue Scale (VAS) at Week 24

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    End point title
    		 Change in Discomfort Due to Fingernail Psoriasis as Measured on a Visual Analogue Scale (VAS) at Week 24
    End point description
    The VAS was used to measure the amount of discomfort felt by the subject in fingernail; it ranges from no discomfort (0) to worst possible discomfort (100). "n" signifies those subjects who were evaluable for this measure at given time point for each group.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 P-3073 Vehicle
    Number of subjects analysed
    181 [19]
    177 [20]
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Change at Week 24, n=156, 157
    -12.63 ( 24.95 )
    -11.25 ( 27.45 )
    Notes
    [19] - FAS
    [20] - FAS
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The linear mixed effects model for repeated measures included treatment, pooled site, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate. The unstructured variance-covariance matrix was used to take into account correlation among repeated measures within subjects.
    Comparison groups
    P-3073 v Vehicle
    Number of subjects included in analysis
    358
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.78
    Method
    		 MMRM Model
    Parameter type
    		 Adjusted mean difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.63
         upper limit
    		 4.23

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of study drug application until follow up (Week 28)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    P-3073
    Reporting group description
    		 Subjects with mild to moderate psoriatic fingernail/s, were treated with P-3073 nail solution as a topical application once daily for 24 weeks.

    Reporting group title
    Vehicle
    Reporting group description
    		 Subjects with mild to moderate psoriatic fingernail/s, were treated with vehicle solution matched to P-3073 nail solution as a topical application once daily for 24 weeks.

    Serious adverse events
    		 P-3073 Vehicle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 176 (5.68%)
    4 / 176 (2.27%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Limb traumatic amputation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nail injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle rupture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Psoriasis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 176 (1.70%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriatic arthropathy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 P-3073 Vehicle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    105 / 176 (59.66%)
    91 / 176 (51.70%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Skin papilloma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypertension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 176 (1.14%)
    2 / 176 (1.14%)
         occurrences all number
    2
    2
    Arteriosclerosis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Hypotension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    Surgical and medical procedures
    Atherosclerosis prophylaxis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Tooth extraction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 176 (2.27%)
    0 / 176 (0.00%)
         occurrences all number
    4
    0
    Cataract operation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Wisdom teeth removal
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Sebaceous cyst excision
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Peripheral swelling
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    5
    Fatigue
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    3 / 176 (1.70%)
         occurrences all number
    1
    9
    Immune system disorders
    Allergy to arthropod bite
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Allergy to arthropod sting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Sarcoidosis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Hypersensitivity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 176 (1.14%)
    0 / 176 (0.00%)
         occurrences all number
    2
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    2
    Menstrual disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Oligomenorrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    Oropharyngeal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 176 (2.27%)
    2 / 176 (1.14%)
         occurrences all number
    4
    2
    Cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 176 (3.41%)
    1 / 176 (0.57%)
         occurrences all number
    8
    1
    Psychiatric disorders
    Anxiety
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Depression
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Insomnia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Stress
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    2
    0
    Sleep disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Blood cholesterol increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Aspartate aminotransferase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 176 (1.14%)
    3 / 176 (1.70%)
         occurrences all number
    2
    3
    Blood bilirubin increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Alanine aminotransferase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 176 (1.14%)
    2 / 176 (1.14%)
         occurrences all number
    2
    2
    Blood glucose increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 176 (1.14%)
    1 / 176 (0.57%)
         occurrences all number
    4
    1
    Blood glucose abnormal
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Blood pressure increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Blood triglycerides increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 176 (1.70%)
    2 / 176 (1.14%)
         occurrences all number
    3
    3
    Blood potassium increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 176 (1.14%)
    1 / 176 (0.57%)
         occurrences all number
    2
    1
    Gamma-glutamyltransferase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 176 (1.70%)
    0 / 176 (0.00%)
         occurrences all number
    4
    0
    Glucose urine present
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    2
    0
    Transaminases increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Liver function test abnormal
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 176 (1.14%)
    2 / 176 (1.14%)
         occurrences all number
    2
    2
    Liver function test increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Contusion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 176 (1.70%)
    4 / 176 (2.27%)
         occurrences all number
    3
    6
    Injury corneal
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Fall
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Eye injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Limb injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 176 (1.14%)
    1 / 176 (0.57%)
         occurrences all number
    2
    1
    Nail injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Laceration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Road traffic accident
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Skin injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    Traumatic haematoma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Wound
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Congenital, familial and genetic disorders
    Type V hyperlipidaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Cardiac disorders
    Angina pectoris
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    31 / 176 (17.61%)
    27 / 176 (15.34%)
         occurrences all number
    89
    56
    Cervical radiculopathy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Hypoaesthesia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Intercostal neuralgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Tremor
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Syncope
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Migraine
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Middle ear inflammation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Eye disorders
    Cataract
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Chalazion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Conjunctival hyperaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Visual acuity reduced
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal distension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Abdominal pain upper
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 176 (1.70%)
    3 / 176 (1.70%)
         occurrences all number
    13
    3
    Abdominal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Aphthous ulcer
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    4 / 176 (2.27%)
         occurrences all number
    1
    4
    Dyspepsia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 176 (1.14%)
    1 / 176 (0.57%)
         occurrences all number
    3
    1
    Gastrointestinal disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Toothache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 176 (2.27%)
    3 / 176 (1.70%)
         occurrences all number
    4
    6
    Skin and subcutaneous tissue disorders
    Dermatitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Dermatitis allergic
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Eczema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    2 / 176 (1.14%)
         occurrences all number
    1
    2
    Hyperkeratosis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Erythema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 176 (1.14%)
    0 / 176 (0.00%)
         occurrences all number
    2
    0
    Onychalgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Nail disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 176 (1.14%)
    2 / 176 (1.14%)
         occurrences all number
    2
    3
    Pruritus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    2
    0
    Onychoclasis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    3
    0
    Psoriasis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 176 (4.55%)
    6 / 176 (3.41%)
         occurrences all number
    10
    8
    Skin disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    2
    Rebound psoriasis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Skin ulcer
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Skin irritation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    18 / 176 (10.23%)
    13 / 176 (7.39%)
         occurrences all number
    51
    32
    Solar dermatitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Swelling face
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    Renal and urinary disorders
    Cystitis noninfective
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Renal colic
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 176 (1.14%)
    1 / 176 (0.57%)
         occurrences all number
    3
    1
    Haematuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    Renal cyst
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Proteinuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Urinary tract inflammation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hypothyroidism
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 176 (1.14%)
    0 / 176 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 176 (1.70%)
    4 / 176 (2.27%)
         occurrences all number
    6
    4
    Arthritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 176 (1.14%)
    0 / 176 (0.00%)
         occurrences all number
    2
    0
    Back pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 176 (3.98%)
    9 / 176 (5.11%)
         occurrences all number
    9
    19
    Muscle spasms
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Joint swelling
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Musculoskeletal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    2 / 176 (1.14%)
         occurrences all number
    1
    2
    Intervertebral disc protrusion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Pain in extremity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Musculoskeletal chest pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Myalgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    2 / 176 (1.14%)
         occurrences all number
    2
    2
    Psoriatic arthropathy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Neck pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    3
    Spinal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 176 (1.70%)
    1 / 176 (0.57%)
         occurrences all number
    4
    1
    Infections and infestations
    Conjunctivitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 176 (2.27%)
    2 / 176 (1.14%)
         occurrences all number
    4
    2
    Bronchitis bacterial
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Cystitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    Ear infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Folliculitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    1 / 176 (0.57%)
         occurrences all number
    3
    1
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 176 (1.70%)
    0 / 176 (0.00%)
         occurrences all number
    4
    0
    Gingivitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis viral
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    Hordeolum
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Gastrointestinal infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    1 / 176 (0.57%)
         occurrences all number
    2
    1
    Infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Herpes zoster
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Influenza
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 176 (3.41%)
    5 / 176 (2.84%)
         occurrences all number
    6
    5
    Paronychia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    19 / 176 (10.80%)
    11 / 176 (6.25%)
         occurrences all number
    22
    14
    Pharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 176 (2.27%)
    0 / 176 (0.00%)
         occurrences all number
    4
    0
    Pulpitis dental
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 176 (1.14%)
    0 / 176 (0.00%)
         occurrences all number
    2
    0
    Sinusitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Rhinitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 176 (2.27%)
    4 / 176 (2.27%)
         occurrences all number
    4
    4
    Skin infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    2
    Tinea versicolour
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 176 (1.14%)
    2 / 176 (1.14%)
         occurrences all number
    2
    3
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Vaginal infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    Viral infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 176 (1.14%)
    1 / 176 (0.57%)
         occurrences all number
    2
    1
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    Hypercholesterolaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 176 (2.27%)
    3 / 176 (1.70%)
         occurrences all number
    4
    3
    Diabetes mellitus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 176 (1.14%)
    0 / 176 (0.00%)
         occurrences all number
    2
    0
    Gout
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    Hyperglycaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 176 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    2
    Hyperuricaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 176 (1.14%)
    0 / 176 (0.00%)
         occurrences all number
    2
    0
    Hyperlipidaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 176 (0.57%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    Hypertriglyceridaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 176 (2.27%)
    4 / 176 (2.27%)
         occurrences all number
    4
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Mar 2016
    - 'Subjects acceptance of study therapy at week 24’ was added as secondary endpoint. - Definition of the secondary endpoint related to Nail PGA response was updated. - Rewording of the exclusion criteria related to the use of concomitant topical and systemic psoriatic treatments.

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

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

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