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    Clinical Trial Results:
    LEO 90100 aerosol foam compared to calcipotriol plus betamethasone dipropionate gel in subjects with psoriasis vulgaris

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2013-004686-14
    Trial protocol
    		 FR  
    Global end of trial date
    04 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Jul 2016
    First version publication date
    17 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LP0053-1003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02132936
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LEO Pharma A/S
    Sponsor organisation address
    Industriparken 55, Ballerup, Denmark, 2750
    Public contact
    Clinical Trial Disclosure Manager, LEO Pharma A/S, 45 44945888, ctr.disclosure@leo-pharma.com
    Scientific contact
    Clinical Trial Disclosure Manager, LEO Pharma A/S, 45 44945888, ctr.disclosure@leo-pharma.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
    11 Sep 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Mar 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of treatment with LEO 90100 at Week 4 to that of calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 in subjects with psoriasis vulgaris
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jun 2014
    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
    United Kingdom: 173
    Country: Number of subjects enrolled
    France: 122
    Country: Number of subjects enrolled
    United States: 168
    Worldwide total number of subjects
    463
    EEA total number of subjects
    295
    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)
    341
    From 65 to 84 years
    121
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first subject was enrolled on 30-Jun-2014 and the last subject completed the trial (last visit, including followup) on 04-Mar-2015.

    Pre-assignment
    Screening details
    		 504 subjects from 41 centres in the UK (15 centres), the US (15 centres) and France (11 centres) were enrolled into the trial. 41 enrolled subjects were not randomised due to the following reasons: screening failures (29 subjects); AE (1); protocol deviation (1); lost to follow-up (2); withdrawal by subject (3); other reasons (5).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Investigator [1]
    Blinding implementation details
    The trial was investigator-blinded. As 2 of the treatments were in an aerosol foam formulation and 2 were in a gel formulation, the subjects knew if they received aerosol foam or gel but did not know if they received active treatment or vehicle. Furthermore, the trial medication was handed out to the subjects by a designated person (a study coordinator) so the investigator did not know which IP the subject received.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LEO 90100 aerosol foam
    Arm description
    		 Calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEO 90100
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous foam
    Routes of administration
    Topical use
    Dosage and administration details
    The investigational product (IP) was applied to psoriasis vulgaris affected areas on the trunk, arms and legs once daily for up to 12 weeks.

    Arm title
    		 Aerosol Foam Vehicle
    Arm description
    		 Aerosol foam vehicle, 60 g per can
    Arm type
    		 Placebo

    Investigational medicinal product name
    Aerosol foam vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous foam
    Routes of administration
    Topical use
    Dosage and administration details
    The IP was applied to psoriasis vulgaris affected areas on the trunk, arms and legs once daily for up to 12 weeks.

    Arm title
    		 Calcipotriol BDP Gel
    Arm description
    		 Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Calcipotriol BDP Gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    The IP was applied to psoriasis vulgaris affected areas on the trunk, arms and legs once daily for up to 12 weeks.

    Arm title
    		 Gel Vehicle
    Arm description
    		 Gel vehicle, 60 g per bottle
    Arm type
    		 Placebo

    Investigational medicinal product name
    Gel Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    The IP was applied to psoriasis vulgaris affected areas on the trunk, arms and legs once daily for up to 12 weeks.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The trial was investigator-blinded to ensure unbiased efficacy assessment. Subjects knew if they were treated with a foam or gel formulation but did not know if they received active treatment or vehicle.
    Number of subjects in period 1
    		LEO 90100 aerosol foam Aerosol Foam Vehicle Calcipotriol BDP Gel Gel Vehicle
    Started
    185
    47
    188
    43
    Completed
    175
    38
    174
    29
    Not completed
    10
    9
    14
    14
         Consent withdrawn by subject
    2
    1
    -
    4
         Subject withdrew consent
    -
    -
    2
    -
         Adverse event, non-fatal
    3
    1
    3
    -
         Lost to follow-up
    2
    2
    5
    1
         Lack of efficacy
    1
    5
    4
    9
         Protocol deviation
    2
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LEO 90100 aerosol foam
    Reporting group description
    		 Calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can

    Reporting group title
    Aerosol Foam Vehicle
    Reporting group description
    		 Aerosol foam vehicle, 60 g per can

    Reporting group title
    Calcipotriol BDP Gel
    Reporting group description
    		 Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle

    Reporting group title
    Gel Vehicle
    Reporting group description
    		 Gel vehicle, 60 g per bottle

    Reporting group values
    		 LEO 90100 aerosol foam Aerosol Foam Vehicle Calcipotriol BDP Gel Gel Vehicle Total
    Number of subjects
    		 185 47 188 43 463
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 137 37 134 33 341
        From 65-84 years
    		 48 10 53 10 121
        85 years and over
    		 0 0 1 0 1
    Gender categorical
    Units: Subjects
        Female
    		 59 18 74 17 168
        Male
    		 126 29 114 26 295

    End points

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    End points reporting groups
    Reporting group title
    LEO 90100 aerosol foam
    Reporting group description
    		 Calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can

    Reporting group title
    Aerosol Foam Vehicle
    Reporting group description
    		 Aerosol foam vehicle, 60 g per can

    Reporting group title
    Calcipotriol BDP Gel
    Reporting group description
    		 Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle

    Reporting group title
    Gel Vehicle
    Reporting group description
    		 Gel vehicle, 60 g per bottle

    Primary: Treatment Success According to the PGA

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    End point title
    		 Treatment Success According to the PGA [1]
    End point description
    To compare the efficacy of treatment of LEO 90100 at Week 4 to that of calcipotriol BDP gel at Week 8 in subjects with psoriasis vulgaris. The severity of psoriasis vulgaris on the trunk and limbs was assessed using the Physician's Global Assessment of disease severity (PGA). A five-point scale (clear, almost clear, mild, moderate, and severe) was used. 'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline.
    End point type
    Primary
    End point timeframe
    Week 4 for LEO 90100 and Week 8 for calcipotriol BDP gel
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The statistical analysis of the primary endpoint was planned and performed to compare the 2 active treatments.
    End point values
    		 LEO 90100 aerosol foam Calcipotriol BDP Gel
    Number of subjects analysed
    185
    188
    Units: Percentage of subjects
        number (not applicable)
    38.3
    22.5
    Statistical analysis title
    		 Treatment Success According to the PGA
    Statistical analysis description
    Mantel-Haenszel odds of treatment success in LEO 90100 group relative to calcipotriol BDP gel group, adjusted for pooled centre and baseline PGA. Multiple imputation was used to handle missing PGA values.
    Comparison groups
    LEO 90100 aerosol foam v Calcipotriol BDP Gel
    Number of subjects included in analysis
    373
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.46
         upper limit
    		 4.46

    Secondary: Subjects With PASI 75 at Week 4 for LEO 90100 and at Week 8 for Calcipotriol BDP Gel

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    End point title
    		 Subjects With PASI 75 at Week 4 for LEO 90100 and at Week 8 for Calcipotriol BDP Gel [2]
    End point description
    Subjects with PASI 75 (a 75% reduction in the modified Psoriasis Area and Severity Index) at Week 4 for LEO 90100 and at Week 8 for calcipotriol BDP gel.
    End point type
    Secondary
    End point timeframe
    Week 4 for LEO 90100 and Week 8 for calcipotriol BDP gel
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The statistical analysis of this secondary endpoint was planned and performed for the 2 active treatments.
    End point values
    		 LEO 90100 aerosol foam Calcipotriol BDP Gel
    Number of subjects analysed
    185
    188
    Units: Percentage of subjects
        number (not applicable)
    52.1
    34.6
    Statistical analysis title
    		 Subjects With PASI 75
    Statistical analysis description
    Mantel-Haenszel odds of having PASI 75 in LEO 90100 group relative to calcipotriol BDP gel group, adjusted for pooled centre and baseline PGA. Multiple imputation was used to handle missing data.
    Comparison groups
    LEO 90100 aerosol foam v Calcipotriol BDP Gel
    Number of subjects included in analysis
    373
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.37
         upper limit
    		 3.47

    Secondary: Time to ‘Treatment Success’ According to PGA.

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    End point title
    		 Time to ‘Treatment Success’ According to PGA. [3]
    End point description
    Definition for 'treatment success' is given under the primary endpoint. Time to treatment success was calculated as the number of weeks from baseline to the visit where the subject first achieved treatment success. LEO 90100 (n=185) Time to treatment success (median): 6 weeks Lower quartile: 4 Upper quartile: NA (could not be estimated as less than 75% of subjects achieved treatment success) Calcipotriol BDP gel (n=188) Time to treatment success (median): NA (could not be estimated for the group as less than 50% of subjects achieved treatment success) Lower quartile: 6 Upper quartile: NA (could not be estimated as less than 75% of subjects achieved treatment success) In the table below, measure type is set to 'number' instead of 'median', and precision type is set to 'not applicable' instead of 'inter-quartile range', as the database does not accept NA values for intra-quartile range to a median number.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The statistical analysis of this secondary endpoint was planned and performed for the 2 active treatments.
    End point values
    		 LEO 90100 aerosol foam Calcipotriol BDP Gel
    Number of subjects analysed
    185
    188
    Units: Weeks
        number (not applicable)
    6
    0
    Statistical analysis title
    		 Time to ‘Treatment Success’ According to PGA.
    Comparison groups
    Calcipotriol BDP Gel v LEO 90100 aerosol foam
    Number of subjects included in analysis
    373
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.46
         upper limit
    		 2.65

    Secondary: Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group)

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    End point title
    		 Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group) [4]
    End point description
    Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale (VAS) - range from 0 (no itch at all) to 100 mm (worst itch one could imagine).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 4
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The statistical analysis of this secondary endpoint was planned and performed to compare LEO 90100 with its vehicle.
    End point values
    		 LEO 90100 aerosol foam Aerosol Foam Vehicle
    Number of subjects analysed
    185
    47
    Units: Units on a scale
        arithmetic mean (confidence interval 95%)
    -30.5 (-33.4 to -27.5)
    -15.9 (-21.3 to 10.5)
    Statistical analysis title
    		 Change in Itch (LEO 90100 vs. the Foam Vehicle)
    Comparison groups
    LEO 90100 aerosol foam v Aerosol Foam Vehicle
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -14.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.64
         upper limit
    		 -8.55
    Notes
    [5] - Mean change in itch adjusted for pooled centre, baseline PGA and baseline itch. Multiple imputation used for missing data.

    Secondary: Change in Itch as Assessed on a VAS Scale From Baseline to Week 4 (LEO 90100) vs. Week 8 (Calcipotriol BDP Gel).

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    End point title
    		 Change in Itch as Assessed on a VAS Scale From Baseline to Week 4 (LEO 90100) vs. Week 8 (Calcipotriol BDP Gel). [6]
    End point description
    Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale - range from 0 (no itch at all) to 100 mm (worst itch one could imagine).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 4 for LEO 90100 and Baseline to Week 8 for calcipotriol BDP gel
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The statistical analysis of this secondary endpoint was planned and performed for the 2 active treatments.
    End point values
    		 LEO 90100 aerosol foam Calcipotriol BDP Gel
    Number of subjects analysed
    185
    188
    Units: Units on a scale
        arithmetic mean (confidence interval 95%)
    -30.5 (-33.4 to -27.5)
    -28.5 (-31.4 to -25.6)
    Statistical analysis title
    		 Change in Itch (LEO 90100 vs. Calcipotriol BDP Ge)
    Statistical analysis description
    Mean change in itch adjusted for pooled centre, baseline PGA and baseline itch. Multiple imputation used for missing data.
    Comparison groups
    LEO 90100 aerosol foam v Calcipotriol BDP Gel
    Number of subjects included in analysis
    373
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.33
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.78
         upper limit
    		 1.93

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 0 until week 12
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    LEO 90100
    Reporting group description
    		 -

    Reporting group title
    Aerosol Foam Vehicle
    Reporting group description
    		 -

    Reporting group title
    Calcipotriol BDP Gel
    Reporting group description
    		 -

    Reporting group title
    Gel Vehicle
    Reporting group description
    		 -

    Serious adverse events
    		 LEO 90100 Aerosol Foam Vehicle Calcipotriol BDP Gel Gel Vehicle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 185 (4.32%)
    0 / 47 (0.00%)
    3 / 188 (1.60%)
    1 / 43 (2.33%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 47 (0.00%)
    0 / 188 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 47 (0.00%)
    1 / 188 (0.53%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 47 (0.00%)
    0 / 188 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 47 (0.00%)
    1 / 188 (0.53%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 47 (0.00%)
    0 / 188 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 47 (0.00%)
    0 / 188 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 47 (0.00%)
    0 / 188 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 47 (0.00%)
    1 / 188 (0.53%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 LEO 90100 Aerosol Foam Vehicle Calcipotriol BDP Gel Gel Vehicle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    77 / 185 (41.62%)
    25 / 47 (53.19%)
    60 / 188 (31.91%)
    28 / 43 (65.12%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon adenoma
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 47 (0.00%)
    0 / 188 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    0
    0
    1
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 47 (0.00%)
    0 / 188 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    0
    0
    1
    Hypertension
         subjects affected / exposed
    2 / 185 (1.08%)
    0 / 47 (0.00%)
    7 / 188 (3.72%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    7
    0
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 47 (2.13%)
    0 / 188 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    0
    1
    Application site pruritus
         subjects affected / exposed
    1 / 185 (0.54%)
    2 / 47 (4.26%)
    1 / 188 (0.53%)
    1 / 43 (2.33%)
         occurrences all number
    1
    2
    1
    1
    Feeling cold
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 47 (2.13%)
    0 / 188 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Influenza like illness
         subjects affected / exposed
    3 / 185 (1.62%)
    0 / 47 (0.00%)
    2 / 188 (1.06%)
    1 / 43 (2.33%)
         occurrences all number
    3
    0
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 185 (0.54%)
    1 / 47 (2.13%)
    2 / 188 (1.06%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    2
    1
    Nasal congestion
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 47 (2.13%)
    0 / 188 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pulmonary congestion
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 47 (2.13%)
    0 / 188 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sinus congestion
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 47 (2.13%)
    0 / 188 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    Vitamin D decreased
         subjects affected / exposed
    2 / 185 (1.08%)
    1 / 47 (2.13%)
    3 / 188 (1.60%)
    1 / 43 (2.33%)
         occurrences all number
    2
    1
    3
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 47 (0.00%)
    1 / 188 (0.53%)
    1 / 43 (2.33%)
         occurrences all number
    0
    0
    1
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 47 (2.13%)
    0 / 188 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Atrial fibrillation
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 47 (0.00%)
    0 / 188 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 185 (1.08%)
    2 / 47 (4.26%)
    1 / 188 (0.53%)
    1 / 43 (2.33%)
         occurrences all number
    2
    2
    1
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 47 (0.00%)
    0 / 188 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    4 / 185 (2.16%)
    0 / 47 (0.00%)
    2 / 188 (1.06%)
    2 / 43 (4.65%)
         occurrences all number
    4
    0
    2
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 185 (1.08%)
    1 / 47 (2.13%)
    1 / 188 (0.53%)
    0 / 43 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Nausea
         subjects affected / exposed
    2 / 185 (1.08%)
    0 / 47 (0.00%)
    2 / 188 (1.06%)
    1 / 43 (2.33%)
         occurrences all number
    2
    0
    2
    1
    Gastroentirits
         subjects affected / exposed
    1 / 185 (0.54%)
    1 / 47 (2.13%)
    1 / 188 (0.53%)
    0 / 43 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    1 / 185 (0.54%)
    1 / 47 (2.13%)
    0 / 188 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 47 (2.13%)
    0 / 188 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dry skin
         subjects affected / exposed
    1 / 185 (0.54%)
    1 / 47 (2.13%)
    0 / 188 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Erythema
         subjects affected / exposed
    1 / 185 (0.54%)
    1 / 47 (2.13%)
    0 / 188 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Pruritus
         subjects affected / exposed
    5 / 185 (2.70%)
    1 / 47 (2.13%)
    2 / 188 (1.06%)
    0 / 43 (0.00%)
         occurrences all number
    6
    1
    2
    0
    Psoriasis
         subjects affected / exposed
    4 / 185 (2.16%)
    1 / 47 (2.13%)
    7 / 188 (3.72%)
    0 / 43 (0.00%)
         occurrences all number
    4
    1
    8
    0
    Renal and urinary disorders
    Renal failure chronic
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 47 (2.13%)
    1 / 188 (0.53%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    5 / 185 (2.70%)
    1 / 47 (2.13%)
    3 / 188 (1.60%)
    2 / 43 (4.65%)
         occurrences all number
    5
    1
    3
    2
    Joint swelling
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 47 (0.00%)
    1 / 188 (0.53%)
    1 / 43 (2.33%)
         occurrences all number
    0
    0
    1
    1
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 47 (0.00%)
    0 / 188 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    0
    0
    1
    Intertrigo candida
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 47 (2.13%)
    0 / 188 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    4 / 185 (2.16%)
    0 / 47 (0.00%)
    1 / 188 (0.53%)
    1 / 43 (2.33%)
         occurrences all number
    4
    0
    1
    1
    Nail infection
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 47 (0.00%)
    0 / 188 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    7 / 185 (3.78%)
    0 / 47 (0.00%)
    4 / 188 (2.13%)
    2 / 43 (4.65%)
         occurrences all number
    7
    0
    4
    2
    Sinusitis
         subjects affected / exposed
    2 / 185 (1.08%)
    0 / 47 (0.00%)
    3 / 188 (1.60%)
    1 / 43 (2.33%)
         occurrences all number
    2
    0
    3
    1
    Tooth abscess
         subjects affected / exposed
    1 / 185 (0.54%)
    1 / 47 (2.13%)
    1 / 188 (0.53%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 185 (2.70%)
    1 / 47 (2.13%)
    9 / 188 (4.79%)
    2 / 43 (4.65%)
         occurrences all number
    6
    1
    9
    2
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    6 / 185 (3.24%)
    0 / 47 (0.00%)
    5 / 188 (2.66%)
    2 / 43 (4.65%)
         occurrences all number
    6
    0
    5
    2

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    NA
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    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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