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    Clinical Trial Results:
    A phase III, multicentre, randomised, double-blind, parallel-group trial to evaluate the efficacy and safety of a generic gel (calcipotriol + betamethasone 50 microg/g + 0.5 mg/g gel) compared to originator gel (Daivobet® gel) and vehicle in the treatment of mild to moderate plaque-type psoriasis

    Summary
    EudraCT number
    		 2018-002532-24
    Trial protocol
    		 DE  
    Global end of trial date
    04 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Dec 2020
    First version publication date
    23 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    0155/2018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Helm AG
    Sponsor organisation address
    Nordkanalstr. 28, Hamburg, Germany, 20097
    Public contact
    Senior Manager Clinical Development, Helm AG, 0049 402375 1446, tertia.dejager@helmag.com
    Scientific contact
    Senior Manager Clinical Development, Helm AG, 0049 402375 1446, tertia.dejager@helmag.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
    19 Mar 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Nov 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    a) To demonstrate that topical treatment with the generic calcipotriol- betamethasone gel is therapeutically equivalent to the originator Daivobet® gel in the treatment of chronic stable, mild to moderate plaque-type psoriasis as determined by the percentage reduction in psoriasis area and severity index (PASI). b) To demonstrate the superiority of the generic gel to its vehicle
    Protection of trial subjects
    Prior to recruitment of patients, all relevant documents of the clinical study were submitted and approved by the Independent Ethics Committees (IECs) responsible for the participating investigators. Written consent documents embodied the elements of informed consent as described in the Declaration of Helsinki, the ICH Guidelines for Good Clinical Practice (GCO) and were in accordance with all applicable laws and regulations. The informed consent form and patient information sheet described the planned and permitted uses, transfers and disclosures of the patient's personal data and personal health information for purposes of conducting the study. The informed consent form and the patient information sheet further explained the nature of the study, its objectives and potential risks and benefits as well as the date informed consent was given. Before being enrolled in the clinical study, every patient was informed that participation in this study was voluntary and that s/he could withdraw from the study at any time without giving a reason and without having to fear any loss in his/her medical care. The patient's consent was obtained in writing before the start of the study. By signing the informed consent the patient declared that s/he was participating voluntarily and intended to follow the study protocol instructions and the instructions of the investigator and to answer the questions asked during the course of the study.
    Background therapy
    		 Any pre-existing long-term medication for treatment of existing disorders, which was not considered to interfere with absorption, efficacy, or safety of the IMP or is not listed in the restrictions, was permitted.
    Evidence for comparator
    		 Comparators were the following products: - Originator (marketed product): Daivobet gel (LEO Pharma, Ireland) - Placebo for test product: Vehicle gel
    Actual start date of recruitment
    28 Feb 2019
    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: 237
    Country: Number of subjects enrolled
    Germany: 49
    Worldwide total number of subjects
    286
    EEA total number of subjects
    286
    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)
    238
    From 65 to 84 years
    47
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Date trial initiated (first subject first screening): 28FEB2019 Date trial completed (last subject last visit): 04NOV2019 Countries: Germany and Poland The subjects were either known patients at a site, referred to the site by other physicians or recruited via advertisements.

    Pre-assignment
    Screening details
    		 Male and female subjects with mild to moderate Psoriasis (IGA 2-4), BSA up to 20%, no clinically relevant disease or condition, no active skin disease, no finding during physical examination, wash-out phases for indication related treatment and prohibited medication, no alcohol and drug abuse

    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, Monitor, Data analyst
    Blinding implementation details
    In order to avoid bias the study was realised with a double-blind approach for assessment of efficacy and safety, i.e. subjects and investigators as well as the laboratory have not been aware of the treatment administered. Test and reference treatments were supplied in identical form and similar in color, and general appearance.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Generic calcipotriol-betamethasone gel
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Generic calcipotriol-betamethasone gel
    Investigational medicinal product code
    IMP 1
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Once daily application of a thin layer of IMP to all psoriatic lesions (except face, and genitoanal and intertriginous regions) for up to 8 weeks (56 consecutive days). Based on application guidance and maximum affected BSA of ≤ 20% (4000 cm2) it is calculated that each application will require approximately 5 g gel. During the course of trial, all new lesions have also to be treated.

    Arm title
    		 Daivobet gel
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Daivobet gel
    Investigational medicinal product code
    IMP 2
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Once daily application of a thin layer of IMP to all psoriatic lesions (except face, and genitoanal and intertriginous regions) for up to 8 weeks (56 consecutive days). Based on application guidance and maximum affected BSA of ≤ 20% (4000 cm2) it is calculated that each application will require approximately 5 g gel. During the course of trial, all new lesions have also to be treated.

    Arm title
    		 Generic vehicle
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Generic vehicle
    Investigational medicinal product code
    IMP 3
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Once daily application of a thin layer of IMP to all psoriatic lesions (except face, and genitoanal and intertriginous regions) for up to 8 weeks (56 consecutive days). Based on application guidance and maximum affected BSA of ≤ 20% (4000 cm2) it is calculated that each application will require approximately 5 g gel. During the course of trial, all new lesions have also to be treated.

    Number of subjects in period 1
    		Generic calcipotriol-betamethasone gel Daivobet gel Generic vehicle
    Started
    124
    123
    39
    Completed
    122
    121
    30
    Not completed
    2
    2
    9
         Consent withdrawn by subject
    -
    1
    3
         Physician decision
    -
    -
    1
         Adverse event, non-fatal
    -
    1
    2
         Pregnancy
    1
    -
    -
         start of prohibited medication
    1
    -
    -
         Lack of efficacy
    -
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 286 286
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 238 238
        From 65-84 years
    		 47 47
        85 years and over
    		 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.7 ( 15.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 137 137
        Male
    		 149 149
    Psoriasis Affected BSA [%]
    Units: 20
        arithmetic mean (standard deviation)
    		 8.1 ( 4.6 ) -
    Baseline IGA
    Units: 4.0
        arithmetic mean (standard deviation)
    		 2.7 ( 0.7 ) -
    Baseline PASI
    Units: 15
        arithmetic mean (standard deviation)
    		 8.32 ( 2.69 ) -
    Subject analysis sets

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) will include all randomised subjects who receive at least one IMP application. Subjects may, however, be excluded from the FAS on individual justification in case of serious violations of inclusion or exclusion criteria which are likely to invalidate the assessment of treatment efficacy, notably those which occurred already before randomisation but were not appropriately considered at the time of randomisation. Subjects will be analyzed for efficacy according to the investigational treatment that they were randomised to.

    Subject analysis set title
    Per Protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per-protocol analysis set (PPS) will include all FAS eligible subjects who complete the 4-week treatment phase with at least 75% of the scheduled applications, attend the efficacy assessments at the Week 4/Day 29 visit within a window of +/- 2 days, and have no major protocol deviations interfering with the assessment of the primary efficacy outcome measure. The administration of an IMP other than the randomised treatment will be considered a serious protocol deviation and will thus also lead to exclusion from the PPS. Subjects terminating their trial participation prior to the efficacy assessments at the Week 4/Day 29 visit due to efficacy or tolerability issues will also be retained in the PPS unless other reasons for exclusion also apply.

    Subject analysis set title
    Safety analysis
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomised subjects who receive at least one dose of the study medication will be included in the safety evaluation set (SES). Subjects will be analyzed for safety according to the investigational treatment that they have actually received.

    Subject analysis sets values
    		 FAS Per Protocol Safety analysis
    Number of subjects
    283
    244
    286
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    236
    206
    238
        From 65-84 years
    46
    37
    47
        85 years and over
    1
    1
    1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    46.6 ( 15.4 )
    46.0 ( 15.3 )
    46.7 ( 15.4 )
    Gender categorical
    Units: Subjects
        Female
    135
    117
    137
        Male
    148
    127
    149
    Psoriasis Affected BSA [%]
    Units: 20
        arithmetic mean (standard deviation)
    8.1 ( 4.6 )
    7.9 ( 4.5 )
    8.1 ( 4.6 )
    Baseline IGA
    Units: 4.0
        arithmetic mean (standard deviation)
    2.7 ( 0.7 )
    2.7 ( 0.7 )
    2.7 ( 0.7 )
    Baseline PASI
    Units: 15
        arithmetic mean (standard deviation)
    8.34 ( 2.68 )
    8.17 ( 2.55 )
    8.32 ( 2.69 )

    End points

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    End points reporting groups
    Reporting group title
    Generic calcipotriol-betamethasone gel
    Reporting group description
    		 -

    Reporting group title
    Daivobet gel
    Reporting group description
    		 -

    Reporting group title
    Generic vehicle
    Reporting group description
    		 -

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) will include all randomised subjects who receive at least one IMP application. Subjects may, however, be excluded from the FAS on individual justification in case of serious violations of inclusion or exclusion criteria which are likely to invalidate the assessment of treatment efficacy, notably those which occurred already before randomisation but were not appropriately considered at the time of randomisation. Subjects will be analyzed for efficacy according to the investigational treatment that they were randomised to.

    Subject analysis set title
    Per Protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per-protocol analysis set (PPS) will include all FAS eligible subjects who complete the 4-week treatment phase with at least 75% of the scheduled applications, attend the efficacy assessments at the Week 4/Day 29 visit within a window of +/- 2 days, and have no major protocol deviations interfering with the assessment of the primary efficacy outcome measure. The administration of an IMP other than the randomised treatment will be considered a serious protocol deviation and will thus also lead to exclusion from the PPS. Subjects terminating their trial participation prior to the efficacy assessments at the Week 4/Day 29 visit due to efficacy or tolerability issues will also be retained in the PPS unless other reasons for exclusion also apply.

    Subject analysis set title
    Safety analysis
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomised subjects who receive at least one dose of the study medication will be included in the safety evaluation set (SES). Subjects will be analyzed for safety according to the investigational treatment that they have actually received.

    Primary: FAS - Mean % change from baseline in PASI

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    End point title
    		 FAS - Mean % change from baseline in PASI
    End point description
    End point type
    Primary
    End point timeframe
    From study day 1 to study day 29
    End point values
    		 Generic calcipotriol-betamethasone gel Daivobet gel Generic vehicle
    Number of subjects analysed
    123
    121
    39
    Units: -100
        least squares mean (confidence interval 95%)
    -58.1 (-62.5 to -53.7)
    -59.8 (-64.2 to -55.3)
    -21.8 (-30.0 to -13.5)
    Statistical analysis title
    		 MMRM - Equivalence
    Comparison groups
    Generic calcipotriol-betamethasone gel v Daivobet gel
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.6
         upper limit
    		 7.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.2
    Statistical analysis title
    		 MMRM - Superiority
    Comparison groups
    Generic calcipotriol-betamethasone gel v Generic vehicle
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -36.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -45.7
         upper limit
    		 -27
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.7

    Primary: PPS -Mean % change from baseline in PASI

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    End point title
    		 PPS -Mean % change from baseline in PASI
    End point description
    End point type
    Primary
    End point timeframe
    From study day 1 to study day 29
    End point values
    		 Generic calcipotriol-betamethasone gel Daivobet gel Generic vehicle
    Number of subjects analysed
    109
    103
    32
    Units: -100
        least squares mean (confidence interval 95%)
    -57.7 (-62.5 to -53.0)
    -59.6 (-64.4 to -54.7)
    -23.2 (-32.2 to -14.2)
    Statistical analysis title
    		 MMRM - Equivalence
    Comparison groups
    Generic calcipotriol-betamethasone gel v Daivobet gel
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.9
         upper limit
    		 8.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.4
    Statistical analysis title
    		 MMRM - Superiority
    Comparison groups
    Generic calcipotriol-betamethasone gel v Generic vehicle
    Number of subjects included in analysis
    141
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -34.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -44.7
         upper limit
    		 -24.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.2

    Secondary: FAS - Improvement in IGA

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    End point title
    		 FAS - Improvement in IGA
    End point description
    End point type
    Secondary
    End point timeframe
    From study day 1 to study day 29
    End point values
    		 Generic calcipotriol-betamethasone gel Daivobet gel Generic vehicle
    Number of subjects analysed
    123
    120
    33
    Units: subjects
        Responder
    95
    93
    10
        Non-Responder
    28
    27
    23
    Statistical analysis title
    		 MI - Equivalence
    Comparison groups
    Generic calcipotriol-betamethasone gel v Daivobet gel
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.959
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.517
         upper limit
    		 1.778
    Statistical analysis title
    		 MI - Superiority
    Comparison groups
    Generic calcipotriol-betamethasone gel v Generic vehicle
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    8.667
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.496
         upper limit
    		 21.487

    Secondary: PPS - Improvement in IGA

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    End point title
    		 PPS - Improvement in IGA
    End point description
    End point type
    Secondary
    End point timeframe
    From study day 1 to study day 29
    End point values
    		 Generic calcipotriol-betamethasone gel Daivobet gel Generic vehicle
    Number of subjects analysed
    109
    103
    32
    Units: subjects
        Responder
    84
    81
    9
        Non-Responder
    25
    22
    19
    Statistical analysis title
    		 MI - Eqilvalence
    Comparison groups
    Generic calcipotriol-betamethasone gel v Daivobet gel
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.896
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.463
         upper limit
    		 1.732
    Statistical analysis title
    		 MI - Superiority
    Comparison groups
    Generic calcipotriol-betamethasone gel v Generic vehicle
    Number of subjects included in analysis
    141
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    8.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.162
         upper limit
    		 25.223

    Secondary: FAS mPASI Subgroup - Mean % change from baseline in mPASI Week 4

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    End point title
    		 FAS mPASI Subgroup - Mean % change from baseline in mPASI Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    From study day 1 to study day 29
    End point values
    		 Generic calcipotriol-betamethasone gel Daivobet gel Generic vehicle
    Number of subjects analysed
    110
    107
    39
    Units: -100
        least squares mean (confidence interval 95%)
    -55.59 (-60.51 to -50.68)
    -58.69 (-63.67 to -53.71)
    -19.81 (-28.51 to -11.12)
    Statistical analysis title
    		 ANCOVA MI - Eqivalence
    Comparison groups
    Generic calcipotriol-betamethasone gel v Daivobet gel
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.89
         upper limit
    		 10.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.55
    Statistical analysis title
    		 ANCOVA MI - Superiority
    Comparison groups
    Generic calcipotriol-betamethasone gel v Generic vehicle
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -35.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -45.76
         upper limit
    		 -25.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.07

    Secondary: PPS mPASI Sungroup - Mean % change from baseline in mPASI Week 4

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    End point title
    		 PPS mPASI Sungroup - Mean % change from baseline in mPASI Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    From study day 1 to study day 29
    End point values
    		 Generic calcipotriol-betamethasone gel Daivobet gel Generic vehicle
    Number of subjects analysed
    97
    90
    32
    Units: -100
        least squares mean (confidence interval 95%)
    -55.07 (-60.38 to -49.76)
    -58.32 (-63.83 to -52.81)
    -21.14 (-30.70 to -11.59)
    Statistical analysis title
    		 ANCOVA MI - Equivalence
    Comparison groups
    Generic calcipotriol-betamethasone gel v Daivobet gel
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    3.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.41
         upper limit
    		 10.91
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.89
    Statistical analysis title
    		 ANCOVA MI - Superiority
    Comparison groups
    Generic calcipotriol-betamethasone gel v Generic vehicle
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -33.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -44.84
         upper limit
    		 -23.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.53

    Secondary: FAS mPASI Subgroup - Mean % change from baseline in mPASI Week 8

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    End point title
    		 FAS mPASI Subgroup - Mean % change from baseline in mPASI Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    From study day 1 to study day 56
    End point values
    		 Generic calcipotriol-betamethasone gel Daivobet gel Generic vehicle
    Number of subjects analysed
    110
    107
    39
    Units: -100
        least squares mean (confidence interval 95%)
    -63.18 (-68.68 to -57.69)
    -67.01 (-72.58 to -61.44)
    -22.00 (-32.41 to -11.58)
    Statistical analysis title
    		 ANCOVA MI - Equivalence
    Comparison groups
    Generic calcipotriol-betamethasone gel v Daivobet gel
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    3.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.98
         upper limit
    		 11.64
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.97
    Statistical analysis title
    		 ANCOVA MI - Superiority
    Comparison groups
    Generic vehicle v Generic calcipotriol-betamethasone gel
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -41.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -52.95
         upper limit
    		 -29.43
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.96

    Secondary: PPS mPASI Subgroup - Mean % change from baseline in mPASI Week 8

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    End point title
    		 PPS mPASI Subgroup - Mean % change from baseline in mPASI Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    From study day 1 to study day 56
    End point values
    		 Generic calcipotriol-betamethasone gel Daivobet gel Generic vehicle
    Number of subjects analysed
    97
    90
    32
    Units: -100
        least squares mean (confidence interval 95%)
    -63.86 (-69.76 to -57.95)
    -67.14 (-73.26 to -61.02)
    -22.08 (-33.36 to -10.8)
    Statistical analysis title
    		 ANCOVA MI - Equivalence
    Comparison groups
    Generic calcipotriol-betamethasone gel v Daivobet gel
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    3.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.23
         upper limit
    		 11.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.32
    Statistical analysis title
    		 ANCOVA MI - Superiority
    Comparison groups
    Generic calcipotriol-betamethasone gel v Generic vehicle
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -41.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -54.47
         upper limit
    		 -29.07
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.44

    Secondary: PSSI Subgroup in FAS - Mean % change from baseline in PSSI

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    End point title
    		 PSSI Subgroup in FAS - Mean % change from baseline in PSSI
    End point description
    End point type
    Secondary
    End point timeframe
    From study day 1 to study day 29
    End point values
    		 Generic calcipotriol-betamethasone gel Daivobet gel Generic vehicle
    Number of subjects analysed
    75
    70
    22
    Units: -100
        least squares mean (confidence interval 95%)
    -66.4 (-75.5 to -57.4)
    -65.8 (-75.2 to -56.3)
    -33.3 (-50.7 to -15.9)
    Statistical analysis title
    		 ANCOVA MI - Equivalence
    Comparison groups
    Generic calcipotriol-betamethasone gel v Daivobet gel
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.6
         upper limit
    		 12.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.6
    Statistical analysis title
    		 ANCOVA MI - Superiority
    Comparison groups
    Generic calcipotriol-betamethasone gel v Generic vehicle
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -33.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -52.6
         upper limit
    		 -13.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.9

    Secondary: PSSI Subgroup in PPS - Mean % change from baseline in PSSI

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    End point title
    		 PSSI Subgroup in PPS - Mean % change from baseline in PSSI
    End point description
    End point type
    Secondary
    End point timeframe
    From study day 1 to study day 29
    End point values
    		 Generic calcipotriol-betamethasone gel Daivobet gel Generic vehicle
    Number of subjects analysed
    67
    59
    19
    Units: -100
        least squares mean (confidence interval 95%)
    -66.3 (-76.0 to -56.5)
    -65.5 (-76.0 to -55.0)
    -27.8 (-47.2 to -8.3)
    Statistical analysis title
    		 ANCOVA MI - Equivalnce
    Comparison groups
    Generic calcipotriol-betamethasone gel v Daivobet gel
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.1
         upper limit
    		 13.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.2
    Statistical analysis title
    		 ANCOVA MI - Superiority
    Comparison groups
    Generic calcipotriol-betamethasone gel v Generic vehicle
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -38.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -60.2
         upper limit
    		 -16.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    11

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From study day 1 to study day 56
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Generic Cal/Bet gel
    Reporting group description
    		 -

    Reporting group title
    Daivobet gel
    Reporting group description
    		 -

    Reporting group title
    Generic vehicle gel
    Reporting group description
    		 -

    Serious adverse events
    		 Generic Cal/Bet gel Daivobet gel Generic vehicle gel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 124 (0.81%)
    4 / 123 (3.25%)
    0 / 39 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive breast carcinoma
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Sensitisation
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cholecystitis infective
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Generic Cal/Bet gel Daivobet gel Generic vehicle gel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 124 (16.94%)
    22 / 123 (17.89%)
    10 / 39 (25.64%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Melanocytic naevus
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Renal neoplasm
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 124 (1.61%)
    0 / 123 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    2
    0
    0
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Application site erythema
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    Application site pruritus
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    General physical health deterioration
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Inflammation
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    Pain
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    2
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 124 (0.00%)
    2 / 123 (1.63%)
    0 / 39 (0.00%)
         occurrences all number
    0
    2
    0
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Joint dislocation
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Headache
         subjects affected / exposed
    4 / 124 (3.23%)
    2 / 123 (1.63%)
    1 / 39 (2.56%)
         occurrences all number
    5
    2
    1
    Sciatica
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    Eye irritation
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    Occular hyperaemia
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    Toothache
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    Photosensitivity reaction
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    Pruritus
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 123 (0.81%)
    2 / 39 (5.13%)
         occurrences all number
    1
    1
    2
    Psoriasis
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    4 / 39 (10.26%)
         occurrences all number
    0
    1
    4
    Pruritus generalised
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    Skin burning sensation
         subjects affected / exposed
    2 / 124 (1.61%)
    0 / 123 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    2
    0
    0
    Skin irritation
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences all number
    0
    5
    0
    Back pain
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 124 (0.00%)
    2 / 123 (1.63%)
    0 / 39 (0.00%)
         occurrences all number
    0
    2
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences all number
    0
    3
    0
    Psoriatic arthropathy
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Spinal pain
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Gastrointestinal viral infection
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 124 (1.61%)
    3 / 123 (2.44%)
    1 / 39 (2.56%)
         occurrences all number
    2
    4
    1
    Oral herpes
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    2
    0
    0
    Pulpitis dental
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 124 (0.81%)
    2 / 123 (1.63%)
    1 / 39 (2.56%)
         occurrences all number
    1
    2
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences all number
    1
    1
    0
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 123 (0.81%)
    0 / 39 (0.00%)
         occurrences all number
    1
    1
    0

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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