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    Clinical Trial Results:
    STUDY OF THE EFFICACY AND SAFETY OF A PAD™ CALCIPOTRIOL CREAM IN THE PSORIASIS PLAQUE TEST

    Summary
    EudraCT number
    		 2015-003893-34
    Trial protocol
    		 FR  
    Global end of trial date
    27 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jun 2020
    First version publication date
    28 Jun 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MC2-16-C1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MC2 Therapeutics Ltd.
    Sponsor organisation address
    C/O Agern Allé 24-26, Hørsholm, Denmark, 2970
    Public contact
    Senior Project Manager, Clinical Operations, MC2 Therapeutics Ltd., 45 20157033, isa@mc2therapeutics.com
    Scientific contact
    Senior Project Manager, Clinical Operations, MC2 Therapeutics Ltd., 45 20157033, isa@mc2therapeutics.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
    27 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate the efficacy of a PAD Calcipotriol cream MC2-01 (calcipotriol) compared to two calcipotriol reference formulations (Daivonex® cream and Daivonex® ointment) in patients with plaque psoriasis
    Protection of trial subjects
    The Risk/benefit ratio assessment was based on a 4-week psoriasis study on 33 patients with psoriasis plaque. This study showed that the three MC1-01 formulations were safe and well tolerated. The patient were treated with once daily application of the investigational medical products, six days a week (every day except Sunday) for 4 weeks. Each application site was of approximately 3 cm2 on one or more psoriatic plaques of identical severity (similar baseline Total Plaque Score (TPS) ≥ 5. Monitoring of Adverse Events and local tolerance assessment was done twice weekly. During and following a patient's participation in the trial, the investigator was to ensure adequate medical care to patients for any adverse events, as applicable.
    Background therapy
    		 -
    Evidence for comparator
    		 The 3 comparator products were all approved topical cream or ointments containing either calcipotriol or calcipotriol/betamethasone.
    Actual start date of recruitment
    19 Apr 2016
    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
    France: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All subjects in the study was selected from an internal database of potential candidates at the clinic. All subject has had previously accepted to be contacted in case of potential participation in a study.

    Pre-assignment
    Screening details
    		 A signed informed consent form was obtained prior to performing any study related activities. Prior to the baseline a washout period up to 21 days had to be completed if the subject was treated or has recently been treated with anti-psoriatic treatments or other relevant medications.

    Period 1
    Period 1 title
    Test phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    All 6 products were provided to an unblinded person in charge of product application. The products were labelled from A - F. The same person was also provided with a randomization list, indicated the allocation of the 6 products to each of the 6 test sites. The subject, Investigator, monitor and assessor were all kept blinded to the product allocation.

    Arms
    Arm title
    		 Test sites
    Arm description
    		 Each patient received repeatedly applications with 6 products: - MC2-01 (calcipotriol) cream - MC2-01 (vehicle) - MC2-01 (Calcipotriol/betamethasone dipropionate) cream - Daivobet (Calcipotriol/betamethasone dipropionate) ointment - Daivonex® (calcipotriol) cream - Daivonex® (calcipotriol) ointment The 6 products was randomly applied by a qualified person, under non-occlusive conditions, using a sticker to define the areas of products application, once daily, except Sundays, for a total of 24 applications.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MC2-01 (calcipotriol) cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    MC2-01 cream contains calcipotriol (50μg/g). The dose regimen was 50 μl repeatedly topical (cutaneous to the skin) applications to a predefined test site with an area of 2 cm in diameter, once daily, except Sundays, for a total of 24 applications. The application was covered with a non-occlusive gaze dressing.

    Investigational medicinal product name
    MC2-01 vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    MC2-01 cream does not contain any active ingredient. The dose regimen was 50 μl repeatedly topical (cutaneous to the skin) applications to a predefined test site with an area of 2 cm in diameter, once daily, except Sundays, for a total of 24 applications. The application was covered with a non-occlusive gaze dressing.

    Investigational medicinal product name
    MC2-01 (Calcipotriol/betamethasone dipropionate) cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    MC2-01 cream contains calcipotriol / betamethasone dipropionate (50μg/g / 0.5mg/g). The dose regimen was 50 μl repeatedly topical (cutaneous to the skin) applications to a predefined test site with an area of 2 cm in diameter, once daily, except Sundays, for a total of 24 applications. The application was covered with a non-occlusive gaze dressing.

    Investigational medicinal product name
    Daivobet® ointment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Daivobet® ointment contains calcipotriol / betamethasonedipropionate (50μg/g / 0.5mg/g). The dose regimen was 50 μl repeatedly topical (cutaneous to the skin) applications to a predefined test site with an area of 2 cm in diameter, once daily, except Sundays, for a total of 24 applications. The application was covered with a non-occlusive gaze dressing.

    Investigational medicinal product name
    Daivonex® cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Daivonex® cream contains calcipotriol (50μg/g). The dose regimen was 50 μl repeatedly topical (cutaneous to the skin) applications to a predefined test site with an area of 2 cm in diameter, once daily, except Sundays, for a total of 24 applications. The application was covered with a non-occlusive gaze dressing.

    Investigational medicinal product name
    Daivonex® ointment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Daivonex® ointment contains calcipotriol (50μg/g). The dose regimen was 50 μl repeatedly topical (cutaneous to the skin) applications to a predefined test site with an area of 2 cm in diameter, once daily, except Sundays, for a total of 24 applications. The application was covered with a non-occlusive gaze dressing.

    Number of subjects in period 1
    		Test sites
    Started
    24
    Completed
    24

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Test phase
    Reporting group description
    		 -

    Reporting group values
    		 Test phase Total
    Number of subjects
    		 24 24
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 24 24
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 15 15
    FitzPatrick Skin Type
    Units: Subjects
        Skintype I
    		 0 0
        Skintype II
    		 2 2
        Skintype III
    		 22 22
        Skintype IV
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Test sites
    Reporting group description
    		 Each patient received repeatedly applications with 6 products: - MC2-01 (calcipotriol) cream - MC2-01 (vehicle) - MC2-01 (Calcipotriol/betamethasone dipropionate) cream - Daivobet (Calcipotriol/betamethasone dipropionate) ointment - Daivonex® (calcipotriol) cream - Daivonex® (calcipotriol) ointment The 6 products was randomly applied by a qualified person, under non-occlusive conditions, using a sticker to define the areas of products application, once daily, except Sundays, for a total of 24 applications.

    Subject analysis set title
    MC2-01 (calcipotriol) cream
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All 24 randomized subjects were included in the Full Analysis Set and analyzed for absolute change in Total Clinical score (TCS) from baseline of End of Trial.

    Subject analysis set title
    MC2-01 vehicle
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All 24 randomized subjects were included in the Full Analysis Set and analyzed for absolute change in Total Clinical score (TCS) from baseline of End of Trial.

    Subject analysis set title
    MC2-01 (Calcipotriol/betamethasone dipropionate) cream
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All 24 randomized subjects were included in the Full Analysis Set and analyzed for absolute change in Total Clinical score (TCS) from baseline of End of Trial.

    Subject analysis set title
    Daivobet® ointment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All 24 randomized subjects were included in the Full Analysis Set and analyzed for absolute change in Total Clinical score (TCS) from baseline of End of Trial.

    Subject analysis set title
    Daivonex® cream
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All 24 randomized subjects were included in the Full Analysis Set and analyzed for absolute change in Total Clinical score (TCS) from baseline of End of Trial.

    Subject analysis set title
    Daivonex® ointment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All 24 randomized subjects were included in the Full Analysis Set and analyzed for absolute change in Total Clinical score (TCS) from baseline of End of Trial.

    Primary: TCS score

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    End point title
    		 TCS score
    End point description
    Absolute change in Trial Clinical Score (TCS).
    End point type
    Primary
    End point timeframe
    Absolute change from baseline to end of trial.
    End point values
    		 MC2-01 (calcipotriol) cream MC2-01 vehicle MC2-01 (Calcipotriol/betamethasone dipropionate) cream Daivobet® ointment Daivonex® cream Daivonex® ointment
    Number of subjects analysed
    24
    24
    24
    24
    24
    24
    Units: Score
        arithmetic mean (standard deviation)
    -2.5 ± 1.3
    -1.2 ± 1.0
    -5.1 ± 1.2
    -5.5 ± 1.1
    -2.7 ± 2.0
    -3.8 ± 1.5
    Statistical analysis title
    		 Absolute change in TCS
    Statistical analysis description
    The primary endpoint is the absolute change in Total Clinical Score (TCS) of clinical signs (intensity of erythema, scaling and infiltration) from baseline to End of Treatment (EOT) was analyzed using a two-way ANOVA with subjects and treatments as factors. Treatment differences will be tested using Tukey’s honestly significant difference method for correcting p-values. Ninety five percent (95%) confidence interval of differences between treatments will be calculated.
    Comparison groups
    MC2-01 (calcipotriol) cream v MC2-01 vehicle v MC2-01 (Calcipotriol/betamethasone dipropionate) cream v Daivobet® ointment v Daivonex® cream v Daivonex® ointment
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 ≤ 0.05
    Method
    		 ANOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Notes
    [1] - 24 subject were each treated with different treatments at 6 individual test sites, which add up to 144 test sites in total

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected/assessed from the time the informed consent form was signed. AEs assessed to reasonably possibly related to the trial medication had to be followed until it was resolved or until the medical condition of the subject was stable.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Test sites
    Reporting group description
    		 Each patient received repeatedly applications with 6 products: - MC2-01 (calcipotriol) cream - MC2-01 (vehicle) - MC2-01 (Calcipotriol/betamethasone dipropionate) cream - Daivobet (Calcipotriol/betamethasone dipropionate) ointment - Daivonex® (calcipotriol) cream - Daivonex® (calcipotriol) ointment The 6 products was randomly applied by a qualified person, under non-occlusive, using a sticker to define the areas of products application, once daily, except Sundays, for a total of 24 applications. Reporting of AEs are done by SOC and preferred terms.

    Serious adverse events
    		 Test sites
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Test sites
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 24 (29.17%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fewer
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Sore Throat
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Shoulder pain
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Infections and infestations
    Common cold
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Flu-like symptoms
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1

    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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