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    Clinical Trial Results:
    A randomized, multi-centre, observer-blind, controlled exploratory study to assess efficacy and safety of new topical formulations (MC2-01) in patients with plaque psoriasis

    Summary
    EudraCT number
    		 2013-005003-14
    Trial protocol
    		 DE  
    Global end of trial date
    01 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jun 2021
    First version publication date
    05 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MC2-01-C1 (Pro_MC2-01_13_Biotek)
    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
    01 Sep 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To investigate the efficacy of MC2-01 (calcipotriol + BDP) compared to MC2-01 (calcipotriol) and to MC2-01 (vehicle control) in the treatment of stable plaque psoriasis assessed by Total Clinical Score (TCS). - To investigate the efficacy of MC2-01 (calcipotriol + BDP) compared to MC2-01 (BDP) and to the marketed reference products Daivobet® Ointment and Daivobet® Gel in the treatment of stable plaque psoriasis assessed by TCS. - To evaluate the safety of the IPs by means of the occurrence of SAEs/AEs.
    Protection of trial subjects
    The investigator performed a physical examination at Screening Visit and at the End of Study Visit. Vital signs (pulse rate, blood pressure and body temperature) were measured at Screening Visit and at the End of Study Visit. Any findings of clinical relevance at Screening Visit were to be documented as concomitant disease. Any changes of clinical relevance compared to the Screening Visit examination were documented as AEs. The general non-clinical safety (pharmacology, pharmacokinetics and toxicology) of the two single active ingredients as well as of the fixed-dose combination in MC2-01, was evaluated with reference to the safety information contained in the Summary of Product Characteristics (SmPC) for the two marketed reference products Daivobet® Ointment and Daivobet® Gel. The investigator took appropriate diagnostic and therapeutic measures to minimize the risk for the patient. Where appropriate, he/she took diagnostic measures to collect evidence for clarification of the relationship between the SAE and the IP. Furthermore, the risk was minimized by the care and expertise of conduction. All assessments were only be conducted by qualified medical personnel and no further precautionary measures were taken.
    Background therapy
    		 -
    Evidence for comparator
    		 The 2 comparator products were both approved topical ointment or gel containing calcipotriol/betamethasone.
    Actual start date of recruitment
    08 May 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
    Germany: 33
    Worldwide total number of subjects
    33
    EEA total number of subjects
    33
    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)
    27
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 It was planned that 1 study site located in Germany should randomize 33 evaluable patients, however due to very slow recruitment 1 additional site was integrated. All subjects approached for the study was selected from an internal database of potential candidates at the clinic or during general appointments in the clinic.

    Pre-assignment
    Screening details
    		 A signed informed consent form was obtained prior to performing any study related activities. Screening visit could take place up to 14 days prior to the baseline visit, or the 2 visits could be conducted together in case all inclusion and exclusion criteria were assessable.

    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
    This trial was an observer-blinded trial. The investigator, responsible for the clinical rating process (observer), had to be blinded throughout the trial. The site staff, responsible for the application of IPs as well as the subjects were non-blinded. To ensure that the investigator remained blinded throughout the study, the test areas were covered with gauze by the non-blinded site staff and IPs were wiped off by the non-blinded site staff before study assessments.

    Arms
    Arm title
    		 Test sites
    Arm description
    		 Each patient received repeatedly applications with 6 products: - MC2-01 (calcipotriol + betamethasone dipropionate (BDP)) cream - MC2-01 (calcipotriol) cream - MC2-01 (betamethasone dipropionate) (BDP) cream - MC2-01 (vehicle) - Daivobet (Calcipotriol/betamethasone dipropionate) ointment - Daivobet (Calcipotriol/betamethasone dipropionate) cream
    Arm type
    		 Experimental

    Investigational medicinal product name
    MC2-01 (calcipotriol + BDP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    MC2-01 cream contained calcipotriol (50μg/g) + Betamethasone (betamethasone dipropionate (BDP) (0.5 mg/g). The dose regimen was 50 μl repeatedly topical (cutaneous to the skin) applications to a predefined test site with an area of 1,4 cm diameter, 6 days a week over a period of 28 days, in total 24 applications. After application of IPs a non-occlusive gauze was fixed using a breathable film dressing.

    Investigational medicinal product name
    MC2-01 (calcipotriol)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    MC2-01 cream contained 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 1,4 cm diameter, 6 days a week over a period of 28 days, in total 24 applications. After application of IPs a non-occlusive gauze was fixed using a breathable film dressing.

    Investigational medicinal product name
    MC2-01 (BDP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    MC2-01 cream contained Betamethasone (betamethasone dipropionate (BDP) (0.5 mg/g). The dose regimen was 50 μl repeatedly topical (cutaneous to the skin) applications to a predefined test site with an area of 1,4 cm diameter, 6 days a week over a period of 28 days, in total 24 applications. After application of IPs a non-occlusive gauze was fixed using a breathable film 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 vehicle 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 1,4 cm diameter, 6 days a week over a period of 28 days, in total 24 applications. After application of IPs a non-occlusive gauze was fixed using a breathable film 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 contained calcipotriol (50μg/g) + Betamethasone (betamethasone dipropionate (BDP) (0.5 mg/g). The dose regimen was 50 μl repeatedly topical (cutaneous to the skin) applications to a predefined test site with an area of 1,4 cm diameter, 6 days a week over a period of 28 days, in total 24 applications. After application of IPs a non-occlusive gauze was fixed using a breathable film dressing.

    Investigational medicinal product name
    Daivobet® Gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Daivobet® Gel contained calcipotriol (50μg/g) + Betamethasone (betamethasone dipropionate (BDP) (0.5 mg/g). The dose regimen was 50 μl repeatedly topical (cutaneous to the skin) applications to a predefined test site with an area of 1,4 cm diameter, 6 days a week over a period of 28 days, in total 24 applications. After application of IPs a non-occlusive gauze was fixed using a breathable film dressing.

    Number of subjects in period 1
    		Test sites
    Started
    33
    Completed
    29
    Not completed
    4
         Consent withdrawn by subject
    2
         Physician decision
    1
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Test sites
    Reporting group description
    		 Each patient received repeatedly applications with 6 products: - MC2-01 (calcipotriol + betamethasone dipropionate (BDP)) cream - MC2-01 (calcipotriol) cream - MC2-01 (betamethasone dipropionate) (BDP) cream - MC2-01 (vehicle) - Daivobet (Calcipotriol/betamethasone dipropionate) ointment - Daivobet (Calcipotriol/betamethasone dipropionate) cream

    Reporting group values
    		 Test sites Total
    Number of subjects
    		 33 33
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 27 27
        From 65-84 years
    		 6 6
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 23 23

    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 + betamethasone dipropionate (BDP)) cream - MC2-01 (calcipotriol) cream - MC2-01 (betamethasone dipropionate) (BDP) cream - MC2-01 (vehicle) - Daivobet (Calcipotriol/betamethasone dipropionate) ointment - Daivobet (Calcipotriol/betamethasone dipropionate) cream

    Subject analysis set title
    MC2-01 (calcipotriol + betamethasone dipropionate (BDP)) cream
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    32 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) cream
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    32 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 (betamethasone dipropionate) (BDP) cream
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    32 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
    32 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 (Calcipotriol/betamethasone dipropionate) ointment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    32 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 (Calcipotriol/betamethasone dipropionate) cream
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    32 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
    End point type
    Primary
    End point timeframe
    32 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.
    End point values
    		 MC2-01 (calcipotriol + betamethasone dipropionate (BDP)) cream MC2-01 (calcipotriol) cream MC2-01 (betamethasone dipropionate) (BDP) cream MC2-01 (vehicle) Daivobet (Calcipotriol/betamethasone dipropionate) ointment Daivobet (Calcipotriol/betamethasone dipropionate) cream
    Number of subjects analysed
    32
    32
    32
    32
    32
    32
    Units: Score
        arithmetic mean (standard deviation)
    -5.1 ( 1.8 )
    -3.5 ( 2.4 )
    -5.5 ( 1.5 )
    -2.1 ( 2.3 )
    -5.6 ( 1.5 )
    -5.0 ( 2.0 )
    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 Study (EOS) 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 + betamethasone dipropionate (BDP)) cream v MC2-01 (calcipotriol) cream v MC2-01 (betamethasone dipropionate) (BDP) cream v MC2-01 (vehicle) v Daivobet (Calcipotriol/betamethasone dipropionate) ointment v Daivobet (Calcipotriol/betamethasone dipropionate) cream
    Number of subjects included in analysis
    192
    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] - 32 subject were each treated with different treatments at 6 individual test sites, which add up to 192 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
    17
    Reporting groups
    Reporting group title
    Test sites
    Reporting group description
    		 Each patient received repeatedly applications with 6 products: - MC2-01 (calcipotriol + betamethasone dipropionate (BDP)) cream - MC2-01 (calcipotriol) cream - MC2-01 (betamethasone dipropionate) (BDP) cream - MC2-01 (vehicle) - Daivobet (Calcipotriol/betamethasone dipropionate) ointment - Daivobet (Calcipotriol/betamethasone dipropionate) cream

    Serious adverse events
    		 Test sites
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 33 (3.03%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Musculoskeletal and connective tissue disorders
    Psoriatic arthropathy
    Additional description: 1 AE of "psoriatic arthropathy ” was reported with “worsening of psoriatic arthropathy" 3 days later. The “worsening of psoriasis arthritis” led to hospitalization of the patient and was reported as SAE.
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 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
    8 / 33 (24.24%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 33 (9.09%)
         occurrences all number
    3
    Eye disorders
    Blepharitis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Psoriatic arthropathy
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    2
    Infections and infestations
    Gastrointestinal infection
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Mar 2014
    Although stability data certified that the IPs were stable for more than 6 month, no in-use stability data of the test products and the vehicle had been made available prior to study start. Requested by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM).
    10 Jun 2014
    With Amendment 2 to CSP the usage and storage conditions for the test products were further specified: Following amendment 2 to CSP the period of possible usage of opened test product containers was extended to 28 days if stored in a refrigerator at 2-8°C.
    25 Jun 2014
    In amendment 3 to CSP (resulting in version 2.0 of the CSP, dated 25 Jun 2014) the number of study sites was increased from one to two study sites. Therefore, the title of the study was changed as the study was no longer a mono-center study. Since this amendment was planned to recruit N=20 subjects per site and accordingly the randomization numbers 1-30 were allocated to site 01 and the randomization numbers 31-60 to site 02. Finally, the recruitment period was extended from 2 to 4 months and overall study duration was extended from 3.5 to 5.5 months.
    24 Sep 2014
    The distance of test areas to plaque outline was reduced from 1.5 cm to 0.5 cm in order to allow inclusion of patients with smaller plaques.
    13 Nov 2014
    The data set for the primary efficacy analysis was changed from PPS to FAS and the data set for the sensitivity analysis was changed from FAS to PPS. Furthermore an interim analysis was added after study completion of 28 patients with the aim to re-determine the sample size necessary for the study.

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

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