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    Clinical Trial Results:
    A Multicentre, Open-label, Single-group Maximal Use Trial, Evaluating the Safety and Pharmacokinetic Profile of the Active Ingredients and their Metabolites after application of MC2-01 Cream in Adolescent Subjects (age 12 to 16 years, 11 months) with Extensive Psoriasis Vulgaris

    Summary
    EudraCT number
    		 2018-000685-12
    Trial protocol
    		 DE   CZ   HU  
    Global end of trial date
    27 May 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Mar 2021
    First version publication date
    21 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MC2-01-C6
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03819218
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MC2 Therapeutic 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, +44 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 May 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 May 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    27 May 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the effect of MC2-01 cream on the HPA axis and calcium metabolism following once daily topical application under maximum-use conditions in subjects with extensive psoriasis vulgaris.
    Protection of trial subjects
    The MC2-01 cream contains two well-known active compounds (CAL/BDP) in a novel topical formulation. The efficacy and safety profile of the combination is well established and have proven to be safe and efficacious, and available data for MC2-01 cream suggest a very benign safety profile resembling that known from the approved CAL/BDP products. A cream formulation of CAL and BDP may benefit subjects by providing improved convenience and ease of use resulting in increased patient adherence to therapy which will improve real-life treatment outcome. It was thus considered that the benefit of obtaining clinical data for this trial outweighed any potential risks. AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the final follow-up visit. AEs that were considered related to the trial product would be followed until they were resolved, or until the medical condition of the subject was stable.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jul 2018
    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
    Czechia: 5
    Country: Number of subjects enrolled
    Germany: 2
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    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)
    7
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All subjects approached for the study were either ongoing or new patients referred to the clinics with the diagnosis Psoriasis Vulgaris.

    Pre-assignment
    Screening details
    		 Prior to randomization, the subject entered a washout period (if required) where anti-psoriatic treatment and other relevant medication/treatments were discontinued as defined by the exclusion criteria. The washout/screening period could last for up to 30 days, depending on which disallowed treatments the subject received.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    The trial was an open-label trial evaluating the Safety and Pharmacokinetic profile of the MC2-01 cream.

    Arms
    Arm title
    		 MC2-01 Cream
    Arm description
    		 Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MC2-01 Cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream

    Number of subjects in period 1
    		MC2-01 Cream
    Started
    7
    Completed
    6
    Not completed
    1
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MC2-01 Cream
    Reporting group description
    		 Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks.

    Reporting group values
    		 MC2-01 Cream Total
    Number of subjects
    		 7 7
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 7 7
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.7 ± 1.4 -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 3 3
    Fitzpatrick Skin Type
    Units: Subjects
        Skintype I
    		 0 0
        Skintype II
    		 2 2
        Skintype III
    		 4 4
        Skintype IV
    		 1 1
        Skintype V
    		 0 0
        Skintype VI
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    MC2-01 Cream
    Reporting group description
    		 Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks.

    Primary: Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 4

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    End point title
    		 Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 4 [1]
    End point description
    Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression. The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 μg/dL
    End point type
    Primary
    End point timeframe
    Change from Baseline to Week 4
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The number and proportion of participants with HPA-axis suppression at Week 4 was summarized using frequency counts. As no HPA suppression was detected, statistical analysis on this parameter was not relevant.
    End point values
    		 MC2-01 Cream
    Number of subjects analysed
    7
    Units: subjects
    0
    No statistical analyses for this end point

    Primary: Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 8

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    End point title
    		 Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 8 [2]
    End point description
    Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression. The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 μg/dL
    End point type
    Primary
    End point timeframe
    Change from Baseline to Week 8
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The number and proportion of participants with HPA-axis suppression at Week 8 was summarized using frequency counts. As no HPA suppression was detected, statistical analysis on this parameter was not relevant.
    End point values
    		 MC2-01 Cream
    Number of subjects analysed
    6
    Units: Subjects
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected/assessed from the time of the signature of the informed consent form by the subject and until the final follow-up visit.
    Adverse event reporting additional description
    AEs that were considered related to the trial product would be followed until they were resolved, or until the medical condition was stable.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    MC2-01 Cream
    Reporting group description
    		 Calcipotriene/betamethasone (Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream. One application daily for 8 weeks.

    Serious adverse events
    		 MC2-01 Cream
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (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
    		 MC2-01 Cream
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 7 (42.86%)
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    1 / 7 (14.29%)
         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? Yes
    Date
    Interruption
    Restart date
    27 May 2020
    Prematurely ended, due to challenges with recruiting subjects, not least due to COVID-19. Up to that point, 7 subjects had been enrolled in the trial; of them, 6 subjects already completed the trial and 1 subject had been withdrawn prematurely.
    -

    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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