Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   39572   clinical trials with a EudraCT protocol, of which   6487   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A randomized (1:1), double-blind, parallel, placebo-controlled exploratory pilot study to evaluate the safety, pharmacokinetics and efficacy of systemic (po) application of MP1032 in patients with moderate to severe chronic plaque psoriasis

    Summary
    EudraCT number
    2015-005159-28
    Trial protocol
    DE  
    Global end of trial date
    29 Dec 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    02 Nov 2017
    First version publication date
    02 Nov 2017
    Other versions
    Summary report(s)
    MP1032-CT02 Study Synopsis

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    MP1032-CT02
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02908347
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    MetrioPharm AG
    Sponsor organisation address
    Bleicherweg 45, Zurich, Switzerland, 8002
    Public contact
    Corporate Communications, MetrioPharm Deutschland GmbH, +49 3033 84 395 40, invest@metriopharm.com
    Scientific contact
    Clinical Disclosure Office, MetrioPharm Deutschland GmbH, +49 3033 84 395 36,
    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
    02 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and pharmacokinetics (PK) of orally administered 100 mg MP1032 twice a day (bid) when taken for 42 days by patients with moderate to severe chronic plaque psoriasis
    Protection of trial subjects
    Safety assessments used in this study included standard measurements that are used routinely in clinical studies of investigational drugs, such as assessment of AEs, physical examinations, vital signs, ECGs, and clinical laboratory evaluations. To ease pain and itching and to prevent phototoxic reactions non-medicated emollients, moisturizers and sunscreens were allowed. Use of low potency topical steroids for critical areas such as the face, genitalia, and scalp were allowed until 24 hours prior to randomization.
    Background therapy
    Apart from the following exceptions there was no background therapy: - Non-medicated emollients, moisturizers and sunscreens were allowed. - Use of low potency topical steroids for critical areas such as the face, genitalia, and scalp were allowed until 24 hours prior to randomization. In some cases prior and/or concomitant medication which was not excluded by inclusion/exclusion criteria was given to treat conditions other than psoriasis.
    Evidence for comparator
    In this Phase 2a trial MP1032 has been compared with placebo only.
    Actual start date of recruitment
    17 May 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
    Germany: 46
    Worldwide total number of subjects
    46
    EEA total number of subjects
    46
    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)
    45
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    in total 46 patients were enrolled after screening and randomized.

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    MP1032
    Arm description
    Treatment group - 100 mg MP1032 b.i.d.
    Arm type
    Experimental

    Investigational medicinal product name
    MP1032 Hard Gelatine Capsules 50 mg
    Investigational medicinal product code
    MP1032
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    2 capsules of "MP1032 Hard Gelatine Capsules 50 mg", i.e. 100 mg MP1032, were administered twice daily over 42 consecutive days

    Arm title
    Placebo
    Arm description
    Placebo group - Placebo b.i.d.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo to MP1032 Hard Gelatine Capsules 50 mg
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    2 capsules of "MP1032 Hard Gelatine Capsules 50 mg (Placebo)" twice daily over 42 consecutive days

    Number of subjects in period 1
    MP1032 Placebo
    Started
    23
    23
    End of Treatment
    22
    22
    Completed
    22
    22
    Not completed
    1
    1
         Adverse event, non-fatal
    -
    1
         Lost to follow-up
    1
    -

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    -

    Reporting group values
    overall trial Total
    Number of subjects
    46 46
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    45 45
        From 65-84 years
    1 1
    Gender categorical
    Units: Subjects
        Female
    11 11
        Male
    35 35
    Subject analysis sets

    Subject analysis set title
    MP1032completed / PK analysis set
    Subject analysis set type
    Per protocol
    Subject analysis set description
    This subset includes all patients from the MP1032 group who provided plasma for PK purposes and completed the study.

    Subject analysis set title
    AUC_2h subgroup 1
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients were grouped into the following AUC subgroups according to AUC2h values estimated using the linear-logarithmic trapezoidal method on Day 1: Group 1: 6 patients with lowest AUCs; Group 2: 5 patients with the next highest AUCs; Group 3: 6 patients with the next highest AUCs; Group 4: 5 patients with the highest AUCs.

    Subject analysis set title
    AUC_2h subgroup 2
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients were grouped into the following AUC subgroups according to AUC2h values estimated using the linear-logarithmic trapezoidal method on Day 1: Group 1: 6 patients with lowest AUCs; Group 2: 5 patients with the next highest AUCs; Group 3: 6 patients with the next highest AUCs; Group 4: 5 patients with the highest AUCs.

    Subject analysis set title
    AUC_2h subgroup 3
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients were grouped into the following AUC subgroups according to AUC2h values estimated using the linear-logarithmic trapezoidal method on Day 1: Group 1: 6 patients with lowest AUCs; Group 2: 5 patients with the next highest AUCs; Group 3: 6 patients with the next highest AUCs; Group 4: 5 patients with the highest AUCs.

    Subject analysis set title
    AUC_2h subgroup 4
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients were grouped into the following AUC subgroups according to AUC2h values estimated using the linear-logarithmic trapezoidal method on Day 1: Group 1: 6 patients with lowest AUCs; Group 2: 5 patients with the next highest AUCs; Group 3: 6 patients with the next highest AUCs; Group 4: 5 patients with the highest AUCs.

    Subject analysis set title
    Placebo completed
    Subject analysis set type
    Per protocol
    Subject analysis set description
    This subset includes all patients from the Placebo group who provided plasma for PK purposes and completed the study.

    Subject analysis set title
    AUC_t subgroup 1
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients were grouped into the following AUC subgroups according to AUCt values estimated using the linear-logarithmic trapezoidal method on Day 1: Group 1: 6 patients with lowest AUCs; Group 2: 5 patients with the next highest AUCs; Group 3: 6 patients with the next highest AUCs; Group 4: 5 patients with the highest AUCs.

    Subject analysis set title
    AUC_t subgroup 2
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients were grouped into the following AUC subgroups according to AUCt values estimated using the linear-logarithmic trapezoidal method on Day 1: Group 1: 6 patients with lowest AUCs; Group 2: 5 patients with the next highest AUCs; Group 3: 6 patients with the next highest AUCs; Group 4: 5 patients with the highest AUCs.

    Subject analysis set title
    AUC_t subgroup 3
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients were grouped into the following AUC subgroups according to AUCt values estimated using the linear-logarithmic trapezoidal method on Day 1: Group 1: 6 patients with lowest AUCs; Group 2: 5 patients with the next highest AUCs; Group 3: 6 patients with the next highest AUCs; Group 4: 5 patients with the highest AUCs.

    Subject analysis set title
    AUC_t subgroup 4
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients were grouped into the following AUC subgroups according to AUCt values estimated using the linear-logarithmic trapezoidal method on Day 1: Group 1: 6 patients with lowest AUCs; Group 2: 5 patients with the next highest AUCs; Group 3: 6 patients with the next highest AUCs; Group 4: 5 patients with the highest AUCs.

    Subject analysis sets values
    MP1032completed / PK analysis set AUC_2h subgroup 1 AUC_2h subgroup 2 AUC_2h subgroup 3 AUC_2h subgroup 4 Placebo completed AUC_t subgroup 1 AUC_t subgroup 2 AUC_t subgroup 3 AUC_t subgroup 4
    Number of subjects
    22
    6
    5
    6
    5
    22
    6
    5
    6
    5
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    21
    6
    5
    6
    4
    22
    6
    5
    6
    4
        From 65-84 years
    1
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    5
    0
    0
    3
    2
    6
    0
    0
    3
    2
        Male
    17
    6
    5
    3
    3
    16
    6
    6
    3
    3

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    MP1032
    Reporting group description
    Treatment group - 100 mg MP1032 b.i.d.

    Reporting group title
    Placebo
    Reporting group description
    Placebo group - Placebo b.i.d.

    Subject analysis set title
    MP1032completed / PK analysis set
    Subject analysis set type
    Per protocol
    Subject analysis set description
    This subset includes all patients from the MP1032 group who provided plasma for PK purposes and completed the study.

    Subject analysis set title
    AUC_2h subgroup 1
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients were grouped into the following AUC subgroups according to AUC2h values estimated using the linear-logarithmic trapezoidal method on Day 1: Group 1: 6 patients with lowest AUCs; Group 2: 5 patients with the next highest AUCs; Group 3: 6 patients with the next highest AUCs; Group 4: 5 patients with the highest AUCs.

    Subject analysis set title
    AUC_2h subgroup 2
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients were grouped into the following AUC subgroups according to AUC2h values estimated using the linear-logarithmic trapezoidal method on Day 1: Group 1: 6 patients with lowest AUCs; Group 2: 5 patients with the next highest AUCs; Group 3: 6 patients with the next highest AUCs; Group 4: 5 patients with the highest AUCs.

    Subject analysis set title
    AUC_2h subgroup 3
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients were grouped into the following AUC subgroups according to AUC2h values estimated using the linear-logarithmic trapezoidal method on Day 1: Group 1: 6 patients with lowest AUCs; Group 2: 5 patients with the next highest AUCs; Group 3: 6 patients with the next highest AUCs; Group 4: 5 patients with the highest AUCs.

    Subject analysis set title
    AUC_2h subgroup 4
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients were grouped into the following AUC subgroups according to AUC2h values estimated using the linear-logarithmic trapezoidal method on Day 1: Group 1: 6 patients with lowest AUCs; Group 2: 5 patients with the next highest AUCs; Group 3: 6 patients with the next highest AUCs; Group 4: 5 patients with the highest AUCs.

    Subject analysis set title
    Placebo completed
    Subject analysis set type
    Per protocol
    Subject analysis set description
    This subset includes all patients from the Placebo group who provided plasma for PK purposes and completed the study.

    Subject analysis set title
    AUC_t subgroup 1
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients were grouped into the following AUC subgroups according to AUCt values estimated using the linear-logarithmic trapezoidal method on Day 1: Group 1: 6 patients with lowest AUCs; Group 2: 5 patients with the next highest AUCs; Group 3: 6 patients with the next highest AUCs; Group 4: 5 patients with the highest AUCs.

    Subject analysis set title
    AUC_t subgroup 2
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients were grouped into the following AUC subgroups according to AUCt values estimated using the linear-logarithmic trapezoidal method on Day 1: Group 1: 6 patients with lowest AUCs; Group 2: 5 patients with the next highest AUCs; Group 3: 6 patients with the next highest AUCs; Group 4: 5 patients with the highest AUCs.

    Subject analysis set title
    AUC_t subgroup 3
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients were grouped into the following AUC subgroups according to AUCt values estimated using the linear-logarithmic trapezoidal method on Day 1: Group 1: 6 patients with lowest AUCs; Group 2: 5 patients with the next highest AUCs; Group 3: 6 patients with the next highest AUCs; Group 4: 5 patients with the highest AUCs.

    Subject analysis set title
    AUC_t subgroup 4
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients were grouped into the following AUC subgroups according to AUCt values estimated using the linear-logarithmic trapezoidal method on Day 1: Group 1: 6 patients with lowest AUCs; Group 2: 5 patients with the next highest AUCs; Group 3: 6 patients with the next highest AUCs; Group 4: 5 patients with the highest AUCs.

    Primary: MP1032 safety evaluation - TEAEs

    Close Top of page
    End point title
    MP1032 safety evaluation - TEAEs [1]
    End point description
    Number of Treatment Emergent Adverse Events (TEAEs) reported
    End point type
    Primary
    End point timeframe
    overall study participation
    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: Only descriptive statistics have been performed for this endpoint.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    23
    23
    Units: TEAEs
        All TEAEs
    27
    32
        Serious TEAEs
    0
    0
        Severe TEAEs
    0
    1
        Related TEAEs
    6
    9
        TEAEs leading to Withdrawal
    0
    1
        TEAEs leading to Death
    0
    0
    No statistical analyses for this end point

    Primary: MP1032 safety evaluation - Patients with TEAEs

    Close Top of page
    End point title
    MP1032 safety evaluation - Patients with TEAEs [2]
    End point description
    End point type
    Primary
    End point timeframe
    overall study participation
    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: Only descriptive statistics have been performed for this endpoint.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    23
    23
    Units: Patients
        All TEAEs
    14
    15
        Serious TEAEs
    0
    0
        Severe TEAEs
    0
    1
        Related TEAEs
    5
    5
        TEAEs leading to Withdrawal
    0
    1
        TEAEs leading to Death
    0
    0
    No statistical analyses for this end point

    Primary: Occurence of related TEAEs by SOC

    Close Top of page
    End point title
    Occurence of related TEAEs by SOC [3]
    End point description
    End point type
    Primary
    End point timeframe
    overall study
    Notes
    [3] - 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: Only descriptive statistics have been performed for this endpoint.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    23
    23
    Units: TEAEs
        All related TEAEs
    6
    9
        Gastrointestinal Disorders
    0
    3
        General Disorders - Administration Site Conditions
    2
    0
        Infections and Infestations
    2
    3
        Nervous System Disorders
    0
    1
        Skin and Subcutaneous Tissue Disorders
    2
    2
    No statistical analyses for this end point

    Primary: Patients with related TEAEs by SOC

    Close Top of page
    End point title
    Patients with related TEAEs by SOC [4]
    End point description
    End point type
    Primary
    End point timeframe
    overall study
    Notes
    [4] - 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: Only descriptive statistics have been performed for this endpoint.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    23
    23
    Units: Patients
        Patients with at least one related TEAE
    5
    5
        Gastrointestinal Disorders
    0
    2
        General Disorders - Administration Site Conditions
    2
    0
        Infections and Infestations
    2
    3
        Nervous System Disorders
    0
    1
        Skin and Subcutaneous Tissue Disorders
    1
    2
    No statistical analyses for this end point

    Primary: MP1032 Plasma Concentrations at Nominal Time Points

    Close Top of page
    End point title
    MP1032 Plasma Concentrations at Nominal Time Points [5]
    End point description
    For study Day 1 - 2 hours 6 of 22 patients had BLQ values. For descriptive statistics values of these patients have been set to zero. For Study Day 43 AM and SD have not been calculated as majority (18 of 22) of measurements was not quantifiable (BLQ). Thus - due to technical reasons - values were set to zero for the purpose of this data table.
    End point type
    Primary
    End point timeframe
    Study Day 1: 15 min, 30 min, 1 and 2 hours after IMP administration, Study Day 15, 29 and 43 (i.e. 1 Day after last treatment) any time after previous IMP administration
    Notes
    [5] - 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: Only descriptive statistics have been performed for this endpoint.
    End point values
    MP1032completed / PK analysis set
    Number of subjects analysed
    22
    Units: ng/mL
    arithmetic mean (standard deviation)
        Day 1 - 15 min
    190.3 ± 153.537
        Day 1 - 30 min
    162.861 ± 64.674
        Day 1 - 1 hour
    56.875 ± 30.8
        Day 1 - 2 hours
    8.677 ± 6.629
        Day 15
    211.545 ± 151.406
        Day 29
    199.652 ± 149.857
        Day 43 (EOT)
    0 ± 0
    No statistical analyses for this end point

    Primary: Summary of Day 1 PK Parameters - C max

    Close Top of page
    End point title
    Summary of Day 1 PK Parameters - C max [6]
    End point description
    C max = maximum plasma concentration
    End point type
    Primary
    End point timeframe
    Study Day 1 - 15 min, 30 min, 1 hour and 2 hours after administration
    Notes
    [6] - 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: Only descriptive statistics have been performed for this endpoint.
    End point values
    MP1032completed / PK analysis set
    Number of subjects analysed
    22
    Units: ng/mL
        arithmetic mean (standard deviation)
    235.585 ± 124.726
    No statistical analyses for this end point

    Primary: Summary of Day 1 PK Parameters - t max

    Close Top of page
    End point title
    Summary of Day 1 PK Parameters - t max [7]
    End point description
    t max = time of occurence of C max
    End point type
    Primary
    End point timeframe
    Study Day 1 - 15 min, 30 min, 1 hour and 2 hours after administration
    Notes
    [7] - 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: Only descriptive statistics have been performed for this endpoint.
    End point values
    MP1032completed / PK analysis set
    Number of subjects analysed
    22
    Units: hours
        median (full range (min-max))
    0.25 (0.25 to 1.02)
    No statistical analyses for this end point

    Primary: Summary of Day 1 PK Parameters - AUC 2h (lin-log)

    Close Top of page
    End point title
    Summary of Day 1 PK Parameters - AUC 2h (lin-log) [8]
    End point description
    AUC 2h = area under the plasma concentration-time curve from time zero to 2 hours
    End point type
    Primary
    End point timeframe
    Study Day 1 - 15 min, 30 min, 1 hour and 2 hours after administration
    Notes
    [8] - 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: Only descriptive statistics have been performed for this endpoint.
    End point values
    MP1032completed / PK analysis set
    Number of subjects analysed
    22
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    142.212 ± 61.874
    No statistical analyses for this end point

    Primary: Summary of Day 1 PK Parameters - AUC 2h (lin-lin)

    Close Top of page
    End point title
    Summary of Day 1 PK Parameters - AUC 2h (lin-lin) [9]
    End point description
    AUC 2h = area under the plasma concentration-time curve from time zero to 2 hours
    End point type
    Primary
    End point timeframe
    Study Day 1 - 15 min, 30 min, 1 hour and 2 hours after administration
    Notes
    [9] - 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: Only descriptive statistics have been performed for this endpoint.
    End point values
    MP1032completed / PK analysis set
    Number of subjects analysed
    22
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    154.161 ± 67.048
    No statistical analyses for this end point

    Primary: Summary of Day 1 PK Parameters - AUC t (lin-log)

    Close Top of page
    End point title
    Summary of Day 1 PK Parameters - AUC t (lin-log) [10]
    End point description
    AUC t = area under the plasma concentration-time curve from time zero to the last quantifiable concentration
    End point type
    Primary
    End point timeframe
    Study Day 1 - 15 min, 30 min, 1 hour and 2 hours after administration
    Notes
    [10] - 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: Only descriptive statistics have been performed for this endpoint.
    End point values
    MP1032completed / PK analysis set
    Number of subjects analysed
    22
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    139.497 ± 63.598
    No statistical analyses for this end point

    Primary: Summary of Day 1 PK Parameters - AUC t (lin-lin)

    Close Top of page
    End point title
    Summary of Day 1 PK Parameters - AUC t (lin-lin) [11]
    End point description
    AUC t = area under the plasma concentration-time curve from time zero to the last quantifiable concentration
    End point type
    Primary
    End point timeframe
    Study Day 1 - 15 min, 30 min, 1 hour and 2 hours after administration
    Notes
    [11] - 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: Only descriptive statistics have been performed for this endpoint.
    End point values
    MP1032completed / PK analysis set
    Number of subjects analysed
    22
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    151.448 ± 68.868
    No statistical analyses for this end point

    Primary: Summary of Day 1 PK Parameters - t last

    Close Top of page
    End point title
    Summary of Day 1 PK Parameters - t last [12]
    End point description
    t last = time of last quantifiable concentration
    End point type
    Primary
    End point timeframe
    Study Day 1 - 15 min, 30 min, 1 hour and 2 hours after administration
    Notes
    [12] - 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: Only descriptive statistics have been performed for this endpoint.
    End point values
    MP1032completed / PK analysis set
    Number of subjects analysed
    22
    Units: hours
        median (full range (min-max))
    1.99 (1 to 2.05)
    No statistical analyses for this end point

    Primary: AUC (lin-log) by subgroups

    Close Top of page
    End point title
    AUC (lin-log) by subgroups [13]
    End point description
    End point type
    Primary
    End point timeframe
    Study Day 1 - 15 min, 30 min, 1 hour and 2 hours after administration
    Notes
    [13] - 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: Only descriptive statistics have been performed for this endpoint.
    End point values
    AUC_2h subgroup 1 AUC_2h subgroup 2 AUC_2h subgroup 3 AUC_2h subgroup 4 AUC_t subgroup 1 AUC_t subgroup 2 AUC_t subgroup 3 AUC_t subgroup 4
    Number of subjects analysed
    6
    5
    6
    5
    6
    5
    6
    5
    Units: h*ng/mL
        median (full range (min-max))
    84.699 (63.87 to 103.92)
    114.1 (108.97 to 123.74)
    137.246 (124.9 to 166.22)
    218.482 (206.25 to 289.74)
    75.934 (63.87 to 103.92)
    114.1 (108.97 to 122.12)
    134.561 (123.13 to 166.09)
    218.482 (206.83 to 289.74)
    No statistical analyses for this end point

    Secondary: PASI Score - Observed Values - Day 1 (Baseline)

    Close Top of page
    End point title
    PASI Score - Observed Values - Day 1 (Baseline)
    End point description
    PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.
    End point type
    Secondary
    End point timeframe
    PASI-Scoring took place on Site visits: baseline (Day 1), Day 29, Day 43 (End of Treatment), and at 2 Follow-Up visits.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    23
    23
    Units: PASI Score
        arithmetic mean (standard deviation)
    16.03 ± 7.203
    17.25 ± 7.458
    No statistical analyses for this end point

    Secondary: PASI Score - Observed Values Day 43 (End of Treatment)

    Close Top of page
    End point title
    PASI Score - Observed Values Day 43 (End of Treatment)
    End point description
    PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.
    End point type
    Secondary
    End point timeframe
    PASI-Scoring took place on Site visits: baseline (Day 1), Day 29, Day 43 (End of Treatment), and at 2 Follow-Up visits.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    23
    23
    Units: PASI Score
        arithmetic mean (standard deviation)
    14.03 ± 9.509
    14.69 ± 8.532
    No statistical analyses for this end point

    Secondary: PASI Score - Observed Values - Day 57 (Follow-Up 1)

    Close Top of page
    End point title
    PASI Score - Observed Values - Day 57 (Follow-Up 1)
    End point description
    PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.
    End point type
    Secondary
    End point timeframe
    PASI-Scoring took place on Site visits: baseline (Day 1), Day 29, Day 43 (End of Treatment), and at 2 Follow-Up visits.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    22
    23
    Units: PASI Score
        arithmetic mean (standard deviation)
    15.28 ± 10.681
    15.97 ± 8.837
    No statistical analyses for this end point

    Secondary: PASI Score - Observed Values - Day 71 (Follow-Up 2)

    Close Top of page
    End point title
    PASI Score - Observed Values - Day 71 (Follow-Up 2)
    End point description
    PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.
    End point type
    Secondary
    End point timeframe
    PASI-Scoring took place on Site visits: baseline (Day 1), Day 29, Day 43 (End of Treatment), and at 2 Follow-Up visits.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    22
    23
    Units: PASI Score
        arithmetic mean (standard deviation)
    15.21 ± 10.03
    16.09 ± 9.363
    No statistical analyses for this end point

    Secondary: PASI Score - Change from Baseline / Treatment Difference (Day 43)

    Close Top of page
    End point title
    PASI Score - Change from Baseline / Treatment Difference (Day 43)
    End point description
    PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.
    End point type
    Secondary
    End point timeframe
    PASI-Scoring took place on Site visits: baseline (Day 1), Day 29, Day 43 (End of Treatment), and at 2 Follow-Up visits.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    23
    23
    Units: PASI Score
        arithmetic mean (standard deviation)
    -2 ± 3.994
    -2.56 ± 5.025
    Statistical analysis title
    Treatment Difference at Day 43
    Statistical analysis description
    LS means, difference and CI are estimated using an ANCOVA model with Baseline as covariate and treatment as a factor. p-value was calculated using the nonparametric Wilcoxon 2-sample test.
    Comparison groups
    Placebo v MP1032
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.8785
    Method
    Wilcoxon (Mann-Whitney)
    Parameter type
    Median difference (final values)
    Point estimate
    0.64
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.09
         upper limit
    3.36

    Secondary: PASI30 at Day 29

    Close Top of page
    End point title
    PASI30 at Day 29
    End point description
    PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.
    End point type
    Secondary
    End point timeframe
    Number of Patients who had an at least 30% reduction in PASI score on Day 29 compared to Baseline.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    22
    23
    Units: Patients
    6
    6
    Statistical analysis title
    PASI30 at Day 29 - Treatment Difference
    Comparison groups
    Placebo v MP1032
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 1
    Method
    Fisher exact
    Confidence interval

    Secondary: PASI30 at Day 29 - Responder Frequency

    Close Top of page
    End point title
    PASI30 at Day 29 - Responder Frequency
    End point description
    PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.
    End point type
    Secondary
    End point timeframe
    Number of Patients who had an at least 30% reduction in PASI score on Day 29 compared to Baseline.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    22
    23
    Units: percent
        number (not applicable)
    27.27
    26.09
    No statistical analyses for this end point

    Secondary: PASI30 at Day 43

    Close Top of page
    End point title
    PASI30 at Day 43
    End point description
    PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no ssymptoms) to 4 (very marked). The total score ranges from 0 to 72.
    End point type
    Secondary
    End point timeframe
    Number of Patients who had an at least 30% reduction in PASI score on Day 43 compared to Baseline.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    23
    23
    Units: Patients
    8
    5
    Statistical analysis title
    PASI30 at Day 43 - Treatment Difference
    Comparison groups
    MP1032 v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5136
    Method
    Fisher exact
    Confidence interval

    Secondary: PASI30 at Day 43 - Responder Frequency

    Close Top of page
    End point title
    PASI30 at Day 43 - Responder Frequency
    End point description
    PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.
    End point type
    Secondary
    End point timeframe
    Frequency of Patients who had an at least 30% reduction in PASI score on Day 43 compared to Baseline.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    23
    23
    Units: percent
        number (not applicable)
    34.78
    21.74
    No statistical analyses for this end point

    Secondary: PASI50 at Day 29

    Close Top of page
    End point title
    PASI50 at Day 29
    End point description
    PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.
    End point type
    Secondary
    End point timeframe
    Number of Patients who had an at least 50% reduction in PASI score on Day 29 compared to Baseline.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    22
    23
    Units: Patients
    2
    2
    Statistical analysis title
    PASI50 at Day 29 - Treatment Difference
    Comparison groups
    MP1032 v Placebo
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 1
    Method
    Fisher exact
    Confidence interval

    Secondary: PASI50 at Day 29 - Responder Frequency

    Close Top of page
    End point title
    PASI50 at Day 29 - Responder Frequency
    End point description
    PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.
    End point type
    Secondary
    End point timeframe
    Frequency of Patients who had an at least 50% reduction in PASI score on Day 29 compared to Baseline.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    22
    23
    Units: percent
        number (not applicable)
    9.09
    8.7
    No statistical analyses for this end point

    Secondary: PASI50 at Day 43

    Close Top of page
    End point title
    PASI50 at Day 43
    End point description
    PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.
    End point type
    Secondary
    End point timeframe
    Number of Patients who had an at least 50% reduction in PASI score on Day 43 compared to Baseline.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    23
    23
    Units: Patients
    3
    4
    Statistical analysis title
    PASI50 at Day 43 - Treatment Difference
    Comparison groups
    MP1032 v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 1
    Method
    Fisher exact
    Confidence interval

    Secondary: PASI50 at Day 43 - Responder Frequency

    Close Top of page
    End point title
    PASI50 at Day 43 - Responder Frequency
    End point description
    PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.
    End point type
    Secondary
    End point timeframe
    Frequency of Patients who had an at least 50% reduction in PASI score on Day 43 compared to Baseline.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    23
    23
    Units: percent
        number (not applicable)
    13.04
    17.39
    No statistical analyses for this end point

    Secondary: PASI percentage change at Day 29

    Close Top of page
    End point title
    PASI percentage change at Day 29
    End point description
    PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.
    End point type
    Secondary
    End point timeframe
    The PASI percentage change in % at Day 29 is calculated as PASI of (Day 29 - Baseline)/Baseline*100.
    End point values
    MP1032completed / PK analysis set AUC_2h subgroup 1 AUC_2h subgroup 2 AUC_2h subgroup 3 AUC_2h subgroup 4 Placebo completed AUC_t subgroup 1 AUC_t subgroup 2 AUC_t subgroup 3 AUC_t subgroup 4
    Number of subjects analysed
    22
    6
    5
    6
    5
    22
    6
    5
    6
    5
    Units: percent
        arithmetic mean (standard deviation)
    -18.24 ± 24.069
    -6.61 ± 25.575
    -14.74 ± 24.96
    -35.46 ± 22.891
    -15.03 ± 16.422
    -14.57 ± 21.5
    -6.61 ± 25.575
    -27.07 ± 33.055
    -25.18 ± 19.510
    -15.03 ± 16.422
    No statistical analyses for this end point

    Secondary: PASI percentage change at Day 43

    Close Top of page
    End point title
    PASI percentage change at Day 43
    End point description
    PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.
    End point type
    Secondary
    End point timeframe
    The PASI percentage change in % at Day 43 is calculated as PASI of (Day 43 - Baseline)/Baseline*100.
    End point values
    MP1032completed / PK analysis set AUC_2h subgroup 1 AUC_2h subgroup 2 AUC_2h subgroup 3 AUC_2h subgroup 4 Placebo completed AUC_t subgroup 1 AUC_t subgroup 2 AUC_t subgroup 3 AUC_t subgroup 4
    Number of subjects analysed
    22
    6
    5
    6
    5
    22
    6
    5
    6
    5
    Units: percent
        arithmetic mean (standard deviation)
    -17.83 ± 29.853
    3.06 ± 23.42
    -21.82 ± 38.572
    -38.31 ± 28.353
    -14.32 ± 13.466
    -15.56 ± 27.181
    3.06 ± 23.42
    -35.88 ± 42.928
    -26.59 ± 24.922
    -14.32 ± 13.466
    No statistical analyses for this end point

    Secondary: PGA Score observed Day 1 (Baseline)

    Close Top of page
    End point title
    PGA Score observed Day 1 (Baseline)
    End point description
    PGA is the physician's global assessment of the severity of psoriasis using a 7-point scale from 0 (clear) to 6 (severe).
    End point type
    Secondary
    End point timeframe
    PGA (physicians global assessment) score has been evaluated on Day 1 (Baseline), Day 29, Day 43 (End of Treatment) and on two Follow-Up Visits.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    23
    23
    Units: PGA score
        arithmetic mean (standard deviation)
    4.2 ± 0.8
    4.4 ± 0.73
    No statistical analyses for this end point

    Secondary: PGA Score observed - Day 43 (End of Treatment)

    Close Top of page
    End point title
    PGA Score observed - Day 43 (End of Treatment)
    End point description
    PGA is the physician's global assessment of the severity of psoriasis using a 7-point scale from 0 (clear) to 6 (severe).
    End point type
    Secondary
    End point timeframe
    PGA (physicians global assessment) score has been evaluated on Day 1 (Baseline), Day 29, Day 43 (End of Treatment) and on two Follow-Up Visits.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    23
    23
    Units: PGA Score
        arithmetic mean (standard deviation)
    3.9 ± 1.32
    4.0 ± 1.11
    No statistical analyses for this end point

    Secondary: PGA Score - Change from Baseline at Day 43

    Close Top of page
    End point title
    PGA Score - Change from Baseline at Day 43
    End point description
    PGA is the physician's global assessment of the severity of psoriasis using a 7-point scale from 0 (clear) to 6 (severe).
    End point type
    Secondary
    End point timeframe
    PGA (physicians global assessment) score has been evaluated on Day 1 (Baseline), Day 29, Day 43 (End of Treatment) and on two Follow-Up Visits.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    23
    23
    Units: PGA Score
        arithmetic mean (standard deviation)
    -0.3 ± 0.98
    -0.4 ± 0.89
    No statistical analyses for this end point

    Secondary: DLQI observed values - Day 1 (Baseline)

    Close Top of page
    End point title
    DLQI observed values - Day 1 (Baseline)
    End point description
    DLQI is a total score computed from answers to 10 questions, with each answer scored from 0 (not at all) to 3 (very much). The total score ranges from 0 to 30.
    End point type
    Secondary
    End point timeframe
    DLQI (dermatology life quality index) score has been evaluated on Day 1 (Baseline), Day 29, Day 43 (End of Treatment) and on two Follow-Up Visits.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    23
    23
    Units: DLQI Score
        arithmetic mean (standard deviation)
    8.2 ± 3.68
    8.6 ± 5.92
    No statistical analyses for this end point

    Secondary: DLQI Observed Values - Day 43 (End of Treatment)

    Close Top of page
    End point title
    DLQI Observed Values - Day 43 (End of Treatment)
    End point description
    DLQI is a total score computed from answers to 10 questions, with each answer scored from 0 (not at all) to 3 (very much). The total score ranges from 0 to 30.
    End point type
    Secondary
    End point timeframe
    DLQI (dermatology life quality index) score has been evaluated on Day 1 (Baseline), Day 29, Day 43 (End of Treatment) and on two Follow-Up Visits.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    23
    23
    Units: DLQI Score
        arithmetic mean (standard deviation)
    7.1 ± 4.66
    7.3 ± 5.59
    No statistical analyses for this end point

    Secondary: DLQI Change from Baseline at Day 43

    Close Top of page
    End point title
    DLQI Change from Baseline at Day 43
    End point description
    DLQI is a total score computed from answers to 10 questions, with each answer scored from 0 (not at all) to 3 (very much). The total score ranges from 0 to 30.
    End point type
    Secondary
    End point timeframe
    DLQI (dermatology life quality index) score has been evaluated on Day 1 (Baseline), Day 29, Day 43 (End of Treatment) and on two Follow-Up Visits.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    23
    23
    Units: DLQI Score
        arithmetic mean (standard deviation)
    -1 ± 3.91
    -1.3 ± 3.51
    No statistical analyses for this end point

    Secondary: EQ-5D 5L Observed Values - Day 1 (Baseline)

    Close Top of page
    End point title
    EQ-5D 5L Observed Values - Day 1 (Baseline)
    End point description
    EQ-5D (VAS) is a total score which records the patients' self-rated health status with the scale numbered 0 to 100 (0=worst imaginable, 100=best imaginable).
    End point type
    Secondary
    End point timeframe
    EQ-5D 5L (VAS) score has been evaluated on Day 1 (Baseline), Day 29, Day 43 (End of Treatment) and on two Follow-Up Visits.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    23
    23
    Units: VAS Score
        arithmetic mean (standard deviation)
    73.7 ± 16.58
    76 ± 11.25
    No statistical analyses for this end point

    Secondary: EQ-5D 5L observed values - Day 43 (End of Treatment)

    Close Top of page
    End point title
    EQ-5D 5L observed values - Day 43 (End of Treatment)
    End point description
    EQ-5D (VAS) is a total score which records the patients' self-rated health status with the scale numbered 0 to 100 (0=worst imaginable, 100=best imaginable).
    End point type
    Secondary
    End point timeframe
    EQ-5D 5L (VAS) score has been evaluated on Day 1 (Baseline), Day 29, Day 43 (End of Treatment) and on two Follow-Up Visits.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    23
    23
    Units: VAS Score
        arithmetic mean (standard deviation)
    74.8 ± 14.62
    76.2 ± 12.48
    No statistical analyses for this end point

    Secondary: EQ-5D 5L Change from Baseline at Day 43

    Close Top of page
    End point title
    EQ-5D 5L Change from Baseline at Day 43
    End point description
    EQ-5D (VAS) is a total score which records the patients' self-rated health status with the scale numbered 0 to 100 (0=worst imaginable, 100=best imaginable).
    End point type
    Secondary
    End point timeframe
    EQ-5D 5L (VAS) score has been evaluated on Day 1 (Baseline), Day 29, Day 43 (End of Treatment) and on two Follow-Up Visits.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    23
    23
    Units: VAS Score
        arithmetic mean (standard deviation)
    1.1 ± 8.14
    0.1 ± 10.6
    No statistical analyses for this end point

    Secondary: mNAPSI Observed Values - Day 1 (Baseline)

    Close Top of page
    End point title
    mNAPSI Observed Values - Day 1 (Baseline)
    End point description
    mNAPSI score is a total score computed from answers to 7 questions, 3 of which can be answered with a score ranging from 0 to 3, and 4 of which can be answered with a score ranging from 0 to 1. The total score ranges from 0 to 13.
    End point type
    Secondary
    End point timeframe
    mNAPSI (modified nail psoriasis severity index) score has been evaluated on Day 1 (Baseline), Day 29, Day 43 (End of Treatment) and on two Follow-Up Visits.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    17 [14]
    15 [15]
    Units: mNAPSI Score
        arithmetic mean (standard deviation)
    3.5 ± 1.37
    4.9 ± 1.49
    Notes
    [14] - Only evaluated in patients with psoriatic nail disease.
    [15] - Only evaluated in patients with psoriatic nail disease.
    No statistical analyses for this end point

    Secondary: mNAPSI Observed Values - Day 43 (End of Treatment)

    Close Top of page
    End point title
    mNAPSI Observed Values - Day 43 (End of Treatment)
    End point description
    mNAPSI score is a total score computed from answers to 7 questions, 3 of which can be answered with a score ranging from 0 to 3, and 4 of which can be answered with a score ranging from 0 to 1. The total score ranges from 0 to 13.
    End point type
    Secondary
    End point timeframe
    mNAPSI (modified nail psoriasis severity index) score has been evaluated on Day 1 (Baseline), Day 29, Day 43 (End of Treatment) and on two Follow-Up Visits.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    17 [16]
    15 [17]
    Units: mNAPSI Score
        arithmetic mean (standard deviation)
    2.8 ± 1.64
    4.8 ± 1.78
    Notes
    [16] - Only evaluated in patients with psoriatic nail disease.
    [17] - Only evaluated in patients with psoriatic nail disease.
    No statistical analyses for this end point

    Secondary: mNAPSI Change from Baseline at Day 43

    Close Top of page
    End point title
    mNAPSI Change from Baseline at Day 43
    End point description
    mNAPSI score is a total score computed from answers to 7 questions, 3 of which can be answered with a score ranging from 0 to 3, and 4 of which can be answered with a score ranging from 0 to 1. The total score ranges from 0 to 13.
    End point type
    Secondary
    End point timeframe
    mNAPSI (modified nail psoriasis severity index) score has been evaluated on Day 1 (Baseline), Day 29, Day 43 (End of Treatment) and on two Follow-Up Visits.
    End point values
    MP1032 Placebo
    Number of subjects analysed
    17 [18]
    15 [19]
    Units: mNAPSI Score
        arithmetic mean (standard deviation)
    -0.8 ± 1.48
    -0.1 ± 0.92
    Notes
    [18] - Only evaluated in patients with psoriatic nail disease.
    [19] - Only evaluated in patients with psoriatic nail disease.
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse event reporting extended from the signing of the ICF until the last follow-up visit.
    Adverse event reporting additional description
    In the following, treatment emergent adverse events (TEAEs) are summarized by system organ class (SOC) and preferred term (PT). For further details (e.g. severity and causality) please refer to the endpoint section.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    MP1032
    Reporting group description
    Treatment group - 100 mg MP1032 b.i.d.

    Reporting group title
    Placebo
    Reporting group description
    Placebo group - Placebo b.i.d.

    Serious adverse events
    MP1032 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 23 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    MP1032 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 23 (60.87%)
    15 / 23 (65.22%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Injury
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Muscle strain
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Skin abrasion
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 23 (26.09%)
    2 / 23 (8.70%)
         occurrences all number
    6
    2
    Migraine
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    3
    Sciatica
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Feeling drunk
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Tympanic membrane perforation
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Ear pain
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1
    Epigastric discomfort
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Renal and urinary disorders
    Leukocyturia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Haematuria
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1
    Pruritus generalised
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Psoriasis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Skin reaction
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Skin ulcer
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Myalgia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Psoriatic arthropathy
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 23 (21.74%)
    6 / 23 (26.09%)
         occurrences all number
    5
    8
    Oral herpes
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Apr 2016
    Protocol Version 1.1 was the first protocol version to receive approval.
    03 May 2016
    Protocol Version 1.2: Amendments: 1. The chapter of determination on sample size was adapted, since the primary objectives of the study do not require any confirmatory statistical testing. The sample size was determined to have to represent a large enough exploratory sample. 2. The premature termination criteria were adapted and the following termination criteria were added: termination upon decision of the Sponsor, the Investigator, the CA or the IEC, because of safety concerns, ethical issues and severe non-compliance.
    04 Aug 2016
    Protocol Version 1.2: Amendments: 1. Change of inclusion criterion #3 to allow inclusion of patients with a BMI between 18.5 and 34.9 kg/m2. 2. Increase of the number of clinical trial sites from 2 to 5 to ensure that sufficient backup sites are in place to compensate for any enrollment rate that is slower than the predicted one. 3. Clarification on adequate contraception measures that are considered acceptable. 4. Clarification on the definition of “post-menopausal women”. 5. Inclusion of the definition “sterile women”. 6. The Drug product section of the IMPD was amended to introduce a shelf life extension plan.

    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
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA