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    Clinical Trial Results:
    A Phase II, Multicenter, Double-blind, Placebo-controlled, Efficacy and Safety Study of Two Oral Doses (150 mg bid / 300 mg bid) of MP1032 in Male and Female Patients with Moderate-to-Severe Chronic Plaque Psoriasis

    Summary
    EudraCT number
    		 2017-003484-36
    Trial protocol
    		 DE   PL  
    Global end of trial date
    12 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jun 2020
    First version publication date
    04 Jun 2020
    Other versions
    Summary report(s)
    		 MP1032-CT04 Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    MP1032-CT04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03706209
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MetrioPharm AG
    Sponsor organisation address
    Bleicherweg 10, Zürich, Switzerland, 80002
    Public contact
    Clinical Trials Group, MetrioPharm Deutschland GmbH, +49 30338439502, info@metriopharm.com
    Scientific contact
    Clinical Trials Group, MetrioPharm Deutschland GmbH, +49 30338439502, info@metriopharm.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
    13 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial is to evaluate the clinical efficacy and safety of two oral doses of MP1032 (150 mg bid and 300 mg bid) when taken for 12 weeks by patients with moderate-to-severe chronic plaque psoriasis
    Protection of trial subjects
    The trial design consisted of a 28 day screening period, a 12 week treatment period, and subsequently a 28 day follow up (FU) period. Each patient had 6 planned visits and additional unscheduled visits as needed. Safety parameters were monitored from the signing of the ICF until the last FU Visit. Safety was assessed through physical examination, vital signs and safety laboratory. A serum pregnancy test was done for all women at Screening Visit followed by 2 subsequent urine pregnancy tests. PK samples were collected in a subgroup at five selected trial sites. Patients who discontinued early from the trial should, if possible, have had an Early Termination Visit. This visit should have taken place as soon as possible after the patient stopped taking IMP. Any medication other than the IMP, was considered a concomitant medication. All medications taken in the 6 weeks before the first dose had to be recorded as concomitant. Medication to treat stable diseases as well as medication to treat AEs were allowed during the course of the trial. Measures were taken concerning treatment compliance. Criteria that might have warranted the discontinuation of an individual patient from study or even the termination of the whole study had been in place.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Feb 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
    Germany: 41
    Country: Number of subjects enrolled
    Poland: 114
    Worldwide total number of subjects
    155
    EEA total number of subjects
    155
    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)
    147
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 About 150 patients were planned to be randomized to receive either 150 mg or 300 mg MP1032 or placebo orally twice daily for 12 weeks. Treatment allocation was based on a blinded 1:1:1 ratio (50:50:50 patients). Finally 155 patients were randomized in the ratio 48:52:55 (300mg/150mg/placebo) using an Interactive Web Response System (IWRS).

    Pre-assignment
    Screening details
    		 204 patients were screened. 155 were randomized to treatment groups within a maximum time frame of 28 days after screening visit (assessment of demographic, efficacy and safety data), 22 failed screening, i.e. did not meet the inclusion criteria or met any exclusion criteria, 27 were not randomized for further associated reasons.

    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 150mg
    Arm description
    		 Treatment Group - 150mg MP1032 b.i.d.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MP1032 Hard Gelantine Capsules 50mg
    Investigational medicinal product code
    MP1032
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    3 capsules of "MP1032 Hard Gelantine Capsules 50 mg", i.e. 150 mg MP1032, were administered twice daily over 84 consecutive days.

    Investigational medicinal product name
    Placebo to MP1032 Hard Gelatine Capsules 50mg
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    3 capsules of " Placebo to MP1032 Hard Gelatine Capsules 50mg", were administered twice daily over 84 consecutive days

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to MP1032 Hard Gelatine Capsules 50mg
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    6 capsules of " Placebo to MP1032 Hard Gelatine Capsules 50mg", were administered twice daily over 84 consecutive days

    Arm title
    		 MP1032 300mg
    Arm description
    		 Treatment Group - 300mg MP1032 b.i.d.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MP1032 Hard Gelatine Capsules 50mg
    Investigational medicinal product code
    MP1032
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    6 capsules of "MP1032 Hard Gelantine Capsules 50 mg", i.e. 300 mg MP1032, were administered twice daily over 84 consecutive days.

    Number of subjects in period 1
    		MP1032 150mg Placebo MP1032 300mg
    Started
    52
    55
    48
    Completed
    34
    38
    37
    Not completed
    18
    17
    11
         Consent withdrawn by subject
    17
    12
    8
         Randomized by Mistake
    -
    1
    -
         Patient took prohibited medication
    -
    1
    -
         Adverse event, non-fatal
    1
    1
    -
         Non-Compliance with study drug
    -
    1
    1
         Lost to follow-up
    -
    1
    2

    Baseline characteristics

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

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 155 155
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 147 147
        From 65-84 years
    		 8 8
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 48 48
        Male
    		 107 107
    Subject analysis sets

    Subject analysis set title
    SES
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety-evaluation-set (SES) included all patients who received any trial medication at least once; all safety analyses will be based on the SES.

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The ITT analysis was based on the FAS. The FAS was considered primary analysis set for the efficacy analysis.

    Subject analysis set title
    PKS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The pharmacokinetics evaluation set (PKS) includes all patients without any protocol deviations that could have interfered with the administration of the treatment or the evaluation of systemic concentrations of MP1032, who received at least one dose of IMP and who had any completed determination of MP1032 levels were included in the PKS.

    Subject analysis set title
    VCS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The valid-cases-set (VCS) included all patients from the FAS, who completed the assessments of the co-primary endpoints without any protocol violation interfering with the precise evaluation of treatment efficacy and with sufficient exposure to IMP.

    Subject analysis set title
    PASI ≤ 15 (FAS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This subgroup comprises all subjects out of the FAS set who had a baseline PASI score ≤ 15. Several study specific categories had been created for subgroup analyses including centers, age, sex, BMI, years of psoriasis, smoking, baseline PGA, baseline PASI and baseline CRP. However, only subgroups that showed relevant results are herewith provided as subject analysis set.

    Subject analysis set title
    Age > 40 (FAS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This subgroup comprises all subjects out of the FAS set who were older than 40 years. Several study specific categories had been created for subgroup analyses including centers, age, sex, BMI, years of psoriasis, smoking, baseline PGA, baseline PASI and baseline CRP. However, only subgroups that showed relevant results are herewith provided as subject analysis set.

    Subject analysis set title
    BMI ≥ 30 (FAS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This subgroup comprises all subjects out of the FAS set who had a body mass index ≥ 30. Several study specific categories had been created for subgroup analyses including centers, age, sex, BMI, years of psoriasis, smoking, baseline PGA, baseline PASI and baseline CRP. However, only subgroups that showed relevant results are herewith provided as subject analysis set.

    Subject analysis sets values
    		 SES FAS PKS VCS PASI ≤ 15 (FAS) Age > 40 (FAS) BMI ≥ 30 (FAS)
    Number of subjects
    154
    151
    23
    102
    97
    79
    41
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
    0
    0
    0
        Adults (18-64 years)
    146
    143
    23
    98
    94
    71
    40
        From 65-84 years
    8
    8
    0
    4
    3
    8
    1
        85 years and over
    0
    0
    0
    0
    0
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    48
    46
    7
    32
    32
    23
    12
        Male
    106
    105
    16
    70
    65
    56
    29

    End points

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    End points reporting groups
    Reporting group title
    MP1032 150mg
    Reporting group description
    		 Treatment Group - 150mg MP1032 b.i.d.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    MP1032 300mg
    Reporting group description
    		 Treatment Group - 300mg MP1032 b.i.d.

    Subject analysis set title
    SES
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety-evaluation-set (SES) included all patients who received any trial medication at least once; all safety analyses will be based on the SES.

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The ITT analysis was based on the FAS. The FAS was considered primary analysis set for the efficacy analysis.

    Subject analysis set title
    PKS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The pharmacokinetics evaluation set (PKS) includes all patients without any protocol deviations that could have interfered with the administration of the treatment or the evaluation of systemic concentrations of MP1032, who received at least one dose of IMP and who had any completed determination of MP1032 levels were included in the PKS.

    Subject analysis set title
    VCS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The valid-cases-set (VCS) included all patients from the FAS, who completed the assessments of the co-primary endpoints without any protocol violation interfering with the precise evaluation of treatment efficacy and with sufficient exposure to IMP.

    Subject analysis set title
    PASI ≤ 15 (FAS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This subgroup comprises all subjects out of the FAS set who had a baseline PASI score ≤ 15. Several study specific categories had been created for subgroup analyses including centers, age, sex, BMI, years of psoriasis, smoking, baseline PGA, baseline PASI and baseline CRP. However, only subgroups that showed relevant results are herewith provided as subject analysis set.

    Subject analysis set title
    Age > 40 (FAS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This subgroup comprises all subjects out of the FAS set who were older than 40 years. Several study specific categories had been created for subgroup analyses including centers, age, sex, BMI, years of psoriasis, smoking, baseline PGA, baseline PASI and baseline CRP. However, only subgroups that showed relevant results are herewith provided as subject analysis set.

    Subject analysis set title
    BMI ≥ 30 (FAS)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This subgroup comprises all subjects out of the FAS set who had a body mass index ≥ 30. Several study specific categories had been created for subgroup analyses including centers, age, sex, BMI, years of psoriasis, smoking, baseline PGA, baseline PASI and baseline CRP. However, only subgroups that showed relevant results are herewith provided as subject analysis set.

    Primary: PASI 75 responders - week 12 (EoT)

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    End point title
    		 PASI 75 responders - week 12 (EoT)
    End point description
    The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. It is a physician’s assessment of psoriasis that is a therapeutic standard in clinical studies for this disease. The number of responders corresponds to the number of patients with an improvement of at least 75% in the PASI score at End-of-Treatment compared to baseline.
    End point type
    Primary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    50
    54
    47
    151
    Units: patients
        Responder
    4
    1
    4
    9
        Non-Responder
    46
    53
    43
    142
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - EoT
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.161
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 35.97
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - EoT
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.111
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    5.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 55.43

    Primary: PGA improvement - week 12 (EoT)

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    End point title
    		 PGA improvement - week 12 (EoT)
    End point description
    The PGA (Physician’s global assessment) provides an overall evaluation of the severity of the disease. The 7-point’s assessment of psoriasis is a therapeutic standard in clinical studies for this disease. The number of responders corresponds to the number of patients with an improvement of 1 or more points on the 7-points PGA scale at End-of-Treatment compared to baseline.
    End point type
    Primary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    50
    54
    47
    151
    Units: Patients
        Responder
    14
    10
    14
    38
        Non-Responder
    36
    44
    33
    113
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - EoT
    Comparison groups
    Placebo v MP1032 150mg
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.222
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 4.25
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - EoT
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.182
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 4.91

    Secondary: PASI 50 responders - week 12 (EoT)

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    End point title
    		 PASI 50 responders - week 12 (EoT)
    End point description
    The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. It is a physician’s assessment of psoriasis that is a therapeutic standard in clinical studies for this disease. The number of responders corresponds to the number of patients with an improvement of at least 50% in the PASI score at End-of-Treatment compared to baseline.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    50
    54
    47
    151
    Units: patients
    8
    6
    10
    24
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - EoT
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.47
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 4.52
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - EoT
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.136
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 7.82

    Secondary: PASI 75 Responders - weeks 4 and 8

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    End point title
    		 PASI 75 Responders - weeks 4 and 8
    End point description
    The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. It is a physician’s assessment of psoriasis that is a therapeutic standard in clinical studies for this disease. The number of responders corresponds to the number of patients with an improvement of at least 75% in the PASI score in the respective weeks compared to baseline.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    50
    54
    47
    151
    Units: patients
        week 4
    0
    2
    1
    3
        week 8
    2
    1
    1
    4
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - 4 weeks
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.178 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Notes
    [1] - As data were too sparse neither OR nor CI have been computed.
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - 8 weeks
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.474
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.21
         upper limit
    		 28.05
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - 4 weeks
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.718
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.05
         upper limit
    		 7.48
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - 8 weeks
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.867
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.08
         upper limit
    		 19.05

    Secondary: PASI 75 responders - week 16 (FU)

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    End point title
    		 PASI 75 responders - week 16 (FU)
    End point description
    The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. It is a physician’s assessment of psoriasis that is a therapeutic standard in clinical studies for this disease. The number of responders corresponds to the number of patients with an improvement of at least 75% in the PASI score at the Follow-Up visit compared to baseline.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    38
    44
    40
    122
    Units: patients
    4
    2
    5
    11
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - FU
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.375
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 12.84
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - FU
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.116
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 27.08

    Secondary: PASI 50 responders - weeks 4 and 8

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    End point title
    		 PASI 50 responders - weeks 4 and 8
    End point description
    The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. It is a physician’s assessment of psoriasis that is a therapeutic standard in clinical studies for this disease. The number of responders corresponds to the number of patients with an improvement of at least 50% in the PASI score in the respective weeks compared to baseline.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    50
    54
    47
    151
    Units: patients
        week 4
    2
    5
    7
    14
        week 8
    5
    7
    9
    21
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - 4 weeks
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.287
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.08
         upper limit
    		 2.27
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - 8 weeks
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.719
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.25
         upper limit
    		 2.63
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - 4 weeks
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.332
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 6.4
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - 8 weeks
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.357
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 5.32

    Secondary: PASI 50 responders - week 16 (FU)

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    End point title
    		 PASI 50 responders - week 16 (FU)
    End point description
    The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. It is a physician’s assessment of psoriasis that is a therapeutic standard in clinical studies for this disease. The number of responders corresponds to the number of patients with an improvement of at least 50% in the PASI score at the Follow-Up visit compared to baseline.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    38
    44
    40
    122
    Units: patients
    8
    6
    10
    24
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - FU
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.355
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 5.72
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - FU
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.198
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 7.37

    Secondary: PASI ANCOVA for change from baseline - weeks 4, 8 and 12 (EoT)

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    End point title
    		 PASI ANCOVA for change from baseline - weeks 4, 8 and 12 (EoT)
    End point description
    The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. It is a physician’s assessment of psoriasis that is a therapeutic standard in clinical studies for this disease. Displayed are changes in the PASI score of the respective weeks compared to baseline in the different arms in patients of the FAS subject analysis set.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg
    Number of subjects analysed
    50
    54
    47
    Units: PASI
    arithmetic mean (standard error)
        week 4
    -0.3 ± 0.7
    -0.6 ± 0.7
    -1.7 ± 0.7
        week 8
    0.2 ± 0.9
    -0.8 ± 0.8
    -1.8 ± 0.9
        week 12
    0.1 ± 1.0
    -0.1 ± 1.0
    -1.1 ± 1.0
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - 4 weeks
    Statistical analysis description
    Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.757
    Method
    		 ANCOVA
    Parameter type
    		 least square means
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 2.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - 8 weeks
    Statistical analysis description
    Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.412
    Method
    		 ANCOVA
    Parameter type
    		 least square means
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 3.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - EoT
    Statistical analysis description
    Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.894
    Method
    		 ANCOVA
    Parameter type
    		 least square means
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.4
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - 4 weeks
    Statistical analysis description
    Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.267
    Method
    		 ANCOVA
    Parameter type
    		 least square means
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - 8 weeks
    Statistical analysis description
    Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.401
    Method
    		 ANCOVA
    Parameter type
    		 least square means
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.5
         upper limit
    		 1.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - EoT
    Statistical analysis description
    Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.456
    Method
    		 ANCOVA
    Parameter type
    		 least square means
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.8
         upper limit
    		 1.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.4

    Secondary: PASI ANCOVA for change from baseline - week 16 (FU)

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    End point title
    		 PASI ANCOVA for change from baseline - week 16 (FU)
    End point description
    The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. It is a physician’s assessment of psoriasis that is a therapeutic standard in clinical studies for this disease. Displayed are changes in the PASI score of the respective weeks compared to baseline in the different arms in patients of the FAS subject analysis set.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg
    Number of subjects analysed
    38
    44
    40
    Units: PASI
        arithmetic mean (standard error)
    -0.3 ± 1.3
    -0.8 ± 1.2
    -0.8 ± 1.2
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - FU
    Statistical analysis description
    Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.801
    Method
    		 ANCOVA
    Parameter type
    		 Estimated Mean
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 3.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.7
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - FU
    Statistical analysis description
    Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.957
    Method
    		 ANCOVA
    Parameter type
    		 Estimated Mean
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 3.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.7

    Secondary: PGA improvement - weeks 4 and 8

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    End point title
    		 PGA improvement - weeks 4 and 8
    End point description
    The PGA (Physician’s global assessment) provides an overall evaluation of the severity of the disease. The 7-point’s assessment of psoriasis is a therapeutic standard in clinical studies for this disease. The number of responders corresponds to the number of patients with an improvement of 1 or more points on the 7-points PGA scale in the respective weeks compared to baseline.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    50
    54
    47
    151
    Units: patients
        week 4
    11
    9
    13
    33
        week 8
    12
    14
    16
    42
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - 4 weeks
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.45
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 3.8
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - 8 weeks
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.884
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 2.18
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - 4 weeks
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.186
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 5.26
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - 8 weeks
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.384
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 3.64

    Secondary: PGA improvement - week 16 (FU)

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    End point title
    		 PGA improvement - week 16 (FU)
    End point description
    The PGA (Physician’s global assessment) provides an overall evaluation of the severity of the disease. The 7-point’s assessment of psoriasis is a therapeutic standard in clinical studies for this disease. The number of responders corresponds to the number of patients with an improvement of 1 or more points on the 7-points PGA scale at the Follow-Up visit compared to baseline.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    38
    44
    40
    122
    Units: patients
    14
    12
    13
    39
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - FU
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.311
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 4.26
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - FU
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.699
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 3.17

    Secondary: PGA descriptive statistics - day 1 (baseline) - week 12 (EoT)

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    End point title
    		 PGA descriptive statistics - day 1 (baseline) - week 12 (EoT)
    End point description
    The PGA (Physician’s global assessment) provides an overall evaluation of the severity of the disease. The 7-point’s assessment of psoriasis is a therapeutic standard in clinical studies for this disease.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    50
    54
    47
    151
    Units: PGA
    arithmetic mean (standard deviation)
        Day 1
    4.1 ± 0.7
    4.1 ± 0.7
    4.2 ± 0.7
    4.1 ± 0.7
        week 4
    3.9 ± 0.9
    4.0 ± 1.0
    3.9 ± 0.9
    3.9 ± 0.9
        week 4 - change from baseline
    -0.1 ± 0.7
    -0.1 ± 0.6
    -0.3 ± 0.6
    -0.2 ± 0.6
        week 8
    4.0 ± 1.1
    3.9 ± 1.1
    3.8 ± 1.1
    3.9 ± 1.1
        week 8 - change from baseline
    -0.1 ± 0.9
    -0.2 ± 0.8
    -0.4 ± 0.8
    -0.2 ± 0.9
        week 12
    4.0 ± 1.3
    4.1 ± 1.0
    3.8 ± 1.2
    4.0 ± 1.2
        week 12 - change from baseline
    -0.1 ± 1.1
    -0.0 ± 0.8
    -0.4 ± 1.0
    -0.1 ± 0.9
    No statistical analyses for this end point

    Secondary: PGA descriptive statistics - week 16 (FU)

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    End point title
    		 PGA descriptive statistics - week 16 (FU)
    End point description
    The PGA (Physician’s global assessment) provides an overall evaluation of the severity of the disease. The 7-point’s assessment of psoriasis is a therapeutic standard in clinical studies for this disease.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    38
    44
    40
    122
    Units: PGA
    arithmetic mean (standard deviation)
        week 16
    3.8 ± 1.3
    3.9 ± 1.1
    3.8 ± 1.3
    3.8 ± 1.3
        week 16 - change from baseline
    -0.2 ± 1.1
    -0.1 ± 0.7
    -0.4 ± 1.1
    -0.3 ± 1.0
    No statistical analyses for this end point

    Secondary: PGA change from baseline - weeks 4, 8 and 12 (EoT)

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    End point title
    		 PGA change from baseline - weeks 4, 8 and 12 (EoT)
    End point description
    The PGA (Physician’s global assessment) provides an overall evaluation of the severity of the disease. The 7-point’s assessment of psoriasis is a therapeutic standard in clinical studies for this disease.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    50
    54
    47
    151
    Units: PGA
    arithmetic mean (standard deviation)
        week 4
    -0.1 ± 0.7
    -0.1 ± 0.6
    -0.3 ± 0.6
    -0.2 ± 0.6
        week 8
    -0.1 ± 0.9
    -0.2 ± 0.8
    -0.4 ± 0.8
    -0.2 ± 0.9
        week 12
    -0.1 ± 1.1
    -0.0 ± 0.8
    -0.4 ± 1.0
    -0.1 ± 0.9
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - 4 weeks
    Comparison groups
    Placebo v MP1032 150mg
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.671
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - 8 weeks
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.542
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - EoT
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.992
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - 4 weeks
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.183
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - 8 weeks
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.328
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - EoT
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.143
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0

    Secondary: PGA change from baseline - week 16 (FU)

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    End point title
    		 PGA change from baseline - week 16 (FU)
    End point description
    The PGA (Physician’s global assessment) provides an overall evaluation of the severity of the disease. The 7-point’s assessment of psoriasis is a therapeutic standard in clinical studies for this disease.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    38
    44
    40
    122
    Units: PGA
        arithmetic mean (standard deviation)
    -0.2 ± 1.1
    -0.1 ± 0.7
    -0.4 ± 1.1
    -0.3 ± 1.0
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - FU
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.921
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - FU
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.488
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0

    Secondary: PGA frequency Counts - day 1 (baseline)

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    End point title
    		 PGA frequency Counts - day 1 (baseline)
    End point description
    The PGA (Physician’s global assessment) provides an overall evaluation of the severity of the disease. The 7-point’s assessment of psoriasis is a therapeutic standard in clinical studies for this disease.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    50
    54
    47
    151
    Units: patients
        0 - Clear
    0
    0
    0
    0
        1 - Almost Clear
    0
    0
    0
    0
        2 - Mild
    1
    0
    0
    1
        3 - Mild to moderate
    8
    11
    8
    27
        4 - Moderate
    28
    27
    24
    79
        5 - Moderate to severe
    13
    15
    14
    42
        6 - Severe
    0
    1
    1
    2
    No statistical analyses for this end point

    Secondary: PGA frequency counts - week 4

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    End point title
    		 PGA frequency counts - week 4
    End point description
    The PGA (Physician’s global assessment) provides an overall evaluation of the severity of the disease. The 7-point’s assessment of psoriasis is a therapeutic standard in clinical studies for this disease.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    50
    54
    47
    151
    Units: patients
        0 - Clear
    0
    0
    0
    0
        1 - Almost clear
    0
    0
    0
    0
        2 - Mild
    2
    5
    2
    9
        3 - Mild to moderate
    15
    10
    13
    38
        4 - Moderate
    19
    20
    21
    60
        5 - Moderate to severe
    12
    19
    10
    41
        6 - Severe
    2
    0
    1
    3
    No statistical analyses for this end point

    Secondary: PGA frequency counts - week 12 (EoT)

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    End point title
    		 PGA frequency counts - week 12 (EoT)
    End point description
    The PGA (Physician’s global assessment) provides an overall evaluation of the severity of the disease. The 7-point’s assessment of psoriasis is a therapeutic standard in clinical studies for this disease.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    50
    54
    47
    122
    Units: patients
        0 - Clear
    0
    0
    0
    0
        1 - Almost clear
    1
    0
    1
    2
        2 - Mild
    6
    4
    7
    17
        3 - Mild to moderate
    10
    11
    9
    30
        4 - Moderate
    15
    18
    15
    48
        5 - Moderate to severe
    12
    18
    13
    43
        6 - Severe
    6
    3
    2
    11
    No statistical analyses for this end point

    Secondary: PGA frequency counts - week 16 (FU)

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    End point title
    		 PGA frequency counts - week 16 (FU)
    End point description
    The PGA (Physician’s global assessment) provides an overall evaluation of the severity of the disease. The 7-point’s assessment of psoriasis is a therapeutic standard in clinical studies for this disease.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    38
    44
    40
    122
    Units: patients
        0 - Clear
    0
    0
    0
    0
        1 - Almost clear
    2
    1
    3
    6
        2 - Mild
    4
    4
    4
    12
        3 - Mild to moderate
    10
    10
    8
    28
        4 - Moderate
    9
    14
    11
    34
        5 - Moderate to severe
    10
    13
    12
    35
        6 - Severe
    3
    2
    2
    7
    No statistical analyses for this end point

    Secondary: BSA descriptive statistics - day 1 (baseline) - week 12 (EoT)

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    End point title
    		 BSA descriptive statistics - day 1 (baseline) - week 12 (EoT)
    End point description
    The BSA (Body Surface Area) provides information on the total surface area of the body affected with psoriasis plaques in percent (%).
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    50
    54
    47
    151
    Units: BSA (%)
    arithmetic mean (standard deviation)
        Day 1
    19 ± 8.8
    17.5 ± 6.3
    19.2 ± 10.5
    18.5 ± 8.6
        week 4
    19.7 ± 12.4
    17.1 ± 7.1
    18.3 ± 11.9
    18.3 ± 10.6
        week 4 - change from baseline
    0.7 ± 8.3
    -0.4 ± 3.1
    -0.9 ± 6.3
    -0.2 ± 6.2
        week 8
    20.4 ± 12.9
    16.6 ± 7.9
    18.6 ± 14.7
    18.5 ± 12.1
        week 8 - change from baseline
    1.4 ± 9.5
    -0.9 ± 3.9
    -0.6 ± 9
    -0.1 ± 7.8
        week 12
    20.2 ± 13
    17.3 ± 8.7
    19.7 ± 17.2
    19.0 ± 13.2
        week 12 - change from baseline
    1.2 ± 9.4
    -0.2 ± 5.3
    0.5 ± 11.3
    0.5 ± 8.8
    No statistical analyses for this end point

    Secondary: BSA descriptive statistics - week 16 (FU)

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    End point title
    		 BSA descriptive statistics - week 16 (FU)
    End point description
    The BSA (Body Surface Area) provides information on the total surface area of the body affected with psoriasis plaques in percent (%).
    End point type
    Secondary
    End point timeframe
    Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    38
    44
    40
    122
    Units: BSA (%)
    arithmetic mean (standard deviation)
        week 16
    20.9 ± 15.5
    15.5 ± 6.4
    20.2 ± 19.8
    18.7 ± 14.8
        week 16 - change from baseline
    0.6 ± 12.8
    -1.1 ± 4.1
    0.4 ± 13.4
    -0.1 ± 10.7
    No statistical analyses for this end point

    Secondary: Time to PASI 75 - weeks 4, 8, 12 (EoT) and 16 (FU)

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    End point title
    		 Time to PASI 75 - weeks 4, 8, 12 (EoT) and 16 (FU)
    End point description
    The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. It is a physician’s assessment of psoriasis that is a therapeutic standard in clinical studies for this disease. The number of responders corresponds to the number of patients that reached an improvement of at least 75% in the PASI score in the respective week.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    50
    54
    47
    151
    Units: patients
        week 4
    0
    2
    1
    3
        week 8
    2
    0
    0
    2
        week 12 (EoT)
    3
    1
    3
    7
        week 16 (FU)
    0
    1
    2
    3
    Statistical analysis title
    		 MP1032 150mg bid vs placebo
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.572
    Method
    		 Logrank
    Confidence interval
    Notes
    [2] - Kaplan-Meier estimate of the median time (day) to reach the PASI 75 criterion was not computed since data were too sparse.
    Statistical analysis title
    		 MP1032 300mg bid vs placebo
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.4494
    Method
    		 Logrank
    Confidence interval
    Notes
    [3] - Kaplan-Meier estimate of the median time (day) to reach the PASI 75 criterion was not computed since data were too sparse.

    Secondary: Time to PASI 50 - weeks 4, 8, 12 (EoT) and 16 (FU)

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    End point title
    		 Time to PASI 50 - weeks 4, 8, 12 (EoT) and 16 (FU)
    End point description
    The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. It is a physician’s assessment of psoriasis that is a therapeutic standard in clinical studies for this disease. The number of responders corresponds to the number of patients that reached an improvement of at least 50% in the PASI score in the respective week.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    50
    54
    47
    151
    Units: patients
        week 4
    2
    5
    7
    14
        week 8
    4
    2
    3
    9
        week 12 (EOT)
    4
    2
    3
    9
        week 16 (FU)
    1
    2
    3
    6
    Statistical analysis title
    		 MP1032 150mg bid vs placebo
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 [4]
    P-value
    		 = 0.7922
    Method
    		 Logrank
    Confidence interval
    Notes
    [4] - Kaplan-Meier estimate of the median time (day) to reach the PASI 50 criterion was not computed since data were too sparse.
    Statistical analysis title
    		 MP1032 300mg bid vs placebo
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 [5]
    P-value
    		 = 0.1425
    Method
    		 Logrank
    Confidence interval
    Notes
    [5] - Kaplan-Meier estimate of the median time (day) to reach the PASI 50 criterion was not computed since data were too sparse.

    Secondary: PASI descriptive statistics - day 1 (baseline) - week 12 (EoT)

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    End point title
    		 PASI descriptive statistics - day 1 (baseline) - week 12 (EoT)
    End point description
    The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. It is a physician’s assessment of psoriasis that is a therapeutic standard in clinical studies for this disease.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    50
    54
    47
    151
    Units: PASI
    arithmetic mean (standard deviation)
        Day 1
    14.7 ± 2.8
    13.8 ± 2.5
    14.2 ± 2.7
    14.2 ± 2.7
        week 4
    14.5 ± 7.1
    13.1 ± 4.6
    12.4 ± 5.5
    13.3 ± 5.8
        week 4 - change from baseline
    -0.2 ± 6.3
    -0.7 ± 4.1
    -1.8 ± 4.2
    -0.8 ± 5.0
        week 8
    15.1 ± 8.1
    12.8 ± 5.4
    12.3 ± 7.8
    13.4 ± 7.2
        week 8 - change from baseline
    0.4 ± 7.4
    -1 ± 4.9
    -1.9 ± 6.4
    -0.8 ± 6.3
        week 12
    15 ± 9.1
    13.5 ± 6
    13 ± 9
    13.8 ± 8.1
        week 12 - change from baseline
    0.3 ± 8.4
    -0.3 ± 5.5
    -1.2 ± 7.6
    -0.4 ± 7.2
    No statistical analyses for this end point

    Secondary: PASI descriptive statistics - week 16 (FU)

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    End point title
    		 PASI descriptive statistics - week 16 (FU)
    End point description
    The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. It is a physician’s assessment of psoriasis that is a therapeutic standard in clinical studies for this disease.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    38
    44
    40
    122
    Units: PASI
    arithmetic mean (standard deviation)
        week 16
    15.1 ± 9.3
    12.3 ± 5.1
    13.6 ± 11
    13.6 ± 8.7
        week 16 - change from baseline
    0.3 ± 9
    -1.2 ± 4.7
    -0.7 ± 9.6
    -0.6 ± 7.9
    No statistical analyses for this end point

    Secondary: PASI 75 responders - week 12 (EoT)

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    End point title
    		 PASI 75 responders - week 12 (EoT)
    End point description
    The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. It is a physician’s assessment of psoriasis that is a therapeutic standard in clinical studies for this disease. The number of responders corresponds to the number of patients with an improvement of at least 75% in the PASI score compared to baseline.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg VCS
    Number of subjects analysed
    32
    34
    36
    102
    Units: patients
    3
    1
    3
    7
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - EoT
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.294
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 25.39
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - EoT
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.291
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.31
         upper limit
    		 53.14

    Secondary: PGA improvement - week 12 (EoT)

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    End point title
    		 PGA improvement - week 12 (EoT)
    End point description
    The PGA (Physician’s global assessment) provides an overall evaluation of the severity of the disease. The 7-point’s assessment of psoriasis is a therapeutic standard in clinical studies for this disease. The number of responders corresponds to the number of patients with an improvement of 1 or more points on the 7-points PGA scale compared to baseline.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg VCS
    Number of subjects analysed
    32
    34
    36
    102
    Units: patients
    9
    8
    13
    30
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - EoT
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.617
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 3.77
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - EoT
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.319
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 5

    Secondary: Pharmacokinetics – Day 1: Cmax

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    End point title
    		 Pharmacokinetics – Day 1: Cmax [6]
    End point description
    Non-compartment parameters: - Cmax is the maximum MP1032 concentration observed. - tmax is the time point (effective) at which the maximum concentration (Cmax) was observed. - AUC(0,t) is the area under the concentration-time curve up to the last quantifiable sample drawn.
    End point type
    Secondary
    End point timeframe
    Plasma samples were taken predose, and 15 minutes, 30 minutes, 1 hour, and 2 hours after the first dose.
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo patients are not part of the PK analysis. However, respective plasma sampling has been performed in placebo patients as the study was blinded.
    End point values
    		 MP1032 150mg MP1032 300mg PKS
    Number of subjects analysed
    6
    8
    14
    Units: ng/mL
        arithmetic mean (standard deviation)
    388 ± 146.3
    612.4 ± 467.3
    516.2 ± 373.0
    No statistical analyses for this end point

    Secondary: Pharmacokinetics – Day 1: Tmax

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    End point title
    		 Pharmacokinetics – Day 1: Tmax [7]
    End point description
    Non-compartment parameters: - Cmax is the maximum MP1032 concentration observed. - tmax is the time point (effective) at which the maximum concentration (Cmax) was observed. - AUC(0,t) is the area under the concentration-time curve up to the last quantifiable sample drawn.
    End point type
    Secondary
    End point timeframe
    Plasma samples were taken predose, and 15 minutes, 30 minutes, 1 hour, and 2 hours after the first dose.
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo patients are not part of the PK analysis. However, respective plasma sampling has been performed in placebo patients as the study was blinded.
    End point values
    		 MP1032 150mg MP1032 300mg PKS
    Number of subjects analysed
    6
    8
    14
    Units: min
        median (full range (min-max))
    15 (13 to 30)
    22.5 (15 to 60)
    15 (13 to 60)
    No statistical analyses for this end point

    Secondary: Extent of exposure - dosed capsules

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    End point title
    		 Extent of exposure - dosed capsules
    End point description
    Total number of dosed capsules = 6 * # planned applications - # missed capsules + # overdose capsules. Average number of capsules per application = # dosed capsules / # applications. Average number of capsules per day = # dosed capsules / days of treatment.
    End point type
    Secondary
    End point timeframe
    overal trial
    End point values
    		 MP1032 150mg Placebo MP1032 300mg SES SES
    Number of subjects analysed
    51
    55
    47
    153
    153
    Units: Capsules
    arithmetic mean (standard deviation)
        Total number of dosed capsules
    821.9 ± 304.3
    872.2 ± 248.3
    920.6 ± 214.2
    870.3 ± 260.4
    870.3 ± 260.4
        Average number of capsules per application
    6.00 ± 0.02
    6.00 ± 0
    6.00 ± 0.01
    6.00 ± 0.01
    6.00 ± 0.01
        Average number of capsules per day
    11.48 ± 1.40
    11.79 ± 0.25
    11.85 ± 0.20
    11.71 ± 0.84
    11.71 ± 0.84
    No statistical analyses for this end point

    Secondary: Sufficient extent of exposure

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    End point title
    		 Sufficient extent of exposure
    End point description
    Exposure was regarded as sufficient if the patient took at least 80% of planned applications wherein % Exposure was calculated as 100 * # dosed capsules / (84 * 2 * 6).
    End point type
    Secondary
    End point timeframe
    overall trial
    End point values
    		 MP1032 150mg Placebo MP1032 300mg SES
    Number of subjects analysed
    51
    55
    47
    153
    Units: patients
        Insufficient
    16
    15
    8
    39
        Sufficient
    35
    40
    39
    114
    No statistical analyses for this end point

    Secondary: Extent of exposure - treatment duration

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    End point title
    		 Extent of exposure - treatment duration
    End point description
    Treatment duration = date of last dose - date of first dose + 1.
    End point type
    Secondary
    End point timeframe
    overall trial
    End point values
    		 MP1032 150mg Placebo MP1032 300mg SES
    Number of subjects analysed
    51
    55
    48
    154
    Units: days
        arithmetic mean (standard deviation)
    70.7 ± 24.1
    73.9 ± 21.0
    76.1 ± 21.1
    73.6 ± 22.1
    No statistical analyses for this end point

    Secondary: Overview on AEs - Incidence of TEAEs

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    End point title
    		 Overview on AEs - Incidence of TEAEs
    End point description
    End point type
    Secondary
    End point timeframe
    Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg SES
    Number of subjects analysed
    51
    55
    48
    154
    Units: patients
        All TEAEs
    22
    33
    15
    70
        Serious TEAEs
    0
    3
    0
    3
        TEAEs leading to study discontinuation
    2
    5
    0
    7
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - TEAEs
    Comparison groups
    Placebo v MP1032 150mg
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1193
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - TEAEs
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0054
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - serious TEAEs
    Comparison groups
    Placebo v MP1032 150mg
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2439
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - serious TEAEs
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2461
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - discontinued
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0593
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - discontinued
    Comparison groups
    Placebo v MP1032 150mg
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4395
    Method
    		 Fisher exact
    Confidence interval

    Secondary: TEAEs by SOCs

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    End point title
    		 TEAEs by SOCs
    End point description
    Only PTs occuring in ≥5% of the patients in total were considered for this overview.
    End point type
    Secondary
    End point timeframe
    Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg SES
    Number of subjects analysed
    51
    55
    48
    154
    Units: patients
        Infections and infestations
    11
    14
    8
    33
        Skin and subcutaneous tissue disorders
    3
    10
    4
    17
        Gastrointestinal disorders
    5
    7
    2
    14
        Nervous system disorders
    2
    2
    4
    8
    No statistical analyses for this end point

    Secondary: Overview on AEs - incidence of TEAEs by intensity

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    End point title
    		 Overview on AEs - incidence of TEAEs by intensity
    End point description
    End point type
    Secondary
    End point timeframe
    Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg SES
    Number of subjects analysed
    51
    55
    48
    154
    Units: patients
        Severe
    2
    4
    0
    6
        Moderate
    7
    15
    4
    26
        Mild
    13
    14
    11
    38
    Statistical analysis title
    		 MP1032 150mg bid vs placebo
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0507
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 MP1032 300mg bid vs placebo
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0005
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Overview on AEs - incidence of TEAEs by relation to the IMP

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    End point title
    		 Overview on AEs - incidence of TEAEs by relation to the IMP
    End point description
    End point type
    Secondary
    End point timeframe
    Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg SES
    Number of subjects analysed
    51
    55
    48
    154
    Units: patients
        Certain
    0
    0
    0
    0
        Probable
    1
    1
    0
    2
        Possible
    4
    8
    2
    14
        Unlikely
    6
    14
    5
    25
        Not related
    11
    10
    8
    29
    Statistical analysis title
    		 MP1032 150mg bid vs placebo
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0504
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 MP1032 300mg bid vs placebo
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0013
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Overview on AEs - incidence of TEAEs by causality with the IMP

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    End point title
    		 Overview on AEs - incidence of TEAEs by causality with the IMP
    End point description
    End point type
    Secondary
    End point timeframe
    Overall Trial - Explicit inquiry on Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg SES
    Number of subjects analysed
    51
    55
    48
    154
    Units: patients
        Related
    5
    9
    2
    16
        Not related
    17
    24
    13
    54
    Statistical analysis title
    		 MP1032 150mg bid vs placebo
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.098
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 MP1032 300mg bid vs placebo
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0032
    Method
    		 Fisher exact
    Confidence interval

    Secondary: PASI ANCOVA for change from baseline - weeks 4, 8 and 12 (EoT) - Score

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    End point title
    		 PASI ANCOVA for change from baseline - weeks 4, 8 and 12 (EoT) - Score
    End point description
    The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. It is a physician’s assessment of psoriasis that is a therapeutic standard in clinical studies for this disease. Displayed are changes in the PASI score of the respective weeks compared to baseline in the different arms in patients of the FAS subject analysis set, wherein this subgroup analysis only considers patients with a PASI ≤ 15 at baseline.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg
    Number of subjects analysed
    29
    37
    31
    Units: PASI
    arithmetic mean (standard error)
        week 4
    -1.3 ± 0.7
    -0.8 ± 0.6
    -2.0 ± 0.7
        week 8
    -0.6 ± 0.9
    -1.3 ± 0.8
    -3.2 ± 0.9
        week 12
    -0.8 ± 0.9
    -0.6 ± 0.8
    -3.0 ± 0.9
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - 4 weeks
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.575
    Method
    		 ANCOVA
    Parameter type
    		 least square means
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 1.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.9
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - 8 weeks
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.574
    Method
    		 ANCOVA
    Parameter type
    		 least square means
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 2.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.1
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - EoT
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.858
    Method
    		 ANCOVA
    Parameter type
    		 least square means
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 2.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - 4 weeks
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.177
    Method
    		 ANCOVA
    Parameter type
    		 least square means
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.9
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - 8 weeks
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.086
    Method
    		 ANCOVA
    Parameter type
    		 least square means
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.1
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - EoT
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.048
    Method
    		 ANCOVA
    Parameter type
    		 least square means
    Point estimate
    -2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.7
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2

    Secondary: PASI ANCOVA for change from baseline - week 16 (FU) - Score

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    End point title
    		 PASI ANCOVA for change from baseline - week 16 (FU) - Score
    End point description
    The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. It is a physician’s assessment of psoriasis that is a therapeutic standard in clinical studies for this disease. Displayed are changes in the PASI score of the respective weeks compared to baseline in the different arms in patients of the FAS subject analysis set, wherein this subgroup analysis only considers patients with a PASI ≤ 15 at baseline.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg
    Number of subjects analysed
    23
    32
    25
    Units: PASI
        arithmetic mean (standard error)
    1.1 ± 1.3
    -1.2 ± 1.1
    -2.9 ± 1.2
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - FU
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.183
    Method
    		 ANCOVA
    Parameter type
    		 least square means
    Point estimate
    2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 5.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.7
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - FU
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.297
    Method
    		 ANCOVA
    Parameter type
    		 least square means
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.9
         upper limit
    		 1.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.6

    Secondary: PGA change from baseline - weeks 4, 8 and 12 (EoT) - age

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    End point title
    		 PGA change from baseline - weeks 4, 8 and 12 (EoT) - age
    End point description
    The PGA (Physician’s global assessment) provides an overall evaluation of the severity of the disease. The 7-point’s assessment of psoriasis is a therapeutic standard in clinical studies for this disease. Subgroup-Analysis only considering patients older than 40 years at baseline.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg Age > 40 (FAS)
    Number of subjects analysed
    25
    28
    26
    79
    Units: PGA
    arithmetic mean (standard deviation)
        week 4
    0 ± 0.8
    0 ± 0.5
    -0.3 ± 0.6
    -0.1 ± 0.7
        week 8
    0.1 ± 1.0
    0 ± 0.9
    -0.4 ± 0.9
    -0.1 ± 0.9
        week 12
    0 ± 1.3
    0.2 ± 0.7
    -0.4 ± 1.0
    -0.1 ± 1.0
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - 4 weeks
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.549
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - 8 weeks
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.783
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - EoT
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.766
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - 4 weeks
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.049
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - 8 weeks
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.095
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - EoT
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.046
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26

    Secondary: PGA change from baseline - week 16 (FU) - age

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    End point title
    		 PGA change from baseline - week 16 (FU) - age
    End point description
    The PGA (Physician’s global assessment) provides an overall evaluation of the severity of the disease. The 7-point’s assessment of psoriasis is a therapeutic standard in clinical studies for this disease. Subgroup-Analysis only considering patients older than 40 years at baseline.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg Age > 40 (FAS)
    Number of subjects analysed
    18
    23
    23
    64
    Units: PGA
        arithmetic mean (standard deviation)
    -0.3 ± 1.4
    0 ± 0.6
    -0.3 ± 1.1
    -0.2 ± 1.1
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - FU
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.97
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.51
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - FU
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.52
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26

    Secondary: PGA change from baseline - weeks 4, 8 and 12 (EoT) - BMI

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    End point title
    		 PGA change from baseline - weeks 4, 8 and 12 (EoT) - BMI
    End point description
    The PGA (Physician’s global assessment) provides an overall evaluation of the severity of the disease. The 7-point’s assessment of psoriasis is a therapeutic standard in clinical studies for this disease. Subgroup-Analysis only considering patients with a body mass index (BMI) of at least 30.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg BMI ≥ 30 (FAS)
    Number of subjects analysed
    11
    20
    10
    41
    Units: PGA
    arithmetic mean (standard deviation)
        week 4
    0.2 ± 1.1
    -0.1 ± 0.4
    -0.3 ± 0.5
    -0.1 ± 0.7
        week 8
    0.5 ± 1.0
    -0.3 ± 0.6
    -0.6 ± 0.7
    -0.1 ± 0.8
        week 12
    0.5 ± 1.3
    0 ± 0.7
    -0.6 ± 0.8
    0.0 ± 1.0
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - 4 weeks
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.69
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - 8 weeks
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.028
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - EoT
    Comparison groups
    MP1032 150mg v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.075
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - 4 weeks
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.402
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - 8 weeks
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.221
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - EoT
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.112
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26

    Secondary: PGA change from baseline - week 16 (FU) - BMI

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    End point title
    		 PGA change from baseline - week 16 (FU) - BMI
    End point description
    The PGA (Physician’s global assessment) provides an overall evaluation of the severity of the disease. The 7-point’s assessment of psoriasis is a therapeutic standard in clinical studies for this disease. Subgroup-Analysis only considering patients with a body mass index (BMI) of at least 30.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg BMI ≥ 30 (FAS)
    Number of subjects analysed
    9
    17
    9
    35
    Units: PGA
        arithmetic mean (standard deviation)
    0.1 ± 1.2
    -0.1 ± 0.9
    -0.4 ± 0.9
    -0.1 ± 1.0
    Statistical analysis title
    		 MP1032 150mg bid vs placebo - FU
    Comparison groups
    Placebo v MP1032 150mg
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.427
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.51
    Statistical analysis title
    		 MP1032 300mg bid vs placebo - FU
    Comparison groups
    Placebo v MP1032 300mg
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.457
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Hodges-Lehmann using location shift
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26

    Secondary: Extent of exposure - applications

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    End point title
    		 Extent of exposure - applications
    End point description
    Total number of applications = # planned applications - # missed applications +# overdose applications.
    End point type
    Secondary
    End point timeframe
    Day1, Week 4, Week 8, Week 12 (EoT), Week 16 (Follow Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg SES
    Number of subjects analysed
    51
    55
    47
    153
    Units: Application
        arithmetic mean (standard deviation)
    137.0 ± 50.7
    145.4 ± 41.4
    153.4 ± 35.7
    145.0 ± 43.4
    No statistical analyses for this end point

    Secondary: Pharmacokinetics – Day 1: AUC(0,t)

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    End point title
    		 Pharmacokinetics – Day 1: AUC(0,t) [8]
    End point description
    Non-compartment parameters: - Cmax is the maximum MP1032 concentration observed. - tmax is the time point (effective) at which the maximum concentration (Cmax) was observed. - AUC(0,t) is the area under the concentration-time curve up to the last quantifiable sample drawn.
    End point type
    Secondary
    End point timeframe
    Plasma samples were taken predose, and 15 minutes, 30 minutes, 1 hour, and 2 hours after the first dose.
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo patients are not part of the PK analysis. However, respective plasma sampling has been performed in placebo patients as the study was blinded.
    End point values
    		 MP1032 150mg MP1032 300mg PKS
    Number of subjects analysed
    6
    8
    14
    Units: ng/mL*min
        arithmetic mean (standard deviation)
    15585.3 ± 5757.4
    26543.8 ± 16592.3
    21847.3 ± 13880.2
    No statistical analyses for this end point

    Secondary: PGA Frequency counts - week 8

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    End point title
    		 PGA Frequency counts - week 8
    End point description
    The PGA (Physician’s global assessment) provides an overall evaluation of the severity of the disease. The 7-point’s assessment of psoriasis is a therapeutic standard in clinical studies for this disease.
    End point type
    Secondary
    End point timeframe
    Scoring took place on Site visits: Day1 (Baseline), Week 4, Week 8, Week 12 (End-of-Treatment), Week 16 (Follow-Up)
    End point values
    		 MP1032 150mg Placebo MP1032 300mg FAS
    Number of subjects analysed
    50
    54
    47
    151
    Units: patients
        0 - Clear
    0
    0
    0
    0
        1 - Almost clear
    0
    1
    1
    2
        2 - Mild
    5
    6
    5
    16
        3 - Mild to moderate
    11
    10
    11
    32
        4 - Moderate
    17
    17
    18
    52
        5 - Moderate to severe
    14
    19
    9
    42
        6 - Severe
    3
    1
    3
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Screening to last follow up visit (week 16)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    MP1032 300mg
    Reporting group description
    		 -

    Reporting group title
    MP1032 150mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 MP1032 300mg MP1032 150mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    3 / 55 (5.45%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Biceps tendon rupture
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Malum perforans
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Exacerbation of psoriasis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 MP1032 300mg MP1032 150mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 48 (31.25%)
    22 / 51 (43.14%)
    32 / 55 (58.18%)
    Vascular disorders
    Hypertension worsened
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    Blood pressure high
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    Hypertension arterial
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    0
    0
    2
    Venous insufficiency
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    Malaise
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    Chest tightness
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    Influenza like illness
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Immune system disorders
    Drug allergy
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Sniffles
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    Sinus pain
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    Sore throat
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    1
    0
    1
    Investigations
    AST increased
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    1
    ALT increased
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Radius fracture
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    Postoperative pain
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Subcutaneous hematoma
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    Headache
         subjects affected / exposed
    2 / 48 (4.17%)
    1 / 51 (1.96%)
    1 / 55 (1.82%)
         occurrences all number
    2
    1
    1
    Migraine
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    Sciatica
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    taste disorder
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    Diabetic polyneuropathy
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Tingling feet/hands
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    0
    0
    2
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Redness of eyes
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    Ocular congestion
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    Eye redness
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Heartburn
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    Lower abdominal pain
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    Stomach pain
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 51 (3.92%)
    3 / 55 (5.45%)
         occurrences all number
    0
    2
    3
    Stools watery
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Feces soft
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    0
    0
    2
    Increased stool frequency
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Hypochondrium pain right
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Gastrointestinal discomfort
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Toothache
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Diarrhea
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 51 (1.96%)
    1 / 55 (1.82%)
         occurrences all number
    1
    1
    1
    Stomach ache
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Exacerbation of psoriasis
         subjects affected / exposed
    1 / 48 (2.08%)
    3 / 51 (5.88%)
    3 / 55 (5.45%)
         occurrences all number
    1
    3
    3
    Plaque psoriasis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    1
    0
    1
    Pruritus aggravated
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    2
    0
    1
    Pustular psoriasis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    Skin rash
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    Diabetic foot
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Pain of skin
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Exanthematic drug eruption
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Psoriasis aggravated
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Psoriatic plaque
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Glycosuria
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Ketonuria
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Microscopic hematuria
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Renal calculus
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    Osteoarthritis aggravated
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle tension
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Bone pain
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Low back pain
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    Joint pain
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Acute osteomyelitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Ascariasis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    Cold sores
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Common cold
         subjects affected / exposed
    4 / 48 (8.33%)
    4 / 51 (7.84%)
    7 / 55 (12.73%)
         occurrences all number
    4
    4
    7
    Cystitis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    Diverticulitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Facial abscess
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Folliculitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Herpes zoster
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
         occurrences all number
    1
    1
    0
    Infected skin atheroma
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Pyoderma
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 51 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    1
    0
    2
    Quinsy
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 51 (1.96%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 48 (4.17%)
    4 / 51 (7.84%)
    2 / 55 (3.64%)
         occurrences all number
    2
    4
    2
    Urinary tract infection
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 51 (3.92%)
    1 / 55 (1.82%)
         occurrences all number
    0
    2
    1
    Metabolism and nutrition disorders
    Hypertriglyceridemia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 51 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Oct 2018
    There are 3 changes in the protocol amendment. 1. The name from the responsible person for SAE notifications was changed. 2. The address from the PK samples was changed. 3. The number of PK sites for Germany and Poland was changed

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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