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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of Orismilast in Adults With Moderate to Severe Atopic Dermatitis

    Summary
    EudraCT number
    		 2021-006707-15
    Trial protocol
    		 DE   HU  
    Global end of trial date
    15 Feb 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Jan 2025
    First version publication date
    31 Jan 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UNI50001-202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND number: 129386
    Sponsors
    Sponsor organisation name
    UNION therapeutics A/S
    Sponsor organisation address
    Tuborg Havnevej 18, Hellerup, Denmark, DK-2900
    Public contact
    Charlotte Oersted Pedersen, UNION therapeutics A/S, +45 53843044, charlotte.oersted.pedersen@uniontherapeutics.com
    Scientific contact
    Charlotte Oersted Pedersen, UNION therapeutics A/S, +45 53843044, charlotte.oersted.pedersen@uniontherapeutics.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
    18 Jan 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Feb 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate the efficacy and safety of a modified-release orismilast tablet versus placebo in patients aged at least 18 years with moderate to severe Atopic Dermatitis (AD).
    Protection of trial subjects
    This clinical trial was conducted in compliance with the Declaration of Helsinki and International Council for Harmonisation Good Clinical Practice (GCP) guidelines. Tiral subjects were monitored throughout the study and safety assessments were performed during each visit.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Apr 2022
    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
    Poland: 34
    Country: Number of subjects enrolled
    Germany: 38
    Country: Number of subjects enrolled
    Hungary: 8
    Country: Number of subjects enrolled
    United States: 155
    Worldwide total number of subjects
    235
    EEA total number of subjects
    80
    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)
    220
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 235 patients were randomized to treatment. A total of 233 randomized patients were treated and included in the Intent-to-Treat and Safety Populations.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Orismilast Modified Release Tablets 20 mg BID
    Arm description
    		 Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Orismilast 20 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Modified-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, 20mg twice daily morning and evening

    Arm title
    		 Orismilast Modified Release Tablets 30 mg BID
    Arm description
    		 Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Orismilast 30 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Modified-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, 30mg twice daily morning and evening

    Arm title
    		 Orismilast Modified Release Tablets 40 mg BID
    Arm description
    		 Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Orismilast 40 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Modified-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, 40mg twice daily morning and evening

    Arm title
    		 Placebo Tablets BID
    Arm description
    		 Placebo matching tablets. Oral, twice daily morning and evening.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Modified-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matching tablets, oral, twice daily morning and evening

    Number of subjects in period 1 [1]
    		Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Started
    58
    61
    59
    55
    Completed
    37
    35
    37
    42
    Not completed
    21
    26
    22
    13
         Consent withdrawn by subject
    7
    6
    4
    5
         Physician decision
    -
    -
    -
    1
         Adverse event, non-fatal
    8
    14
    13
    2
         Lost to follow-up
    2
    5
    3
    3
         Lack of efficacy
    4
    1
    2
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: While all 235 participants attended a randomization visit, two of them were not exposed to study medication, left the study, and did not attend another visit.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Orismilast Modified Release Tablets 20 mg BID
    Reporting group description
    		 Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation.

    Reporting group title
    Orismilast Modified Release Tablets 30 mg BID
    Reporting group description
    		 Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation.

    Reporting group title
    Orismilast Modified Release Tablets 40 mg BID
    Reporting group description
    		 Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation.

    Reporting group title
    Placebo Tablets BID
    Reporting group description
    		 Placebo matching tablets. Oral, twice daily morning and evening.

    Reporting group values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID Total
    Number of subjects
    		 58 61 59 55 233
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.2 ( 14.34 ) 39.1 ( 13.30 ) 42.5 ( 15.69 ) 40.9 ( 16.87 ) -
    Gender categorical
    Units: Subjects
        Female
    		 37 27 28 27 119
        Male
    		 21 34 31 28 114
    Child-bearing potential
    Units: Subjects
        Yes
    		 26 19 18 17 80
        No
    		 31 42 41 37 151
        Missing
    		 1 0 0 1 2
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 2 5 4 2 13
        Native Hawaiian or Other Pacific Islander
    		 2 1 0 2 5
        Black or African American
    		 9 11 15 9 44
        White
    		 43 42 37 41 163
        More than one race
    		 0 0 0 0 0
        Unknown or Not Reported
    		 2 2 3 1 8
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 20 19 16 23 78
        Not Hispanic or Latino
    		 38 42 42 32 154
        Unknown or Not Reported
    		 0 0 1 0 1
    Asthma Diagnosis
    Units: Subjects
        Yes
    		 13 15 10 10 48
        No
    		 45 46 49 45 185
    Disease Duration >2 years
    Units: Subjects
        Yes
    		 55 59 54 50 218
        No
    		 3 2 5 5 15
    Disease Duration
    Units: year
        arithmetic mean (standard deviation)
    		 19.6 ( 12.83 ) 19.9 ( 14.91 ) 20.4 ( 14.40 ) 17.6 ( 14.16 ) -
    Height
    Units: centimetre
        arithmetic mean (standard deviation)
    		 168.02 ( 10.955 ) 170.45 ( 10.236 ) 172.13 ( 11.659 ) 169.25 ( 10.422 ) -
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 80.52 ( 17.123 ) 80.73 ( 19.469 ) 86.57 ( 23.368 ) 80.89 ( 21.250 ) -
    Body Mass Index (BMI)
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    		 28.550 ( 5.7815 ) 27.632 ( 6.3312 ) 29.485 ( 8.3062 ) 28.178 ( 6.7782 ) -

    End points

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    End points reporting groups
    Reporting group title
    Orismilast Modified Release Tablets 20 mg BID
    Reporting group description
    		 Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation.

    Reporting group title
    Orismilast Modified Release Tablets 30 mg BID
    Reporting group description
    		 Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation.

    Reporting group title
    Orismilast Modified Release Tablets 40 mg BID
    Reporting group description
    		 Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation.

    Reporting group title
    Placebo Tablets BID
    Reporting group description
    		 Placebo matching tablets. Oral, twice daily morning and evening.

    Primary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Week 16

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    End point title
    		 Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Week 16
    End point description
    The EASI is a tool to measure the severity of clinical signs and the percentage of affected body surface area (BSA) in patients with atopic dermatitis (AD). The EASI is a composite scoring system to evaluate the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/papulation, excoriation, and lichenification are scored on a scale of 0 (absent) to 3 (severe) for each body region: head and neck, upper limbs (including the external axillae and hands), trunk (including the internal axillae and groin), and lower limbs (including the buttocks and feet). The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).
    End point type
    Primary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    58
    61
    59
    55
    Units: percent
        least squares mean (standard error)
    -55.1 ( 4.89 )
    -52.2 ( 5.39 )
    -61.4 ( 5.02 )
    -50.4 ( 4.98 )
    Statistical analysis title
    		 Orismilast 20 mg vs Placebo
    Comparison groups
    Orismilast Modified Release Tablets 20 mg BID v Placebo Tablets BID
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -4.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.2
         upper limit
    		 9
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.93
    Statistical analysis title
    		 Orismilast 30 mg vs Placebo
    Comparison groups
    Orismilast Modified Release Tablets 30 mg BID v Placebo Tablets BID
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -7.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.8
         upper limit
    		 12.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.15
    Statistical analysis title
    		 Orismilast 40 mg vs Placebo
    Comparison groups
    Placebo Tablets BID v Orismilast Modified Release Tablets 40 mg BID
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -10.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.6
         upper limit
    		 2.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.99

    Secondary: Percentage of Participants Achieving 75% Reduction in Eczema Area and Severity Index EASI (EASI75) Response at Week 16

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    End point title
    		 Percentage of Participants Achieving 75% Reduction in Eczema Area and Severity Index EASI (EASI75) Response at Week 16
    End point description
    The EASI is a tool to measure the severity of clinical signs and the percentage of affected body surface area (BSA) in patients with atopic dermatitis (AD). The EASI is a composite scoring system to evaluate the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/papulation, excoriation, and lichenification are scored on a scale of 0 (absent) to 3 (severe) for each body region: head and neck, upper limbs (including the external axillae and hands), trunk (including the internal axillae and groin), and lower limbs (including the buttocks and feet). The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    58
    61
    59
    55
    Units: percent
    number (not applicable)
        Yes
    30.4
    25.9
    36.4
    36.1
        No
    69.6
    74.1
    63.6
    63.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for AD (IGA-AD) at Week 16

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    End point title
    		 Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for AD (IGA-AD) at Week 16
    End point description
    At Week 16
    End point type
    Secondary
    End point timeframe
    The IGA-AD is a measure used by physicians to determine a patient’s overall severity of disease. The static version was used for measurement at a single point in time. The Investigator rated the severity of the patient’s AD on a 5-point scale ranging from
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    58
    61
    59
    55
    Units: percent
    number (not applicable)
        Yes
    26.3
    24.3
    30.9
    9.5
        No
    73.7
    75.7
    69.1
    90.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20

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    End point title
    		 Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20
    End point description
    The severity of itch (pruritus) due to AD was assessed using a horizontal 11-point NRS. Patients were asked to assess their “worst itching due to AD over the past 24 hours” on an NRS anchored by the terms “no itching” (0) and “worst possible itching” (10).
    End point type
    Secondary
    End point timeframe
    At Weeks 1, 2, 4, 8, 12, 16 and 20
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    55
    60
    56
    53
    Units: percent
    number (not applicable)
        Week 1, Yes
    21.4
    24.7
    31.5
    8.0
        Week 1, No
    78.6
    75.3
    68.5
    92.0
        Week 2, Yes
    30.4
    32.5
    34.1
    10.3
        Week 2, No
    69.6
    67.5
    65.9
    89.7
        Week 4, Yes
    33.6
    35.9
    30.2
    28.4
        Week 4, No
    66.4
    64.1
    69.8
    71.6
        Week 8, Yes
    39.5
    39.3
    46.1
    37.2
        Week 8, No
    60.5
    60.7
    53.9
    62.8
        Week 12, Yes
    49.5
    49.7
    52.2
    45.2
        Week 12, No
    50.5
    50.3
    47.8
    54.8
        Week 16, Yes
    57.0
    50.4
    59.6
    41.7
        Week 16, No
    43.0
    49.6
    40.4
    58.3
        Week 20, Yes
    51.2
    45.0
    47.4
    52.1
        Week 20, No
    48.8
    55.0
    52.6
    47.9
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Week 16

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    End point title
    		 Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Week 16
    End point description
    The severity of itch (pruritus) due to AD was assessed using a horizontal 11-point NRS. Patients were asked to assess their “worst itching due to AD over the past 24 hours” on an NRS anchored by the terms “no itching” (0) and “worst possible itching” (10).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    36
    35
    38
    42
    Units: Units on a scale
        least squares mean (standard error)
    -3.8 ( 0.38 )
    -4.2 ( 0.39 )
    -4.2 ( 0.38 )
    -0.32 ( 0.37 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20

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    End point title
    		 Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20
    End point description
    The IGA-AD is a measure used by physicians to determine a patient’s overall severity of disease. The static version was used for measurement at a single point in time. The Investigator rated the severity of the patient’s AD on a 5-point scale ranging from 0 (clear) to 4 (severe).
    End point type
    Secondary
    End point timeframe
    At Weeks 2, 4, 8, 12, and 20
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    58
    61
    59
    55
    Units: percent
    number (not applicable)
        Week 2, Yes
    1.8
    3.3
    3.4
    0.0
        Week 2, No
    98.2
    96.7
    96.6
    100
        Week 4, Yes
    4.7
    5.3
    5.6
    1.9
        Week 4, No
    95.3
    94.7
    94.4
    98.1
        Week 8, Yes
    19.2
    13.0
    11.6
    6.2
        Week 8, No
    80.8
    87.0
    88.4
    93.8
        Week 12, Yes
    20.9
    17.5
    18.7
    7.2
        Week 12, No
    79.1
    82.5
    81.3
    92.8
        Week 20, Yes
    28.0
    28.2
    26.4
    16.6
        Week 20, No
    72.0
    71.8
    73.6
    83.4
    No statistical analyses for this end point

    Secondary: Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Week 16

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    End point title
    		 Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Week 16
    End point description
    The EASI is an investigator-assessed instrument measuring the severity of clinical signs and the percentage of affected BSA in patients with AD. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).
    End point type
    Secondary
    End point timeframe
    At Week 16.
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    39
    35
    38
    43
    Units: Number of participants
        Yes
    25
    21
    30
    27
        No
    14
    14
    8
    16
    No statistical analyses for this end point

    Secondary: Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Week16

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    End point title
    		 Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Week16
    End point description
    The EASI is an investigator-assessed instrument measuring the severity of clinical signs and the percentage of affected BSA in patients with AD. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).
    End point type
    Secondary
    End point timeframe
    At Week 16.
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    39
    35
    38
    43
    Units: Number of participants
        Yes
    7
    7
    10
    7
        No
    32
    28
    28
    36
    No statistical analyses for this end point

    Secondary: Change From Baseline in Affected Body Surface Area (BSA) at Week 16

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    End point title
    		 Change From Baseline in Affected Body Surface Area (BSA) at Week 16
    End point description
    The BSA assessment estimated the extent of disease or skin affected by AD and was expressed as a percentage of total BSA. BSA was determined by the Investigator or designee using the participant’s hand (palm + fingers) = 1% BSA rule.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16.
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    38
    35
    38
    42
    Units: units on a scale
        least squares mean (standard error)
    -13.9 ( 1.57 )
    -12.4 ( 1.61 )
    -17.4 ( 1.57 )
    -13.8 ( 1.53 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16

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    End point title
    		 Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
    End point description
    The DLQI is a 10-item validated questionnaire completed by the patient and used to assess the effect of skin disease on the patient’s quality of life during the previous week. The 10 questions cover the following topics: symptoms; embarrassment; interference with shopping and home care, clothing choices, social and leisure activities, sports participation, work or study, close relationships, and sex; and treatment. Each question is scored from 0 to 3 (“not at all,” “a little,” “a lot,” and “very much,” respectively), giving a total score ranging from 0 to 30. A high score is indicative of a poor quality of life.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16.
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    36
    35
    38
    42
    Units: score on a scale
        least squares mean (standard error)
    -7.5 ( 0.87 )
    -8.2 ( 0.89 )
    -9.0 ( 0.86 )
    -7.5 ( 0.83 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 16

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    End point title
    		 Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 16
    End point description
    The POEM is a 7-item, validated questionnaire completed by the patient to assess disease symptoms. Patients were asked to respond to questions on frequency of sleep loss and skin dryness, itching, flaking, cracking, bleeding, and weeping over the past week. All answers carry equal weight, with a total possible score ranging from 0 to 28. A high score is indicative of a poor quality of life.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16.
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    36
    35
    38
    42
    Units: score on a scale
        least squares mean (standard error)
    -9.8 ( 0.97 )
    -9.1 ( 0.98 )
    -10.1 ( 0.95 )
    -7.5 ( 0.93 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Week 16

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    End point title
    		 Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Week 16
    End point description
    The PGIS scale is a single question asking the patient how he or she would rate his or her overall AD symptoms over the past 24 hours. The 5 categories of responses are (0) “no symptoms”, (1) “very mild”, (2) “mild”, (3) “moderate”, and (4) “severe.”
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16.
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    36
    35
    38
    38
    Units: score on a scale
        least squares mean (standard error)
    -1.5 ( 0.17 )
    -1.4 ( 0.17 )
    -1.5 ( 0.16 )
    -1.1 ( 0.16 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Patient Global Impression of Change (PGIC) Score at Week 16

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    End point title
    		 Change From Baseline in Patient Global Impression of Change (PGIC) Score at Week 16
    End point description
    The PGIC scale measures change in clinical status of AD. The PGIC is based on a 7-point scale, and the patient will rate the change from the start of treatment as 1 “very much improved,” 2 “much improved,” 3 “minimally improved,” 4 “no change,” 5 “minimally worse,” 6 “much worse,” and 7 “very much worse.”
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    37
    35
    38
    43
    Units: score on a scale
        least squares mean (standard error)
    2.2 ( 0.20 )
    2.3 ( 0.21 )
    2.3 ( 0.20 )
    2.9 ( 0.19 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Week 16

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    End point title
    		 Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Week 16
    End point description
    The sleep disturbance NRS is a scale used by the patients to report their degree of sleep loss related to AD. Patients were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being “no sleep loss related to signs/symptoms of AD” and 10 being “I cannot sleep at all because of the signs/symptoms of AD”. Higher scores indicate worse outcomes.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16.
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    36
    35
    38
    42
    Units: score on a scale
        least squares mean (standard error)
    -3.4 ( 0.41 )
    -3.7 ( 0.42 )
    -2.9 ( 0.40 )
    -2.5 ( 0.39 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Skin Pain Numerical Rating Scale (NRS) Score at Week 16

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    End point title
    		 Change From Baseline in Skin Pain Numerical Rating Scale (NRS) Score at Week 16
    End point description
    The skin pain NRS is a patient-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing “no pain” and 10 representing “worst pain imaginable.” Overall severity of a participant’s skin pain is indicated by selecting the number that best describes the worst level of skin pain in the past 24 hours.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16.
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    36
    35
    38
    42
    Units: score on a scale
        least squares mean (standard error)
    -3.5 ( 0.39 )
    -3.7 ( 0.39 )
    -3.6 ( 0.38 )
    -2.9 ( 0.38 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment Emergent Adverse Events (TEAE)

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    End point title
    		 Number of Participants With Treatment Emergent Adverse Events (TEAE)
    End point description
    An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at screening, worsens during the study, regardless of the suspected cause of the event.
    End point type
    Secondary
    End point timeframe
    From Baseline through Weeks 16 and 20.
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    58
    61
    59
    55
    Units: Number of participants
        Any TEAEs
    44
    48
    51
    35
        Any related TEAEs
    37
    39
    42
    14
        Any Treatment Emergent Serious Adverse Events
    1
    0
    1
    0
        Death
    0
    0
    0
    0
        Treatment Emergent Adverse Event of Special Intere
    3
    10
    9
    1
        TEAEs leading to study drug discontinuation
    8
    16
    14
    2
        TESAEs leading to study drug discontinuation
    0
    0
    1
    0
        TEAEs by relationship, unrelated
    18
    17
    22
    21
        TEAEs by relationship, unlikely
    6
    7
    8
    5
        TEAEs by relationship, possibly
    16
    19
    22
    8
        TEAEs by relationship, probably
    17
    20
    15
    4
        TEAEs by relationship, definitely
    18
    17
    15
    3
        TEAEs by toxicity grade, Grade 1
    37
    41
    44
    30
        TEAEs by toxicity grade, Grade 2
    19
    26
    20
    9
        TEAEs by toxicity grade, Grade 3
    4
    6
    2
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in Body Temperature at Week 16

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    End point title
    		 Change From Baseline in Body Temperature at Week 16
    End point description
    A complete physical examination that included body temperature measurement was performed at screening (Visit 1) and Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 16.
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    39
    35
    38
    43
    Units: degree
        arithmetic mean (standard deviation)
    -0.07 ( 0.300 )
    0.05 ( 0.239 )
    -0.01 ( 0.350 )
    0.00 ( 0.324 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Respiration Rate at Week 16

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    End point title
    		 Change From Baseline in Respiration Rate at Week 16
    End point description
    A complete physical examination that included respiration rate measurement was performed at screening (Visit 1) and Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16.
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    38
    35
    38
    43
    Units: breathes per minute
        arithmetic mean (standard deviation)
    0.1 ( 1.51 )
    0.2 ( 1.37 )
    0.1 ( 1.26 )
    0.3 ( 1.72 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Heart Rate at Week 16

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    End point title
    		 Change From Baseline in Heart Rate at Week 16
    End point description
    A complete physical examination that included heart rate measurement was performed at screening (Visit 1) and Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16.
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    39
    35
    38
    43
    Units: Beats per minute
        arithmetic mean (standard error)
    3.3 ( 9.59 )
    1.1 ( 9.99 )
    4.4 ( 9.01 )
    -2.5 ( 11.07 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Systolic and Diastolic Blood Pressure at Week 16

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    End point title
    		 Change From Baseline in Systolic and Diastolic Blood Pressure at Week 16
    End point description
    A complete physical examination that included systolic and diastolic blood pressure measurements was performed at screening (Visit 1) and Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16.
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    39
    35
    38
    43
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic Blood Pressure
    0.3 ( 11.62 )
    1.0 ( 12.04 )
    -1.4 ( 12.66 )
    -0.1 ( 9.76 )
        Diastolic Blood Pressure
    -0.5 ( 8.46 )
    -0.6 ( 8.33 )
    -2.1 ( 6.93 )
    -1.8 ( 8.23 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Body Mass Index at Week 16

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    End point title
    		 Change From Baseline in Body Mass Index at Week 16
    End point description
    A complete physical examination that included body mass index measurements was performed at screening (Visit 1) and Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    38
    35
    37
    43
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    -0.28 ( 1.081 )
    -0.13 ( 0.758 )
    -0.34 ( 1.252 )
    0.16 ( 0.773 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECF) at Week 16

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    End point title
    		 Number of Participants With Clinically Significant Changes in Electrocardiogram (ECF) at Week 16
    End point description
    Electrocardiograms were assessed by the investigators based on automatically generated parameters.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    58
    61
    59
    55
    Units: Number of participants
        QT interval > 450 msec
    0
    1
    1
    2
        QT interval > 480 msec
    0
    0
    1
    1
        QT interval > 500 msec
    0
    0
    1
    0
        QTc interval > 450 msec
    1
    4
    2
    2
        QTc interval > 480 msec
    0
    0
    1
    1
        QTc interval > 500 msec
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration at Week 16

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    End point title
    		 Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration at Week 16
    End point description
    Laboratory parameters including hematology was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    36
    32
    37
    42
    Units: g/L
        arithmetic mean (standard deviation)
    5.2 ( 16.82 )
    5.8 ( 20.08 )
    2.0 ( 17.65 )
    4.3 ( 18.07 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin at Week 16

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    End point title
    		 Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin at Week 16
    End point description
    Laboratory parameters including hematology was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    36
    32
    37
    42
    Units: g/L
        arithmetic mean (standard deviation)
    -0.24 ( 1.057 )
    -0.27 ( 0.690 )
    -0.25 ( 0.816 )
    -0.14 ( 0.710 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume at Week 16

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    End point title
    		 Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume at Week 16
    End point description
    Laboratory parameters including hematology was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    36
    32
    37
    42
    Units: g/L
        arithmetic mean (standard deviation)
    -2.34 ( 4.833 )
    -2.80 ( 6.069 )
    -1.52 ( 6.262 )
    -1.52 ( 6.535 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hematology Parameter: Hematocrit at Week 16

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    End point title
    		 Change From Baseline in Hematology Parameter: Hematocrit at Week 16
    End point description
    Laboratory parameters including hematology was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    36
    32
    37
    42
    Units: L/L
        arithmetic mean (standard deviation)
    -0.0125 ( 0.03242 )
    -0.0100 ( 0.03359 )
    -0.0061 ( 0.03420 )
    -0.0045 ( 0.03509 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hematology Parameter: Hemoglobin at Week 16

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    End point title
    		 Change From Baseline in Hematology Parameter: Hemoglobin at Week 16
    End point description
    Laboratory parameters including hematology was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    36
    32
    37
    42
    Units: g/L
        arithmetic mean (standard deviation)
    -1.5 ( 6.70 )
    -0.2 ( 6.89 )
    -1.0 ( 8.12 )
    0.2 ( 8.33 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16

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    End point title
    		 Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16
    End point description
    Laboratory parameters including hematology was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    36
    32
    37
    42
    Units: 10^9/L
    arithmetic mean (standard deviation)
        Leukocytes
    0.357 ( 2.5643 )
    -0.061 ( 1.8343 )
    -0.372 ( 1.6455 )
    -0.153 ( 1.3115 )
        Basophils
    0.002 ( 0.0131 )
    0.007 ( 0.0187 )
    -0.002 ( 0.0133 )
    -0.002 ( 0.0206 )
        Eosinophils
    -0.048 ( 0.2048 )
    -0.131 ( 0.6653 )
    -0.055 ( 0.3146 )
    -0.020 ( 0.1309 )
        Lymphocytes
    0.031 ( 0.5119 )
    0.009 ( 0.4377 )
    -0.065 ( 0.3665 )
    0.020 ( 0.4073 )
        Monocytes
    0.031 ( 0.1884 )
    0.017 ( 0.1336 )
    -0.008 ( 0.1070 )
    0.021 ( 0.1205 )
        Neutrophils
    0.339 ( 2.2070 )
    0.040 ( 1.3733 )
    -0.233 ( 1.5109 )
    -0.170 ( 1.3980 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hematology Parameter: Platelets at Week 16

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    End point title
    		 Change From Baseline in Hematology Parameter: Platelets at Week 16
    End point description
    Laboratory parameters including hematology was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    36
    32
    36
    42
    Units: 10^9/L
        arithmetic mean (standard deviation)
    22.5 ( 51.03 )
    11.7 ( 55.24 )
    -1.8 ( 61.72 )
    -3.0 ( 37.53 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hematology Parameter: Reticulocytes at Week 16

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    End point title
    		 Change From Baseline in Hematology Parameter: Reticulocytes at Week 16
    End point description
    Laboratory parameters including hematology was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    36
    32
    36
    42
    Units: percent
        arithmetic mean (standard deviation)
    0.008 ( 0.4376 )
    0.025 ( 0.3758 )
    -0.137 ( 0.4313 )
    -0.024 ( 0.3411 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Chemistry Parameter: Alkaline Phosphatase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16

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    End point title
    		 Change From Baseline in Chemistry Parameter: Alkaline Phosphatase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16
    End point description
    Laboratory parameters including chemistry was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    38
    34
    38
    43
    Units: U/L
    arithmetic mean (standard deviation)
        Alkaline Phosphatase
    -4.8 ( 25.88 )
    2.1 ( 11.55 )
    1.5 ( 11.32 )
    -1.7 ( 11.11 )
        Gamma Glutamyl Transferase
    -6.8 ( 62.55 )
    -0.8 ( 9.11 )
    3.3 ( 23.98 )
    -1.7 ( 6.75 )
        Lactate Dehydrogenase
    -15.8 ( 41.47 )
    -12.9 ( 58.24 )
    -12.9 ( 50.15 )
    -7.9 ( 36.44 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Chemistry Parameter: Alanine Aminotransferase and Aspartate Aminotransferase at Week 16

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    End point title
    		 Change From Baseline in Chemistry Parameter: Alanine Aminotransferase and Aspartate Aminotransferase at Week 16
    End point description
    Laboratory parameters including chemistry was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    38
    34
    37
    43
    Units: U/L
    arithmetic mean (standard deviation)
        Alanine Aminotransferase
    -1.5 ( 17.16 )
    -0.7 ( 10.06 )
    1.0 ( 10.87 )
    -0.6 ( 13.13 )
        Aspartate Aminotransferase
    -1.6 ( 13.08 )
    0.6 ( 9.75 )
    -0.4 ( 11.35 )
    -1.4 ( 11.50 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Chemistry Parameter: Albumin at Week 16

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    End point title
    		 Change From Baseline in Chemistry Parameter: Albumin at Week 16
    End point description
    Laboratory parameters including chemistry was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    38
    34
    38
    43
    Units: g/L
        arithmetic mean (standard deviation)
    -0.4 ( 2.67 )
    0.0 ( 2.80 )
    0.0 ( 2.57 )
    0.1 ( 2.36 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Chemistry Parameter: Bilirubin and Direct Bilirubin at Week 16

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    End point title
    		 Change From Baseline in Chemistry Parameter: Bilirubin and Direct Bilirubin at Week 16
    End point description
    Laboratory parameters including chemistry was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    38
    34
    37
    43
    Units: umol/L
    arithmetic mean (standard deviation)
        Bilirubin
    0.29 ( 2.487 )
    0.13 ( 2.948 )
    0.32 ( 2.361 )
    0.68 ( 3.234 )
        Direct Bilirubin
    0.03 ( 0.205 )
    -0.13 ( 0.552 )
    0.01 ( 0.084 )
    0.17 ( 0.739 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Chemistry Parameter: Creatinine at Week 16

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    End point title
    		 Change From Baseline in Chemistry Parameter: Creatinine at Week 16
    End point description
    Laboratory parameters including chemistry was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    38
    34
    38
    43
    Units: umol/L
        arithmetic mean (standard deviation)
    2.9 ( 13.41 )
    2.3 ( 12.07 )
    2.3 ( 12.59 )
    -1.0 ( 7.58 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hematology Parameter: Basophils/Leukocytes at Week 16

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    End point title
    		 Change From Baseline in Hematology Parameter: Basophils/Leukocytes at Week 16
    End point description
    Laboratory parameters including hematology was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    36
    32
    37
    42
    Units: percent
        arithmetic mean (standard deviation)
    0.02 ( 0.216 )
    0.10 ( 0.269 )
    0.01 ( 0.225 )
    -0.03 ( 0.359 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes at Week 16

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    End point title
    		 Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes at Week 16
    End point description
    Laboratory parameters including hematology was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    36
    32
    37
    42
    Units: percent
        arithmetic mean (standard deviation)
    -0.42 ( 2.353 )
    -0.96 ( 4.705 )
    -0.35 ( 3.323 )
    -0.28 ( 2.268 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes at Week 16

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    End point title
    		 Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes at Week 16
    End point description
    Laboratory parameters including hematology was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    36
    32
    37
    42
    Units: percent
        arithmetic mean (standard deviation)
    -0.48 ( 7.737 )
    0.46 ( 6.139 )
    1.05 ( 7.232 )
    0.94 ( 6.922 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hematology Parameter: Monocytes/Leukocytes at Week 16

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    End point title
    		 Change From Baseline in Hematology Parameter: Monocytes/Leukocytes at Week 16
    End point description
    Laboratory parameters including hematology was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16.
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    36
    32
    37
    42
    Units: percent
        arithmetic mean (standard deviation)
    0.18 ( 2.468 )
    0.31 ( 1.487 )
    0.09 ( 1.679 )
    0.29 ( 2.130 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes at Week 16

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    End point title
    		 Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes at Week 16
    End point description
    Laboratory parameters including hematology was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16.
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    36
    32
    37
    42
    Units: percent
        arithmetic mean (standard deviation)
    0.72 ( 9.487 )
    0.13 ( 8.508 )
    -0.67 ( 9.060 )
    -0.90 ( 9.247 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16

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    End point title
    		 Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16
    End point description
    Laboratory parameters including chemistry was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    38
    34
    38
    43
    Units: mmol/L
    arithmetic mean (standard deviation)
        Calcium
    -0.021 ( 0.1430 )
    0.013 ( 0.1085 )
    0.006 ( 0.1260 )
    -0.015 ( 0.1300 )
        Chloride
    -0.2 ( 3.29 )
    0.0 ( 3.08 )
    0.2 ( 3.05 )
    0.1 ( 3.07 )
        Potassium
    -0.01 ( 0.498 )
    -0.01 ( 0.393 )
    -0.18 ( 0.449 )
    -0.06 ( 0.372 )
        Sodium
    -0.1 ( 2.89 )
    0.6 ( 3.47 )
    1.4 ( 2.75 )
    0.5 ( 2.66 )
        Urea Nitrogen
    -0.207 ( 1.1653 )
    -0.315 ( 1.2731 )
    0.104 ( 1.3782 )
    -0.041 ( 1.5732 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Chemistry Parameter: Phosphate at Week 16

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    End point title
    		 Change From Baseline in Chemistry Parameter: Phosphate at Week 16
    End point description
    Laboratory parameters including chemistry was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    38
    34
    37
    43
    Units: mmol/L
        arithmetic mean (standard deviation)
    0.003 ( 0.1986 )
    0.045 ( 0.2010 )
    0.043 ( 0.2661 )
    -0.009 ( 0.1579 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16

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    End point title
    		 Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16
    End point description
    Laboratory parameters including chemistry was evaluated at baseline and at Week 16.
    End point type
    Secondary
    End point timeframe
    At Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    58
    61
    59
    55
    Units: Number of participants
        Amorphous Crystals, Present
    1
    0
    0
    0
        Bacteria, Increase to 1+
    0
    0
    2
    4
        Bacteria, Increase to 2+
    2
    1
    1
    0
        Bacteria, Increase to 3+
    0
    0
    1
    0
        Bacteria, Increase to 4+
    0
    0
    0
    1
        Calcium Oxalate Crystals, 1-5
    2
    1
    0
    0
        Calcium Oxalate Crystals, 6-9
    1
    0
    0
    0
        Calcium Oxalate Crystals, 10-15
    0
    0
    0
    1
        Calcium Oxalate Crystals, 16-29
    0
    0
    1
    0
        Calcium Oxalate Crystals, 30-49
    1
    0
    0
    0
        Calcium Oxalate Crystals, None
    16
    11
    20
    22
        Erythrocytes, 1-2
    9
    2
    6
    11
        Erythrocytes, 3-5
    1
    1
    4
    3
        Erythrocytes, 6-9
    0
    1
    0
    0
        Erythrocytes, >75
    0
    0
    0
    1
        Erythrocytes, None
    6
    4
    7
    4
        Erythrocytes, Occasional
    4
    4
    4
    4
        Hyaline Casts, 1-5
    0
    0
    0
    1
        Hyaline Casts, None
    20
    12
    21
    22
        Leukocytes, 1-5
    8
    6
    8
    9
        Leukocytes, 6-9
    0
    2
    1
    0
        Leukocytes, 16-29
    0
    0
    1
    1
        Leukocytes, 30-49
    1
    0
    1
    0
        Leukocytes, 50-75
    0
    0
    1
    0
        Leukocytes, None
    5
    1
    2
    5
        Leukocytes, Occasional
    6
    3
    7
    8
        Mucous Threads, Present
    4
    4
    5
    5
        Squamous Epithelial Cells, 1-5
    10
    2
    8
    6
        Squamous Epithelial Cells, 6-9
    1
    1
    1
    2
        Squamous Epithelial Cells, 10-15
    2
    1
    2
    1
        Squamous Epithelial Cells, 16-29
    0
    1
    1
    1
        Squamous Epithelial Cells, None
    5
    5
    5
    9
        Squamous Epithelial Cells, Occasional
    2
    2
    4
    4
        Transitional Epithelial Cells, Occasional
    2
    1
    0
    1
        Uric Acid Crystals, >75
    0
    0
    1
    0
        Uric Acid Crystals, None
    20
    11
    21
    23
        Yeast Cells, Present
    0
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 16

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    End point title
    		 Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 16
    End point description
    The HADS is a patient reported outcome, comprises of 7 questions for anxiety and 7 questions for depression, with each answer graded from 0 to 3 with a higher score indicating a worse condition. For each group of questions, scores of 7 or less indicate cases without anxiety or depression, whereas scores of 8 to 10, 11 to 14, and 15 to 21 indicate mild, moderate, and severe cases, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    37
    35
    38
    43
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -2.2 ( 3.11 )
    -1.7 ( 3.22 )
    -1.5 ( 4.25 )
    -1.4 ( 3.21 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)

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    End point title
    		 Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
    End point description
    The C-SSRS, Investigator-administered version, was designed to provide a prospective, standardized measure of suicidality. C-SSRS is administered in the form of a clinical interview. The C-SSRS categories have been re-ordered from the actual scale to facilitate the definitions of the endpoints, and to enable clarity in the presentation of the results: Category 1 – Wish to be Dead, Category 2 – Non-specific Active Suicidal Thoughts, Category 3 – Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Category 4 – Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Category 5 – Active Suicidal Ideation with Specific Plan and Intent, Category 6 – Preparatory Acts or Behavior, Category 7 – Aborted Attempt, Category 8 – Interrupted Attempt, Category 9 – Actual Attempt (non-fatal), Category 10 – Completed Suicide.
    End point type
    Secondary
    End point timeframe
    At Week 16.
    End point values
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Number of subjects analysed
    58
    61
    59
    55
    Units: number of subjetcs
        Suicidal Ideation
    0
    0
    0
    0
        Suicidal Behavior
    0
    0
    0
    0
        Self-injurious behavior without suicidal intent
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    16 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Orismilast Modified Release Tablets 20 mg BID
    Reporting group description
    		 Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation.

    Reporting group title
    Orismilast Modified Release Tablets 30 mg BID
    Reporting group description
    		 Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation.

    Reporting group title
    Orismilast Modified Release Tablets 40 mg BID
    Reporting group description
    		 Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation.

    Reporting group title
    Placebo Tablets BID
    Reporting group description
    		 Placebo matching tablets. Oral, twice daily morning and evening.

    Serious adverse events
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Presyncope
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Placebo Tablets BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 58 (75.86%)
    48 / 61 (78.69%)
    51 / 59 (86.44%)
    35 / 55 (63.64%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hot flush
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypertension
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 58 (1.72%)
    2 / 61 (3.28%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Chest pain
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Drug tolerance decreased
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 58 (1.72%)
    4 / 61 (6.56%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    4
    0
    0
    Hunger
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    1
    Influenza like illness
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    1
    Malaise
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Influenza
         subjects affected / exposed
    2 / 58 (3.45%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Immune system disorders
    Allergy to metals
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    1
    Food allergy
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    1
    0
    0
    1
    Paranasal sinus discomfort
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Wheezing
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    Adjustment disorder with depressed mood
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Anxiety
         subjects affected / exposed
    2 / 58 (3.45%)
    5 / 61 (8.20%)
    5 / 59 (8.47%)
    7 / 55 (12.73%)
         occurrences all number
    2
    5
    6
    7
    Anxiety disorder
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Depression
         subjects affected / exposed
    1 / 58 (1.72%)
    4 / 61 (6.56%)
    3 / 59 (5.08%)
    3 / 55 (5.45%)
         occurrences all number
    1
    5
    4
    3
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 58 (0.00%)
    2 / 61 (3.28%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Blood pressure systolic increased
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    1
    Electrocardiogram ST segment depression
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 58 (0.00%)
    3 / 61 (4.92%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    5
    0
    0
    Mean cell haemoglobin concentration decreased
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Mean cell volume increased
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Weight decreased
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 61 (0.00%)
    5 / 59 (8.47%)
    1 / 55 (1.82%)
         occurrences all number
    2
    0
    5
    1
    Injury, poisoning and procedural complications
    Accident at work
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fall
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    2 / 59 (3.39%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Ligament rupture
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ligament sprain
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sunburn
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Wrist fracture
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Bundle branch block left
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Bundle branch block right
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Myocardial infarction
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Palpitations
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    6 / 58 (10.34%)
    8 / 61 (13.11%)
    5 / 59 (8.47%)
    0 / 55 (0.00%)
         occurrences all number
    7
    10
    5
    0
    Headache
         subjects affected / exposed
    12 / 58 (20.69%)
    11 / 61 (18.03%)
    17 / 59 (28.81%)
    5 / 55 (9.09%)
         occurrences all number
    15
    13
    20
    5
    Nerve compression
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sinus headache
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Somnolence
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    2
    0
    0
    3
    Syncope
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 58 (0.00%)
    2 / 61 (3.28%)
    2 / 59 (3.39%)
    0 / 55 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Sleep disorder
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Leukocytosis
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lymphadenitis
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 58 (3.45%)
    1 / 61 (1.64%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye swelling
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Abdominal distension
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    3 / 59 (5.08%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Abdominal pain
         subjects affected / exposed
    1 / 58 (1.72%)
    5 / 61 (8.20%)
    5 / 59 (8.47%)
    0 / 55 (0.00%)
         occurrences all number
    1
    6
    6
    0
    Abdominal pain upper
         subjects affected / exposed
    3 / 58 (5.17%)
    2 / 61 (3.28%)
    2 / 59 (3.39%)
    0 / 55 (0.00%)
         occurrences all number
    3
    2
    3
    0
    Chronic gastritis
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Constipation
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    1
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    19 / 58 (32.76%)
    24 / 61 (39.34%)
    20 / 59 (33.90%)
    3 / 55 (5.45%)
         occurrences all number
    22
    32
    24
    3
    Dry mouth
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    1
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    4 / 58 (6.90%)
    2 / 61 (3.28%)
    2 / 59 (3.39%)
    1 / 55 (1.82%)
         occurrences all number
    4
    2
    24
    1
    Epigastric discomfort
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Faeces soft
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    3 / 59 (5.08%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Flatulence
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 61 (0.00%)
    2 / 59 (3.39%)
    0 / 55 (0.00%)
         occurrences all number
    2
    0
    24
    0
    Frequent bowel movements
         subjects affected / exposed
    2 / 58 (3.45%)
    1 / 61 (1.64%)
    2 / 59 (3.39%)
    0 / 55 (0.00%)
         occurrences all number
    2
    1
    2
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    1
    Nausea
         subjects affected / exposed
    17 / 58 (29.31%)
    23 / 61 (37.70%)
    27 / 59 (45.76%)
    5 / 55 (9.09%)
         occurrences all number
    24
    29
    31
    7
    Toothache
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vomiting
         subjects affected / exposed
    2 / 58 (3.45%)
    9 / 61 (14.75%)
    9 / 59 (15.25%)
    1 / 55 (1.82%)
         occurrences all number
    3
    13
    10
    1
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    3 / 58 (5.17%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    3 / 55 (5.45%)
         occurrences all number
    3
    1
    0
    3
    Dermatitis contact
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 61 (1.64%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    1
    0
    0
    1
    Rosacea
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin disorder
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Bone pain
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    4
    0
    Myalgia
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    1
    Infections and infestations
    Asymptomatic bacteriuria
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Diverticulitis
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ear infection
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Febrile infection
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Folliculitis
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Herpes simplex
         subjects affected / exposed
    0 / 58 (0.00%)
    2 / 61 (3.28%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Herpes simplex reactivation
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    1
    Herpes zoster
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 58 (1.72%)
    2 / 61 (3.28%)
    4 / 59 (6.78%)
    4 / 55 (7.27%)
         occurrences all number
    1
    4
    4
    5
    Ophthalmic herpes simplex
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Paronychia
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pyelonephritis
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rhinolaryngitis
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 61 (1.64%)
    1 / 59 (1.69%)
    2 / 55 (3.64%)
         occurrences all number
    0
    1
    1
    2
    Urinary tract infection
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    2 / 55 (3.64%)
         occurrences all number
    0
    0
    1
    2
    Urinary tract infection fungal
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Abnormal loss of weight
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    2 / 59 (3.39%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Decreased appetite
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    2 / 59 (3.39%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Glucose tolerance impaired
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypercalcaemia
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Back pain
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    2
    0
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 May 2022
    The purpose of this amendment was to update the protocol per FDA recommendations related to subject inclusion/exclusion criteria, AESIs, and the Investigator Global Assessment for Atopic Dermatitis scale. Additional updates were made to the statistical analyses per the Sponsor’s statistician.
    13 Apr 2023
    The purpose of this amendment was to update the protocol per notification letter dated 09-FEB2023 for adjustment of laboratory ranges in exclusion criterion No. 14, the update of the Investigators Brochure for orismilast version 15, dated 05. April 2023 and learnings from the recently completed clinical phase 2b trial, UNI50001-203, with orismilast in patients with moderate to severe psoriasis.

    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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