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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 Plaque-Type Psoriasis

    Summary
    EudraCT number
    		 2021-003209-22
    Trial protocol
    		 DE  
    Global end of trial date
    20 Dec 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Dec 2023
    First version publication date
    31 Dec 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    UNI50001-203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05190419
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UNION therapeutics A/S
    Sponsor organisation address
    Tuborg Havnevej 18, Hellerup, Denmark, DK-2900
    Public contact
    Morten Lind Jensen, UNION therapeutics A/S, +45 5357 30 44, clinicaltrials@uniontherapeutics.com
    Scientific contact
    Morten Lind Jensen, UNION therapeutics A/S, +45 5357 30 44, morten.lind.jensen@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
    13 Feb 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Nov 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Dec 2022
    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 adults with moderate-to-severe plaque-type psoriasis.
    Protection of trial subjects
    The study was conducted according to the ethical principles in line with the International Conference on Harmonisation (ICH) guidelines for Good Clinical Practice (GCP) and applicable regulatory requirements, ensuring welfare of the study subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Dec 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 126
    Country: Number of subjects enrolled
    Germany: 46
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    United States: 26
    Worldwide total number of subjects
    202
    EEA total number of subjects
    172
    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)
    178
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 202 participants were randomized at 26 sites in Germany (8 sites), Poland (12 sites), the United Kingdom (1 site), and the US (5 sites).

    Pre-assignment
    Screening details
    		 The screening visit took place up to 28 days prior to Day 1. Subjects were screened for eligibility and signed the informed consent form.

    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
    Blinding implementation details
    At the investigational site, each screened subject was assigned a subject identifier number during screening that was be used on all subject documentation. The subject identifier number contains the site number and the subject number and was assigned in numerical order at the screening visit based on chronological order of screening dates.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo Tablets BID
    Arm description
    		 Subjects took placebo tablets twice a day during 16 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo. Oral, twice daily morning and evening.

    Arm title
    		 Orismilast Modified Release Tablets 20 mg BID
    Arm description
    		 Subjects took Orismilast Modified Release Tablets 20 mg BID twice a day during 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Orismilast Modified Release Tablets 20 mg BID
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg BID Oral, twice daily morning and evening.

    Arm title
    		 Orismilast Modified Release Tablets 30 mg BID
    Arm description
    		 Subjects took Orismilast Modified Release Tablets 30 mg BID twice a day during 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Orismilast Modified Release Tablets 30 mg BID
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg BID. Oral, twice daily morning and evening.

    Arm title
    		 Orismilast Modified Release Tablets 40 mg BID
    Arm description
    		 Subjects took Orismilast Modified Release Tablets 40 mg BID twice a day during 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Orismilast Modified Release Tablets 40 mg BID
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg BID. Oral, twice daily morning and evening.

    Number of subjects in period 1
    		Placebo Tablets BID Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID
    Started
    51
    48
    50
    53
    Completed
    32
    34
    33
    26
    Not completed
    19
    14
    17
    27
         Consent withdrawn by subject
    7
    1
    2
    2
         Adverse event, non-fatal
    2
    10
    11
    21
         Other
    1
    1
    -
    3
         Lost to follow-up
    1
    2
    3
    1
         Lack of efficacy
    8
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo Tablets BID
    Reporting group description
    		 Subjects took placebo tablets twice a day during 16 weeks.

    Reporting group title
    Orismilast Modified Release Tablets 20 mg BID
    Reporting group description
    		 Subjects took Orismilast Modified Release Tablets 20 mg BID twice a day during 16 weeks.

    Reporting group title
    Orismilast Modified Release Tablets 30 mg BID
    Reporting group description
    		 Subjects took Orismilast Modified Release Tablets 30 mg BID twice a day during 16 weeks.

    Reporting group title
    Orismilast Modified Release Tablets 40 mg BID
    Reporting group description
    		 Subjects took Orismilast Modified Release Tablets 40 mg BID twice a day during 16 weeks.

    Reporting group values
    		 Placebo Tablets BID Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID Total
    Number of subjects
    		 51 48 50 53 202
    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)
    		 45.10 ( 11.98 ) 45.40 ( 13.87 ) 48.20 ( 13.40 ) 44.30 ( 14.60 ) -
    Gender categorical
    Units: Subjects
        Female
    		 12 17 11 15 55
        Male
    		 39 31 39 38 147
    Psoriatic Arthritis
    Units: Subjects
        Yes
    		 1 2 5 6 14
        No
    		 50 46 45 47 188
    Disease duration > 2 years
    Units: Subjects
        Yes
    		 49 47 47 49 192
        No
    		 2 1 3 4 10
    Child-bearing potential
    Units: Subjects
        Yes
    		 10 13 5 10 38
        No
    		 41 35 45 43 164
    Disease duration
    Units: year
        arithmetic mean (standard deviation)
    		 19.3 ( 11.33 ) 22.0 ( 14.21 ) 18.1 ( 11.99 ) 19.8 ( 13.69 ) -
    Height
    Units: centimetre
        arithmetic mean (standard deviation)
    		 176.26 ( 8.67 ) 174.14 ( 8.78 ) 173.87 ( 9.30 ) 176.90 ( 8.57 ) -
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 91.48 ( 20.33 ) 94.85 ( 29.96 ) 91.65 ( 16.17 ) 91.08 ( 21.17 ) -
    BMI
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    		 29.420 ( 6.271 ) 31.019 ( 8.548 ) 30.464 ( 5.963 ) 29.000 ( 5.921 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo Tablets BID
    Reporting group description
    		 Subjects took placebo tablets twice a day during 16 weeks.

    Reporting group title
    Orismilast Modified Release Tablets 20 mg BID
    Reporting group description
    		 Subjects took Orismilast Modified Release Tablets 20 mg BID twice a day during 16 weeks.

    Reporting group title
    Orismilast Modified Release Tablets 30 mg BID
    Reporting group description
    		 Subjects took Orismilast Modified Release Tablets 30 mg BID twice a day during 16 weeks.

    Reporting group title
    Orismilast Modified Release Tablets 40 mg BID
    Reporting group description
    		 Subjects took Orismilast Modified Release Tablets 40 mg BID twice a day during 16 weeks.

    Primary: Percentage change in Psoriasis Activity and Severity Index (PASI) score from baseline at Week 16

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    End point title
    		 Percentage change in Psoriasis Activity and Severity Index (PASI) score from baseline at Week 16
    End point description
    The Psoriasis Activity and Severity Index (PASI) is a measure of psoriatic disease severity, taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI.
    End point type
    Primary
    End point timeframe
    From baseline to Week 16.
    End point values
    		 Placebo Tablets BID Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID
    Number of subjects analysed
    51
    48
    50
    53
    Units: percent
        least squares mean (standard error)
    -17.30 ( 7.07 )
    -52.60 ( 6.80 )
    -61.20 ( 6.67 )
    -63.70 ( 6.96 )
    Statistical analysis title
    		 Comparison between placebo and Orismilast 20mg
    Comparison groups
    Placebo Tablets BID v Orismilast Modified Release Tablets 20 mg BID
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -35.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -54.7
         upper limit
    		 -16
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.38
    Statistical analysis title
    		 Comparison between placebo and Orismilast 30mg
    Comparison groups
    Placebo Tablets BID v Orismilast Modified Release Tablets 30 mg BID
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -43.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -63.1
         upper limit
    		 -24.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.75
    Statistical analysis title
    		 Comparison between placebo and Orismilast 40mg
    Comparison groups
    Orismilast Modified Release Tablets 40 mg BID v Placebo Tablets BID
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -46.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -65.6
         upper limit
    		 -27.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.75

    Secondary: Patients achieving 75% reduction in PASI (PASI75) response at Week 16

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    End point title
    		 Patients achieving 75% reduction in PASI (PASI75) response at Week 16
    End point description
    The PASI is a measure of psoriatic disease severity, taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI. PASI75 is 75% reduction from Baseline in PASI score.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Placebo Tablets BID Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID
    Number of subjects analysed
    51
    48
    50
    53
    Units: Number of patients
        Yes
    8
    17
    22
    17
        No
    26
    18
    13
    11
    No statistical analyses for this end point

    Secondary: Patients achieving a score of clear (0) or almost clear (1) and an ≥2-point improvement in Investigator Global Assessment (IGA) at Week 16

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    End point title
    		 Patients achieving a score of clear (0) or almost clear (1) and an ≥2-point improvement in Investigator Global Assessment (IGA) at Week 16
    End point description
    The IGA is a measure used by physicians to determine the patient’s overall severity of disease. The static version is used in this trial for measurement at a single point in time as indicated in the schedule of assessments. The investigator will rate the severity of patient’s psoriasis on a 5-point scale ranging from 0 (clear) to 4 (severe).
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16
    End point values
    		 Placebo Tablets BID Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID
    Number of subjects analysed
    51
    48
    50
    53
    Units: percent
    number (not applicable)
        Yes
    6.9
    26.2
    24.5
    20.6
        No
    93.1
    73.8
    75.5
    79.4
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved a Score of Clear (0) or Almost Clear (1) and an at Least 2-point Improvement in Investigator Global Assessment (IGA) at Weeks 4, 8, 12, and 20

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    End point title
    		 Percentage of Participants Who Achieved a Score of Clear (0) or Almost Clear (1) and an at Least 2-point Improvement in Investigator Global Assessment (IGA) at Weeks 4, 8, 12, and 20
    End point description
    The IGA is a measure used by physicians to determine the patient’s overall severity of disease. The static version is used in this trial for measurement at a single point in time as indicated in the schedule of assessments. The investigator will rate the severity of patient’s psoriasis on a 5-point scale ranging from 0 (clear) to 4 (severe).
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 4, 8, 12 and 20.
    End point values
    		 Placebo Tablets BID Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID
    Number of subjects analysed
    51
    48
    50
    53
    Units: percent
    number (not applicable)
        Week 4, Yes
    2.1
    4.2
    4.3
    4.1
        Week 4, No
    97.9
    95.8
    95.7
    95.9
        Week 8, Yes
    0
    10.9
    17.0
    8.4
        Week 8, No
    100
    89.1
    83
    91.6
        Week 12, Yes
    4.6
    25.4
    23.4
    17.6
        Week 12, No
    95.4
    74.6
    76.6
    82.4
        Week 20, Yes
    11.3
    20.8
    11.1
    10.8
        Week 20, No
    88.7
    79.3
    88.9
    89.2
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20

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    End point title
    		 Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20
    End point description
    The PASI is a measure of psoriatic disease severity, taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI. PASI75 is 75% reduction from Baseline in PASI score.
    End point type
    Secondary
    End point timeframe
    Baseline to Weeks 4, 8, 12, and 20.
    End point values
    		 Placebo Tablets BID Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID
    Number of subjects analysed
    51
    48
    50
    53
    Units: percent
    number (not applicable)
        Week 4, Yes
    6.0
    8.4
    10.8
    9.6
        Week 4, No
    94.0
    91.6
    89.2
    90.4
        Week 8, Yes
    11.8
    32.5
    37.0
    31.2
        Week 8, No
    88.2
    67.5
    63.0
    68.8
        Week 12, Yes
    12.3
    42.5
    49.5
    38.5
        Week 12, No
    87.7
    57.5
    50.5
    61.5
        Week 20, Yes
    18.7
    31.6
    22.0
    29.7
        Week 20, No
    81.3
    68.4
    78.0
    70.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20

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    End point title
    		 Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20
    End point description
    The PASI is a measure of psoriatic disease severity, taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI. PASI 50, 90, and 100 is 50%, 90%, and 100% reduction from Baseline in PASI score, respectively.
    End point type
    Secondary
    End point timeframe
    From Baseline to Weeks 4, 8, 12, 16, and 20.
    End point values
    		 Placebo Tablets BID Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID
    Number of subjects analysed
    51
    48
    50
    53
    Units: percent
    number (not applicable)
        Week 4, PASI 50
    15.69
    33.33
    36
    39.62
        Week 4, PASI 90
    0
    2.08
    4
    5.66
        Week 4, PASI 100
    0
    0
    0
    0
        Week 8, PASI 50
    21.57
    58.33
    56
    50.94
        Week 8, PASI 90
    1.96
    8.33
    12
    9.43
        Week 8, PASI 100
    0
    0
    6
    1.89
        Week 12, PASI 50
    29.41
    56.25
    64
    41.51
        Week 12, PASI 90
    5.88
    20.83
    18
    15.09
        Week 12, PASI 100
    0
    10.42
    8
    0
        Week 16, PASI 50
    25.49
    47.92
    60
    47.17
        Week 16, PASI 90
    7.84
    22.92
    20
    22.64
        Week 16, PASI 100
    1.96
    8.33
    8
    1.89
        Week 20, PASI 50
    23.53
    39.58
    38
    32.08
        Week 20, PASI 90
    5.88
    18.75
    12
    7.55
        Week 20, PASI 100
    3.92
    4.17
    2
    1.89
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20

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    End point title
    		 Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20
    End point description
    The Psoriasis Activity and Severity Index (PASI) is a measure of psoriatic disease severity, taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI.
    End point type
    Secondary
    End point timeframe
    From Baseline to Weeks 4, 8, 12, and 20.
    End point values
    		 Placebo Tablets BID Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID
    Number of subjects analysed
    51
    48
    50
    53
    Units: percent
    least squares mean (standard error)
        Week 4
    -14.40 ( 4.33 )
    -35.40 ( 4.40 )
    -38.40 ( 4.43 )
    -38.70 ( 4.24 )
        Week 8
    -16.10 ( 5.79 )
    -48.30 ( 5.76 )
    -54.20 ( 5.94 )
    -53.60 ( 5.87 )
        Week 12
    -18.10 ( 6.61 )
    -56.10 ( 6.30 )
    -61.70 ( 6.40 )
    -57.50 ( 6.59 )
        Week 20
    -13.70 ( 9.69 )
    -35.00 ( 9.11 )
    -30.50 ( 9.11 )
    -36.20 ( 10.57 )
    No statistical analyses for this end point

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

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    End point title
    		 Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16
    End point description
    The DLQI is a 10-item validated questionnaire completed by the patient used to assess the impact of skin disease on the patient’s quality of life (QoL) during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, 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 QoL.
    End point type
    Secondary
    End point timeframe
    From Baseline to Weeks 16.
    End point values
    		 Placebo Tablets BID Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID
    Number of subjects analysed
    34
    34
    35
    27
    Units: percent
        least squares mean (standard error)
    -4.9 ( 1.02 )
    -8.8 ( 1.01 )
    -7.7 ( 1.00 )
    -7.3 ( 1.14 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 20

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    End point title
    		 Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 20
    End point description
    The DLQI is a 10-item validated questionnaire completed by the patient used to assess the impact of skin disease on the patient’s quality of life (QoL) during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, 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 QoL.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 20.
    End point values
    		 Placebo Tablets BID Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID
    Number of subjects analysed
    30
    33
    33
    25
    Units: percent
        least squares mean (standard error)
    -5.1 ( 1.06 )
    -5.0 ( 1.02 )
    -4.0 ( 1.02 )
    -4.9 ( 1.17 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Experienced Psoriasis Rebound by Week 20

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    End point title
    		 Percentage of Participants Who Experienced Psoriasis Rebound by Week 20
    End point description
    The Psoriasis Activity and Severity Index (PASI) is a measure of psoriatic disease severity, taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 20.
    End point values
    		 Placebo Tablets BID Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID
    Number of subjects analysed
    51
    48
    50
    53
    Units: percent
        number (not applicable)
    11.76
    4.17
    10
    3.77
    No statistical analyses for this end point

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

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    End point title
    		 Percent Change From Baseline in Affected Body Surface Area (BSA) at Week 16
    End point description
    The BSA assessment estimates the extent of disease or skin affected by psoriasis and is expressed as a percentage of total body surface. BSA was determined by the Investigator or designee using the patient palm = 1% BSA rule. The patient’s palm is measured from the wrist to the proximal interphalangeal and thumb.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Placebo Tablets BID Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID
    Number of subjects analysed
    34
    35
    35
    28
    Units: percent
        least squares mean (standard error)
    -6.90 ( 1.87 )
    -13.50 ( 1.86 )
    -14.40 ( 1.85 )
    -18.10 ( 2.08 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Week 16

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    End point title
    		 Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Week 16
    End point description
    The PSS is a 4-item patient-completed questionnaire (Rentz 2017). It is patient relevant, its domains are reliable and valid, and it takes few minutes to complete. The PSS assesses severity of pain, itching, redness, and burning during the past 24 hours using a 5-point severity scale from 0 = none to 4 = very severe.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Placebo Tablets BID Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID
    Number of subjects analysed
    34
    35
    35
    27
    Units: percent
        arithmetic mean (standard deviation)
    -1.8 ( 3.27 )
    -5.7 ( 4.25 )
    -4.8 ( 4.32 )
    -5.1 ( 3.48 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Week 16

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    End point title
    		 Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Week 16
    End point description
    The PSS is a 4-item patient-completed questionnaire (Rentz 2017). It is patient relevant, its domains are reliable and valid, and it takes few minutes to complete. The PSS assesses severity of pain, itching, redness, and burning during the past 24 hours using a 5-point severity scale from 0 = none to 4 = very severe.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16.
    End point values
    		 Placebo Tablets BID Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID
    Number of subjects analysed
    34
    35
    35
    27
    Units: percent
    least squares mean (standard error)
        Pain
    -0.4 ( 0.15 )
    -1.0 ( 0.15 )
    -0.8 ( 0.15 )
    -0.7 ( 0.17 )
        Redness
    -0.6 ( 0.15 )
    -1.4 ( 0.15 )
    -0.4 ( 0.16 )
    -1.3 ( 0.16 )
        Itching
    -0.4 ( 0.16 )
    -1.3 ( 0.16 )
    -1.2 ( 0.16 )
    -0.9 ( 0.17 )
        Burning
    -0.5 ( 0.16 )
    -1.3 ( 0.16 )
    -1.1 ( 0.16 )
    -0.9 ( 0.18 )
    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
    Placebo Tablets BID
    Reporting group description
    		 -

    Reporting group title
    Orismilast Modified Release Tablets 20 mg BID
    Reporting group description
    		 -

    Reporting group title
    Orismilast Modified Release Tablets 30 mg BID
    Reporting group description
    		 -

    Reporting group title
    Orismilast Modified Release Tablets 40 mg BID
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Tablets BID Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    1 / 50 (2.00%)
    0 / 53 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    0 / 53 (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
    Skin and subcutaneous tissue disorders
    Erythrodermic psoriasis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    0 / 53 (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: 1%
    Non-serious adverse events
    		 Placebo Tablets BID Orismilast Modified Release Tablets 20 mg BID Orismilast Modified Release Tablets 30 mg BID Orismilast Modified Release Tablets 40 mg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 51 (45.10%)
    37 / 48 (77.08%)
    42 / 50 (84.00%)
    50 / 53 (94.34%)
    Investigations
    Electrocardiogram
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 48 (2.08%)
    1 / 50 (2.00%)
    1 / 53 (1.89%)
         occurrences all number
    1
    2
    2
    1
    Weight increased
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    0
    1
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    1
    C-reactive protein increased
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    0
    1
    Crystal urine present
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    1
    Haematocrit increased
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    0
    1
    Mean cell haemoglobin concentration increased
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    0
    1
    Mean cell volume increased
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    0
    1
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 48 (4.17%)
    1 / 50 (2.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    2
    1
    1
    Hypertension
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    1 / 50 (2.00%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 48 (4.17%)
    1 / 50 (2.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    3
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 51 (5.88%)
    6 / 48 (12.50%)
    13 / 50 (26.00%)
    11 / 53 (20.75%)
         occurrences all number
    6
    9
    16
    14
    Dizziness
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 48 (6.25%)
    7 / 50 (14.00%)
    8 / 53 (15.09%)
         occurrences all number
    0
    3
    8
    10
    Paraesthesia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    0
    1
    3
    Sciatica
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 48 (2.08%)
    2 / 50 (4.00%)
    3 / 53 (5.66%)
         occurrences all number
    3
    1
    2
    4
    Asthenia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    3 / 50 (6.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    0
    5
    2
    Discomfort
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    1
    Malaise
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    1 / 50 (2.00%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Blood and lymphatic system disorders
    Back pain
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    2 / 50 (4.00%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 51 (3.92%)
    18 / 48 (37.50%)
    24 / 50 (48.00%)
    24 / 53 (45.28%)
         occurrences all number
    2
    24
    35
    43
    Nausea
         subjects affected / exposed
    2 / 51 (3.92%)
    11 / 48 (22.92%)
    19 / 50 (38.00%)
    22 / 53 (41.51%)
         occurrences all number
    2
    12
    23
    24
    Vomiting
         subjects affected / exposed
    1 / 51 (1.96%)
    3 / 48 (6.25%)
    4 / 50 (8.00%)
    7 / 53 (13.21%)
         occurrences all number
    1
    3
    6
    19
    Abdominal pain upper
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    3 / 50 (6.00%)
    6 / 53 (11.32%)
         occurrences all number
    0
    2
    3
    9
    Abdominal pain
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    6 / 53 (11.32%)
         occurrences all number
    1
    0
    2
    8
    Abdominal discomfort
         subjects affected / exposed
    1 / 51 (1.96%)
    4 / 48 (8.33%)
    0 / 50 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    1
    4
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 48 (4.17%)
    1 / 50 (2.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    2
    1
    2
    Frequent bowel movements
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    3 / 50 (6.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    3
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    1 / 50 (2.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    1
    1
    3
    Gastritis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    1 / 50 (2.00%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    3 / 51 (5.88%)
    3 / 48 (6.25%)
    1 / 50 (2.00%)
    0 / 53 (0.00%)
         occurrences all number
    4
    3
    1
    0
    Rash
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 48 (2.08%)
    1 / 50 (2.00%)
    2 / 53 (3.77%)
         occurrences all number
    1
    1
    2
    2
    Infections and infestations
    COVID-19
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 48 (2.08%)
    2 / 50 (4.00%)
    4 / 53 (7.55%)
         occurrences all number
    3
    1
    2
    4
    Nasopharyngitis
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 48 (2.08%)
    4 / 50 (8.00%)
    1 / 53 (1.89%)
         occurrences all number
    3
    1
    4
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 48 (2.08%)
    2 / 50 (4.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Bronchitis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 48 (2.08%)
    1 / 50 (2.00%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    1
    Cystitis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 48 (0.00%)
    2 / 50 (4.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 48 (2.08%)
    1 / 50 (2.00%)
    5 / 53 (9.43%)
         occurrences all number
    1
    1
    1
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jul 2021
    The purpose of this amendment was to update the protocol to provide further details about the study design, study objectives and endpoints, subject selection criteria, as well as data collection and analyses.
    20 May 2022
    The main purpose of this amendment is to add PK sampling to enable meaningful PK data from the trial. Updates to the study design, study endpoint, subject selection criteria, as well as data collection and analyses were also made.

    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
    For support, Contact us.
    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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