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    Clinical Trial Results:
    A Phase 4, Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Subjects With Manifestations of Plaque Psoriasis and Impaired Quality of Life

    Summary
    EudraCT number
    		 2018-002850-58
    Trial protocol
    		 GB   DE   FR   IT  
    Global end of trial date
    03 Nov 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Aug 2022
    First version publication date
    26 Aug 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CC-10004-PSOR-020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03774875
    WHO universal trial number (UTN)
    		 U1111-1224-8381
    Sponsors
    Sponsor organisation name
    Amgen Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, CA, United States, 91320
    Public contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Scientific contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.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
    03 Nov 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Nov 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to assess the impact of apremilast 30 mg twice daily (BID), compared to placebo, on health-related quality of life in subjects with manifestations of plaque psoriasis and impaired quality of life at week 16.
    Protection of trial subjects
    This study was conducted in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and in accordance with the general ethical principles outlined in the Declaration of Helsinki. The study protocol and all amendments, the informed consent form, and any accompanying materials provided to the subjects were reviewed and approved by an Independent Ethics Committee (IEC) at each study center. The investigator or his/her designee informed the subject of all aspects pertaining to the subject’s participation in the study before any screening procedures were performed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Mar 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 147
    Country: Number of subjects enrolled
    France: 19
    Country: Number of subjects enrolled
    Italy: 19
    Country: Number of subjects enrolled
    Spain: 47
    Country: Number of subjects enrolled
    Switzerland: 8
    Country: Number of subjects enrolled
    United Kingdom: 37
    Worldwide total number of subjects
    277
    EEA total number of subjects
    232
    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)
    231
    From 65 to 84 years
    46
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Eligible participants were enrolled at 55 centers in France, Germany, Italy, Spain, Switzerland, and the United Kingdom. The study consisted of a 16-week placebo-controlled period and a 36-week apremilast extension period.

    Pre-assignment
    Screening details
    		 Participants were randomized in a 1:2 ratio to receive placebo or apremilast. Participants were block-randomized to each of the manifestations of psoriasis (scalp psoriasis, nail psoriasis, palmoplantar psoriasis, genital psoriasis, and psoriasis in visible locations).

    Period 1
    Period 1 title
    Placebo-controlled Period (Week 1-16)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo tablets orally twice a day for 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
    Administered twice a day by mouth

    Arm title
    		 Apremilast 30 mg
    Arm description
    		 Participants received apremilast 30 mg orally twice a day for 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Apremilast
    Investigational medicinal product code
    CC-10004
    Other name
    Otezla
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered twice a day by mouth

    Number of subjects in period 1
    		Placebo Apremilast 30 mg
    Started
    92
    185
    Received Study Drug
    91
    185
    Completed
    69
    152
    Not completed
    23
    33
         Consent withdrawn by subject
    12
    10
         Reason Unknown
    1
    -
         Adverse event, non-fatal
    8
    16
         Protocol Deviation
    -
    1
         Lost to follow-up
    -
    2
         Lack of efficacy
    2
    4
    Period 2
    Period 2 title
    Apremilast Extension Period (Week 16-52)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo / Apremilast 30 mg
    Arm description
    		 At week 16 participants switched to receive apremilast 30 mg orally twice a day up to week 52.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Apremilast
    Investigational medicinal product code
    CC-10004
    Other name
    Otezla
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered twice a day by mouth

    Arm title
    		 Apremilast 30 mg / Apremilast 30 mg
    Arm description
    		 Participants continued to receive apremilast 30 mg orally twice a day from week 16 to week 52.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Apremilast
    Investigational medicinal product code
    CC-10004
    Other name
    Otezla
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered twice a day by mouth

    Number of subjects in period 2
    		Placebo / Apremilast 30 mg Apremilast 30 mg / Apremilast 30 mg
    Started
    69
    152
    Completed
    53
    105
    Not completed
    16
    47
         Consent withdrawn by subject
    7
    20
         Non-compliance with Study Drug
    -
    2
         Adverse event, non-fatal
    6
    9
         Protocol Deviation
    -
    1
         Other
    1
    1
         Lost to follow-up
    -
    3
         Lack of efficacy
    2
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo tablets orally twice a day for 16 weeks.

    Reporting group title
    Apremilast 30 mg
    Reporting group description
    		 Participants received apremilast 30 mg orally twice a day for 16 weeks.

    Reporting group values
    		 Placebo Apremilast 30 mg Total
    Number of subjects
    		 92 185 277
    Age Categorical
    Units: participants
        < 65 years
    		 73 158 231
        ≥ 65 years
    		 19 27 46
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.9 ( 13.68 ) 47.4 ( 14.28 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 35 79 114
        Male
    		 57 106 163
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 89 179 268
        Black or African American
    		 0 2 2
        Asian
    		 1 1 2
        Not Collected or Unknown
    		 2 3 5
    Region of Enrollment
    Units: Subjects
        France
    		 6 13 19
        Germany
    		 45 102 147
        Italy
    		 8 11 19
        Spain
    		 23 24 47
        Switzerland
    		 1 7 8
        United Kingdom
    		 9 28 37
    Primary Manifestations for Stratifications
    Units: Subjects
        Scalp Psoriasis
    		 23 45 68
        Nail Psoriasis
    		 20 40 60
        Palmoplantar Psoriasis
    		 10 22 32
        Genital Psoriasis
    		 15 28 43
        Psoriasis in Visible Locations
    		 24 50 74
    Duration of Plaque Psoriasis
    Units: years
        arithmetic mean (standard deviation)
    		 18.41 ( 13.350 ) 16.31 ( 13.116 ) -
    Dermatology Life Quality Index (DLQI) Score
    The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life (QOL). The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL.
    Units: score on a scale
        arithmetic mean (standard deviation)
    		 18.5 ( 4.94 ) 18.1 ( 4.86 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo tablets orally twice a day for 16 weeks.

    Reporting group title
    Apremilast 30 mg
    Reporting group description
    		 Participants received apremilast 30 mg orally twice a day for 16 weeks.
    Reporting group title
    Placebo / Apremilast 30 mg
    Reporting group description
    		 At week 16 participants switched to receive apremilast 30 mg orally twice a day up to week 52.

    Reporting group title
    Apremilast 30 mg / Apremilast 30 mg
    Reporting group description
    		 Participants continued to receive apremilast 30 mg orally twice a day from week 16 to week 52.

    Subject analysis set title
    All Apremilast 30 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants initially randomized to placebo received apremilast 30 mg orally twice a day from week 16 to week 52. Participants initially randomized to apremilast received apremilast 30 mg orally twice a day for 52 weeks.

    Primary: Percentage of Participants who Achieved a ≥ 4-point Reduction from Baseline in Dermatology Life Quality Index (DLQI) at Week 16

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    End point title
    		 Percentage of Participants who Achieved a ≥ 4-point Reduction from Baseline in Dermatology Life Quality Index (DLQI) at Week 16
    End point description
    The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life (QOL). The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL. The analysis includes all randomized participants; missing data at week 16 were imputed using multiple imputation.
    End point type
    Primary
    End point timeframe
    Baseline and week 16
    End point values
    		 Placebo Apremilast 30 mg
    Number of subjects analysed
    92
    185
    Units: percentage of participants
        number (confidence interval 95%)
    41.3 (30.0 to 52.6)
    73.3 (66.7 to 79.9)
    Statistical analysis title
    		 Treatment Comparison
    Comparison groups
    Placebo v Apremilast 30 mg
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Adjusted Difference in Response Rates
    Point estimate
    31.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.6
         upper limit
    		 45.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.78
    Notes
    [1] - The CMH (Cochran-Mantel-Haenszel) test adjusting for the stratification of the 5 difficult to treat manifestation types at randomization.

    Secondary: Change from Baseline in DLQI at Week 16

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    End point title
    		 Change from Baseline in DLQI at Week 16
    End point description
    The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life. The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL. A negative change from baseline indicates improvement in quality of life. The analysis includes all randomized participants; missing data at week 16 were imputed using multiple imputation.
    End point type
    Secondary
    End point timeframe
    Baseline and week 16
    End point values
    		 Placebo Apremilast 30 mg
    Number of subjects analysed
    92
    185
    Units: score on a scale
        least squares mean (standard error)
    -3.4 ( 0.80 )
    -8.7 ( 0.54 )
    Statistical analysis title
    		 Treatment Comparison
    Comparison groups
    Placebo v Apremilast 30 mg
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.15
         upper limit
    		 -3.43
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.95
    Notes
    [2] - ANCOVA model with treatment arm and stratification factor as independent variables and baseline value as a covariate.

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

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    End point title
    		 Percent Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16
    End point description
    Body surface area is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA. The analysis includes all randomized participants; missing data at week 16 were imputed using multiple imputation.
    End point type
    Secondary
    End point timeframe
    Baseline and week 16
    End point values
    		 Placebo Apremilast 30 mg
    Number of subjects analysed
    92
    185
    Units: percent change
        least squares mean (standard error)
    18.5 ( 12.95 )
    -19.8 ( 6.58 )
    Statistical analysis title
    		 Treatment Comparison
    Comparison groups
    Placebo v Apremilast 30 mg
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0085 [3]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -38.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -66.58
         upper limit
    		 -10.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    14.12
    Notes
    [3] - ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate variable.

    Secondary: Change from Baseline in Itch Numeric Rating Scale (NRS) Score at Week 16

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    End point title
    		 Change from Baseline in Itch Numeric Rating Scale (NRS) Score at Week 16
    End point description
    The Itch Numeric Rating Scale (NRS) asked participants to assess the worst severity of itch experienced over the past 24 hours on an 11-point scale anchored from 0, representing 'no itching' to 10, representing 'worst itch imaginable'. A negative change from baseline indicates improvement in itch severity. The analysis includes all randomized participants; missing data at week 16 were imputed using multiple imputation.
    End point type
    Secondary
    End point timeframe
    Baseline and week 16
    End point values
    		 Placebo Apremilast 30 mg
    Number of subjects analysed
    92
    185
    Units: score on a scale
        least squares mean (standard error)
    -0.9 ( 0.32 )
    -2.5 ( 0.21 )
    Statistical analysis title
    		 Treatment Comparison
    Comparison groups
    Placebo v Apremilast 30 mg
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [4]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.34
         upper limit
    		 -0.86
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.38
    Notes
    [4] - ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.

    Secondary: Change from Baseline in Skin Discomfort/Pain Visual Analog Scale (VAS) at Week 16

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    End point title
    		 Change from Baseline in Skin Discomfort/Pain Visual Analog Scale (VAS) at Week 16
    End point description
    Participants were asked to indicate their level of skin discomfort/pain in the past week by placing a vertical stroke on a 100 mm horizontal line on which the left-hand boundary (0) represents no skin discomfort/pain, and the right-hand boundary (100) represents worst possible skin discomfort/pain. The distance from the mark to the left-hand boundary was recorded. A negative change from baseline indicates improvement in skin discomfort/pain. The analysis includes all randomized participants; missing data at week 16 were imputed using multiple imputation.
    End point type
    Secondary
    End point timeframe
    Baseline and week 16
    End point values
    		 Placebo Apremilast 30 mg
    Number of subjects analysed
    92
    185
    Units: score on a scale
        least squares mean (standard error)
    -5.4 ( 3.61 )
    -21.5 ( 2.36 )
    Statistical analysis title
    		 Treatment Comparison
    Comparison groups
    Placebo v Apremilast 30 mg
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003 [5]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -16.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.63
         upper limit
    		 -7.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.31
    Notes
    [5] - ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.

    Secondary: Percentage of Participants who Achieved a Psoriasis Area Severity Index (PASI) Score < 3 at Week 16

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    End point title
    		 Percentage of Participants who Achieved a Psoriasis Area Severity Index (PASI) Score < 3 at Week 16
    End point description
    The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, 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 and the values for each anatomic region are summed to yield the PASI score. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The analysis includes all randomized participants; missing data at week 16 were imputed using multiple imputation.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Apremilast 30 mg
    Number of subjects analysed
    92
    185
    Units: percentage of participants
        number (confidence interval 95%)
    26.3 (16.6 to 36.0)
    39.7 (32.3 to 47.1)
    Statistical analysis title
    		 Treatment Comparison
    Comparison groups
    Placebo v Apremilast 30 mg
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0328 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Adjusted Difference in Response Rates
    Point estimate
    13.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.1
         upper limit
    		 25.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.3
    Notes
    [6] - Cochran-Mantel-Haenszel test adjusted for the stratification of the 5 difficult to treat manifestation types at randomization.

    Secondary: Percentage of Participants who Achieved a Patient Benefit Index (PBI) Global Score of ≥ 1 at Week 16

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    End point title
    		 Percentage of Participants who Achieved a Patient Benefit Index (PBI) Global Score of ≥ 1 at Week 16
    End point description
    The PBI is a validated patient-reported instrument to assess patient-relevant benefits of psoriasis treatment. Prior to starting study treatment, participants were asked to assess the importance of a series of treatment goals (from not important to very important) by completing the Patient Needs Questionnaire (PNQ). After a period of treatment (16 weeks), participants were then asked to assess the extent to which these goals were achieved (from not at all to very) by completing the Patient Benefit Questionnaire (PBQ). The Patient Benefit Index represents the benefits realized as a function of most important needs. The PBI score ranges from 0 (no benefit) to 4 (maximum benefit). The analysis includes all randomized participants; missing data at week 16 were imputed using multiple imputation.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Apremilast 30 mg
    Number of subjects analysed
    92
    185
    Units: percentage of participants
        number (confidence interval 95%)
    39.9 (28.8 to 51.0)
    76.6 (70.2 to 83.1)
    Statistical analysis title
    		 Treatment Comparison
    Comparison groups
    Placebo v Apremilast 30 mg
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [7]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Adjusted Difference in Response Rates
    Point estimate
    37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 24.1
         upper limit
    		 49.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.58
    Notes
    [7] - Cochran-Mantel-Haenszel test adjusting for the stratification of the 5 difficult to treat manifestation types at randomization.

    Secondary: Percent Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) VAS Score at Week 16

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    End point title
    		 Percent Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) VAS Score at Week 16
    End point description
    EQ-5D measures the participant’s general health state on a vertical VAS and five quality of life domains. The EQ-5D VAS score ranges from 0 to 100, where a score of 0 indicates the worst imaginable health states and a score of 100 indicates the best imaginable health state. A positive change from baseline indicates improvement. The analysis includes all randomized participants with available data at baseline and week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and week 16
    End point values
    		 Placebo Apremilast 30 mg
    Number of subjects analysed
    70
    160
    Units: percent change
        least squares mean (standard error)
    18.9 ( 15.96 )
    33.8 ( 10.67 )
    Statistical analysis title
    		 Treatment Comparison
    Comparison groups
    Placebo v Apremilast 30 mg
    Number of subjects included in analysis
    230
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4216 [8]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    14.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.62
         upper limit
    		 51.48
    Variability estimate
    Standard error of the mean
    Dispersion value
    18.55
    Notes
    [8] - ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.

    Secondary: Percent Change from Baseline in EQ-5D Index Score at Week 16

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    End point title
    		 Percent Change from Baseline in EQ-5D Index Score at Week 16
    End point description
    EQ-5D measures the participants general health state as a vertical VAS and 5 quality of life domains: mobility, self-care, main activity (work, study, housework, family/leisure activities), pain/discomfort, and anxiety/depression. Each dimension is rated on three levels (no problems, some/moderate problems, extreme problems). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. EQ-5D index values were derived using the UK scoring algorithm, where a higher score indicates a better health state. The range of the score is from −0.224 to 1, with 0 corresponding to death, 1 corresponding to full health, and negative numbers indicate health states worse than death. A positive change from baseline indicates improvement. The analysis includes all randomized participants with available data at baseline and week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and week 16
    End point values
    		 Placebo Apremilast 30 mg
    Number of subjects analysed
    70
    160
    Units: percent change
        least squares mean (standard error)
    165.9 ( 89.80 )
    17.8 ( 59.59 )
    Statistical analysis title
    		 Treatment Comparison
    Comparison groups
    Placebo v Apremilast 30 mg
    Number of subjects included in analysis
    230
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1559 [9]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -148.024
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -352.8793
         upper limit
    		 56.8304
    Variability estimate
    Standard error of the mean
    Dispersion value
    103.9525
    Notes
    [9] - ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.

    Secondary: Change from Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI: PSO) at Week 16: Percentage Work Time Missed

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    End point title
    		 Change from Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI: PSO) at Week 16: Percentage Work Time Missed
    End point description
    The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to psoriasis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed, and a negative change from baseline indicates improvement. The analysis includes randomized participants with available data and who had reported being employed at baseline and at week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and week 16
    End point values
    		 Placebo Apremilast 30 mg
    Number of subjects analysed
    36
    104
    Units: percent impairment
        least squares mean (standard error)
    -4.1 ( 2.56 )
    -0.9 ( 1.54 )
    Statistical analysis title
    		 Treatment Comparison
    Comparison groups
    Placebo v Apremilast 30 mg
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2667 [10]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.43
         upper limit
    		 8.73
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.82
    Notes
    [10] - ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.

    Secondary: Change from Baseline in WPAI: PSO at Week 16: Percentage Work Impairment

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    End point title
    		 Change from Baseline in WPAI: PSO at Week 16: Percentage Work Impairment
    End point description
    The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent impairment while working was derived from the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement. The analysis includes randomized participants with available data and who had reported being employed at baseline and at week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and week 16
    End point values
    		 Placebo Apremilast 30 mg
    Number of subjects analysed
    36
    102
    Units: percent impairment
        least squares mean (standard error)
    -11.5 ( 3.82 )
    -13.9 ( 2.32 )
    Statistical analysis title
    		 Treatment Comparison
    Comparison groups
    Placebo v Apremilast 30 mg
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.562 [11]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.83
         upper limit
    		 5.91
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.23
    Notes
    [11] - ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.

    Secondary: Change from Baseline in WPAI: PSO at Week 16: Percentage Overall Work Impairment

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    End point title
    		 Change from Baseline in WPAI: PSO at Week 16: Percentage Overall Work Impairment
    End point description
    The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent overall work impairment takes into account both hours missed due to psoriasis symptoms and the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement. The analysis includes randomized participants with available data and who had reported being employed at baseline and at week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and week 16
    End point values
    		 Placebo Apremilast 30 mg
    Number of subjects analysed
    36
    104
    Units: percent impairment
        least squares mean (standard error)
    -13.2 ( 4.35 )
    -13.8 ( 2.63 )
    Statistical analysis title
    		 Treatment Comparison
    Comparison groups
    Placebo v Apremilast 30 mg
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8927 [12]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.16
         upper limit
    		 8.86
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.81
    Notes
    [12] - ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.

    Secondary: Change from Baseline in WPAI: PSO at Week 16: Percentage Activity Impairment

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    End point title
    		 Change from Baseline in WPAI: PSO at Week 16: Percentage Activity Impairment
    End point description
    The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which psoriasis affected their regular daily unpaid activities, measured on a VAS from 1 (no effect on daily activities) to 10 (psoriasis completely prevented daily activities). A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement. The analysis includes all randomized participants with available data at baseline and at week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and week 16
    End point values
    		 Placebo Apremilast 30 mg
    Number of subjects analysed
    42
    116
    Units: percent impairment
        least squares mean (standard error)
    -13.4 ( 3.66 )
    -21.2 ( 2.24 )
    Statistical analysis title
    		 Treatment Comparison
    Comparison groups
    Placebo v Apremilast 30 mg
    Number of subjects included in analysis
    158
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0572 [13]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -7.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.9
         upper limit
    		 0.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.09
    Notes
    [13] - ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.

    Secondary: Number of Participants with Treatment-emergent Adverse Events (TEAEs) During the Placebo-controlled Period

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    End point title
    		 Number of Participants with Treatment-emergent Adverse Events (TEAEs) During the Placebo-controlled Period
    End point description
    An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant’s health, including laboratory test values, regardless of etiology. Any worsening of a preexisting condition was considered an AE. A serious adverse event (SAE) is any AE occurring at any dose that: - Resulted in death; - Was life-threatening; - Required inpatient hospitalization or prolongation of existing hospitalization; - Resulted in persistent or significant disability/incapacity; - Was a congenital anomaly/birth defect; - Constituted an important medical event. The Investigator assessed the severity/intensity of each event as mild, moderate, or severe based on level of symptoms. Analysis includes all randomized participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period.
    End point values
    		 Placebo Apremilast 30 mg
    Number of subjects analysed
    91
    185
    Units: participants
        Any TEAE
    54
    152
        Drug-related TEAE
    26
    113
        Severe TEAEs
    1
    10
        Serious TEAEs
    0
    8
        Serious drug-related TEAE
    0
    1
        TEAE leading to drug interruption
    0
    9
        TEAE leading to drug withdrawal
    8
    18
        TEAE leading to death
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Marked Laboratory Abnormalities During the Placebo-controlled Period

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    End point title
    		 Number of Participants with Marked Laboratory Abnormalities During the Placebo-controlled Period
    End point description
    Marked laboratory abnormalities are defined in the table below for each parameter. ULN = upper limit of normal The analysis includes all randomized participants who received at least one dose of study drug with at least one post-baseline measurement.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Placebo Apremilast 30 mg
    Number of subjects analysed
    80
    162
    Units: participants
        Alanine Aminotransferase > 3 × ULN (N = 80, 161)
    0
    2
        Albumin < 25 g/L
    0
    0
        Alkaline Phosphatase > 400 U/L
    0
    0
        Aspartate Aminotransferase > 3 × ULN (N = 79, 160)
    0
    1
        Bilirubin > 1.8 × ULN (N = 80, 161)
    0
    0
        Blood Urea Nitrogen > 15 mmol/L
    0
    2
        Calcium < 1.8 mmol/L
    0
    0
        Calcium > 3.0 mmol/L
    0
    0
        Cholesterol > 7.8 mmol/L
    0
    1
        Creatinine > 1.7 × ULN
    0
    1
        Glucose < 2.8 mmol/L
    0
    0
        Glucose > 13.9 mmol/L
    0
    3
        Hemoglobin A1C (Fasting) > 9% (N = 35, 97)
    0
    3
        Lactate Dehydrogenase > 3 × ULN (N = 69, 155)
    0
    0
        Potassium < 3.0 mmol/L (N = 80, 161)
    0
    0
        Potassium > 5.5 mmol/L (N = 80, 161)
    0
    1
        Sodium < 130 mmol/L (N = 80, 161)
    0
    0
        Sodium > 150 mmol/L (N = 80, 161)
    0
    0
        Triglycerides > 3.4 mmol/L
    6
    6
        Hemoglobin: Women <85 g/L; Men <105 g/L (N=79,160)
    0
    0
        Hemoglobin: Women >170g/L; Men >185 g/L (N=79,160)
    0
    0
        Leukocytes < 1.5 × 10^9/L (N = 79, 160)
    0
    0
        Lymphocytes < 0.8 × 10^9/L (N = 79, 159)
    1
    2
        Neutrophils, Segmented < 1.0 × 10^9/L (N=79, 159)
    0
    0
        Platelets < 75 × 10^9/L (N = 79, 159)
    0
    1
        Platelets > 600 × 10^9/L (N = 79, 159)
    0
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline in Blood Pressure During the Placebo-controlled Period

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    End point title
    		 Change from Baseline in Blood Pressure During the Placebo-controlled Period
    End point description
    The analysis includes randomized participants who received at least one dose of study drug and with a baseline value and a post-baseline value at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, week 2, week 4, and week 16
    End point values
    		 Placebo Apremilast 30 mg
    Number of subjects analysed
    91
    185
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic: Week 2 (N = 88, 174)
    -0.5 ( 11.17 )
    0.1 ( 12.44 )
        Systolic: Week 4 (N = 79, 170)
    1.9 ( 12.29 )
    0.4 ( 11.88 )
        Systolic: Week 16 (N = 67, 153)
    2.2 ( 13.77 )
    1.0 ( 12.66 )
        Diastolic: Week 2 (N = 88, 174)
    -0.1 ( 7.89 )
    -0.6 ( 8.27 )
        Diastolic: Week 4 (N = 79, 170)
    1.3 ( 7.62 )
    -1.0 ( 9.51 )
        Diastolic: Week 16 (N = 67, 153)
    0.8 ( 8.29 )
    0.6 ( 9.12 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Pulse Rate During the Placebo-controlled Period

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    End point title
    		 Change from Baseline in Pulse Rate During the Placebo-controlled Period
    End point description
    The analysis includes randomized participants who received at least one dose of study drug and with a baseline value and a post-baseline value at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and week 2, week 4, and week 16
    End point values
    		 Placebo Apremilast 30 mg
    Number of subjects analysed
    91
    185
    Units: beats/minute
    arithmetic mean (standard deviation)
        Week 2 (N = 87, 173)
    0.3 ( 10.82 )
    3.4 ( 9.75 )
        Week 4 (N = 79, 170)
    -0.4 ( 10.17 )
    3.5 ( 10.43 )
        Week 16 (N = 67, 149)
    1.0 ( 9.97 )
    2.0 ( 10.99 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Body Weight During the Placebo-controlled Period

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    End point title
    		 Change from Baseline in Body Weight During the Placebo-controlled Period
    End point description
    The analysis includes randomized participants who received at least one dose of study drug and with a baseline value and a post-baseline value at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and week 2, week 4, and week 16
    End point values
    		 Placebo Apremilast 30 mg
    Number of subjects analysed
    91
    185
    Units: kg
    arithmetic mean (standard deviation)
        Week 2 (N = 88, 174)
    -0.02 ( 1.161 )
    -0.31 ( 1.188 )
        Week 4 (N = 79, 170)
    0.04 ( 1.285 )
    -0.57 ( 2.060 )
        Week 16 (N = 67, 153)
    0.08 ( 2.337 )
    -0.98 ( 2.722 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Waist Circumference During the Placebo-controlled Period

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    End point title
    		 Change from Baseline in Waist Circumference During the Placebo-controlled Period
    End point description
    The analysis includes randomized participants who received at least one dose of study drug and with a baseline value and a post-baseline value at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and week 2, week 4, and week 16
    End point values
    		 Placebo Apremilast 30 mg
    Number of subjects analysed
    91
    185
    Units: cm
    arithmetic mean (standard deviation)
        Week 2 (N = 88, 174)
    -0.2 ( 3.93 )
    0.2 ( 3.49 )
        Week 4 (N = 79, 168)
    -0.1 ( 4.89 )
    -0.3 ( 3.63 )
        Week 16 (N = 67, 151)
    0.1 ( 6.16 )
    -0.9 ( 5.06 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Achieved a ≥ 4-point Reduction from Baseline in DLQI at Weeks 32 and 52

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    End point title
    		 Percentage of Participants who Achieved a ≥ 4-point Reduction from Baseline in DLQI at Weeks 32 and 52
    End point description
    The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life (QOL). The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL. The analysis includes randomized participants who entered the apremilast extension phase. Missing data were imputed using non-responder imputation.
    End point type
    Secondary
    End point timeframe
    Baseline, week 32 and week 52
    End point values
    		 Placebo / Apremilast 30 mg Apremilast 30 mg / Apremilast 30 mg
    Number of subjects analysed
    69
    152
    Units: percentage of participants
    number (confidence interval 95%)
        Week 32
    68.1 (55.8 to 78.8)
    68.4 (60.4 to 75.7)
        Week 52
    76.8 (65.1 to 86.1)
    79.6 (72.3 to 85.7)
    No statistical analyses for this end point

    Secondary: Change from Baseline in DLQI at Weeks 32 and 52

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    End point title
    		 Change from Baseline in DLQI at Weeks 32 and 52
    End point description
    The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life. The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL. A negative change from baseline indicates improvement in quality of life. The analysis includes randomized participants who entered the apremilast extension phase with available data at baseline and each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, week 32 and week 52
    End point values
    		 Placebo / Apremilast 30 mg Apremilast 30 mg / Apremilast 30 mg
    Number of subjects analysed
    69
    152
    Units: score on a scale
    arithmetic mean (standard deviation)
        Week 32 (N = 62, 127)
    -9.8 ( 8.19 )
    -9.9 ( 7.28 )
        Week 52 (N = 55, 112)
    -11.3 ( 7.84 )
    -11.2 ( 7.08 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Itch NRS Score at Weeks 32 and 52

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    End point title
    		 Change from Baseline in Itch NRS Score at Weeks 32 and 52
    End point description
    The Itch Numeric Rating Scale (NRS) asked participants to assess the worst severity of itch experienced over the past 24 hours on an 11-point scale anchored from 0, representing 'no itching' to 10, representing 'worst itch imaginable'. A negative change from baseline indicates improvement in itch severity. The analysis includes randomized participants who entered the apremilast extension phase with available data at baseline and each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, week 32 and week 52
    End point values
    		 Placebo / Apremilast 30 mg Apremilast 30 mg / Apremilast 30 mg
    Number of subjects analysed
    69
    151
    Units: score on a scale
    arithmetic mean (standard deviation)
        Week 32 (N = 62, 127)
    -3.2 ( 3.50 )
    -2.8 ( 3.22 )
        Week 52 (N = 54, 112)
    -3.9 ( 3.61 )
    -3.3 ( 3.19 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Skin Discomfort/Pain VAS at Weeks 32 and 52

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    End point title
    		 Change from Baseline in Skin Discomfort/Pain VAS at Weeks 32 and 52
    End point description
    Participants were asked to indicate their level of skin discomfort/pain in the past week by placing a vertical stroke on a 100 mm horizontal line on which the left-hand boundary (0) represents no skin discomfort/pain, and the right-hand boundary (100) represents worst possible skin discomfort/pain. The distance from the mark to the left-hand boundary was recorded. A negative change from baseline indicates improvement in skin discomfort/pain. The analysis includes randomized participants who entered the apremilast extension phase with available data at baseline and each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, week 32 and week 52
    End point values
    		 Placebo / Apremilast 30 mg Apremilast 30 mg / Apremilast 30 mg
    Number of subjects analysed
    69
    151
    Units: score on a scale
    arithmetic mean (standard deviation)
        Week 32 (N = 57, 114)
    -28.4 ( 38.40 )
    -22.6 ( 33.71 )
        Week 52 (N = 51, 104)
    -35.0 ( 36.76 )
    -31.0 ( 34.77 )
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in BSA Affected by Psoriasis at Weeks 32 and 52

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    End point title
    		 Percent Change from Baseline in BSA Affected by Psoriasis at Weeks 32 and 52
    End point description
    Body surface area is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA. The analysis includes randomized participants who entered the apremilast extension phase with available data at baseline and each time point.
    End point type
    Secondary
    End point timeframe
    Baseline, week 32 and week 52
    End point values
    		 Placebo / Apremilast 30 mg Apremilast 30 mg / Apremilast 30 mg
    Number of subjects analysed
    69
    152
    Units: percent change
    arithmetic mean (standard deviation)
        Week 32 (N = 57, 114)
    -49.5 ( 47.35 )
    -40.2 ( 51.79 )
        Week 52 (N = 51, 104)
    -49.9 ( 53.25 )
    -32.0 ( 93.09 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Achieved a PBI Score of ≥ 1 at Weeks 32 and 52

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    End point title
    		 Percentage of Participants who Achieved a PBI Score of ≥ 1 at Weeks 32 and 52
    End point description
    The PBI is a validated patient-reported instrument to assess patient-relevant benefits of psoriasis treatment. Prior to starting study treatment, participants were asked to assess the importance of a series of treatment goals (from not important to very important) by completing the Patient Needs Questionnaire (PNQ). After a period of treatment (32 weeks and 52 weeks), participants were then asked to assess the extent to which these goals were achieved (from not at all to very) by completing the Patient Benefit Questionnaire (PBQ). The Patient Benefit Index represents the benefits realized as a function of most important needs. The PBI score ranges from 0 (no benefit) to 4 (maximum benefit). The analysis includes randomized participants who entered the apremilast extension phase. Missing data were imputed using non-responder imputation.
    End point type
    Secondary
    End point timeframe
    Week 32 and week 52
    End point values
    		 Placebo / Apremilast 30 mg Apremilast 30 mg / Apremilast 30 mg
    Number of subjects analysed
    69
    152
    Units: percentage of participants
    number (confidence interval 95%)
        Week 32
    66.7 (54.3 to 77.6)
    67.8 (59.7 to 75.1)
        Week 52
    65.2 (52.8 to 76.3)
    63.8 (55.6 to 71.4)
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Achieved a PASI Score < 3 at Weeks 32 and 52

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    End point title
    		 Percentage of Participants who Achieved a PASI Score < 3 at Weeks 32 and 52
    End point description
    The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement. Erythema, 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 and the values for each anatomic region are summed to yield the PASI score, which ranges from 0 to 72, with higher scores reflecting greater disease severity. The analysis includes randomized participants who entered the apremilast extension phase. Missing data were imputed using non-responder imputation.
    End point type
    Secondary
    End point timeframe
    Week 32 and week 52
    End point values
    		 Placebo / Apremilast 30 mg Apremilast 30 mg / Apremilast 30 mg
    Number of subjects analysed
    69
    152
    Units: percentage of participants
    number (confidence interval 95%)
        Week 32
    58.0 (45.5 to 69.8)
    40.1 (32.3 to 48.4)
        Week 52
    50.7 (38.4 to 63.0)
    37.5 (29.8 to 45.7)
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in EQ-5D VAS Score at Week 52

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    End point title
    		 Percent Change from Baseline in EQ-5D VAS Score at Week 52
    End point description
    EQ-5D measures the participant’s general health state on a vertical VAS and five quality of life domains. The EQ-5D VAS score ranges from 0 to 100, where a score of 0 indicates the worst imaginable health states and a score of 100 indicates the best imaginable health state. A positive change from baseline indicates improvement. The analysis includes randomized participants who entered the apremilast extension phase with available data at baseline and week 52.
    End point type
    Secondary
    End point timeframe
    Baseline and week 52
    End point values
    		 Placebo / Apremilast 30 mg Apremilast 30 mg / Apremilast 30 mg
    Number of subjects analysed
    54
    112
    Units: percent change
        arithmetic mean (standard deviation)
    51.4 ( 132.13 )
    33.6 ( 78.53 )
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in EQ-5D Index Score at Week 52

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    End point title
    		 Percent Change from Baseline in EQ-5D Index Score at Week 52
    End point description
    EQ-5D measures the participants general health state as a vertical VAS and 5 quality of life domains: mobility, self-care, main activity (work, study, housework, family/leisure activities), pain/discomfort, and anxiety/depression. Each dimension is rated on three levels (no problems, some/moderate problems, extreme problems). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. EQ-5D index values were derived using the UK scoring algorithm, where a higher score indicates a better health state. The range of the score is from −0.224 to 1, with 0 corresponding to death, 1 corresponding to full health, and negative numbers indicate health states worse than death. A positive change from baseline indicates improvement. The analysis includes randomized participants who entered the apremilast extension phase with available data at baseline and week 52.
    End point type
    Secondary
    End point timeframe
    Baseline and week 52
    End point values
    		 Placebo / Apremilast 30 mg Apremilast 30 mg / Apremilast 30 mg
    Number of subjects analysed
    54
    112
    Units: percent change
        arithmetic mean (standard deviation)
    214.103 ( 1799.6328 )
    11.039 ( 224.3001 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in WPAI: PSO at Week 52: Percentage Work Time Missed

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    End point title
    		 Change from Baseline in WPAI: PSO at Week 52: Percentage Work Time Missed
    End point description
    The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to psoriasis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed, and a negative change from baseline indicates improvement. The analysis includes randomized participants who entered the apremilast extension phase with available data and who had reported being employed at baseline and at week 52.
    End point type
    Secondary
    End point timeframe
    Baseline and week 52
    End point values
    		 Placebo / Apremilast 30 mg Apremilast 30 mg / Apremilast 30 mg
    Number of subjects analysed
    31
    64
    Units: percent impairment
        arithmetic mean (standard deviation)
    -4.6 ( 17.43 )
    -3.2 ( 17.11 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in WPAI: PSO at Week 52: Percentage Work Impairment

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    End point title
    		 Change from Baseline in WPAI: PSO at Week 52: Percentage Work Impairment
    End point description
    The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent impairment while working was derived from the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement. The analysis includes randomized participants who entered the apremilast extension phase with available data and who had reported being employed at baseline and at week 52.
    End point type
    Secondary
    End point timeframe
    Baseline and week 52
    End point values
    		 Placebo / Apremilast 30 mg Apremilast 30 mg / Apremilast 30 mg
    Number of subjects analysed
    31
    64
    Units: percent impairment
        arithmetic mean (standard deviation)
    -21.0 ( 29.82 )
    -24.4 ( 26.78 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in WPAI: PSO at Week 52: Percentage Activity Impairment

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    End point title
    		 Change from Baseline in WPAI: PSO at Week 52: Percentage Activity Impairment
    End point description
    The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which psoriasis affected their regular daily unpaid activities, measured on a VAS from 1 (no effect on daily activities) to 10 (psoriasis completely prevented daily activities). A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement. The analysis includes randomized participants who entered the apremilast extension phase with available data at baseline and week 52.
    End point type
    Secondary
    End point timeframe
    Baseline and week 52
    End point values
    		 Placebo / Apremilast 30 mg Apremilast 30 mg / Apremilast 30 mg
    Number of subjects analysed
    33
    75
    Units: percent impairment
        arithmetic mean (standard deviation)
    -32.7 ( 33.94 )
    -30.5 ( 27.01 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in WPAI: PSO at Week 52: Percentage Overall Work Impairment

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    End point title
    		 Change from Baseline in WPAI: PSO at Week 52: Percentage Overall Work Impairment
    End point description
    The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent overall work impairment takes into account both hours missed due to psoriasis symptoms and the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement. The analysis includes randomized participants who entered the apremilast extension phase with available data and who had reported being employed at baseline and at week 52.
    End point type
    Secondary
    End point timeframe
    Baseline and week 52
    End point values
    		 Placebo / Apremilast 30 mg Apremilast 30 mg / Apremilast 30 mg
    Number of subjects analysed
    31
    64
    Units: percent impairment
        arithmetic mean (standard deviation)
    -21.7 ( 30.12 )
    -25.3 ( 29.91 )
    No statistical analyses for this end point

    Secondary: Number of Participants with TEAEs During Apremilast Treatment

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    End point title
    		 Number of Participants with TEAEs During Apremilast Treatment
    End point description
    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant’s health, including laboratory test values, regardless of etiology. Any worsening of a preexisting condition was considered an AE. A serious adverse event (SAE) is any AE occurring at any dose that: - Resulted in death; - Was life-threatening; - Required inpatient hospitalization or prolongation of existing hospitalization; - Resulted in persistent or significant disability/incapacity; - Was a congenital anomaly/birth defect; - Constituted an important medical event. The Investigator assessed the severity/intensity of each event as mild, moderate, or severe based on level of symptoms.
    End point type
    Secondary
    End point timeframe
    From first dose of apremilast up to 28 days after last dose; up to 40 weeks for participants initially randomized to placebo and 56 weeks for participants initially randomized to apremilast.
    End point values
    		 All Apremilast 30 mg
    Number of subjects analysed
    254
    Units: participants
        Any TEAE
    217
        Drug-related TEAE
    152
        Severe TEAEs
    14
        Serious TEAEs
    18
        Serious drug-related TEAE
    2
        TEAE leading to drug interruption
    19
        TEAE leading to drug withdrawal
    31
        TEAE leading to death
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Marked Laboratory Abnormalities During Apremilast Treatment

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    End point title
    		 Number of Participants with Marked Laboratory Abnormalities During Apremilast Treatment
    End point description
    The analysis includes randomized participants who received at least 1 dose of apremilast, ie, participants originally randomized to apremilast and participants originally randomized to placebo who entered the apremilast extension phase with at least 1 treatment of apremilast, and at least 1 post-baseline measurement.
    End point type
    Secondary
    End point timeframe
    From first dose of apremilast up to 28 days after last dose; up to 40 weeks for participants initially randomized to placebo and 56 weeks for participants initially randomized to apremilast.
    End point values
    		 All Apremilast 30 mg
    Number of subjects analysed
    235
    Units: participants
        Alanine Aminotransferase > 3 × ULN
    2
        Albumin < 25 g/L
    0
        Alkaline Phosphatase > 400 U/L
    0
        Aspartate Aminotransferase > 3 × ULN (N=234)
    1
        Bilirubin > 1.8 × ULN
    1
        Blood Urea Nitrogen > 15 mmol/L
    2
        Calcium < 1.8 mmol/L
    1
        Calcium > 3.0 mmol/L
    0
        Cholesterol > 7.8 mmol/L
    3
        Creatinine > 1.7 × ULN
    1
        Glucose < 2.8 mmol/L
    0
        Glucose > 13.9 mmol/L
    7
        Hemoglobin A1C (Fasting) > 9% (N=142)
    3
        Lactate Dehydrogenase > 3 × ULN (N=228)
    0
        Potassium < 3.0 mmol/L
    0
        Potassium > 5.5 mmol/L
    2
        Sodium < 130 mmol/L
    0
        Sodium > 150 mmol/L
    0
        Triglycerides > 3.4 mmol/L
    22
        Hemoglobin: Women < 85 g/L; Men < 105 g/L (N=232)
    1
        Hemoglobin: Women >170 g/L; Men >185 g/L (N=232)
    0
        Leukocytes < 1.5 × 10^9/L (N=232)
    0
        Lymphocytes < 0.8 × 10^9/L (N=232)
    3
        Neutrophils, Segmented < 1.0 × 10^9/L (N=232)
    0
        Platelets < 75 × 10^9/L (N=232)
    2
        Platelets > 600 × 10^9/L (N=232)
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline in Pulse Rate at End of Apremilast Extension Period

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    End point title
    		 Change from Baseline in Pulse Rate at End of Apremilast Extension Period
    End point description
    The analysis includes randomized participants who received at least 1 dose of apremilast, ie, participants originally randomized to apremilast and participants originally randomized to placebo who entered the apremilast extension phase with at least 1 treatment of apremilast, with a baseline value and at least 1 post-baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52
    End point values
    		 All Apremilast 30 mg
    Number of subjects analysed
    246
    Units: beats/minute
        arithmetic mean (standard deviation)
    1.0 ( 10.29 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Blood Pressure at End of Apremilast Extension Period

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    End point title
    		 Change from Baseline in Blood Pressure at End of Apremilast Extension Period
    End point description
    The analysis includes randomized participants who received at least 1 dose of apremilast, ie, participants originally randomized to apremilast and participants originally randomized to placebo who entered the apremilast extension phase, with a baseline value and at least 1 post-baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52
    End point values
    		 All Apremilast 30 mg
    Number of subjects analysed
    246
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic
    0.1 ( 13.68 )
        Diastolic
    0.1 ( 8.98 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Body Weight at End of Apremilast Extension Period

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    End point title
    		 Change from Baseline in Body Weight at End of Apremilast Extension Period
    End point description
    The analysis includes randomized participants who received at least 1 dose of apremilast, ie, participants originally randomized to apremilast and participants originally randomized to placebo who entered the apremilast extension phase with at least 1 treatment of apremilast, with a baseline value and at least 1 post-baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52
    End point values
    		 All Apremilast 30 mg
    Number of subjects analysed
    246
    Units: kg
        arithmetic mean (standard deviation)
    -1.20 ( 3.802 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Waist Circumference at End of Apremilast Extension Period

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    End point title
    		 Change from Baseline in Waist Circumference at End of Apremilast Extension Period
    End point description
    The analysis includes randomized participants who received at least 1 dose of apremilast, ie, participants originally randomized to apremilast and participants originally randomized to placebo who entered the apremilast extension phase with at least 1 treatment of apremilast, with a baseline value and at least 1 post-baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52
    End point values
    		 All Apremilast 30 mg
    Number of subjects analysed
    246
    Units: cm
        arithmetic mean (standard deviation)
    -0.8 ( 4.97 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    PPlacebo-controlled period: From first dose of study drug to week 16 or 28 days after last dose for subjects who didn't enter the extension period. Apremilast extension period: From first in the extension period to 28 days after last dose, 40 weeks.
    Adverse event reporting additional description
    Adverse events are reported for all participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Placebo-controlled Period: Placebo
    Reporting group description
    		 Participants received placebo tablets orally twice a day for 16 weeks.

    Reporting group title
    Apremilast Extension Period: Apremilast 30 mg
    Reporting group description
    		 Participants received apremilast 30 mg tablets orally twice a day from week 16 to week 52 (36 weeks).

    Reporting group title
    Placebo-controlled Period: Apremilast 30 mg
    Reporting group description
    		 Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.

    Serious adverse events
    		 Placebo-controlled Period: Placebo Apremilast Extension Period: Apremilast 30 mg Placebo-controlled Period: Apremilast 30 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 92 (0.00%)
    12 / 221 (5.43%)
    8 / 185 (4.32%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder transitional cell carcinoma
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 221 (0.45%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prolactin-producing pituitary tumour
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 221 (0.45%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 221 (0.45%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral ischaemia
         subjects affected / exposed
    0 / 92 (0.00%)
    0 / 221 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 221 (0.45%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 92 (0.00%)
    0 / 221 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    0 / 92 (0.00%)
    0 / 221 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 92 (0.00%)
    0 / 221 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 221 (0.45%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 221 (0.45%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 221 (0.45%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Iridocyclitis
         subjects affected / exposed
    0 / 92 (0.00%)
    0 / 221 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis acute
         subjects affected / exposed
    0 / 92 (0.00%)
    0 / 221 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 221 (0.45%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 221 (0.45%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 221 (0.45%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 221 (0.45%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 92 (0.00%)
    0 / 221 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 221 (0.45%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 221 (0.45%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 92 (0.00%)
    0 / 221 (0.00%)
    2 / 185 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 221 (0.45%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal infection
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 221 (0.45%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 221 (0.45%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erythema migrans
         subjects affected / exposed
    0 / 92 (0.00%)
    1 / 221 (0.45%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo-controlled Period: Placebo Apremilast Extension Period: Apremilast 30 mg Placebo-controlled Period: Apremilast 30 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 92 (41.30%)
    93 / 221 (42.08%)
    113 / 185 (61.08%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 92 (5.43%)
    19 / 221 (8.60%)
    37 / 185 (20.00%)
         occurrences all number
    6
    34
    50
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 92 (1.09%)
    4 / 221 (1.81%)
    10 / 185 (5.41%)
         occurrences all number
    1
    4
    10
    Abdominal pain upper
         subjects affected / exposed
    4 / 92 (4.35%)
    3 / 221 (1.36%)
    12 / 185 (6.49%)
         occurrences all number
    4
    3
    13
    Diarrhoea
         subjects affected / exposed
    6 / 92 (6.52%)
    22 / 221 (9.95%)
    61 / 185 (32.97%)
         occurrences all number
    7
    25
    72
    Nausea
         subjects affected / exposed
    5 / 92 (5.43%)
    10 / 221 (4.52%)
    37 / 185 (20.00%)
         occurrences all number
    5
    10
    38
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    10 / 92 (10.87%)
    20 / 221 (9.05%)
    5 / 185 (2.70%)
         occurrences all number
    10
    20
    5
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 92 (4.35%)
    12 / 221 (5.43%)
    6 / 185 (3.24%)
         occurrences all number
    4
    12
    6
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    11 / 92 (11.96%)
    25 / 221 (11.31%)
    18 / 185 (9.73%)
         occurrences all number
    11
    28
    22

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jan 2019
    Major changes included: • Added safety endpoints. • Clarified inclusion/exclusion criteria. • Modified Table of Events to include additional vital signs and body weight measures. • Clarified demography data collection, clinical laboratory evaluation, and efficacy assessments. • Added description of safety assessments. • Clarified data collection of permitted concomitant medications and added information on concomitant medications not permitted. • Clarified safety analyses. • Added clarification specifying electronic AE and SAE reporting through database. • Clarified treatment discontinuation.
    01 Nov 2019
    Major changes included: • Removed the requirement for equal block-randomization to each of the 5 manifestations of plaque psoriasis. • Updated reporting modalities to reflect the use of an eCRF-based system for reporting of SAEs and clarified expectations for pregnancy reporting.
    01 May 2020
    Major changes included: • Updated to reflect the change in Sponsor from Celgene to Amgen, as well as key contact and emergency information. • Updated safety reporting and product complaints information to align with Amgen processes.

    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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