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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects with Moderate to Severe Genital Psoriasis

    Summary
    EudraCT number
    2018-002608-15
    Trial protocol
    FR   BE   IT  
    Global end of trial date
    09 Feb 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CC-10004-PSOR-025
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03777436
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Amgen Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, CA, United States,
    Public contact
    Study Director, Amgen Inc., +1 866-572-6436, medinfo@amgen.com
    Scientific contact
    Study Director, Amgen Inc., +1 866-572-6436, medinfo@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
    09 Feb 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Feb 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the clinical efficacy of oral apremilast 30 mg twice daily (BID), compared to placebo, in participants with moderate to severe genital psoriasis during the 16-week Placebo-controlled Phase.
    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. Essential documents will be retained in accordance with ICH GCP. The study sponsor declares that the information provided in this report is an accurate representation of the data captured and analyses performed for this study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    11 Feb 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
    France: 11
    Country: Number of subjects enrolled
    Canada: 45
    Country: Number of subjects enrolled
    United States: 141
    Country: Number of subjects enrolled
    Germany: 66
    Country: Number of subjects enrolled
    Italy: 19
    Country: Number of subjects enrolled
    Belgium: 7
    Worldwide total number of subjects
    289
    EEA total number of subjects
    103
    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)
    255
    From 65 to 84 years
    34
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were enrolled at 49 centers in Belgium, Canada, France, Germany, Italy, and the United States from February 2019 to February 2022.

    Pre-assignment
    Screening details
    Participants were randomized in a 1:1 ratio to receive either apremilast or matched placebo for the first 16 weeks (Placebo-controlled Phase) of the study. At Week 16, eligible participants may have continued on active treatment by entering a 16-week extension phase (Apremilast Extension Phase). Total treatment duration = 32 weeks.

    Period 1
    Period 1 title
    Placebo-controlled Phase
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo-controlled Phase: Placebo
    Arm description
    Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16).
    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 orally.

    Arm title
    Placebo-controlled Phase: Apremilast 30 mg
    Arm description
    Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
    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 orally.

    Number of subjects in period 1
    Placebo-controlled Phase: Placebo Placebo-controlled Phase: Apremilast 30 mg
    Started
    146
    143
    Took at Least 1 Dose of IP
    145
    143
    Completed
    111
    119
    Not completed
    35
    24
         Consent withdrawn by subject
    19
    3
         Physician decision
    -
    1
         Due to COVID-19 control measures
    1
    -
         Adverse event, non-fatal
    8
    10
         Non-compliance with study drug
    -
    2
         Lost to follow-up
    7
    7
         Lack of efficacy
    -
    1
    Period 2
    Period 2 title
    Apremilast Extension Phase
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Apremilast Extension Phase: Apremilast 30 mg
    Arm description
    Eligible participants who completed the Placebo-controlled Phase entered the Apremilast Extension Phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32).
    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 orally.

    Number of subjects in period 2 [1]
    Apremilast Extension Phase: Apremilast 30 mg
    Started
    229
    Took at Least 1 Dose of IP
    228
    Completed
    201
    Not completed
    28
         Consent withdrawn by subject
    13
         Adverse event, non-fatal
    6
         Miscellaneous
    1
         Lost to follow-up
    7
         Lack of efficacy
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 1 participant did not enter the Apremilast Extension Phase as they were lost to follow-up.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo-controlled Phase: Placebo
    Reporting group description
    Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16).

    Reporting group title
    Placebo-controlled Phase: Apremilast 30 mg
    Reporting group description
    Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).

    Reporting group values
    Placebo-controlled Phase: Placebo Placebo-controlled Phase: Apremilast 30 mg Total
    Number of subjects
    146 143 289
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    46.4 ( 14.38 ) 43.5 ( 13.36 ) -
    Sex: Female, Male
    Units:
        Female
    44 43 87
        Male
    102 100 202
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0
        Asian
    8 4 12
        Native Hawaiian or Other Pacific Islander
    1 0 1
        Black or African American
    3 6 9
        White
    131 131 262
        More than one race
    0 0 0
        Unknown or Not Reported
    3 2 5
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    13 18 31
        Not Hispanic or Latino
    131 125 256
        Unknown or Not Reported
    2 0 2
    Modified Static Physician Global Assessment of Genitalia (sPGA-G) Score
    The modified sPGA-G is the assessment by the Investigator of the participant's psoriasis lesions’ overall disease severity in the genital area at the time of evaluation. The modified sPGA-G is a 5-point scale ranging from clear (0), almost clear (1), mild (2), moderate (3), to severe (4), incorporating an assessment of the severity of the three primary signs of the disease: erythema, plaque elevation, and scaling.
    Units: Subjects
        3 (Moderate)
    128 123 251
        4 (Severe)
    18 20 38

    End points

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    End points reporting groups
    Reporting group title
    Placebo-controlled Phase: Placebo
    Reporting group description
    Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16).

    Reporting group title
    Placebo-controlled Phase: Apremilast 30 mg
    Reporting group description
    Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
    Reporting group title
    Apremilast Extension Phase: Apremilast 30 mg
    Reporting group description
    Eligible participants who completed the Placebo-controlled Phase entered the Apremilast Extension Phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32).

    Primary: Percentage of Participants With a Modified sPGA-G Response at Week 16

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    End point title
    Percentage of Participants With a Modified sPGA-G Response at Week 16
    End point description
    The modified sPGA-G is the assessment by the Investigator of the participant's psoriasis lesions’ overall disease severity in the genital area at the time of evaluation. The modified sPGA-G is a 5-point scale ranging from clear (0), almost clear (1), mild (2), moderate (3), to severe (4), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, plaque elevation, and scaling. A modified sPGA-G response is defined as modified sPGA-G score of clear (0) or almost clear (1) and with ≥ 2-point reduction from Baseline at Week 16. Missing values were imputed using the multiple imputation (MI) method. Two-sided 95% confidence intervals (CIs) for the within-group proportions were based on the Wilson-score method. The intent-to-treat (ITT) analysis set consisted of all participants who are randomized regardless of whether the participant received investigational product (IP).
    End point type
    Primary
    End point timeframe
    Baseline and Week 16 of the Placebo-controlled Phase
    End point values
    Placebo-controlled Phase: Placebo Placebo-controlled Phase: Apremilast 30 mg
    Number of subjects analysed
    146
    143
    Units: Percentage of participants
        number (confidence interval 95%)
    19.1 (12.4 to 25.7)
    38.7 (30.4 to 47.0)
    Statistical analysis title
    Placebo versus (vs.) Apremilast 30 mg
    Comparison groups
    Placebo-controlled Phase: Placebo v Placebo-controlled Phase: Apremilast 30 mg
    Number of subjects included in analysis
    289
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.0003
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted difference
    Point estimate
    19.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    9
         upper limit
    30.3

    Secondary: Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16

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    End point title
    Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16
    End point description
    The sPGA is the assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 3 (moderate) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling and plaque elevation. An sPGA response is defined as sPGA score of clear (0) or almost clear (1) and with ≥ 2-point reduction from Baseline at Week 16. Missing values were imputed using the MI method. Two-sided 95% CIs for the within-group proportions were based on the Wilson-score method. The ITT analysis set consisted of all participants who are randomized regardless of whether the participant received IP.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16 of the placebo-controlled phase
    End point values
    Placebo-controlled Phase: Placebo Placebo-controlled Phase: Apremilast 30 mg
    Number of subjects analysed
    146
    143
    Units: Percentage of participants
        number (confidence interval 95%)
    7.2 (2.9 to 11.5)
    21.5 (14.4 to 28.5)
    Statistical analysis title
    Placebo vs. Apremilast 30 mg
    Comparison groups
    Placebo-controlled Phase: Placebo v Placebo-controlled Phase: Apremilast 30 mg
    Number of subjects included in analysis
    289
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.0007
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted difference
    Point estimate
    14.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6
         upper limit
    22.5

    Secondary: Percentage of Participants With a Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) Response at Week 16

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    End point title
    Percentage of Participants With a Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) Response at Week 16
    End point description
    The GPI-NRS is a self-reported measure where participants were asked to assess their psoriasis symptoms in the genital area and select a number on a scale of 0-10, where 0 represents no itch, and 10 represents the worst imaginable itch. A GPI-NRS response is defined as ≥ 4 point reduction (improvement) from Baseline. Missing values were imputed using the MI method. Two-sided 95% CIs for the within-group proportions were based on the Wilson-score method. ITT analysis set with Baseline GPI-NRS score ≥ 4.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16 of the placebo-controlled phase
    End point values
    Placebo-controlled Phase: Placebo Placebo-controlled Phase: Apremilast 30 mg
    Number of subjects analysed
    121
    122
    Units: Percentage of participants
        number (confidence interval 95%)
    19.6 (12.2 to 27.0)
    46.0 (36.8 to 55.3)
    Statistical analysis title
    Placebo vs. Apremilast 30 mg
    Comparison groups
    Placebo-controlled Phase: Placebo v Placebo-controlled Phase: Apremilast 30 mg
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.0001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted difference
    Point estimate
    26.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    14.5
         upper limit
    38

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

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    End point title
    Change from Baseline in Affected Body Surface Area (BSA) at Week 16
    End point description
    The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand. The surface area of the whole body is made up of approximately 100 palms or "handprints" (each entire palmar surface or "handprint" equates to approximately 1% of total BSA). A negative change from Baseline indicates a reduction of affected BSA. Based on mixed-effect model for repeated measures (MMRM) model. ITT analysis set with Baseline and at least one post-baseline value at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16 of the placebo-controlled phase
    End point values
    Placebo-controlled Phase: Placebo Placebo-controlled Phase: Apremilast 30 mg
    Number of subjects analysed
    111
    120
    Units: Change in percentage of affected BSA
        least squares mean (standard error)
    -0.79 ( 0.669 )
    -4.12 ( 0.664 )
    Statistical analysis title
    Placebo vs. Apremilast 30 mg
    Comparison groups
    Placebo-controlled Phase: Placebo v Placebo-controlled Phase: Apremilast 30 mg
    Number of subjects included in analysis
    231
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.0005
    Method
    MMRM
    Parameter type
    Least squares mean difference
    Point estimate
    -3.33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.18
         upper limit
    -1.47
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.942

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

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    End point title
    Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16
    End point description
    The DLQI is a 10 item questionnaire dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from 0 (not at all) to 3 (very much). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being 0 (not at all), 1 (a little) and 2 (a lot). Total scores have a possible range of 0-30, where 0 represents the best score, and 30 represents the worst health-related quality of life. A negative change from Baseline indicates an improvement in health-related quality of life scores. Based on MMRM model. ITT analysis set with Baseline and at least one post-baseline value at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16 of the placebo-controlled phase
    End point values
    Placebo-controlled Phase: Placebo Placebo-controlled Phase: Apremilast 30 mg
    Number of subjects analysed
    107
    117
    Units: Scores on a scale
        least squares mean (standard error)
    -2.6 ( 0.57 )
    -5.3 ( 0.55 )
    Statistical analysis title
    Placebo vs. Apremilast 30 mg
    Comparison groups
    Placebo-controlled Phase: Placebo v Placebo-controlled Phase: Apremilast 30 mg
    Number of subjects included in analysis
    224
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.0008
    Method
    MMRM
    Parameter type
    Least squares mean difference
    Point estimate
    -2.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.2
         upper limit
    -1.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.79

    Secondary: Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16

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    End point title
    Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16
    End point description
    The GPSS is a self-reported measure where participants were asked to assess each of their psoriasis symptoms (itch, pain, discomfort, stinging, burning, redness, scaling, and cracking) in the genital area and select a number on a scale of 0-10, where 0 represents no, and 10 represents the worst imaginable. Results from each symptom assessment were summed to generate a total GPSS score ranging from 0 (no genital psoriasis symptoms) to 80 (worst imaginable genital psoriasis symptoms). A negative change from Baseline indicates an improvement in genital psoriasis symptoms. Based on MMRM model. ITT analysis set with Baseline and at least one post-baseline value at Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16 of the placebo-controlled phase
    End point values
    Placebo-controlled Phase: Placebo Placebo-controlled Phase: Apremilast 30 mg
    Number of subjects analysed
    107
    116
    Units: Score on a scale
        least squares mean (standard error)
    -5.3 ( 1.85 )
    -20.5 ( 1.83 )
    Statistical analysis title
    Placebo vs. Apremilast 30 mg
    Comparison groups
    Placebo-controlled Phase: Placebo v Placebo-controlled Phase: Apremilast 30 mg
    Number of subjects included in analysis
    223
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.0001
    Method
    MMRM
    Parameter type
    Difference
    Point estimate
    -15.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -20.3
         upper limit
    -10
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.6

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to a maximum of 41.4 weeks
    Adverse event reporting additional description
    The safety analysis set consisted of all participants who were randomized and received at least one dose of IP.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Placebo-controlled Phase: Placebo
    Reporting group description
    Participants received placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).

    Reporting group title
    Apremilast Extension Phase: Apremilast 30 mg
    Reporting group description
    Eligible participants who completed the Placebo-controlled Phase entered the Apremilast Extension Phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32).

    Reporting group title
    Placebo-controlled Phase: Apremilast 30 mg
    Reporting group description
    Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).

    Serious adverse events
    Placebo-controlled Phase: Placebo Apremilast Extension Phase: Apremilast 30 mg Placebo-controlled Phase: Apremilast 30 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 145 (1.38%)
    2 / 229 (0.87%)
    3 / 143 (2.10%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 229 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 229 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 229 (0.44%)
    0 / 143 (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
    Psoriasis
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 229 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 229 (0.44%)
    0 / 143 (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
    Clostridium difficile infection
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 229 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 229 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 229 (0.00%)
    1 / 143 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 229 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 229 (0.00%)
    0 / 143 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    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 Phase: Placebo Apremilast Extension Phase: Apremilast 30 mg Placebo-controlled Phase: Apremilast 30 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 145 (26.90%)
    53 / 229 (23.14%)
    73 / 143 (51.05%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    16 / 145 (11.03%)
    15 / 229 (6.55%)
    33 / 143 (23.08%)
         occurrences all number
    18
    18
    41
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    12 / 145 (8.28%)
    27 / 229 (11.79%)
    37 / 143 (25.87%)
         occurrences all number
    13
    28
    38
    Nausea
         subjects affected / exposed
    11 / 145 (7.59%)
    17 / 229 (7.42%)
    32 / 143 (22.38%)
         occurrences all number
    12
    17
    32
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    12 / 145 (8.28%)
    11 / 229 (4.80%)
    12 / 143 (8.39%)
         occurrences all number
    13
    14
    14

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 May 2019
    - Specified that use of strong cytochrome P450 3A4 (CYP3A4) enzyme inducers is not recommended during the study. - Specified prohibitive concomitant use of antifungal and antiseptic treatment in the genital area. - Removed blinded language in reference to the apremilast extension phase and added dispensation of IP bottles at Week 20.
    01 May 2020
    - Updated to reflect the change in sponsor from Celgene to Amgen. - Updated safety reporting and product complaints information to align with Amgen processes.
    03 Mar 2021
    - Specified that the strata with BSA ≥ 10% would be ≥ 40% of the total enrollment (and the strata with BSA < 10% would comprise ≤ 60% of the total enrollment). - Updated the sample size from approximately 332 participants to approximately 286 participants. - Updated the power calculation based on the change in sample size.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Apr 2020
    In April 2020, screening and enrollment were temporarily paused at all participating countries/sites to limit potential COVID-19 exposure for study participants, sponsor employees, and staff at clinical study sites.
    01 Jun 2020

    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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