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    Clinical Trial Results:
    A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor-blinded Study of Risankizumab Compared to Apremilast for the Treatment of Adult Subjects With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy

    Summary
    EudraCT number
    		 2020-005512-21
    Trial protocol
    		 DE  
    Global end of trial date
    20 Apr 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Apr 2024
    First version publication date
    20 Apr 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M20-326
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04908475
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4UB
    Public contact
    Global Medical Services, Abbvie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, Abbvie, 001 8006339110, abbvieclinicaltrials@abbvie.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
    20 Apr 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Apr 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the study is to evaluate the efficacy and safety of risankizumab versus apremilast for the treatment of adult subjects with moderate plaque PsO who are candidates for systemic therapy.
    Protection of trial subjects
    Subject and/or legal guardian read and understood the information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jun 2021
    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
    Canada: 77
    Country: Number of subjects enrolled
    Germany: 94
    Country: Number of subjects enrolled
    Israel: 14
    Country: Number of subjects enrolled
    Poland: 47
    Country: Number of subjects enrolled
    United States: 120
    Worldwide total number of subjects
    352
    EEA total number of subjects
    141
    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)
    314
    From 65 to 84 years
    38
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 352 participants were enrolled from 48 sites across 5 countries including Canada, Germany, Israel, Poland, and the United States.

    Pre-assignment
    Screening details
    		 Period A: participants were randomized in a 1:2 ratio to risankizumab (RZB) or apremilast (APR). Period B: participants receiving RZB were continued up to Week 52; participants receiving APR were re-randomized (stratified by PASI 75 response) in a 1:1 ratio to receive either RZB or APR (with the option to receive RZB as rescue) up to Week 52.

    Period 1
    Period 1 title
    Period A (Baseline to Week 16)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Blinded Efficacy Assessor: A qualified physician (may be a non-dermatologist) or designee (may be a non-physician) from the site was responsible for performing the efficacy assessments, including PASI, BSA, and sPGA at all appropriate study visits. The efficacy assessor remained blinded to patient's treatment, clinical laboratory results, and all subject safety data during the course of the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Period A: APR
    Arm description
    		 Apremilast 30 mg orally twice daily (BID) up to Week 16
    Arm type
    		 Active comparator

    Investigational medicinal product name
    apremilast
    Investigational medicinal product code
    Other name
    Otezla
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Study drug administration for apremilast began at Baseline (Day 1) based on the dose titration schedule from Day 1 to Day 5 and continued with 30 mg BID until the day prior to the Week 16 visit where re-randomization occurred.

    Arm title
    		 Period A: RZB
    Arm description
    		 Risankizumab 150 mg as a single subcutaneous (SC) injection at Baseline (Day 1) and Week 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    risankizumab
    Investigational medicinal product code
    ABBV-066
    Other name
    Skyrizi
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Study drug administration for risankizumab will occur at Baseline (Day 1) and Week 4.

    Number of subjects in period 1
    		Period A: APR Period A: RZB
    Started
    234
    118
    Completed
    216
    118
    Not completed
    18
    0
         Consent withdrawn by subject
    9
    -
         Lost to follow-up
    3
    -
         Other, Not Specified
    6
    -
    Period 2
    Period 2 title
    Period B (Week 16 to Week 52)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Blinded Efficacy Assessor: A qualified physician (may be a non-dermatologist) or designee (may be a non-physician) from the site was responsible for performing the efficacy assessments, including PASI, BSA, and sPGA at all appropriate study visits. The efficacy assessor remained blinded to patient's treatment, clinical laboratory results, and all subject safety data during the course of the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Period B: RZB/RZB
    Arm description
    		 Risankizumab 150 mg as a single SC injection at Weeks 16, 28, and 40.
    Arm type
    		 Experimental

    Investigational medicinal product name
    risankizumab
    Investigational medicinal product code
    ABBV-066
    Other name
    Skyrizi
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received risankizumab 150 mg as a single SC injection at Weeks 16, 28, and 40.

    Arm title
    		 Period B: APR/APR, NR
    Arm description
    		 Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (non-responders [NR]) and were re-randomized to apremilast 30 mg orally BID up to Week 52.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    apremilast
    Investigational medicinal product code
    Other name
    Otezla
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received apremilast 30 mg orally BID up to Week 52.

    Investigational medicinal product name
    risankizumab
    Investigational medicinal product code
    ABBV-066
    Other name
    Skyrizi
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Rescue risankizumab was offered to participants re-randomized to apremilast who were PASI 50 nonresponders at Week 28 (rescue risankizumab administered at Weeks 28, 32, and 44) or Week 40 (rescue risankizumab administered at Weeks 40 and 44).

    Arm title
    		 Period B: APR/RZB, NR
    Arm description
    		 Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (NR) and were re-randomized to risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, and 44.
    Arm type
    		 Experimental

    Investigational medicinal product name
    risankizumab
    Investigational medicinal product code
    ABBV-066
    Other name
    Skyrizi
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, and 44.

    Arm title
    		 Period B: APR/APR, R
    Arm description
    		 Participants who were randomized to apremilast in Period A, achieved PASI 75 at Week 16 (responders [R]) and were re-randomized to apremilast 30 mg orally BID up to Week 52.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    apremilast
    Investigational medicinal product code
    Other name
    Otezla
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received apremilast 30 mg orally BID up to Week 52.

    Investigational medicinal product name
    risankizumab
    Investigational medicinal product code
    ABBV-066
    Other name
    Skyrizi
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Rescue risankizumab was offered to participants re-randomized to apremilast who were PASI 50 nonresponders at Week 28 (rescue risankizumab administered at Weeks 28, 32, and 44) or Week 40 (rescue risankizumab administered at Weeks 40 and 44).

    Arm title
    		 Period B: APR/RZB, R
    Arm description
    		 Participants who were randomized to apremilast in Period A, achieved PASI 75 at Week 16 (R) and were re-randomized to risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, and 44.
    Arm type
    		 Experimental

    Investigational medicinal product name
    risankizumab
    Investigational medicinal product code
    ABBV-066
    Other name
    Skyrizi
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, and 44.

    Number of subjects in period 2 [1]
    		Period B: RZB/RZB Period B: APR/APR, NR Period B: APR/RZB, NR Period B: APR/APR, R Period B: APR/RZB, R
    Started
    118
    78
    83
    22
    20
    Received ≥1 Dose of Study Drug
    116
    75
    82
    22
    20
    Received RZB as Rescue Medication
    0 [2]
    47
    0 [3]
    1 [4]
    0 [5]
    Completed
    69
    42
    57
    15
    13
    Not completed
    49
    36
    26
    7
    7
         Consent withdrawn by subject
    5
    13
    2
    3
    -
         Lost to follow-up
    6
    4
    6
    -
    -
         Other, Not Specified
    38
    19
    18
    4
    7
    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: Only participants re-randomized for Part B are included.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Milestones are correct as presented.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only participants re-randomized for Part B are included.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Milestones are correct as presented.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Milestones are correct as presented.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period A: APR
    Reporting group description
    		 Apremilast 30 mg orally twice daily (BID) up to Week 16

    Reporting group title
    Period A: RZB
    Reporting group description
    		 Risankizumab 150 mg as a single subcutaneous (SC) injection at Baseline (Day 1) and Week 4.

    Reporting group values
    		 Period A: APR Period A: RZB Total
    Number of subjects
    		 234 118 352
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.2 ( 14.27 ) 45.5 ( 13.63 ) -
    Gender categorical
    Units: Subjects
        Female
    		 79 42 121
        Male
    		 155 76 231
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 23 7 30
        Not Hispanic or Latino
    		 211 111 322
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 1
        Asian
    		 14 12 26
        Native Hawaiian or Other Pacific Islander
    		 1 2 3
        Black or African American
    		 9 5 14
        White
    		 209 98 307
        More Than One Race
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Period A: APR
    Reporting group description
    		 Apremilast 30 mg orally twice daily (BID) up to Week 16

    Reporting group title
    Period A: RZB
    Reporting group description
    		 Risankizumab 150 mg as a single subcutaneous (SC) injection at Baseline (Day 1) and Week 4.
    Reporting group title
    Period B: RZB/RZB
    Reporting group description
    		 Risankizumab 150 mg as a single SC injection at Weeks 16, 28, and 40.

    Reporting group title
    Period B: APR/APR, NR
    Reporting group description
    		 Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (non-responders [NR]) and were re-randomized to apremilast 30 mg orally BID up to Week 52.

    Reporting group title
    Period B: APR/RZB, NR
    Reporting group description
    		 Participants who were randomized to apremilast in Period A, failed to achieve PASI 75 at Week 16 (NR) and were re-randomized to risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, and 44.

    Reporting group title
    Period B: APR/APR, R
    Reporting group description
    		 Participants who were randomized to apremilast in Period A, achieved PASI 75 at Week 16 (responders [R]) and were re-randomized to apremilast 30 mg orally BID up to Week 52.

    Reporting group title
    Period B: APR/RZB, R
    Reporting group description
    		 Participants who were randomized to apremilast in Period A, achieved PASI 75 at Week 16 (R) and were re-randomized to risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32, and 44.

    Primary: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 (Defined as at Least 90% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A)

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    End point title
    		 Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 (Defined as at Least 90% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A)
    End point description
    The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease. ITT_A Population: all participants randomized in Period A
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Period A: APR Period A: RZB
    Number of subjects analysed
    234
    118
    Units: percentage of participants
        number (confidence interval 95%)
    5.1 (2.3 to 8.0)
    55.9 (47.0 to 64.9)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Period A: APR v Period A: RZB
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Adjusted Difference
    Point estimate
    50.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 41.3
         upper limit
    		 60.1
    Notes
    [1] - Adjusted for strata (baseline body weight [≤100 kg, > 100 kg] and prior exposure to any systemic and/or biologic treatment for psoriasis [0, ≥1]) for the comparison of 2 treatment groups.

    Primary: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at least 2-grade Improvement From Baseline in Intent to Treat Population at Week 16 (ITT_A)

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    End point title
    		 Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at least 2-grade Improvement From Baseline in Intent to Treat Population at Week 16 (ITT_A)
    End point description
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe). ITT_A Population: all participants randomized in Period A.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Period A: APR Period A: RZB
    Number of subjects analysed
    234
    118
    Units: percentage of participants
        number (confidence interval 95%)
    18.4 (13.4 to 23.3)
    75.4 (67.7 to 83.2)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Period A: APR v Period A: RZB
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Adjusted Difference
    Point estimate
    56.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 47.7
         upper limit
    		 66
    Notes
    [2] - Adjusted for strata (baseline body weight [≤100 kg, > 100 kg] and prior exposure to any systemic and/or biologic treatment for psoriasis [0, ≥1]) for the comparison of 2 treatment groups.

    Primary: Percentage of Participants Achieving PASI 90 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)

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    End point title
    		 Percentage of Participants Achieving PASI 90 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)
    End point description
    The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease. ITT_B_NR Population: participants randomized to APR at Baseline who failed to achieve PASI 75 at Week 16 and were re-randomized to APR or RZB in Period B.
    End point type
    Primary
    End point timeframe
    Week 52
    End point values
    		 Period B: APR/APR, NR Period B: APR/RZB, NR
    Number of subjects analysed
    78
    83
    Units: percentage of participants
        number (confidence interval 95%)
    2.6 (0.0 to 6.1)
    72.3 (62.7 to 81.9)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Period B: APR/APR, NR v Period B: APR/RZB, NR
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Chi-squared
    Parameter type
    		 Difference
    Point estimate
    69.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 59.5
         upper limit
    		 80

    Secondary: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at least 2-grade Improvement From Baseline in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)

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    End point title
    		 Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at least 2-grade Improvement From Baseline in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)
    End point description
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe). ITT_B_NR Population: participants randomized to APR at Baseline who failed to achieve PASI 75 at Week 16 and were re-randomized to APR or RZB in Period B.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Period B: APR/APR, NR Period B: APR/RZB, NR
    Number of subjects analysed
    78
    83
    Units: percentage of participants
        number (confidence interval 95%)
    7.7 (1.8 to 13.6)
    77.1 (68.1 to 86.1)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Period B: APR/APR, NR v Period B: APR/RZB, NR
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Chi-squared
    Parameter type
    		 Difference
    Point estimate
    69.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 58.6
         upper limit
    		 80.2

    Secondary: Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A)

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    End point title
    		 Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A)
    End point description
    The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease. ITT_A Population: all participants randomized in Period A
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Period A: APR Period A: RZB
    Number of subjects analysed
    234
    118
    Units: percentage of participants
        number (confidence interval 95%)
    18.8 (13.8 to 23.8)
    84.7 (78.3 to 91.2)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Period A: APR v Period A: RZB
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Adjusted Difference
    Point estimate
    65.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 57.6
         upper limit
    		 73.9
    Notes
    [3] - Adjusted for strata (baseline body weight [≤100 kg, > 100 kg] and prior exposure to any systemic and/or biologic treatment for psoriasis [0, ≥1] for the comparison of 2 treatment groups.

    Secondary: Percentage of Participants Achieving PASI 75 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)

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    End point title
    		 Percentage of Participants Achieving PASI 75 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)
    End point description
    The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease. ITT_B_NR Population: participants randomized to APR at Baseline who failed to achieve PASI 75 at Week 16 and were re-randomized to APR or RZB in Period B.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Period B: APR/APR, NR Period B: APR/RZB, NR
    Number of subjects analysed
    78
    83
    Units: percentage of participants
        number (confidence interval 95%)
    11.5 (4.4 to 18.6)
    83.1 (75.1 to 91.2)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Period B: APR/APR, NR v Period B: APR/RZB, NR
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Chi-squared
    Parameter type
    		 Difference
    Point estimate
    71.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 60.9
         upper limit
    		 82.3

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (Week 40 or Week 44) or approximately 4 weeks (28 days) after the last dose of APR (Week 52).
    Adverse event reporting additional description
    Safety Population: participants who received ≥1 dose of study drug. Note: Response at Week 16 was not applicable to the Safety Reporting Groups.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Period A: APR
    Reporting group description
    		 Apremilast 30 mg orally BID up to Week 16

    Reporting group title
    Period B: APR/APR/RZB
    Reporting group description
    		 Participants who received apremilast in Period A who were re-randomized to receive apremilast 30 mg orally BID and received rescue medication with risankizumab.

    Reporting group title
    Period B: APR/RZB
    Reporting group description
    		 Participants who received apremilast in Period A who were re-randomized to receive risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32 and 44.

    Reporting group title
    Period B: RZB/RZB
    Reporting group description
    		 Participants who received risankizumab 150 mg as a single subcutaneous (SC) injection at Day 1 and continued on risankizumab at Weeks 16, 28, and 40

    Reporting group title
    Period A: RZB
    Reporting group description
    		 Risankizumab 150 mg as a single SC injection at Day 1 and Week 4

    Reporting group title
    Period B: APR/APR
    Reporting group description
    		 Participants who received apremilast in Period A who were re-randomized to receive apremilast 30 mg orally BID up to Week 52.

    Serious adverse events
    		 Period A: APR Period B: APR/APR/RZB Period B: APR/RZB Period B: RZB/RZB Period A: RZB Period B: APR/APR
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 234 (1.71%)
    0 / 48 (0.00%)
    3 / 102 (2.94%)
    8 / 116 (6.90%)
    1 / 118 (0.85%)
    2 / 97 (2.06%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    PROSTATE CANCER
         subjects affected / exposed
    0 / 234 (0.00%)
    0 / 48 (0.00%)
    0 / 102 (0.00%)
    0 / 116 (0.00%)
    0 / 118 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    FALL
         subjects affected / exposed
    0 / 234 (0.00%)
    0 / 48 (0.00%)
    1 / 102 (0.98%)
    0 / 116 (0.00%)
    0 / 118 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LOWER LIMB FRACTURE
         subjects affected / exposed
    0 / 234 (0.00%)
    0 / 48 (0.00%)
    1 / 102 (0.98%)
    0 / 116 (0.00%)
    0 / 118 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    ACUTE MYOCARDIAL INFARCTION
         subjects affected / exposed
    1 / 234 (0.43%)
    0 / 48 (0.00%)
    0 / 102 (0.00%)
    0 / 116 (0.00%)
    0 / 118 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CORONARY ARTERY DISEASE
         subjects affected / exposed
    0 / 234 (0.00%)
    0 / 48 (0.00%)
    0 / 102 (0.00%)
    0 / 116 (0.00%)
    0 / 118 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    CAROTID ARTERY STENOSIS
         subjects affected / exposed
    1 / 234 (0.43%)
    0 / 48 (0.00%)
    0 / 102 (0.00%)
    0 / 116 (0.00%)
    0 / 118 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SCIATICA
         subjects affected / exposed
    0 / 234 (0.00%)
    0 / 48 (0.00%)
    0 / 102 (0.00%)
    1 / 116 (0.86%)
    0 / 118 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    GENERALISED TONIC-CLONIC SEIZURE
         subjects affected / exposed
    0 / 234 (0.00%)
    0 / 48 (0.00%)
    0 / 102 (0.00%)
    1 / 116 (0.86%)
    0 / 118 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    HYPERSENSITIVITY
         subjects affected / exposed
    0 / 234 (0.00%)
    0 / 48 (0.00%)
    1 / 102 (0.98%)
    0 / 116 (0.00%)
    0 / 118 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    GASTROINTESTINAL HAEMORRHAGE
         subjects affected / exposed
    0 / 234 (0.00%)
    0 / 48 (0.00%)
    1 / 102 (0.98%)
    0 / 116 (0.00%)
    0 / 118 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    OBSTRUCTIVE PANCREATITIS
         subjects affected / exposed
    0 / 234 (0.00%)
    0 / 48 (0.00%)
    0 / 102 (0.00%)
    1 / 116 (0.86%)
    0 / 118 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SMALL INTESTINAL OBSTRUCTION
         subjects affected / exposed
    0 / 234 (0.00%)
    0 / 48 (0.00%)
    0 / 102 (0.00%)
    1 / 116 (0.86%)
    0 / 118 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    UMBILICAL HERNIA
         subjects affected / exposed
    0 / 234 (0.00%)
    0 / 48 (0.00%)
    0 / 102 (0.00%)
    1 / 116 (0.86%)
    0 / 118 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    NASAL INFLAMMATION
         subjects affected / exposed
    0 / 234 (0.00%)
    0 / 48 (0.00%)
    0 / 102 (0.00%)
    0 / 116 (0.00%)
    1 / 118 (0.85%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PULMONARY EMBOLISM
         subjects affected / exposed
    0 / 234 (0.00%)
    0 / 48 (0.00%)
    0 / 102 (0.00%)
    2 / 116 (1.72%)
    0 / 118 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    URTICARIA
         subjects affected / exposed
    0 / 234 (0.00%)
    0 / 48 (0.00%)
    1 / 102 (0.98%)
    0 / 116 (0.00%)
    0 / 118 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    OSTEOCHONDROSIS
         subjects affected / exposed
    1 / 234 (0.43%)
    0 / 48 (0.00%)
    0 / 102 (0.00%)
    0 / 116 (0.00%)
    0 / 118 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    OSTEOARTHRITIS
         subjects affected / exposed
    0 / 234 (0.00%)
    0 / 48 (0.00%)
    0 / 102 (0.00%)
    1 / 116 (0.86%)
    0 / 118 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    APPENDICITIS PERFORATED
         subjects affected / exposed
    0 / 234 (0.00%)
    0 / 48 (0.00%)
    0 / 102 (0.00%)
    1 / 116 (0.86%)
    0 / 118 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SEPSIS
         subjects affected / exposed
    1 / 234 (0.43%)
    0 / 48 (0.00%)
    0 / 102 (0.00%)
    0 / 116 (0.00%)
    0 / 118 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    HYPONATRAEMIA
         subjects affected / exposed
    0 / 234 (0.00%)
    0 / 48 (0.00%)
    0 / 102 (0.00%)
    1 / 116 (0.86%)
    0 / 118 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Period A: APR Period B: APR/APR/RZB Period B: APR/RZB Period B: RZB/RZB Period A: RZB Period B: APR/APR
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    101 / 234 (43.16%)
    15 / 48 (31.25%)
    31 / 102 (30.39%)
    36 / 116 (31.03%)
    24 / 118 (20.34%)
    27 / 97 (27.84%)
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    3 / 234 (1.28%)
    3 / 48 (6.25%)
    1 / 102 (0.98%)
    6 / 116 (5.17%)
    2 / 118 (1.69%)
    0 / 97 (0.00%)
         occurrences all number
    3
    3
    1
    6
    2
    0
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    27 / 234 (11.54%)
    1 / 48 (2.08%)
    5 / 102 (4.90%)
    1 / 116 (0.86%)
    3 / 118 (2.54%)
    4 / 97 (4.12%)
         occurrences all number
    28
    1
    6
    1
    3
    4
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    47 / 234 (20.09%)
    0 / 48 (0.00%)
    1 / 102 (0.98%)
    0 / 116 (0.00%)
    1 / 118 (0.85%)
    1 / 97 (1.03%)
         occurrences all number
    50
    0
    1
    0
    1
    1
    NAUSEA
         subjects affected / exposed
    41 / 234 (17.52%)
    0 / 48 (0.00%)
    0 / 102 (0.00%)
    2 / 116 (1.72%)
    0 / 118 (0.00%)
    3 / 97 (3.09%)
         occurrences all number
    45
    0
    0
    2
    0
    3
    Infections and infestations
    COVID-19
         subjects affected / exposed
    16 / 234 (6.84%)
    6 / 48 (12.50%)
    12 / 102 (11.76%)
    19 / 116 (16.38%)
    13 / 118 (11.02%)
    14 / 97 (14.43%)
         occurrences all number
    16
    6
    12
    20
    13
    14
    NASOPHARYNGITIS
         subjects affected / exposed
    10 / 234 (4.27%)
    5 / 48 (10.42%)
    10 / 102 (9.80%)
    11 / 116 (9.48%)
    4 / 118 (3.39%)
    8 / 97 (8.25%)
         occurrences all number
    13
    6
    11
    14
    5
    10
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    2 / 234 (0.85%)
    1 / 48 (2.08%)
    6 / 102 (5.88%)
    5 / 116 (4.31%)
    3 / 118 (2.54%)
    3 / 97 (3.09%)
         occurrences all number
    2
    1
    8
    5
    3
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Nov 2022
    - Text was updated throughout the Protocol to align with revisions in the protocol template and changes due to new safety information available. Protocol sections include: Section 2.2, Section 4.1, Section 5.1, Section 5.4, Section 5.5, Section 5.6, Section 6.1, Section 9, Section 11, Appendix B, Appendix C, Appendix D, and Appendix E. - Protocol Section 7.1: added the interim lock for primary analysis for Period B. - Administrative Change 2: Update the Sponsor/Emergency Medical Contact information

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

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

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