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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Dose-Ranging Study of BI 655066/ABBV-066/Risankizumab in Patients with Active Psoriatic Arthritis

    Summary
    EudraCT number
    		 2015-003625-34
    Trial protocol
    		 FI   ES   NL   DE   BE   CZ   FR  
    Global end of trial date
    24 Aug 2017

    Results information
    Results version number
    		 v2(current)
    This version publication date
    23 Sep 2018
    First version publication date
    04 Aug 2018
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    1311.5
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02719171
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173, Ingelheim am Rhein, Germany, 55216
    Public contact
    QRPE Processes and Systems Coordination, Clinical Trial Information Disclosure, Boehringer Ingelheim, 001 8002430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    QRPE Processes and Systems Coordination, Clinical Trial Information Disclosure, Boehringer Ingelheim, 001 8002430127, clintriage.rdg@boehringer-ingelheim.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to provide proof-of-concept and dose-ranging for the efficacy of risankizumab as a treatment for psoriatic arthritis.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all patients as required.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Apr 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 11
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Czech Republic: 21
    Country: Number of subjects enrolled
    Finland: 22
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Germany: 25
    Country: Number of subjects enrolled
    Japan: 17
    Country: Number of subjects enrolled
    Poland: 44
    Country: Number of subjects enrolled
    Spain: 13
    Country: Number of subjects enrolled
    Taiwan: 8
    Country: Number of subjects enrolled
    United States: 66
    Worldwide total number of subjects
    239
    EEA total number of subjects
    137
    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)
    205
    From 65 to 84 years
    34
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This Phase 2, multi-national, randomized, parallel-design, multiple-dose, placebo controlled, double-blind study compared risankizumab with placebo in patients with active psoriatic arthritis. Patients were randomized at a 2:2:2:1:2 ratio, stratified based on prior tumor necrosis factor inhibitor (TNFi) use and concurrent methotrexate (MTX) use

    Pre-assignment
    Screening details
    		 This study included a 6-week screening period. All subjects were screened for eligibility to participate in the trial. Subjects attended a specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Subjects were not to be entered to trial treatment if any one of the specific entry criteria was violated.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Dose-Ranging Study

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo for Risankizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.

    Arm title
    		 Risankizumab 150 mg Every 4 Weeks
    Arm description
    		 Participants randomized to receive double-blind (DB) risankizumab 150 milligram (mg) by subcutaneous (SC) injection every 4 weeks for 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Risankizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.

    Arm title
    		 Risankizumab 150 mg Weeks 0, 4, and 16
    Arm description
    		 Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Risankizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.

    Arm title
    		 Risankizumab 150 mg Weeks 0 and 12
    Arm description
    		 Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Risankizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.

    Arm title
    		 Risankizumab 75 mg Week 0
    Arm description
    		 Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Risankizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0.

    Number of subjects in period 1 [1]
    		Placebo Risankizumab 150 mg Every 4 Weeks Risankizumab 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0 and 12 Risankizumab 75 mg Week 0
    Started
    42
    42
    42
    39
    20
    Completed
    41
    38
    39
    37
    18
    Not completed
    1
    4
    3
    2
    2
         Adverse event, non-fatal
    1
    2
    -
    -
    2
         Subject Withdrawal
    -
    2
    2
    1
    -
         Not Specified
    -
    -
    -
    1
    -
         Lost to follow-up
    -
    -
    1
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline characteristics are based on the patients who were randomized after successfully completing the screening period and received at least one of the trial medication.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.

    Reporting group title
    Risankizumab 150 mg Every 4 Weeks
    Reporting group description
    		 Participants randomized to receive double-blind (DB) risankizumab 150 milligram (mg) by subcutaneous (SC) injection every 4 weeks for 16 weeks.

    Reporting group title
    Risankizumab 150 mg Weeks 0, 4, and 16
    Reporting group description
    		 Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.

    Reporting group title
    Risankizumab 150 mg Weeks 0 and 12
    Reporting group description
    		 Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.

    Reporting group title
    Risankizumab 75 mg Week 0
    Reporting group description
    		 Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.

    Reporting group values
    		 Placebo Risankizumab 150 mg Every 4 Weeks Risankizumab 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0 and 12 Risankizumab 75 mg Week 0 Total
    Number of subjects
    		 42 42 42 39 20 185
    Age categorical
    Full Analysis Set (FAS): All randomized participants who received at least one dose of study drug.
    Units: Subjects
    Age Continuous
    Full Analysis Set (FAS): All randomized participants who received at least one dose of study drug. Age at the time of signing informed consent form is presented.
    Units: years
        arithmetic mean (standard deviation)
    		 49.0 ( 11.16 ) 51.8 ( 14.56 ) 50.1 ( 12.33 ) 51.6 ( 11.87 ) 53.8 ( 10.98 ) -
    Sex: Female, Male
    Full Analysis Set (FAS): All randomized participants who received at least one dose of study drug. Participants are categorized as Male or Female.
    Units: Subjects
        Female
    		 18 21 14 17 10 80
        Male
    		 24 21 28 22 10 105
    Race
    Full Analysis Set (FAS): All randomized participants who received at least one dose of study drug. Participants are categorized as per race.
    Units: Subjects
        White|
    		 36 35 37 34 15 157
        Black or African American|
    		 0 0 0 0 0 0
        Asian|
    		 5 6 3 4 4 22
        American Indian or Alaska Native|
    		 1 0 0 0 0 1
        Missing|
    		 0 1 2 1 1 5
    Ethnicity
    (Full Analysis Set (FAS): All randomized participants who received at least one dose of study drug. Participants are categorized as per ethnicity
    Units: Subjects
        Hispanic or Latino
    		 2 0 1 0 0 3
        Not Hispanic or Latino
    		 40 41 39 38 19 177
        Missing
    		 0 1 2 1 1 5

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.

    Reporting group title
    Risankizumab 150 mg Every 4 Weeks
    Reporting group description
    		 Participants randomized to receive double-blind (DB) risankizumab 150 milligram (mg) by subcutaneous (SC) injection every 4 weeks for 16 weeks.

    Reporting group title
    Risankizumab 150 mg Weeks 0, 4, and 16
    Reporting group description
    		 Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.

    Reporting group title
    Risankizumab 150 mg Weeks 0 and 12
    Reporting group description
    		 Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.

    Reporting group title
    Risankizumab 75 mg Week 0
    Reporting group description
    		 Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.

    Subject analysis set title
    Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks AND participants randomized to receive DB risankizumab 150 mg by SC injection at Weeks 0, 4, and 16.

    Subject analysis set title
    Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16 AND participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.

    Primary: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 16

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    End point title
    		 Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 16
    End point description
    Response defined by ACR20 criteria (improvement from baseline) at Week 16: ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: ◦Patient assessment of pain ◦Patient global assessment of disease activity ◦Investigator’s global assessment of disease activity ◦Health Assessment Questionnaire Disability Index (HAQ-DI) ◦Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data. Full Analysis Set (FAS): All randomized participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Placebo Risankizumab 150 mg Every 4 Weeks Risankizumab 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0 and 12 Risankizumab 75 mg Week 0 Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects analysed
    42 [1]
    42 [2]
    42 [3]
    39 [4]
    20 [5]
    84 [6]
    81 [7]
    Units: Percentage of participants
        number (confidence interval 90%)
    35.7 (23.5 to 49.5)
    57.1 (43.3 to 70.2)
    61.9 (48.0 to 74.4)
    59.0 (44.6 to 72.3)
    65.0 (44.2 to 82.3)
    59.5 (50.0 to 68.6)
    60.5 (50.8 to 69.6)
    Notes
    [1] - FAS
    [2] - FAS
    [3] - FAS
    [4] - FAS
    [5] - FAS
    [6] - FAS
    [7] - FAS
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The 90% confidence interval (CI) for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior tumor necrosis factor inhibitor (TNFi) use and concurrent methotrexate use.
    Comparison groups
    Placebo v Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.007
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    24
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 9.3
         upper limit
    		 38.7

    Secondary: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 16

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    End point title
    		 Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 16
    End point description
    Response defined by ACR50 criteria (improvement from baseline) at Week 16: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: ◦Patient assessment of pain ◦Patient global assessment of disease activity ◦Investigator’s global assessment of disease activity ◦HAQ-DI ◦Acute phase reactant value (C-reactive protein). NRI was used for missing data. Full Analysis Set (FAS): All randomized participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Risankizumab 150 mg Every 4 Weeks Risankizumab 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0 and 12 Risankizumab 75 mg Week 0 Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects analysed
    42 [8]
    42 [9]
    42 [10]
    39 [11]
    20 [12]
    84 [13]
    81 [14]
    Units: Percentage of participants
        number (confidence interval 90%)
    11.9 (4.8 to 23.4)
    23.8 (13.5 to 37.0)
    23.8 (13.5 to 37.0)
    38.5 (25.4 to 52.9)
    25.0 (10.4 to 45.6)
    23.8 (16.4 to 32.7)
    30.9 (22.5 to 40.4)
    Notes
    [8] - FAS
    [9] - FAS
    [10] - FAS
    [11] - FAS
    [12] - FAS
    [13] - FAS
    [14] - FAS
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.
    Comparison groups
    Placebo v Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.074
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    12
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 23

    Secondary: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 16

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    End point title
    		 Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 16
    End point description
    Response defined by ACR70 criteria (improvement from baseline) at Week 16: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters: ◦Patient assessment of pain ◦Patient global assessment of disease activity ◦Investigator’s global assessment of disease activity ◦HAQ-DI ◦Acute phase reactant value (C-reactive protein). NRI was used for missing data. Full Analysis Set (FAS): All randomized participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Risankizumab 150 mg Every 4 Weeks Risankizumab 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0 and 12 Risankizumab 75 mg Week 0 Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects analysed
    42 [15]
    42 [16]
    42 [17]
    39 [18]
    20 [19]
    84 [20]
    81 [21]
    Units: Percentage of participants
        number (confidence interval 90%)
    0.0 (0.0 to 6.9)
    14.3 (6.4 to 26.3)
    7.1 (2.0 to 17.4)
    25.6 (14.6 to 39.6)
    15.0 (4.2 to 34.4)
    10.7 (5.7 to 18.0)
    16.0 (9.8 to 24.3)
    Notes
    [15] - FAS
    [16] - FAS
    [17] - FAS
    [18] - FAS
    [19] - FAS
    [20] - FAS
    [21] - FAS
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.
    Comparison groups
    Placebo v Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.006
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 4.1
         upper limit
    		 16.4

    Secondary: Tender Joint Count (TJC68): Change from Baseline to Week 16

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    End point title
    		 Tender Joint Count (TJC68): Change from Baseline to Week 16
    End point description
    Sixty-eight joints were assessed and classified as either tender (1) or not tender (0). A negative change represents a decrease in the number of tender joints. Participants in the FAS with available data at Baseline and Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Risankizumab 150 mg Every 4 Weeks Risankizumab 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0 and 12 Risankizumab 75 mg Week 0 Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects analysed
    42 [22]
    40 [23]
    41 [24]
    38 [25]
    18 [26]
    81 [27]
    79 [28]
    Units: Tender joints
        least squares mean (confidence interval 90%)
    -7.9 (-10.6 to -5.2)
    -7.8 (-10.6 to -5.1)
    -9.6 (-12.4 to -6.9)
    -10.4 (-13.2 to -7.5)
    -10.8 (-14.9 to -6.8)
    -8.6 (-10.5 to -6.6)
    -9.9 (-11.8 to -8.0)
    Notes
    [22] - Participants in the FAS with available data at Baseline and Week 16.
    [23] - Participants in the FAS with available data at Baseline and Week 16.
    [24] - Participants in the FAS with available data at Baseline and Week 16.
    [25] - Participants in the FAS with available data at Baseline and Week 16.
    [26] - Participants in the FAS with available data at Baseline and Week 16.
    [27] - Participants in the FAS with available data at Baseline and Week 16.
    [28] - Participants in the FAS with available data at Baseline and Week 16.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.
    Comparison groups
    Placebo v Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.69
    Method
    		 mixed model repeated measures model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 2.5
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.
    Comparison groups
    Placebo v Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.26
    Method
    		 mixed model repeated measures model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -5.3
         upper limit
    		 1

    Secondary: Swollen Joint Count (SJC): Change from Baseline to Week 16

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    End point title
    		 Swollen Joint Count (SJC): Change from Baseline to Week 16
    End point description
    Sixty-six joints were assessed and classified as either swollen (1) or not swollen (0). A negative change represents a decrease in the number of swollen joints. Participants in the FAS with available data at Baseline and Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Risankizumab 150 mg Every 4 Weeks Risankizumab 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0 and 12 Risankizumab 75 mg Week 0 Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects analysed
    42 [29]
    40 [30]
    41 [31]
    38 [32]
    18 [33]
    81 [34]
    79 [35]
    Units: Swollen joints
        least squares mean (confidence interval 90%)
    -7.1 (-8.5 to -5.7)
    -6.8 (-8.3 to -5.4)
    -7.8 (-9.3 to -6.4)
    -8.3 (-9.7 to -6.8)
    -7.8 (-9.9 to -5.7)
    -7.3 (-8.5 to -6.2)
    -8.3 (-9.4 to -7.2)
    Notes
    [29] - Participants in the FAS with available data at Baseline and Week 16.
    [30] - Participants in the FAS with available data at Baseline and Week 16.
    [31] - Participants in the FAS with available data at Baseline and Week 16.
    [32] - Participants in the FAS with available data at Baseline and Week 16.
    [33] - Participants in the FAS with available data at Baseline and Week 16.
    [34] - Participants in the FAS with available data at Baseline and Week 16.
    [35] - Participants in the FAS with available data at Baseline and Week 16.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.
    Comparison groups
    Placebo v Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.791
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 1.5
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.
    Comparison groups
    Placebo v Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.32
    Method
    		 mixed model repeated measures model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 0.7

    Secondary: Health Assessment Questionnaire Disability Index (HAQ-DI) Score: Change from Baseline to Week 16

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    End point title
    		 Health Assessment Questionnaire Disability Index (HAQ-DI) Score: Change from Baseline to Week 16
    End point description
    The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. Negative change from Baseline indicates improvement. Participants in the FAS with available data at Baseline and Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Risankizumab 150 mg Every 4 Weeks Risankizumab 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0 and 12 Risankizumab 75 mg Week 0 Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects analysed
    42 [36]
    39 [37]
    40 [38]
    38 [39]
    18 [40]
    79 [41]
    78 [42]
    Units: Units on a scale
        least squares mean (confidence interval 90%)
    -0.089 (-0.204 to 0.026)
    -0.182 (-0.299 to -0.065)
    -0.163 (-0.280 to -0.047)
    -0.245 (-0.365 to -0.126)
    -0.147 (-0.317 to 0.023)
    -0.184 (-0.270 to -0.099)
    -0.206 (-0.291 to -0.120)
    Notes
    [36] - Participants in the FAS with available data at Baseline and Week 16.
    [37] - Participants in the FAS with available data at Baseline and Week 16.
    [38] - Participants in the FAS with available data at Baseline and Week 16.
    [39] - Participants in the FAS with available data at Baseline and Week 16.
    [40] - Participants in the FAS with available data at Baseline and Week 16.
    [41] - Participants in the FAS with available data at Baseline and Week 16.
    [42] - Participants in the FAS with available data at Baseline and Week 16.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.
    Comparison groups
    Placebo v Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.341
    Method
    		 mixed model repeated measures model
    Parameter type
    		 mixed model repeated measures model
    Point estimate
    -0.082
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.225
         upper limit
    		 0.06
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.
    Comparison groups
    Placebo v Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.181
    Method
    		 mixed model repeated measures model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.114
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.254
         upper limit
    		 0.027

    Secondary: Short Form-36 Health Status Survey (SF-36) Physical Component: Change from Baseline to Week 16

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    End point title
    		 Short Form-36 Health Status Survey (SF-36) Physical Component: Change from Baseline to Week 16
    End point description
    The SF-36 determined participant's overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Participants in the FAS with available data at Baseline and Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Risankizumab 150 mg Every 4 Weeks Risankizumab 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0 and 12 Risankizumab 75 mg Week 0 Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects analysed
    42 [43]
    37 [44]
    41 [45]
    39 [46]
    19 [47]
    78 [48]
    80 [49]
    Units: Units on a scale
        least squares mean (confidence interval 90%)
    1.93 (0.17 to 3.70)
    3.87 (2.03 to 5.71)
    3.50 (1.72 to 5.27)
    3.10 (1.27 to 4.93)
    7.42 (4.81 to 10.03)
    3.80 (2.52 to 5.08)
    3.32 (2.03 to 4.62)
    Notes
    [43] - Participants in the FAS with available data at Baseline and Week 16.
    [44] - Participants in the FAS with available data at Baseline and Week 16.
    [45] - Participants in the FAS with available data at Baseline and Week 16.
    [46] - Participants in the FAS with available data at Baseline and Week 16.
    [47] - Participants in the FAS with available data at Baseline and Week 16.
    [48] - Participants in the FAS with available data at Baseline and Week 16.
    [49] - Participants in the FAS with available data at Baseline and Week 16.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.
    Comparison groups
    Placebo v Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.174
    Method
    		 mixed model repeated measures model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.36
         upper limit
    		 3.77
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.
    Comparison groups
    Placebo v Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.284
    Method
    		 mixed model repeated measures model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.35
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.73
         upper limit
    		 3.44

    Secondary: Short Form-36 Health Status Survey (SF-36) Mental Component: Change from Baseline to Week 16

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    End point title
    		 Short Form-36 Health Status Survey (SF-36) Mental Component: Change from Baseline to Week 16
    End point description
    The SF-36 determined participant's overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Participants in the FAS with available data at Baseline and Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Risankizumab 150 mg Every 4 Weeks Risankizumab 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0 and 12 Risankizumab 75 mg Week 0 Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects analysed
    42 [50]
    37 [51]
    41 [52]
    39 [53]
    19 [54]
    78 [55]
    80 [56]
    Units: Units on a scale
        least squares mean (confidence interval 90%)
    0.48 (-1.74 to 2.69)
    -0.36 (-2.68 to 1.96)
    2.26 (0.03 to 4.49)
    2.84 (0.54 to 5.14)
    -1.08 (-4.35 to 2.19)
    1.31 (-0.38 to 3.00)
    2.29 (0.59 to 3.99)
    Notes
    [50] - Participants in the FAS with available data at Baseline and Week 16.
    [51] - Participants in the FAS with available data at Baseline and Week 16.
    [52] - Participants in the FAS with available data at Baseline and Week 16.
    [53] - Participants in the FAS with available data at Baseline and Week 16.
    [54] - Participants in the FAS with available data at Baseline and Week 16.
    [55] - Participants in the FAS with available data at Baseline and Week 16.
    [56] - Participants in the FAS with available data at Baseline and Week 16.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.
    Comparison groups
    Placebo v Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.718
    Method
    		 mixed model repeated measures model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.59
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.12
         upper limit
    		 3.3
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.
    Comparison groups
    Placebo v Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.204
    Method
    		 mixed model repeated measures model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.06
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.61
         upper limit
    		 4.74

    Secondary: Dactylitis Count: Change from Baseline to Week 16 in Participants with Dactylitis at Baseline

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    End point title
    		 Dactylitis Count: Change from Baseline to Week 16 in Participants with Dactylitis at Baseline
    End point description
    The number of fingers and toes with dactylitis (ranging from 0 to 20). A negative change represents a decrease in the number of fingers and toes affected by dactylitis. Participants in the FAS with available data at Baseline and Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Risankizumab 150 mg Every 4 Weeks Risankizumab 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0 and 12 Risankizumab 75 mg Week 0 Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects analysed
    9 [57]
    11 [58]
    11 [59]
    10 [60]
    5 [61]
    22 [62]
    21 [63]
    Units: Fingers and toes with dactylitis
        least squares mean (confidence interval 90%)
    -2.6 (-3.9 to -1.4)
    -1.1 (-2.2 to 0.1)
    -1.9 (-3.0 to -0.8)
    -2.9 (-4.1 to -1.7)
    -3.5 (-5.2 to -1.8)
    -1.5 (-2.4 to -0.6)
    -2.4 (-3.0 to -1.9)
    Notes
    [57] - Participants in the FAS with available data at Baseline and Week 16.
    [58] - Participants in the FAS with available data at Baseline and Week 16.
    [59] - Participants in the FAS with available data at Baseline and Week 16.
    [60] - Participants in the FAS with available data at Baseline and Week 16.
    [61] - Participants in the FAS with available data at Baseline and Week 16.
    [62] - Participants in the FAS with available data at Baseline and Week 16.
    [63] - Participants in the FAS with available data at Baseline and Week 16.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.
    Comparison groups
    Placebo v Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.243
    Method
    		 mixed model repeated measures model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 2.8
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.
    Comparison groups
    Placebo v Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.906
    Method
    		 mixed model repeated measures model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 1.1

    Secondary: Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Change from Baseline to Week 16 in Participants with Enthesitis at Baseline

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    End point title
    		 Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Change from Baseline to Week 16 in Participants with Enthesitis at Baseline
    End point description
    Assessment of enthesitis was performed in the following 16 domains: left and right (L/R) medial epicondyle; L/R lateral epicondyle; L/R supraspinatus insertion into the greater tuberosity of humerus; L/R greater trochanter; L/R quadriceps insertion into superior border of patella; L/R patellar ligament insertion into inferior pole of patella or tibial tubercle; L/R Achilles tendon insertion into calcaneum; L/R plantar fascia insertion into calcaneum. Tenderness at each site was classified as either absent (0) or present (1) to yield total SPARCC scores ranging from 0 (0 sites with tenderness) to 16 (16 sites with tenderness). A negative change from Baseline indicates improvement. Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Risankizumab 150 mg Every 4 Weeks Risankizumab 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0 and 12 Risankizumab 75 mg Week 0 Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects analysed
    27 [64]
    27 [65]
    24 [66]
    25 [67]
    11 [68]
    51 [69]
    49 [70]
    Units: Fingers and toes with dactylitis
        least squares mean (confidence interval 90%)
    -1.1 (-2.1 to -0.2)
    -1.4 (-2.3 to -0.5)
    -2.4 (-3.3 to -1.4)
    -1.8 (-2.7 to -0.8)
    -3.7 (-5.1 to -2.3)
    -1.7 (-2.4 to -1.0)
    -2.1 (-2.7 to -1.4)
    Notes
    [64] - Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16.
    [65] - Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16.
    [66] - Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16.
    [67] - Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16.
    [68] - Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16.
    [69] - Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16.
    [70] - Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.
    Comparison groups
    Placebo v Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.325
    Method
    		 mixed model repeated measures model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 0.5
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.
    Comparison groups
    Placebo v Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.16
    Method
    		 mixed model repeated measures model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.9
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 0.2

    Secondary: Modified Nail Psoriasis Severity Index (mNAPSI): Change from Baseline to Week 16

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    End point title
    		 Modified Nail Psoriasis Severity Index (mNAPSI): Change from Baseline to Week 16
    End point description
    mNAPSI grades each fingernail for onycholysis (separation of the nail plate from the nail bed) and oil-drop (salmon patch) dyschromia (reddish-brown discoloration under the nail plate) on a scale of 0 (none present) to 3 (>30% of the nail); pitting (small, sharply defined depressions in the nail surface) on a scale of 0 (0 pits present) to 3 (>50 pits present); nail plate crumbling on a scale of 0 (no crumbling) to 3 (>50% of nail has crumbling); and presence (1) or absence (0) of leukonychia (white spots), splinter hemorrhages, nail bed hyperkeratosis, and red spots in the lunula. mNAPSI is calculated as the sum of all the components for all of the participants fingernails, for a maximal score of 130. A negative change from Baseline indicate improvement. Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo Risankizumab 150 mg Every 4 Weeks Risankizumab 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0 and 12 Risankizumab 75 mg Week 0 Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects analysed
    28 [71]
    19 [72]
    23 [73]
    25 [74]
    9 [75]
    42 [76]
    48 [77]
    Units: Fingers and toes with dactylitis
        least squares mean (confidence interval 90%)
    -5.2 (-7.4 to -3.0)
    -6.7 (-9.4 to -4.1)
    -5.8 (-8.2 to -3.4)
    -10.7 (-13.1 to -8.3)
    -6.8 (-10.6 to -3.0)
    -5.5 (-7.3 to -3.8)
    -8.1 (-9.9 to -6.3)
    Notes
    [71] - Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16.
    [72] - Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16.
    [73] - Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16.
    [74] - Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16.
    [75] - Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16.
    [76] - Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16.
    [77] - Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.
    Comparison groups
    Placebo v Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.453
    Method
    		 mixed model repeated measures model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 1.5
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.
    Comparison groups
    Placebo v Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.111
    Method
    		 mixed model repeated measures model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -5.7
         upper limit
    		 0.1

    Secondary: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16

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    End point title
    		 Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16
    End point description
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. The percentage of participants achieving PASI 90 at Week 16 are provided. NRI was used for missing data. Full Analysis Set (FAS): All randomized participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo Risankizumab 150 mg Every 4 Weeks Risankizumab 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0 and 12 Risankizumab 75 mg Week 0 Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects analysed
    21 [78]
    12 [79]
    18 [80]
    23 [81]
    9 [82]
    30 [83]
    41 [84]
    Units: Percentage of participants
        number (confidence interval 90%)
    9.5 (1.7 to 27.1)
    58.3 (31.5 to 81.9)
    66.7 (44.6 to 84.4)
    52.2 (33.5 to 70.4)
    55.6 (25.1 to 83.1)
    63.3 (46.7 to 77.9)
    58.5 (44.5 to 71.6)
    Notes
    [78] - FAS, only patients with BSA >/= 3% psoriatic plaque involvment at baseline were included
    [79] - FAS, only patients with BSA >/= 3% psoriatic plaque involvment at baseline were included
    [80] - FAS, only patients with BSA >/= 3% psoriatic plaque involvment at baseline were included
    [81] - FAS, only patients with BSA >/= 3% psoriatic plaque involvment at baseline were included
    [82] - FAS, only patients with BSA >/= 3% psoriatic plaque involvment at baseline were included
    [83] - FAS, only patients with BSA >/= 3% psoriatic plaque involvment at baseline were included
    [84] - FAS, only patients with BSA >/= 3% psoriatic plaque involvment at baseline were included
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.
    Comparison groups
    Placebo v Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, and 16
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    53.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 35.9
         upper limit
    		 71.1
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.
    Comparison groups
    Placebo v Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    48.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 33.1
         upper limit
    		 64.5

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.

    Reporting group title
    Risankizumab 150 mg Every 4 Weeks
    Reporting group description
    		 Participants randomized to receive double-blind (DB) risankizumab 150 milligram (mg) by subcutaneous (SC) injection every 4 weeks for 16 weeks.

    Reporting group title
    Risankizumab 150 mg Weeks 0, 4, and 16
    Reporting group description
    		 Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.

    Reporting group title
    Risankizumab 150 mg Weeks 0 and 12
    Reporting group description
    		 Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.

    Reporting group title
    Risankizumab 75 mg Week 0
    Reporting group description
    		 Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.

    Serious adverse events
    		 Placebo Risankizumab 150 mg Every 4 Weeks Risankizumab 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0 and 12 Risankizumab 75 mg Week 0
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 42 (4.76%)
    3 / 42 (7.14%)
    0 / 42 (0.00%)
    2 / 39 (5.13%)
    3 / 20 (15.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Investigations
    Alanine aminot
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspartate amin
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood bilirubi
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ovarian cancer
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    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
    Cardiac disorders
    Acute myocardi
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    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
    Cardiac failur
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    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
    Coronary arter
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    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
    Surgical and medical procedures
    Nasal septal o
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascula
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 42 (2.38%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    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
    Immune system disorders
    Anaphylactic r
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 42 (2.38%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal herni
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 42 (2.38%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    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
    Renal and urinary disorders
    Acute kidney i
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    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
    Musculoskeletal and connective tissue disorders
    Intervertebral
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 42 (2.38%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    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
    Musculoskeleta
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff s
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    1 / 39 (2.56%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteriti
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    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
    Sepsis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Risankizumab 150 mg Every 4 Weeks Risankizumab 150 mg Weeks 0, 4, and 16 Risankizumab 150 mg Weeks 0 and 12 Risankizumab 75 mg Week 0
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 42 (59.52%)
    16 / 42 (38.10%)
    13 / 42 (30.95%)
    19 / 39 (48.72%)
    8 / 20 (40.00%)
    Investigations
    Alanine aminot
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 42 (0.00%)
    1 / 42 (2.38%)
    2 / 39 (5.13%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    2
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 42 (0.00%)
    1 / 42 (2.38%)
    1 / 39 (2.56%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    1
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 42 (7.14%)
    3 / 42 (7.14%)
    1 / 42 (2.38%)
    3 / 39 (7.69%)
    1 / 20 (5.00%)
         occurrences all number
    3
    3
    2
    4
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 42 (0.00%)
    3 / 42 (7.14%)
    1 / 42 (2.38%)
    1 / 39 (2.56%)
    0 / 20 (0.00%)
         occurrences all number
    0
    3
    1
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 42 (0.00%)
    1 / 42 (2.38%)
    2 / 39 (5.13%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    1
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 42 (4.76%)
    3 / 42 (7.14%)
    1 / 42 (2.38%)
    1 / 39 (2.56%)
    0 / 20 (0.00%)
         occurrences all number
    2
    3
    1
    1
    0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 42 (2.38%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Pain in extrem
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 42 (2.38%)
    1 / 42 (2.38%)
    1 / 39 (2.56%)
    1 / 20 (5.00%)
         occurrences all number
    3
    1
    1
    1
    1
    Influenza
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 42 (2.38%)
    1 / 42 (2.38%)
    2 / 39 (5.13%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    1
    2
    0
    Pharyngitis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    2 / 39 (5.13%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    Sinusitis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 42 (2.38%)
    2 / 42 (4.76%)
    2 / 39 (5.13%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    2
    2
    0
    Upper respirat
         subjects affected / exposed
    5 / 42 (11.90%)
    2 / 42 (4.76%)
    3 / 42 (7.14%)
    2 / 39 (5.13%)
    1 / 20 (5.00%)
         occurrences all number
    6
    2
    6
    2
    1
    Viral upper re
         subjects affected / exposed
    2 / 42 (4.76%)
    7 / 42 (16.67%)
    5 / 42 (11.90%)
    9 / 39 (23.08%)
    4 / 20 (20.00%)
         occurrences all number
    2
    12
    6
    11
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Oct 2016
    Major changes from the original protocol to amendment 1 included the notification to sites of a change in sponsor of the study in the United States (from BI to AbbVie), and informed sites of an open label extension study for subjects completing required participation in this study. The open label extension study is sponsored by AbbVie as part of the collaboration between BI and AbbVie in the development of risankizumab. Amendment 1 also revised the study visit schedule and other protocol sections to clarify eligibility and study requirements for those subjects enrolling into the open label extension study. Amendment 1 was not considered to have an impact on the integrity or interpretation of the data.

    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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