Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35554   clinical trials with a EudraCT protocol, of which   5841   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    BI 655066/ABBV-066 (risankizumab) Versus Adalimumab in a Randomized, Double Blind, Parallel Group Trial in Moderate to Severe Plaque Psoriasis to Assess Safety and Efficacy After 16 Weeks of Treatment and After Incomplete Adalimumab Treatment Response (IMMvent)

    Summary
    EudraCT number
    2015-003623-65
    Trial protocol
    DE   SE   FI   PT   CZ   PL  
    Global end of trial date
    24 Aug 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Sep 2018
    First version publication date
    09 Sep 2018
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    1311.30
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02694523
    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
    05 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Feb 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 main objectives of this study were to assess the efficacy and safety of risankizumab compared with adalimumab in subjects with moderate to severe chronic plaque psoriasis, and the efficacy and safety of switching to risankizumab compared with continued adalimumab in patients with an inadequate response to adalimumab at Week 16.
    Protection of trial subjects
    Only patients that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All patients were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all patients 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
    31 Mar 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: 94
    Country: Number of subjects enrolled
    Czech Republic: 29
    Country: Number of subjects enrolled
    Finland: 10
    Country: Number of subjects enrolled
    France: 21
    Country: Number of subjects enrolled
    Germany: 88
    Country: Number of subjects enrolled
    Mexico: 21
    Country: Number of subjects enrolled
    Poland: 79
    Country: Number of subjects enrolled
    Portugal: 22
    Country: Number of subjects enrolled
    Sweden: 12
    Country: Number of subjects enrolled
    Taiwan: 58
    Country: Number of subjects enrolled
    United States: 250
    Worldwide total number of subjects
    684
    EEA total number of subjects
    261
    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)
    621
    From 65 to 84 years
    63
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    Confirmatory,Randomized,DoubleBlind,DoubleDummy,ActiveControlled,ParallelDesign trial to compare risankizumab with adalimumab in patients with moderate to severe chronic plaque psoriasis. Randomization ratio was 1:1 to risankizumab or adalimumab, stratified by weight and by prior exposure to TNF antagonists. 684 were enrolled and 605 were treated.

    Pre-assignment
    Screening details
    Patients were randomized to adalimumab or risankizumab inPartA. Who received risankizumab continued risankizumab in PartB;adalimumab responders(≥PsoriasisArea andSeverityIndex(PASI)90) continued adalimumab,nonresponders(<PASI50) switched to risankizumab,indadequate responders(PASI50to<PASI90)were rerandomized to adalimumab or risankizumab inPartB.

    Period 1
    Period 1 title
    Part A
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    This was a double-blind trial. Patients were randomized in blocks to double-blind treatments.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Adalimumab (Part A)
    Arm description
    Participants randomized to receive double-blind adalimumab 80 milligram (mg) at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
    Arm type
    Active comparator

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants randomized to receive double-blind adalimumab 80 mg at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).

    Arm title
    Risankizumab (Part A)
    Arm description
    Participants randomized to receive risankizumab at Weeks 0 and 4 (Part A) continued to receive risankizumab at Weeks 16 and 28.
    Arm type
    Experimental

    Investigational medicinal product name
    Risankizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants randomized to receive risankizumab at Weeks 0 and 4 (Part A) continued to receive risankizumab at Weeks 16 and 28.

    Number of subjects in period 1 [1]
    Adalimumab (Part A) Risankizumab (Part A)
    Started
    304
    301
    Completed
    291
    294
    Not completed
    13
    7
         Protocol deviation
    1
    -
         Adverse event, non-fatal
    7
    3
         Consent withdrawn by subject
    3
    1
         Not Specified
    1
    1
         Lost to follow-up
    1
    2
    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 patients who were randomised after successfully completing the screening period and received at least one dose of the trial medication.
    Period 2
    Period 2 title
    Part B
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    This was a double-blind trial. Patients were randomized in blocks to double-blind treatments.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Risankizumab/Risankizumab (Part B)
    Arm description
    Participants randomized to receive double-blind risankizumab in Part A continued to receive risankizumab 150 mg at Weeks 16, and 28 (Part B).
    Arm type
    Experimental

    Investigational medicinal product name
    Risankizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants randomized to receive double-blind risankizumab in Part A continued to receive risankizumab 150 mg at Weeks 16, and 28 (Part B).

    Arm title
    Adalimumab/Adalimumab (Part B)
    Arm description
    Participants who were responders after receiving adalimumab in Part A continued adalimumab 40 mg every other week through Week 41 (Part B).
    Arm type
    Active comparator

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants who were responders after receiving adalimumab in Part A continued adalimumab 40 mg every other week through Week 41 (Part B).

    Arm title
    Adalimumab/Risankizumab (Part B)
    Arm description
    Participants who were nonresponders after receiving adalimumab in Part A switched to risankizumab 150 mg at Weeks 16, 20, and 32 (Part B).
    Arm type
    Experimental

    Investigational medicinal product name
    Risankizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants who were nonresponders after receiving adalimumab in Part A switched to risankizumab 150 mg at Weeks 16, 20, and 32 (Part B).

    Arm title
    Adalimumab/Rerandomized to Adalimumab (Part B)
    Arm description
    Participants who were inadequate responders after receiving adalimumab in Part A, and re-randomized to continue to receive adalimumab 40 mg every 2 weeks through Week 41 (Part B).
    Arm type
    Active comparator

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants who were inadequate responders after receiving adalimumab in Part A, and re-randomized to continue to receive adalimumab 40 mg every 2 weeks through Week 41 (Part B).

    Arm title
    Adalimumab/Rerandomized to Risankizumab (Part B)
    Arm description
    Participants who were inadequate responders after receiving adalimumab in Part A, and re-randomized to receive risankizumab 150 mg at Weeks 16, 20, and 32 (Part B).
    Arm type
    Experimental

    Investigational medicinal product name
    Risankizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants who were inadequate responders after receiving adalimumab in Part A, and re-randomized to receive risankizumab 150 mg at Weeks 16, 20, and 32 (Part B).

    Number of subjects in period 2
    Risankizumab/Risankizumab (Part B) Adalimumab/Adalimumab (Part B) Adalimumab/Risankizumab (Part B) Adalimumab/Rerandomized to Adalimumab (Part B) Adalimumab/Rerandomized to Risankizumab (Part B)
    Started
    294
    144
    38
    56
    53
    Completed
    274
    140
    34
    51
    51
    Not completed
    20
    4
    4
    5
    2
         Protocol deviation
    1
    -
    -
    -
    -
         Adverse event, non-fatal
    7
    1
    1
    2
    -
         Consent withdrawn by subject
    9
    -
    1
    3
    -
         Not Specified
    1
    -
    -
    -
    1
         Lost to follow-up
    2
    3
    2
    -
    1

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Adalimumab (Part A)
    Reporting group description
    Participants randomized to receive double-blind adalimumab 80 milligram (mg) at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).

    Reporting group title
    Risankizumab (Part A)
    Reporting group description
    Participants randomized to receive risankizumab at Weeks 0 and 4 (Part A) continued to receive risankizumab at Weeks 16 and 28.

    Reporting group values
    Adalimumab (Part A) Risankizumab (Part A) Total
    Number of subjects
    304 301 605
    Age categorical
    Units: Subjects
    Age Continuous
    Age at the time of signing informed consent form is presented. Intent-to-treat population in Part A (ITT_A): All subjects randomized at Baseline.
    Units: years
        arithmetic mean (standard deviation)
    47.0 ± 13.09 45.3 ± 13.79 -
    Sex: Female, Male
    Number of subjects is categorized as Male or Female. Intent-to-treat population in Part A (ITT_A): All subjects randomized at Baseline.
    Units: Subjects
        Female
    92 91 183
        Male
    212 210 422
    Race (NIH/OMB)
    Number of subjects is categorized for race data. Intent-to-treat population in Part A (ITT_A): All subjects randomized at Baseline.
    Units: Subjects
        American Indian or Alaska Native
    0 2 2
        Asian
    35 41 76
        Native Hawaiian or Other Pacific Islander
    0 0 0
        Black or African American
    6 11 17
        White
    263 245 508
        More than one race
    0 2 2
        Unknown or Not Reported
    0 0 0
    Ethnicity (NIH/OMB)
    Number of subjects is categorized for ethnicity data. Intent-to-treat population in Part A (ITT_A): All subjects randomized at Baseline.
    Units: Subjects
        Hispanic or Latino
    59 44 103
        Not Hispanic or Latino
    245 257 502

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Adalimumab (Part A)
    Reporting group description
    Participants randomized to receive double-blind adalimumab 80 milligram (mg) at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).

    Reporting group title
    Risankizumab (Part A)
    Reporting group description
    Participants randomized to receive risankizumab at Weeks 0 and 4 (Part A) continued to receive risankizumab at Weeks 16 and 28.
    Reporting group title
    Risankizumab/Risankizumab (Part B)
    Reporting group description
    Participants randomized to receive double-blind risankizumab in Part A continued to receive risankizumab 150 mg at Weeks 16, and 28 (Part B).

    Reporting group title
    Adalimumab/Adalimumab (Part B)
    Reporting group description
    Participants who were responders after receiving adalimumab in Part A continued adalimumab 40 mg every other week through Week 41 (Part B).

    Reporting group title
    Adalimumab/Risankizumab (Part B)
    Reporting group description
    Participants who were nonresponders after receiving adalimumab in Part A switched to risankizumab 150 mg at Weeks 16, 20, and 32 (Part B).

    Reporting group title
    Adalimumab/Rerandomized to Adalimumab (Part B)
    Reporting group description
    Participants who were inadequate responders after receiving adalimumab in Part A, and re-randomized to continue to receive adalimumab 40 mg every 2 weeks through Week 41 (Part B).

    Reporting group title
    Adalimumab/Rerandomized to Risankizumab (Part B)
    Reporting group description
    Participants who were inadequate responders after receiving adalimumab in Part A, and re-randomized to receive risankizumab 150 mg at Weeks 16, 20, and 32 (Part B).

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

    Close Top of page
    End point title
    Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A)
    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. Nonresponder imputation (NRI) was used for missing data. Intent-to-treat population in Part A (ITT_A): All subjects randomized at Baseline.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    Adalimumab (Part A) Risankizumab (Part A)
    Number of subjects analysed
    304 [1]
    301 [2]
    Units: Percentage of participants
        number (not applicable)
    47.4
    72.4
    Notes
    [1] - ITT_A population
    [2] - ITT_A population
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value calculated according to the Cohran-Mantel-Haenszel test adjusted for baseline weight (≤100 kilogram (kg) vs >100 kg) and prior exposure to Tumor Necrosis Factor (TNF) antagonists (0 vs ≥1).
    Comparison groups
    Adalimumab (Part A) v Risankizumab (Part A)
    Number of subjects included in analysis
    605
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage of participants
    Point estimate
    24.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    17.5
         upper limit
    32.4

    Primary: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) score of Clear or Almost Clear at Week 16 (Part A)

    Close Top of page
    End point title
    Percentage of Participants Achieving Static Physician Global Assessment (sPGA) score of Clear or Almost Clear at Week 16 (Part A)
    End point description
    The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. No Response Imputation (NRI) was used for missing data.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    Adalimumab (Part A) Risankizumab (Part A)
    Number of subjects analysed
    304 [3]
    301 [4]
    Units: Percentage of participants
        number (not applicable)
    60.2
    83.7
    Notes
    [3] - ITT_A population
    [4] - ITT_A population
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    P-value calculated according to the Cohran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).
    Comparison groups
    Adalimumab (Part A) v Risankizumab (Part A)
    Number of subjects included in analysis
    605
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage of participants
    Point estimate
    23.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    16.6
         upper limit
    30.1

    Primary: Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B)

    Close Top of page
    End point title
    Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B)
    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. NRI was used for missing data. Intent-to-treat population in Part B who were re-randomized (ITT_B_RR): All subjects who started with adalimumab at Baseline and were re-randomized at Week 16.
    End point type
    Primary
    End point timeframe
    Week 44
    End point values
    Adalimumab/Rerandomized to Adalimumab (Part B) Adalimumab/Rerandomized to Risankizumab (Part B)
    Number of subjects analysed
    56 [5]
    53 [6]
    Units: Percentage of participants
        number (not applicable)
    21.4
    66.0
    Notes
    [5] - ITT_B_RR population
    [6] - ITT_B_RR population
    Statistical analysis title
    Statistical Analysis 3
    Statistical analysis description
    P-value calculated according to the Cohran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).
    Comparison groups
    Adalimumab/Rerandomized to Adalimumab (Part B) v Adalimumab/Rerandomized to Risankizumab (Part B)
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage of participants
    Point estimate
    45
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    28.9
         upper limit
    61.1

    Secondary: Percentage of Participants Achieving PASI75 at Week 16 (Part A)

    Close Top of page
    End point title
    Percentage of Participants Achieving PASI75 at Week 16 (Part A)
    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. PASI75 is defined as at least a 75% 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. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Adalimumab (Part A) Risankizumab (Part A)
    Number of subjects analysed
    304 [7]
    301 [8]
    Units: Percentage of participants
        number (not applicable)
    71.7
    90.7
    Notes
    [7] - ITT_A population
    [8] - ITT_A population
    Statistical analysis title
    Statistical Analysis 4
    Statistical analysis description
    P-value calculated according to the Cohran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).
    Comparison groups
    Adalimumab (Part A) v Risankizumab (Part A)
    Number of subjects included in analysis
    605
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage of participants
    Point estimate
    18.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    13
         upper limit
    24.9

    Secondary: Percentage of Participants Achieving PASI100 at Week 16 (Part A)

    Close Top of page
    End point title
    Percentage of Participants Achieving PASI100 at Week 16 (Part A)
    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. PASI100 is defined as a 100% 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. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Adalimumab (Part A) Risankizumab (Part A)
    Number of subjects analysed
    304 [9]
    301 [10]
    Units: Percentage of participants
        number (not applicable)
    23.0
    39.9
    Notes
    [9] - ITT_A population
    [10] - ITT_A population
    Statistical analysis title
    Statistical Analysis 5
    Statistical analysis description
    P-value calculated according to the Cohran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).
    Comparison groups
    Adalimumab (Part A) v Risankizumab (Part A)
    Number of subjects included in analysis
    605
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage of participants
    Point estimate
    16.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    9.5
         upper limit
    23.9

    Secondary: Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI100 at Week 44 (Part B)

    Close Top of page
    End point title
    Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI100 at Week 44 (Part B)
    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. PASI100 is defined as a 100% 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. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 44
    End point values
    Adalimumab/Rerandomized to Adalimumab (Part B) Adalimumab/Rerandomized to Risankizumab (Part B)
    Number of subjects analysed
    56 [11]
    53 [12]
    Units: Percentage of participants
        number (not applicable)
    7.1
    39.6
    Notes
    [11] - ITT_B_RR population
    [12] - ITT_B_RR population
    Statistical analysis title
    Statistical Analysis 6
    Statistical analysis description
    P-value calculated according to the Cohran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).
    Comparison groups
    Adalimumab/Rerandomized to Adalimumab (Part B) v Adalimumab/Rerandomized to Risankizumab (Part B)
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage of participants
    Point estimate
    32.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.8
         upper limit
    46.9

    Secondary: Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA score of Clear at Week 44 (Part B)

    Close Top of page
    End point title
    Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA score of Clear at Week 44 (Part B)
    End point description
    The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 44
    End point values
    Adalimumab/Rerandomized to Adalimumab (Part B) Adalimumab/Rerandomized to Risankizumab (Part B)
    Number of subjects analysed
    56 [13]
    53 [14]
    Units: Percentage of participants
        number (not applicable)
    7.1
    39.6
    Notes
    [13] - ITT_B_RR population
    [14] - ITT_B_RR population
    Statistical analysis title
    Statistical Analysis 7
    Statistical analysis description
    P-value calculated according to the Cohran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).
    Comparison groups
    Adalimumab/Rerandomized to Adalimumab (Part B) v Adalimumab/Rerandomized to Risankizumab (Part B)
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage of participants
    Point estimate
    32.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.8
         upper limit
    46.9

    Other pre-specified: Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA score of Clear or Almost Clear at Week 44 (Part B)

    Close Top of page
    End point title
    Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA score of Clear or Almost Clear at Week 44 (Part B)
    End point description
    The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.
    End point type
    Other pre-specified
    End point timeframe
    Week 44
    End point values
    Adalimumab/Rerandomized to Adalimumab (Part B) Adalimumab/Rerandomized to Risankizumab (Part B)
    Number of subjects analysed
    56 [15]
    53 [16]
    Units: Percentage of participants
        number (not applicable)
    33.9
    73.6
    Notes
    [15] - ITT_B_RR population
    [16] - ITT_B_RR population
    Statistical analysis title
    Statistical Analysis 8
    Statistical analysis description
    P-value calculated according to the Cohran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).
    Comparison groups
    Adalimumab/Rerandomized to Adalimumab (Part B) v Adalimumab/Rerandomized to Risankizumab (Part B)
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Difference in percentage of participants
    Point estimate
    38.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    22
         upper limit
    55.8

    Adverse events

    Close Top of page
    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 48 weeks
    Adverse event reporting additional description
    AEs in Part A defined as events from the first dose of drug in Part A until prior to the first dose in Part B (Week16) or up to 15 weeks after the last dose of study drug if the participant discontinued in Part A; AEs in Part B defined as events from first dose of drug in Part B (Week16) until up to 15 weeks after last dose of study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Adalimumab (Part A)
    Reporting group description
    Participants randomized to receive double-blind adalimumab 80 mg at Week 0, then 40 milligram (mg) at Week 1 and every 2 weeks for 15 weeks (Part A).

    Reporting group title
    Risankizumab (Part A)
    Reporting group description
    Participants randomized to receive risankizumab at Weeks 0 and 4 (Part A) continued to receive risankizumab at Weeks 16 and 28.

    Reporting group title
    Adalimumab/Rerandomized to Adalimumab (Part B)
    Reporting group description
    Participants who were inadequate responders after receiving adalimumab in Part A, and re-randomized to continue to receive adalimumab 40 mg every 2 weeks through Week 41 (Part B).

    Reporting group title
    Adalimumab/Rerandomized to Risankizumab (Part B)
    Reporting group description
    Participants who were inadequate responders after receiving adalimumab in Part A, and re-randomized to receive risankizumab 150 mg at Weeks 16, 20, and 32 (Part B).

    Reporting group title
    Adalimumab/Risankizumab (Part B)
    Reporting group description
    Participants who were nonresponders after receiving adalimumab in Part A switched to risankizumab 150 mg at Weeks 16, 20, and 32 (Part B).

    Reporting group title
    Risankizumab/Risankizumab (Part B)
    Reporting group description
    Participants randomized to receive double-blind risankizumab in Part A continued to receive risankizumab 150 mg at Weeks 16, and 28 (Part B).

    Serious adverse events
    Adalimumab (Part A) Risankizumab (Part A) Adalimumab/Rerandomized to Adalimumab (Part B) Adalimumab/Rerandomized to Risankizumab (Part B) Adalimumab/Risankizumab (Part B) Risankizumab/Risankizumab (Part B)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 304 (2.96%)
    10 / 301 (3.32%)
    2 / 56 (3.57%)
    3 / 53 (5.66%)
    4 / 38 (10.53%)
    12 / 294 (4.08%)
         number of deaths (all causes)
    2
    1
    2
    0
    0
    0
         number of deaths resulting from adverse events
    1
    0
    0
    0
    0
    0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (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
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    1 / 294 (0.34%)
         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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    1 / 294 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Gallbladder cancer
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 301 (0.33%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    1 / 294 (0.34%)
         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
    Psychiatric disorders
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    1 / 38 (2.63%)
    0 / 294 (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
    Anxiety
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    1 / 294 (0.34%)
         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
    Depression
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 301 (0.33%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    1 / 294 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    Suicide attempt
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 301 (0.33%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    0 / 0
    Reproductive system and breast disorders
    Haemorrhagic ovarian cyst
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (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
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    1 / 294 (0.34%)
         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
    Joint dislocation
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    1 / 53 (1.89%)
    0 / 38 (0.00%)
    0 / 294 (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
    Radius fracture
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 301 (0.33%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Respiratory fume inhalation disorder
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 301 (0.33%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    1 / 294 (0.34%)
         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
    Investigations
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    1 / 38 (2.63%)
    0 / 294 (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
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 301 (0.33%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (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
    Coronary artery occlusion
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    1 / 38 (2.63%)
    0 / 294 (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
    Myocardial infarction
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    1 / 294 (0.34%)
         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
    Palpitations
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    1 / 56 (1.79%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (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
    Congenital, familial and genetic disorders
    Macrocornea
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 301 (0.33%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 301 (0.33%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 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
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 301 (0.33%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenopathy mediastinal
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    1 / 294 (0.34%)
         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
    Syncope
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (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
    Eye disorders
    Macular hole
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    1 / 294 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    1 / 38 (2.63%)
    0 / 294 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Gastric perforation
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (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
    Gastritis
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    1 / 294 (0.34%)
         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
    Pancreatitis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (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
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (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
    Liver injury
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 301 (0.33%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    1 / 294 (0.34%)
         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
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    1 / 294 (0.34%)
         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
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (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
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    1 / 56 (1.79%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (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
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (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
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    2 / 38 (5.26%)
    0 / 294 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    1 / 53 (1.89%)
    0 / 38 (0.00%)
    0 / 294 (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
    Perirectal abscess
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 301 (0.33%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    0 / 38 (0.00%)
    0 / 294 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 301 (0.33%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    1 / 38 (2.63%)
    1 / 294 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    1 / 38 (2.63%)
    1 / 294 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    1 / 53 (1.89%)
    0 / 38 (0.00%)
    1 / 294 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         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
    Adalimumab (Part A) Risankizumab (Part A) Adalimumab/Rerandomized to Adalimumab (Part B) Adalimumab/Rerandomized to Risankizumab (Part B) Adalimumab/Risankizumab (Part B) Risankizumab/Risankizumab (Part B)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    71 / 304 (23.36%)
    76 / 301 (25.25%)
    21 / 56 (37.50%)
    24 / 53 (45.28%)
    16 / 38 (42.11%)
    95 / 294 (32.31%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    8 / 304 (2.63%)
    1 / 301 (0.33%)
    1 / 56 (1.79%)
    1 / 53 (1.89%)
    3 / 38 (7.89%)
    9 / 294 (3.06%)
         occurrences all number
    12
    1
    1
    1
    3
    9
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Seborrhoeic keratosis
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 301 (0.00%)
    0 / 56 (0.00%)
    0 / 53 (0.00%)
    2 / 38 (5.26%)
    2 / 294 (0.68%)
         occurrences all number
    0
    0
    0
    0
    2
    2
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    3 / 304 (0.99%)
    6 / 301 (1.99%)
    1 / 56 (1.79%)
    2 / 53 (3.77%)
    2 / 38 (5.26%)
    3 / 294 (1.02%)
         occurrences all number
    3
    6
    1
    2
    2
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    20 / 304 (6.58%)
    12 / 301 (3.99%)
    3 / 56 (5.36%)
    3 / 53 (5.66%)
    2 / 38 (5.26%)
    6 / 294 (2.04%)
         occurrences all number
    29
    13
    4
    3
    2
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    9 / 304 (2.96%)
    11 / 301 (3.65%)
    3 / 56 (5.36%)
    2 / 53 (3.77%)
    0 / 38 (0.00%)
    4 / 294 (1.36%)
         occurrences all number
    12
    12
    5
    2
    0
    4
    Back pain
         subjects affected / exposed
    6 / 304 (1.97%)
    9 / 301 (2.99%)
    3 / 56 (5.36%)
    2 / 53 (3.77%)
    0 / 38 (0.00%)
    6 / 294 (2.04%)
         occurrences all number
    6
    9
    3
    3
    0
    6
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 304 (0.99%)
    4 / 301 (1.33%)
    3 / 56 (5.36%)
    2 / 53 (3.77%)
    2 / 38 (5.26%)
    7 / 294 (2.38%)
         occurrences all number
    3
    4
    3
    2
    2
    8
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 304 (3.95%)
    21 / 301 (6.98%)
    5 / 56 (8.93%)
    4 / 53 (7.55%)
    3 / 38 (7.89%)
    34 / 294 (11.56%)
         occurrences all number
    15
    26
    5
    6
    5
    44
    Viral upper respiratory tract infection
         subjects affected / exposed
    24 / 304 (7.89%)
    26 / 301 (8.64%)
    7 / 56 (12.50%)
    14 / 53 (26.42%)
    9 / 38 (23.68%)
    39 / 294 (13.27%)
         occurrences all number
    29
    31
    8
    19
    14
    48

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jun 2016
    Abbreviation added. “Biologic therapy history” changed to “Psoriasis therapy history” and % body surface area involvement at Visit 1 and 2 added. Anti-drug antibodies sampling at Week 4 added. Randomization, Re-Randomization at Visit 8 should read footer 14. Several text changed in Overall Trial Design and Plan. Clarification on how efficacy data will be used upon submission to the Data Monitoring Committee (DMC) as well as additional information on unbinding. Thrombotic events added. New inclusion criterion added. Exclusion criteria number 4 and 7 slightly changed. Patients that discontinue study medication should complete all study visits and procedures as initially planned, if possible. Method of assigning patients to treatment groups Section revised. Revised text to specify timing of vital sign measurements and hypersensitivity monitoring at dosing visits; further information regarding drug injection details; additional description on patients late visit added. Added facitinib (Xeljanz®) and apremilast (Otezla®) and removed efalizumab (Raptiva®). Added “Absolute Psoriasis Area Severity Index (PASI) score of <3 at all visits collected” in further endpoints. Some laboratory parameters are better specified. Added Albumin/creatinine ratio in urine. Removed information from details of trial procedures. Some information added and removed from baseline conditions. Last paragraph of treatment period section revised. Patients that discontinue study medication should complete all study visits and procedures as initially planned, if possible. Clarified the important protocol violations. Hypothesis tests as described in Section 7.2 will be repeated on the Per Protocol Set or Re-Randomized Per Protocol Set, as appropriate. Added “Time to onset of Endpoint” definition. Clarified Residual Effect Period (REP). Interim analysis planning added. The Work Limitations Questionnaire (WLQ) is not applicable to unemployed patients added.
    05 Jul 2016
    Clarification provided in section 11, to implemente only after approval of the Institutional Review Board (IRB) / Independent Ethics Committee (IEC) / Competent Authorities.
    17 Oct 2016
    1. In title page changed BI drug or BI 655066 to refer to either names for this compound: BI 655066/ABBV-066 (risankizumab). 2. Changed sponsor from Boehringer Ingelheim (BI) to AbbVie in the USA; BI remains the sponsor for all other participating countries. 3. Changed text to specify Statistical Evaluation will be done by AbbVie according to their SOPs.. 4. Updated text to “AbbVie/Boehringer Ingelheim reserves the right to discontinue the trial overall or at a particular trial site at any time for the following reasons”. 5. Changed DNA banking sample storage from Boehringer Ingelheim to AbbVie or a third party delegate. 6. Skin biopsies will be collected only at Visit 2 (lesional and non-lesional) and at Visit 7 (only lesional) as shown in the Flow Chart. 7. Changed text to specify that AbbVie summary tables and listings will be produced and analyses are based on AbbVie standards.

    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
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA