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    Clinical Trial Results:
    BI 655066/ABBV-066 (Risankizumab) versus Ustekinumab and Placebo Comparators in a Randomized Double Blind Trial for Maintenance Use in Moderate to Severe Plaque Type Psoriasis-2

    Summary
    EudraCT number
    2015-003622-13
    Trial protocol
    BE   DE   AT   PT   ES   PL  
    Global end of trial date
    04 Sep 2017

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

    Trial information

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    Trial identification
    Sponsor protocol code
    1311.28
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02684357
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    AbbVie: M15-995
    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
    17 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Sep 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 to ustekinumab and placebo, in subjects with moderate to severe chronic plaque psoriasis. In addition, this study was to assess pharmacokinetics (PK) and the emergence of anti-drug antibodies and their effect on efficacy and safety.
    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
    31 Mar 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 14
    Country: Number of subjects enrolled
    Belgium: 15
    Country: Number of subjects enrolled
    Canada: 155
    Country: Number of subjects enrolled
    France: 28
    Country: Number of subjects enrolled
    Germany: 27
    Country: Number of subjects enrolled
    Mexico: 22
    Country: Number of subjects enrolled
    Poland: 15
    Country: Number of subjects enrolled
    Portugal: 7
    Country: Number of subjects enrolled
    Spain: 30
    Country: Number of subjects enrolled
    United States: 264
    Worldwide total number of subjects
    577
    EEA total number of subjects
    136
    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)
    505
    From 65 to 84 years
    72
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Participants were randomized to placebo, ustekinumab, or risankizumab in Part A. Participants who received placebo in Part A switched to risankizumab in Part B; participants who received ustekinumab in Part A continued ustekinumab in Part B; and participants who received risankizumab in Part A continued risankizumab in Part B.

    Period 1
    Period 1 title
    Part A
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Subject
    Blinding implementation details
    All participants received 2 sets of injections to maintain the blind (the placebo arm received placebo for risankizumab and placebo for ustekinumab) the risankizumab arm received risankizumab and placebo for ustekinumab and the ustekinumab arm received ustekinumab and placebo for risankizumab

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo (Part A)
    Arm description
    Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

    Arm title
    Ustekinumab (Part A)
    Arm description
    Participants randomized to receive double-blind (DB) ustekinumab 45 or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). They received 2 sets of injections to maintain the blind ( ustekinumab and placebo for risankizumab)
    Arm type
    Active comparator

    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 randomized to receive Placebo for Risankizumab subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants randomized to receive double-blind (DB) ustekinumab 45 or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

    Arm title
    Risankizumab (Part A)
    Arm description
    Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). They received 2 sets of injections to maintain the blind (risankizumab and placebo for ustekinumab)
    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 randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

    Investigational medicinal product name
    Placebo for Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants randomized to receive Placebo for Ustekinumab subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

    Number of subjects in period 1 [1]
    Placebo (Part A) Ustekinumab (Part A) Risankizumab (Part A)
    Started
    98
    99
    294
    Completed
    94
    96
    292
    Not completed
    4
    3
    2
         Not specified
    -
    1
    -
         Adverse Event (Worsening of Disease)
    1
    -
    -
         Consent withdrawn by subject
    3
    -
    -
         Lost to follow-up
    -
    2
    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: The number of subjects starting the period 1 (Part A) have switched their treatments in period 2 (Part B)
    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
    All participants received 2 sets of injections to maintain the blind (the placebo arm received placebo for risankizumab and placebo for ustekinumab) the risankizumab arm received risankizumab and placebo for ustekinumab and the ustekinumab arm received ustekinumab and placebo for risankizumab

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo/Risankizumab (Part B)
    Arm description
    Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
    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 randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

    Arm title
    Ustekinumab/Ustekinumab (Part B)
    Arm description
    Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
    Arm type
    Active comparator

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg(based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

    Arm title
    Risankizumab/Risankizumab (Part B)
    Arm description
    Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
    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 randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

    Number of subjects in period 2 [2]
    Placebo/Risankizumab (Part B) Ustekinumab/Ustekinumab (Part B) Risankizumab/Risankizumab (Part B)
    Started
    94
    94
    291
    Completed
    91
    90
    278
    Not completed
    3
    4
    13
         Adverse Event (Other)
    1
    1
    1
         Not specified
    1
    -
    1
         Consent withdrawn by subject
    -
    2
    4
         Lost to follow-up
    1
    1
    7
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: The number of subjects starting the period 1 (Part A) have switched their treatments in period 2 (Part B)

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo (Part A)
    Reporting group description
    Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

    Reporting group title
    Ustekinumab (Part A)
    Reporting group description
    Participants randomized to receive double-blind (DB) ustekinumab 45 or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). They received 2 sets of injections to maintain the blind ( ustekinumab and placebo for risankizumab)

    Reporting group title
    Risankizumab (Part A)
    Reporting group description
    Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). They received 2 sets of injections to maintain the blind (risankizumab and placebo for ustekinumab)

    Reporting group values
    Placebo (Part A) Ustekinumab (Part A) Risankizumab (Part A) Total
    Number of subjects
    98 99 294 491
    Age categorical
    Units: Subjects
    Age Continuous
    Intent-to-treat (ITT) population: all randomized participants
    Units: years
        arithmetic mean (standard deviation)
    46.3 ± 13.26 48.6 ± 14.81 46.2 ± 13.68 -
    Sex: Female, Male
    Intent-to-treat (ITT) population: all randomized participants
    Units: Subjects
        Female
    31 33 91 155
        Male
    67 66 203 336
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    19 12 44 75
        Not Hispanic or Latino
    79 87 250 416
        Unknown or Not Reported
    0 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    1 0 2 3
        Asian
    7 4 25 36
        Native Hawaiian or Other Pacific Islander
    1 1 0 2
        Black or African American
    2 2 10 14
        White
    87 91 255 433
        More than one race
    0 1 2 3
        Unknown or Not Reported
    0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Placebo (Part A)
    Reporting group description
    Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

    Reporting group title
    Ustekinumab (Part A)
    Reporting group description
    Participants randomized to receive double-blind (DB) ustekinumab 45 or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). They received 2 sets of injections to maintain the blind ( ustekinumab and placebo for risankizumab)

    Reporting group title
    Risankizumab (Part A)
    Reporting group description
    Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). They received 2 sets of injections to maintain the blind (risankizumab and placebo for ustekinumab)
    Reporting group title
    Placebo/Risankizumab (Part B)
    Reporting group description
    Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

    Reporting group title
    Ustekinumab/Ustekinumab (Part B)
    Reporting group description
    Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

    Reporting group title
    Risankizumab/Risankizumab (Part B)
    Reporting group description
    Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

    Subject analysis set title
    Placebo/Risankizumab (Part B)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

    Subject analysis set title
    Ustekinumab/Ustekinumab (Part B)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

    Subject analysis set title
    Risankizumab/Risankizumab (Part B)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

    Primary: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in participants who received risankizumab compared with placebo (Part A)

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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 in participants who received risankizumab compared with placebo (Part A) [1]
    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. Non-responder imputation (NRI) was used for missing data. Intent-to-treat (ITT) population: all randomized participants.
    End point type
    Primary
    End point timeframe
    Week 16
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    Placebo (Part A) Risankizumab (Part A)
    Number of subjects analysed
    98 [2]
    294 [3]
    Units: percentage of participants
        number (not applicable)
    2.0
    74.8
    Notes
    [2] - ITT
    [3] - ITT
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    Comparison groups
    Placebo (Part A) v Risankizumab (Part A)
    Number of subjects included in analysis
    392
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [4]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    72.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    66.8
         upper limit
    78.2
    Notes
    [4] - Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

    Primary: Percentage of participants achieving a static Physician Global Assessment (sPGA) score of clear or almost clear at Week 16 in participants who received Risankizumab compared with Placebo (Part A)

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    End point title
    Percentage of participants achieving a static Physician Global Assessment (sPGA) score of clear or almost clear at Week 16 in participants who received Risankizumab compared with Placebo (Part A) [5]
    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
    Primary
    End point timeframe
    Week 16
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    Placebo (Part A) Risankizumab (Part A)
    Number of subjects analysed
    98 [6]
    294 [7]
    Units: percentage of participants
        number (not applicable)
    5.1
    83.7
    Notes
    [6] - ITT
    [7] - ITT
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CI for adjusted difference of 2 treatment groups, calculated by the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    Comparison groups
    Placebo (Part A) v Risankizumab (Part A)
    Number of subjects included in analysis
    392
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [8]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    78.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    72.4
         upper limit
    84.5
    Notes
    [8] - Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

    Secondary: Percentage of participants achieving sPGA score of clear at Week 16 in participants who received Risankizumab compared with Placebo (Part A)

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    End point title
    Percentage of participants achieving sPGA score of clear at Week 16 in participants who received Risankizumab compared with Placebo (Part A) [9]
    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 16
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    Placebo (Part A) Risankizumab (Part A)
    Number of subjects analysed
    98 [10]
    294 [11]
    Units: percentage of participants
        number (not applicable)
    3.1
    51.0
    Notes
    [10] - ITT
    [11] - ITT
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    Comparison groups
    Placebo (Part A) v Risankizumab (Part A)
    Number of subjects included in analysis
    392
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [12]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    47.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    40.9
         upper limit
    54.2
    Notes
    [12] - Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

    Secondary: Percentage of Participants Achieving PASI100 at Week 16 in participants who received Risankizumab compared with Placebo (Part A)

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    End point title
    Percentage of Participants Achieving PASI100 at Week 16 in participants who received Risankizumab compared with Placebo (Part A) [13]
    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
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    Placebo (Part A) Risankizumab (Part A)
    Number of subjects analysed
    98 [14]
    294 [15]
    Units: percentage of participants
        number (not applicable)
    2.0
    50.7
    Notes
    [14] - ITT
    [15] - ITT
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    Comparison groups
    Placebo (Part A) v Risankizumab (Part A)
    Number of subjects included in analysis
    392
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [16]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    48.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    41.9
         upper limit
    54.6
    Notes
    [16] - Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

    Secondary: Percentage of participants achieving a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16 in participants who received Risankizumab compared with Placebo (Part A)

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    End point title
    Percentage of participants achieving a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16 in participants who received Risankizumab compared with Placebo (Part A) [17]
    End point description
    DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30, where 0-1 = no effect on patient’s life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient’s life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 16
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    Placebo (Part A) Risankizumab (Part A)
    Number of subjects analysed
    98 [18]
    294 [19]
    Units: percentage of participants
        number (not applicable)
    4.1
    66.7
    Notes
    [18] - ITT
    [19] - ITT
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    Comparison groups
    Placebo (Part A) v Risankizumab (Part A)
    Number of subjects included in analysis
    392
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [20]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    62.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    55.5
         upper limit
    68.9
    Notes
    [20] - Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

    Secondary: Percentage of Participants Achieving a Psoriasis Symptom Scale (PSS) Score of 0 at Week 16 in participants who received Risankizumab compared with Placebo (Part A)

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    End point title
    Percentage of Participants Achieving a Psoriasis Symptom Scale (PSS) Score of 0 at Week 16 in participants who received Risankizumab compared with Placebo (Part A) [21]
    End point description
    The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert –type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 16
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    Placebo (Part A) Risankizumab (Part A)
    Number of subjects analysed
    98 [22]
    294 [23]
    Units: percentage of participants
        number (not applicable)
    0
    31.3
    Notes
    [22] - ITT
    [23] - ITT
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    Comparison groups
    Placebo (Part A) v Risankizumab (Part A)
    Number of subjects included in analysis
    392
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [24]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    31.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    25.7
         upper limit
    36.6
    Notes
    [24] - Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

    Secondary: Percentage of participants achieving PASI90 at Week 16 in participants who received Risankizumab compared with Ustekinumab (Part A)

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    End point title
    Percentage of participants achieving PASI90 at Week 16 in participants who received Risankizumab compared with Ustekinumab (Part A) [25]
    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.
    End point type
    Secondary
    End point timeframe
    Week 16
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    Ustekinumab (Part A) Risankizumab (Part A)
    Number of subjects analysed
    99 [26]
    294 [27]
    Units: percentage of participants
        number (not applicable)
    47.5
    74.8
    Notes
    [26] - ITT
    [27] - ITT
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    Comparison groups
    Ustekinumab (Part A) v Risankizumab (Part A)
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [28]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    27.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    16.7
         upper limit
    38.5
    Notes
    [28] - Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

    Secondary: Percentage of participants achieving sPGA score of clear or almost clear at Week 16 in participants who received Risankizumab compared with Ustekinumab (Part A)

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    End point title
    Percentage of participants achieving sPGA score of clear or almost clear at Week 16 in participants who received Risankizumab compared with Ustekinumab (Part A) [29]
    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 16
    Notes
    [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    Ustekinumab (Part A) Risankizumab (Part A)
    Number of subjects analysed
    99 [30]
    294 [31]
    Units: percentage of participants
        number (not applicable)
    61.6
    83.7
    Notes
    [30] - ITT
    [31] - ITT
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    Comparison groups
    Ustekinumab (Part A) v Risankizumab (Part A)
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [32]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    22.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    12
         upper limit
    32.5
    Notes
    [32] - Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

    Secondary: Percentage of participants achieving PASI100 at Week 16 in participants who received Risankizumab compared with Ustekinumab (Part A)

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    End point title
    Percentage of participants achieving PASI100 at Week 16 in participants who received Risankizumab compared with Ustekinumab (Part A) [33]
    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. PASI00 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
    Notes
    [33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    Ustekinumab (Part A) Risankizumab (Part A)
    Number of subjects analysed
    99 [34]
    294 [35]
    Units: percentage of participants
        number (not applicable)
    24.2
    50.7
    Notes
    [34] - ITT
    [35] - ITT
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    Comparison groups
    Ustekinumab (Part A) v Risankizumab (Part A)
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [36]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    17
         upper limit
    37
    Notes
    [36] - Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

    Secondary: Percentage of participants achieving sPGA score of clear at Week 16 in participants who received Risankizumab compared with Ustekinumab (Part A)

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    End point title
    Percentage of participants achieving sPGA score of clear at Week 16 in participants who received Risankizumab compared with Ustekinumab (Part A) [37]
    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 16
    Notes
    [37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    Ustekinumab (Part A) Risankizumab (Part A)
    Number of subjects analysed
    99 [38]
    294 [39]
    Units: percentage of participants
        number (not applicable)
    25.3
    51.0
    Notes
    [38] - ITT
    [39] - ITT
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    Comparison groups
    Ustekinumab (Part A) v Risankizumab (Part A)
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [40]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    26.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    16.1
         upper limit
    36.4
    Notes
    [40] - Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

    Secondary: Percentage of participants Achieving PASI90 at Week 52 in participants who received Risankizumab compared with Ustekinumab (Part B)

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    End point title
    Percentage of participants Achieving PASI90 at Week 52 in participants who received Risankizumab compared with Ustekinumab (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.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    Ustekinumab/Ustekinumab (Part B) Risankizumab/Risankizumab (Part B)
    Number of subjects analysed
    99 [41]
    294 [42]
    Units: percentage of participants
        number (not applicable)
    50.5
    80.6
    Notes
    [41] - ITT
    [42] - ITT
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    Comparison groups
    Ustekinumab/Ustekinumab (Part B) v Risankizumab/Risankizumab (Part B)
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [43]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    30.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    19.6
         upper limit
    40.9
    Notes
    [43] - Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

    Secondary: Percentage of participants achieving PASI100 at Week 52 in participants who received Risankizumab compared with Ustekinumab (Part B)

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    End point title
    Percentage of participants achieving PASI100 at Week 52 in participants who received Risankizumab compared with Ustekinumab (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. PASI00 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 52
    End point values
    Ustekinumab/Ustekinumab (Part B) Risankizumab/Risankizumab (Part B)
    Number of subjects analysed
    99 [44]
    294 [45]
    Units: percentage of participants
        number (not applicable)
    30.3
    59.5
    Notes
    [44] - ITT
    [45] - ITT
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    Comparison groups
    Ustekinumab/Ustekinumab (Part B) v Risankizumab/Risankizumab (Part B)
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [46]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    29.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.9
         upper limit
    40.1
    Notes
    [46] - Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

    Secondary: Percentage of participants achieving sPGA score of clear at Week 52 in participants who received Risankizumab compared with Ustekinumab (Part B)

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    End point title
    Percentage of participants achieving sPGA score of clear at Week 52 in participants who received Risankizumab compared with Ustekinumab (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 52
    End point values
    Ustekinumab/Ustekinumab (Part B) Risankizumab/Risankizumab (Part B)
    Number of subjects analysed
    99 [47]
    294 [48]
    Units: percentage of participants
        number (not applicable)
    30.3
    59.5
    Notes
    [47] - ITT
    [48] - ITT
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    Comparison groups
    Ustekinumab/Ustekinumab (Part B) v Risankizumab/Risankizumab (Part B)
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [49]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    29.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.9
         upper limit
    40.1
    Notes
    [49] - Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

    Secondary: Percentage of Participants Achieving PASI75 at Week 12 in participants who received Risankizumab compared with Ustekinumab (Part A)

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    End point title
    Percentage of Participants Achieving PASI75 at Week 12 in participants who received Risankizumab compared with Ustekinumab (Part A) [50]
    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 12
    Notes
    [50] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    Ustekinumab (Part A) Risankizumab (Part A)
    Number of subjects analysed
    99 [51]
    294 [52]
    Units: percentage of participants
        number (not applicable)
    69.7
    88.8
    Notes
    [51] - ITT
    [52] - ITT
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    Comparison groups
    Ustekinumab (Part A) v Risankizumab (Part A)
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [53]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    19.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    9.5
         upper limit
    28.8
    Notes
    [53] - Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

    Secondary: Percentage of participants achieving sPGA score of clear or almost clear at Week 12 in participants who received Risankizumab compared with Ustekinumab (Part A)

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    End point title
    Percentage of participants achieving sPGA score of clear or almost clear at Week 12 in participants who received Risankizumab compared with Ustekinumab (Part A) [54]
    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 12
    Notes
    [54] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    Ustekinumab (Part A) Risankizumab (Part A)
    Number of subjects analysed
    99 [55]
    294 [56]
    Units: percentage of participants
        number (not applicable)
    64.6
    82.3
    Notes
    [55] - ITT
    [56] - ITT
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    Comparison groups
    Ustekinumab (Part A) v Risankizumab (Part A)
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [57]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    18
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    7.8
         upper limit
    28.3
    Notes
    [57] - Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

    Secondary: Percentage of participants achieving a DLQI score of 0 or 1 at Week 16 in participants who received Risankizumab compared with Ustekinumab (Part A)

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    End point title
    Percentage of participants achieving a DLQI score of 0 or 1 at Week 16 in participants who received Risankizumab compared with Ustekinumab (Part A) [58]
    End point description
    DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30, where 0-1 = no effect on patient’s life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient’s life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 16
    Notes
    [58] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    Ustekinumab (Part A) Risankizumab (Part A)
    Number of subjects analysed
    99 [59]
    294 [60]
    Units: percentage of participants
        number (not applicable)
    46.5
    66.7
    Notes
    [59] - ITT
    [60] - ITT
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    Comparison groups
    Ustekinumab (Part A) v Risankizumab (Part A)
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [61]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    20.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    9.1
         upper limit
    31.4
    Notes
    [61] - Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

    Secondary: Change from baseline in PSS total score at week 16 in participants who received Risankizumab compared with Placebo (Part A)

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    End point title
    Change from baseline in PSS total score at week 16 in participants who received Risankizumab compared with Placebo (Part A) [62]
    End point description
    The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert –type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. Last observation carried forward (LOCF) imputation was used for missing data. A negative change in PSS total score indicates improvement.
    End point type
    Secondary
    End point timeframe
    Week 16
    Notes
    [62] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    Placebo (Part A) Risankizumab (Part A)
    Number of subjects analysed
    85 [63]
    227 [64]
    Units: units on a scale
        least squares mean (standard error)
    -0.027 ± 0.3316
    -6.402 ± 0.2193
    Notes
    [63] - ITT
    [64] - ITT
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    P-value calculated by the van Elteren test stratified for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).
    Comparison groups
    Placebo (Part A) v Risankizumab (Part A)
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    van Elteren test
    Parameter type
    Mean difference (final values)
    Point estimate
    -6.375
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.102
         upper limit
    -5.648

    Secondary: Percentage of participants Achieving PASI75 at Week 16 in participants who received Risankizumab compared with Placebo (Part A)

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    End point title
    Percentage of participants Achieving PASI75 at Week 16 in participants who received Risankizumab compared with Placebo (Part A) [65]
    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
    Notes
    [65] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.
    End point values
    Placebo (Part A) Risankizumab (Part A)
    Number of subjects analysed
    98 [66]
    294 [67]
    Units: percentage of participants
        number (not applicable)
    6.1
    90.8
    Notes
    [66] - ITT
    [67] - ITT
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    Comparison groups
    Placebo (Part A) v Risankizumab (Part A)
    Number of subjects included in analysis
    392
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [68]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    84.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    79
         upper limit
    90.4
    Notes
    [68] - Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

    Secondary: Percentage of participants achieving sPGA score of clear or almost clear at Week 52 in participants who received Risankizumab compared with Ustekinumab (Part B)

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    End point title
    Percentage of participants achieving sPGA score of clear or almost clear at Week 52 in participants who received Risankizumab compared with Ustekinumab (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 52
    End point values
    Ustekinumab/Ustekinumab (Part B) Risankizumab/Risankizumab (Part B)
    Number of subjects analysed
    99 [69]
    294 [70]
    Units: percentage of participants
        number (not applicable)
    54.5
    83.3
    Notes
    [69] - ITT
    [70] - ITT
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    Comparison groups
    Ustekinumab/Ustekinumab (Part B) v Risankizumab/Risankizumab (Part B)
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001 [71]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    29.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.5
         upper limit
    39.6
    Notes
    [71] - Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

    Secondary: Percentage of participants Achieving PASI75 at Week 52 in participants who received Risankizumab compared with Ustekinumab (Part B)

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    End point title
    Percentage of participants Achieving PASI75 at Week 52 in participants who received Risankizumab compared with Ustekinumab (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. 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 52
    End point values
    Ustekinumab/Ustekinumab (Part B) Risankizumab/Risankizumab (Part B)
    Number of subjects analysed
    99 [72]
    294 [73]
    Units: percentage of participants
        number (not applicable)
    76.8
    91.5
    Notes
    [72] - ITT
    [73] - ITT
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.
    Comparison groups
    Ustekinumab/Ustekinumab (Part B) v Risankizumab/Risankizumab (Part B)
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.001 [74]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Adjusted percentage difference
    Point estimate
    14.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    5.9
         upper limit
    23.5
    Notes
    [74] - Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

    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 55 weeks).
    Adverse event reporting additional description
    TEAEs and TESAEs in Part A: Events from first dose of study drug in Part A until prior to first dose in Part B (Week 16) or up to 105 days after last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B: Events from first dose of study drug in Part B (Week 16) until up to 105 days 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
    Placebo (Part A)
    Reporting group description
    Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

    Reporting group title
    Ustekinumab (Part A)
    Reporting group description
    Participants randomized to receive double-blind (DB) ustekinumab 45 or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

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

    Reporting group title
    Placebo/Risankizumab (Part B)
    Reporting group description
    Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

    Reporting group title
    Ustekinumab/Ustekinumab (Part B)
    Reporting group description
    Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

    Reporting group title
    Risankizumab/Risankizumab (Part B)
    Reporting group description
    Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

    Serious adverse events
    Placebo (Part A) Ustekinumab (Part A) Risankizumab (Part A) Placebo/Risankizumab (Part B) Ustekinumab/Ustekinumab (Part B) Risankizumab/Risankizumab (Part B)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 98 (1.02%)
    3 / 99 (3.03%)
    6 / 294 (2.04%)
    3 / 94 (3.19%)
    4 / 94 (4.26%)
    13 / 291 (4.47%)
         number of deaths (all causes)
    0
    0
    1
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 99 (1.01%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 291 (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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    1 / 294 (0.34%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    1 / 94 (1.06%)
    0 / 94 (0.00%)
    0 / 291 (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
    Prostate cancer
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    1 / 94 (1.06%)
    0 / 291 (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
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    1 / 94 (1.06%)
    0 / 291 (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
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 291 (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
    Reproductive system and breast disorders
    Menometrorrhagia
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 291 (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 / 98 (0.00%)
    1 / 99 (1.01%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 291 (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
    Fibula fracture
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 99 (1.01%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 291 (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
    Meniscus injury
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 291 (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
    Tibia fracture
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 99 (1.01%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 291 (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
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 291 (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
    Atrial flutter
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    1 / 94 (1.06%)
    0 / 94 (0.00%)
    0 / 291 (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
    Cardiac aneurysm
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 291 (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
    Cardiac failure congestive
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    1 / 294 (0.34%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac ventricular thrombosis
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 291 (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
    Coronary artery disease
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    1 / 294 (0.34%)
    1 / 94 (1.06%)
    0 / 94 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 291 (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
    Seizure
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 291 (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 / 1
    Transient ischaemic attack
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 291 (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
    Eye disorders
    Glaucoma
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    1 / 94 (1.06%)
    0 / 291 (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
    Retinal detachment
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 291 (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
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    1 / 94 (1.06%)
    0 / 291 (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
    Enterovesical fistula
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    1 / 294 (0.34%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 291 (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
    Gastric dilatation
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    1 / 294 (0.34%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 291 (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
    Hiatus hernia
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Renal colic
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 291 (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 and connective tissue disorders
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 291 (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
    Muscular weakness
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    1 / 94 (1.06%)
    0 / 94 (0.00%)
    0 / 291 (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
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    1 / 291 (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
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    1 / 294 (0.34%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 291 (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
    Diverticulitis
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    1 / 294 (0.34%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 291 (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
    Herpes zoster
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 99 (1.01%)
    1 / 294 (0.34%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 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
    Osteomyelitis
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    1 / 294 (0.34%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 291 (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
    Pneumonia
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    0 / 294 (0.00%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 99 (0.00%)
    1 / 294 (0.34%)
    0 / 94 (0.00%)
    0 / 94 (0.00%)
    0 / 291 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo (Part A) Ustekinumab (Part A) Risankizumab (Part A) Placebo/Risankizumab (Part B) Ustekinumab/Ustekinumab (Part B) Risankizumab/Risankizumab (Part B)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 98 (8.16%)
    14 / 99 (14.14%)
    29 / 294 (9.86%)
    26 / 94 (27.66%)
    27 / 94 (28.72%)
    67 / 291 (23.02%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 98 (3.06%)
    5 / 99 (5.05%)
    3 / 294 (1.02%)
    3 / 94 (3.19%)
    2 / 94 (2.13%)
    6 / 291 (2.06%)
         occurrences all number
    3
    6
    3
    3
    2
    6
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 99 (0.00%)
    6 / 294 (2.04%)
    5 / 94 (5.32%)
    2 / 94 (2.13%)
    4 / 291 (1.37%)
         occurrences all number
    1
    0
    6
    7
    2
    5
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 98 (2.04%)
    4 / 99 (4.04%)
    11 / 294 (3.74%)
    8 / 94 (8.51%)
    9 / 94 (9.57%)
    24 / 291 (8.25%)
         occurrences all number
    2
    4
    11
    8
    13
    28
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 98 (2.04%)
    5 / 99 (5.05%)
    10 / 294 (3.40%)
    14 / 94 (14.89%)
    17 / 94 (18.09%)
    34 / 291 (11.68%)
         occurrences all number
    2
    5
    10
    16
    22
    40

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 May 2016
    Substantive changes from the original protocol to Amendment 1 were to require an additional anti-drug antibody (ADA) sample at Week 4, to clarify the definition of analysis sets in the Statistical Methods upon a request from Health Authorities, and to add a definition for "time to onset of endpoint."
    12 Oct 2016
    Substantive changes from Amendment 1 to Amendment 2 were to transition the United States (US) Investigational New Drug application for risankizumab from BI to AbbVie, to change the sponsor for Study M15-995 within the US to AbbVie, and to change the Sponsor information and the ownership of various study responsibilities (e.g., statistical analysis).

    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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