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    Clinical Trial Results:
    A Multicenter, Randomized, Open Label, Efficacy Assessor-Blinded Study of Risankizumab Compared to Secukinumab for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy

    Summary
    EudraCT number
    		 2017-004932-12
    Trial protocol
    		 DE   GB   NL   ES   FR   IT  
    Global end of trial date
    07 Jul 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jul 2021
    First version publication date
    07 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M16-766
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03478787
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4UB
    Public contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Jul 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.
    Protection of trial subjects
    Subject and/or legal guardian read and understood the information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 May 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 45
    Country: Number of subjects enrolled
    France: 34
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Poland: 30
    Country: Number of subjects enrolled
    Spain: 32
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    United States: 171
    Worldwide total number of subjects
    327
    EEA total number of subjects
    102
    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)
    290
    From 65 to 84 years
    35
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 327 participants were randomized from 53 sites across 9 countries including Canada, France, Germany, Italy, The Netherlands, Poland, Spain, the United Kingdom, and the United States.

    Pre-assignment
    Screening details
    		 Eligible participants were randomized to receive risankizumab or secukinumab in a 1:1 ratio. The randomization was stratified by weight (≤ 100 kg vs. > 100 kg) and prior systemic biologic for psoriasis (0 vs. ≥ 1).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This is an open-label study; however, the efficacy assessor remained blinded to each subject's treatment, clinical laboratory results, and all subject safety data during the course of the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Secukinumab
    Arm description
    		 Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    Other name
    Cosentyx
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Study site staff administered comparator subcutaneously (secukinumab 300 mg [2 × 150 mg pre-filled syringe]).

    Arm title
    		 Risankizumab
    Arm description
    		 Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Risankizumab
    Investigational medicinal product code
    ABBV-066
    Other name
    BI 655066, SKYRIZI
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Study site staff will administer study drug subcutaneously (risankizumab 150 mg [2 × 75 mg pre-filled syringe]).

    Number of subjects in period 1
    		Secukinumab Risankizumab
    Started
    163
    164
    Completed
    134
    151
    Not completed
    29
    13
         Consent withdrawn by subject
    2
    6
         Other, not specified
    3
    -
         Adverse event
    5
    1
         Lost to follow-up
    9
    5
         Protocol deviation
    3
    -
         Lack of efficacy
    7
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Secukinumab
    Reporting group description
    		 Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.

    Reporting group title
    Risankizumab
    Reporting group description
    		 Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).

    Reporting group values
    		 Secukinumab Risankizumab Total
    Number of subjects
    		 163 164 327
    Age categorical
    Units: Subjects
        < 40 years
    		 60 50 110
        40 to < 65 years
    		 81 99 180
        >/= 65 years
    		 22 15 37
    Gender categorical
    Units: Subjects
        Female
    		 62 52 114
        Male
    		 101 112 213
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 34 37 71
        Not Hispanic or Latino
    		 129 127 256
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 1
        Asian
    		 11 6 17
        Native Hawaiian or Other Pacific Islander
    		 2 0 2
        Black or African American
    		 6 6 12
        White
    		 144 151 295

    End points

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    End points reporting groups
    Reporting group title
    Secukinumab
    Reporting group description
    		 Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48.

    Reporting group title
    Risankizumab
    Reporting group description
    		 Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France).

    Primary: Percentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16

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    End point title
    		 Percentage of Participants With a 90% Reduction From Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16
    End point description
    The Psoriasis Area and Severity Index (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 PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 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) analysis set: all participants who were randomized at Baseline. Non-responder imputation (NRI) was used for missing data.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Secukinumab Risankizumab
    Number of subjects analysed
    163
    164
    Units: percentage of participants
        number (not applicable)
    65.6
    73.8
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Across the strata, 96.25% confidence interval (CI) for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.
    Comparison groups
    Secukinumab v Risankizumab
    Number of subjects included in analysis
    327
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Adjusted percentage difference
    Point estimate
    8.2
    Confidence interval
         level
    		 96.25%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 18.6
    Notes
    [1] - Non-inferiority is met if the lower bound of the 96.25% CI of adjusted treatment difference is above –12%.

    Primary: Percentage of Participants With a PASI 90 at Week 52

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    End point title
    		 Percentage of Participants With a PASI 90 at Week 52
    End point description
    The 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 PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 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. ITT analysis set: all participants who were randomized at Baseline. NRI was used for missing data.
    End point type
    Primary
    End point timeframe
    Week 52
    End point values
    		 Secukinumab Risankizumab
    Number of subjects analysed
    163
    164
    Units: percentage of participants
        number (not applicable)
    57.1
    86.6
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.
    Comparison groups
    Secukinumab v Risankizumab
    Number of subjects included in analysis
    327
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Adjusted percentage difference
    Point estimate
    29.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.8
         upper limit
    		 38.8
    Notes
    [2] - Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.

    Secondary: Percentage of Participants With a 100% Reduction From Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52

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    End point title
    		 Percentage of Participants With a 100% Reduction From Baseline Psoriasis Area and Severity Index (PASI 100) at Week 52
    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 PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as 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. ITT analysis set: all participants who were randomized at Baseline. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Secukinumab Risankizumab
    Number of subjects analysed
    163
    164
    Units: percentage of participants
        number (not applicable)
    39.9
    65.9
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.
    Comparison groups
    Secukinumab v Risankizumab
    Number of subjects included in analysis
    327
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Adjusted percentage difference
    Point estimate
    26.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 15.9
         upper limit
    		 36.5
    Notes
    [3] - Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.

    Secondary: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 52

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    End point title
    		 Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 52
    End point description
    The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions 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. ITT analysis set: all participants who were randomized at Baseline. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Secukinumab Risankizumab
    Number of subjects analysed
    163
    164
    Units: percentage of participants
        number (not applicable)
    58.3
    87.8
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.
    Comparison groups
    Secukinumab v Risankizumab
    Number of subjects included in analysis
    327
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Adjusted percentage difference
    Point estimate
    29.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.9
         upper limit
    		 38.8
    Notes
    [4] - Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.

    Secondary: Percentage of Participants With a 75% Reduction From Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52

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    End point title
    		 Percentage of Participants With a 75% Reduction From Baseline Psoriasis Area and Severity Index (PASI 75) at Week 52
    End point description
    The 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 PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 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. ITT analysis set: all participants who were randomized at Baseline. NRI was used for missing data.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Secukinumab Risankizumab
    Number of subjects analysed
    163
    164
    Units: percentage of participants
        number (not applicable)
    69.9
    89.6
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.
    Comparison groups
    Risankizumab v Secukinumab
    Number of subjects included in analysis
    327
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [5]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Adjusted percentage difference
    Point estimate
    20
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.7
         upper limit
    		 28.3
    Notes
    [5] - Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events are reported from first dose of study drug through 20 weeks after last dose of study drug (up to Week 68 for the Secukinumab arm, and up to Week 84 for the Risankizumab arm).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Secukinumab
    Reporting group description
    		 Participants randomized to secukinumab received 2 injections of active secukinumab (300 mg total dosage) subcutaneously (SC) at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks (q4w) thereafter until the last dose at Week 48 and received at least one dose of study drug.

    Reporting group title
    Risankizumab
    Reporting group description
    		 Participants randomized to risankizumab received 2 injections of active risankizumab (150 mg total dosage) SC at Weeks 0 and 4, and then every 12 weeks (q12w) thereafter until the last dose at Week 40 (Week 64 for participants in France) and received at least one dose of study drug.

    Serious adverse events
    		 Secukinumab Risankizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 163 (3.68%)
    9 / 164 (5.49%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    HISTIOCYTIC NECROTISING LYMPHADENITIS
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    ARTERIOSCLEROSIS
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 164 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    OVARIAN CYST
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ACUTE RESPIRATORY FAILURE
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 164 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    MENTAL STATUS CHANGES
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUICIDAL IDEATION
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUICIDE ATTEMPT
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    OVERDOSE
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 164 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    ACUTE MYOCARDIAL INFARCTION
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARRHYTHMIA SUPRAVENTRICULAR
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYOCARDIAL INFARCTION
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    TOXIC ENCEPHALOPATHY
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 164 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    COLITIS ULCERATIVE
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 164 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIVERTICULUM INTESTINAL HAEMORRHAGIC
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 164 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SMALL INTESTINAL OBSTRUCTION
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 164 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLELITHIASIS
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 164 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    RASH PRURITIC
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 164 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    NEPHROLITHIASIS
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    BASEDOW'S DISEASE
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 163 (0.00%)
    2 / 164 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Secukinumab Risankizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    71 / 163 (43.56%)
    66 / 164 (40.24%)
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    5 / 163 (3.07%)
    9 / 164 (5.49%)
         occurrences all number
    5
    10
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    15 / 163 (9.20%)
    9 / 164 (5.49%)
         occurrences all number
    27
    20
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    9 / 163 (5.52%)
    9 / 164 (5.49%)
         occurrences all number
    12
    11
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    10 / 163 (6.13%)
    9 / 164 (5.49%)
         occurrences all number
    13
    12
    Infections and infestations
    BRONCHITIS
         subjects affected / exposed
    11 / 163 (6.75%)
    3 / 164 (1.83%)
         occurrences all number
    11
    3
    NASOPHARYNGITIS
         subjects affected / exposed
    27 / 163 (16.56%)
    35 / 164 (21.34%)
         occurrences all number
    38
    48
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    14 / 163 (8.59%)
    21 / 164 (12.80%)
         occurrences all number
    20
    25

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Aug 2019
    Of the 327 subjects in the global study, 16 subjects in France who were randomized to risankizumab had 2 additional dosing visits at Week 52 and Week 64 under Amendment 1.

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

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

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