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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab

    Summary
    EudraCT number
    		 2014-000721-20
    Trial protocol
    		 GB   ES  
    Global end of trial date
    24 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 May 2017
    First version publication date
    27 May 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO1959PSO3003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02203032
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 Route, 202 Raritan, New Jersey , United States, 08869
    Public contact
    Clinical Registry group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.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
    24 May 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objectives of this study were to compare the efficacy of the following 2 treatment groups in subjects who had an inadequate (Investigator's Global Assessment [IGA] >= 2) response to ustekinumab at Week 16: 1) switching to guselkumab treatment, or 2) remaining on ustekinumab treatment, and to assess the safety and tolerability of guselkumab in subjects with moderate to severe plaque-type psoriasis and an inadequate (IGA>=2) response to ustekinumab at Week 16.
    Protection of trial subjects
    The safety and tolerability of guselkumab and ustekinumab were monitored by collecting information on adverse events (AEs), including injection-site reactions (ISRs), allergic reactions, clinical laboratory tests, physical examinations, vital signs, concomitant medication review, and early detection of active tuberculosis (TB). An independent data monitoring committee was commissioned for this study to review unblinded data at regularly scheduled intervals.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Oct 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 19
    Country: Number of subjects enrolled
    Canada: 61
    Country: Number of subjects enrolled
    Germany: 96
    Country: Number of subjects enrolled
    Spain: 24
    Country: Number of subjects enrolled
    United Kingdom: 11
    Country: Number of subjects enrolled
    Korea, Republic of: 29
    Country: Number of subjects enrolled
    Poland: 294
    Country: Number of subjects enrolled
    Russian Federation: 88
    Country: Number of subjects enrolled
    Taiwan: 55
    Country: Number of subjects enrolled
    United States: 194
    Worldwide total number of subjects
    871
    EEA total number of subjects
    425
    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)
    818
    From 65 to 84 years
    53
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 1105 subjects were screened for this study. Among them 871 subjects were enrolled and received study treatment. The target population was adult men or women with a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug.

    Period 1
    Period 1 title
    Week 0 - Week 16 (Open Label Run-in)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Ustekinumab
    Arm description
    		 Subject received ustekinumab 45 milligram (mg) (subjects weighing less than or equal to [<=]100 kilogram [kg]) or 90 mg (subjects weighing >100 kg) at Week 0 and 4.
    Arm type
    		 Other

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Enrolled subjects received ustekinumab 45 mg or 90 mg at Weeks 0 and 4 [according to their weight at baseline (Week 0)].

    Number of subjects in period 1
    		Ustekinumab
    Started
    871
    Completed
    853
    Not completed
    18
         Consent withdrawn by subject
    6
         Adverse event, non-fatal
    1
         Other
    2
         Adverse event, serious non-fatal
    1
         Lost to follow-up
    3
         Lack of efficacy
    1
         Protocol deviation
    4
    Period 2
    Period 2 title
    Blinded Phase (Week 16 - Week 44)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Guselkumab (Randomized)
    Arm description
    		 Subjects with an IGA>=2 at Week 16 were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received guselkumab 100 mg at Weeks 16, 20, 28, 36 and 44

    Investigational medicinal product name
    Placebo for Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects randomized to guselkumab received placebo for ustekinumab at Weeks 16, 28, and 40.

    Arm title
    		 Ustekinumab (Randomized)
    Arm description
    		 Subjects with an IGA>=2 at Week 16 were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects randomized to ustekinumab continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40.

    Investigational medicinal product name
    Placebo for Guselkumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects randomized to ustekinumab received placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.

    Arm title
    		 Ustekinumab (Non randomized Open Label (OL) Continuation)
    Arm description
    		 Subjects with an IGA=0 or 1 at Week 16 received ustekinumab 45 mg or 90 mg (according to their baseline weight [Week 0]) at Weeks 16, 28, and 40.
    Arm type
    		 other

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received ustekinumab (according to their baseline weight [Week 0]) at Weeks 16, 28, and 40.

    Number of subjects in period 2
    		Guselkumab (Randomized) Ustekinumab (Randomized) Ustekinumab (Non randomized Open Label (OL) Continuation)
    Started
    135
    133
    585
    Completed
    126
    113
    568
    Not completed
    9
    20
    17
         Adverse event, serious fatal
    -
    -
    1
         Consent withdrawn by subject
    2
    5
    5
         Adverse event, non-fatal
    1
    2
    3
         Other
    1
    2
    3
         Adverse event, serious non-fatal
    2
    -
    3
         Lost to follow-up
    -
    1
    1
         Lack of efficacy
    3
    10
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ustekinumab
    Reporting group description
    		 Subject received ustekinumab 45 milligram (mg) (subjects weighing less than or equal to [<=]100 kilogram [kg]) or 90 mg (subjects weighing >100 kg) at Week 0 and 4.

    Reporting group values
    		 Ustekinumab Total
    Number of subjects
    		 871 871
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 818 818
        From 65 to 84 years
    		 53 53
        85 years and over
    		 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.1 ( 13.21 ) -
    Title for Gender
    Units: subjects
        Female
    		 305 305
        Male
    		 566 566

    End points

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    End points reporting groups
    Reporting group title
    Ustekinumab
    Reporting group description
    		 Subject received ustekinumab 45 milligram (mg) (subjects weighing less than or equal to [<=]100 kilogram [kg]) or 90 mg (subjects weighing >100 kg) at Week 0 and 4.
    Reporting group title
    Guselkumab (Randomized)
    Reporting group description
    		 Subjects with an IGA>=2 at Week 16 were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.

    Reporting group title
    Ustekinumab (Randomized)
    Reporting group description
    		 Subjects with an IGA>=2 at Week 16 were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.

    Reporting group title
    Ustekinumab (Non randomized Open Label (OL) Continuation)
    Reporting group description
    		 Subjects with an IGA=0 or 1 at Week 16 received ustekinumab 45 mg or 90 mg (according to their baseline weight [Week 0]) at Weeks 16, 28, and 40.

    Primary: Number of Visits at Which Subjects Achieved an Investigator’s Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (from Week 16) Between Week 28 and Week 40

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    End point title
    		 Number of Visits at Which Subjects Achieved an Investigator’s Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (from Week 16) Between Week 28 and Week 40
    End point description
    The IGA documents the investigator's assessment of the subjects psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling on a scale of 0 to 4 (higher score = more severe). The subjects psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). The efficacy population included all subjects who were randomized at Week 16 (randomized analysis set).
    End point type
    Primary
    End point timeframe
    Week 28 through Week 40
    End point values
    		 Guselkumab (Randomized) Ustekinumab (Randomized)
    Number of subjects analysed
    135
    133
    Units: visits
        arithmetic mean (standard deviation)
    1.5 ( 1.57 )
    0.7 ( 1.26 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Guselkumab (Randomized) v Ustekinumab (Randomized)
    Number of subjects included in analysis
    268
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Row mean score test
    Confidence interval

    Secondary: Number of Visits at Which Subjects Achieved a Psoriasis Area and Severity Index (PASI) 90 Response Between Week 28 and Week 40

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    End point title
    		 Number of Visits at Which Subjects Achieved a Psoriasis Area and Severity Index (PASI) 90 Response Between Week 28 and Week 40
    End point description
    The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents subjects achieved at least a 90 percent improvement from baseline in the PASI score. The efficacy population included all subjects who were randomized at Week 16 (randomized analysis set).
    End point type
    Secondary
    End point timeframe
    Week 28 through Week 40
    End point values
    		 Guselkumab (Randomized) Ustekinumab (Randomized)
    Number of subjects analysed
    135
    133
    Units: visits
        arithmetic mean (standard deviation)
    2.2 ( 1.69 )
    1.1 ( 1.53 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Guselkumab (Randomized) v Ustekinumab (Randomized)
    Number of subjects included in analysis
    268
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Row mean score test
    Confidence interval

    Secondary: Number of Visits at Which Subjects Achieved an IGA Score of Cleared (0) Between Week 28 and Week 40

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    End point title
    		 Number of Visits at Which Subjects Achieved an IGA Score of Cleared (0) Between Week 28 and Week 40
    End point description
    The IGA documents the investigator's assessment of the subjects psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling on a scale of 0 to 4 (higher score = more severe). The subjects psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). The efficacy population included all subjects who were randomized at Week 16 (randomized analysis set).
    End point type
    Secondary
    End point timeframe
    Week 28 through Week 40
    End point values
    		 Guselkumab (Randomized) Ustekinumab (Randomized)
    Number of subjects analysed
    135
    133
    Units: visits
        arithmetic mean (standard deviation)
    0.9 ( 1.34 )
    0.4 ( 1.06 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Guselkumab (Randomized) v Ustekinumab (Randomized)
    Number of subjects included in analysis
    268
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Row mean score test
    Confidence interval

    Secondary: Percentage of Subjects With an Investigator’s Global Assessment (IGA) Score of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) at Week 28

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    End point title
    		 Percentage of Subjects With an Investigator’s Global Assessment (IGA) Score of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) at Week 28
    End point description
    The IGA documents the investigator's assessment of the subjects psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling on a scale of 0 to 4 (higher score = more severe). The subjects psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). The efficacy population included all subjects who were randomized at Week 16 (randomized analysis set).
    End point type
    Secondary
    End point timeframe
    Week 28
    End point values
    		 Guselkumab (Randomized) Ustekinumab (Randomized)
    Number of subjects analysed
    135
    133
    Units: percentage of subjects
        number (not applicable)
    31.1
    14.3
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Guselkumab (Randomized) v Ustekinumab (Randomized)
    Number of subjects included in analysis
    268
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 60
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Ustekinumab Open Label Run-in (Week 0 - Week 16)
    Reporting group description
    		 Subject received ustekinumab 45 milli gram (mg) (subjects weighing less than or equal to [<=]100 kilogram [kg]) and 90 mg (Subjects weighing >100 kg) at Week 0 and 4.

    Reporting group title
    Guselkumab Randomized (Week 16 - Week 60)
    Reporting group description
    		 Subjects (with an IGA>=2 at Week 16) received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.

    Reporting group title
    Ustekinumab Randomized (Week 16 - Week 60)
    Reporting group description
    		 Subjects (with an IGA>=2 at Week 16) received ustekinumab, according to their weight at baseline (Week 0), at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.

    Reporting group title
    Ustekinumab Nonrandomized OL Continuation (Week 16 - Week 60)
    Reporting group description
    		 Subjects (with an IGA=0 or 1) at Week 16 received ustekinumab (according to their baseline weight [Week 0]) at Weeks 16, 28, and 40.

    Serious adverse events
    		 Ustekinumab Open Label Run-in (Week 0 - Week 16) Guselkumab Randomized (Week 16 - Week 60) Ustekinumab Randomized (Week 16 - Week 60) Ustekinumab Nonrandomized OL Continuation (Week 16 - Week 60)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 871 (1.26%)
    9 / 135 (6.67%)
    6 / 133 (4.51%)
    20 / 585 (3.42%)
         number of deaths (all causes)
    0
    0
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bile Duct Cancer
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic Carcinoma Metastatic
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Squamous Cell Carcinoma
         subjects affected / exposed
    0 / 871 (0.00%)
    1 / 135 (0.74%)
    0 / 133 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transitional Cell Carcinoma
         subjects affected / exposed
    0 / 871 (0.00%)
    1 / 135 (0.74%)
    0 / 133 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous
         subjects affected / exposed
    0 / 871 (0.00%)
    1 / 135 (0.74%)
    0 / 133 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ectopic Pregnancy
         subjects affected / exposed
    0 / 871 (0.00%)
    1 / 135 (0.74%)
    0 / 133 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest Discomfort
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest Pain
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Alcohol Poisoning
         subjects affected / exposed
    1 / 871 (0.11%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scapula Fracture
         subjects affected / exposed
    1 / 871 (0.11%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to Various Agents
         subjects affected / exposed
    0 / 871 (0.00%)
    1 / 135 (0.74%)
    0 / 133 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia Fracture
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Myocardial Infarction
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    1 / 133 (0.75%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina Unstable
         subjects affected / exposed
    0 / 871 (0.00%)
    1 / 135 (0.74%)
    0 / 133 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    1 / 871 (0.11%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    0 / 871 (0.00%)
    2 / 135 (1.48%)
    0 / 133 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus Node Dysfunction
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    0 / 871 (0.00%)
    1 / 135 (0.74%)
    0 / 133 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 871 (0.11%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Blindness
         subjects affected / exposed
    1 / 871 (0.11%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    2 / 585 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal Artery Embolism
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal Detachment
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    1 / 133 (0.75%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large Intestinal Stenosis
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile Duct Stenosis
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 871 (0.11%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    1 / 133 (0.75%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    2 / 871 (0.23%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    1 / 133 (0.75%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot Deformity
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal Abscess
         subjects affected / exposed
    1 / 871 (0.11%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis Bacterial
         subjects affected / exposed
    0 / 871 (0.00%)
    1 / 135 (0.74%)
    0 / 133 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 871 (0.11%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraspinal Abscess
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periodontitis
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia Bacterial
         subjects affected / exposed
    1 / 871 (0.11%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salpingitis
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    0 / 133 (0.00%)
    1 / 585 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes Mellitus
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    1 / 133 (0.75%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Type 2 Diabetes Mellitus
         subjects affected / exposed
    0 / 871 (0.00%)
    0 / 135 (0.00%)
    1 / 133 (0.75%)
    0 / 585 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ustekinumab Open Label Run-in (Week 0 - Week 16) Guselkumab Randomized (Week 16 - Week 60) Ustekinumab Randomized (Week 16 - Week 60) Ustekinumab Nonrandomized OL Continuation (Week 16 - Week 60)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    80 / 871 (9.18%)
    37 / 135 (27.41%)
    33 / 133 (24.81%)
    60 / 585 (10.26%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    47 / 871 (5.40%)
    23 / 135 (17.04%)
    23 / 133 (17.29%)
    33 / 585 (5.64%)
         occurrences all number
    47
    23
    23
    33
    Upper Respiratory Tract Infection
         subjects affected / exposed
    33 / 871 (3.79%)
    15 / 135 (11.11%)
    11 / 133 (8.27%)
    27 / 585 (4.62%)
         occurrences all number
    33
    15
    11
    27

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Jul 2014
    Electrocardiogram (ECG) collection timepoints were added beyond Week 0 (Weeks 16, 32, and 52) to obtain additional ECG measurements for safety assessment in randomized subjects only; A physical examination and a urine pregnancy test were added at Week 52; An additional discontinuation criterion was added for subjects who experience signs and symptoms suspicious for reversible posterior leukoencephalopathy syndrome; Information was added about the presence of dry natural rubber on the ustekinumab prefilled syringe (PFS) needle cover, which might cause allergic reactions in individuals sensitive to latex.

    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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