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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-blind Placebo-controlled Study Evaluating the Efficacy and Safety of CNTO 1959 (Guselkumab) Delivered via a SelfDose Device in the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis

    Summary
    EudraCT number
    2016-002022-37
    Trial protocol
    PL  
    Global end of trial date
    07 Feb 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Jan 2019
    First version publication date
    09 Jan 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO1959PSO3006
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02905331
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    1000 U.S. Route 202 South, Raritan, NJ, 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
    07 Feb 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the efficacy of guselkumab delivered using the SelfDose device for the treatment of subjects with moderate to severe plaque-type psoriasis and to assess the safety and tolerability of guselkumab delivered using the SelfDose device in subjects with moderate to severe plaque-type psoriasis.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical practices and applicable regulatory requirements. The safety assessments included included adverse events (AEs), including injection site and allergic reactions, clinical laboratory tests (hematology, serum chemistry panel, lipid panel), physical examinations, vital signs (pulse rate, blood pressure), electronic columbia-suicide severity rating scale (eC-SSRS) questionnaires, concomitant medication review, early detection of tuberculosis (TB).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Mar 2017
    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: 24
    Country: Number of subjects enrolled
    Poland: 25
    Country: Number of subjects enrolled
    United States: 29
    Worldwide total number of subjects
    78
    EEA total number of subjects
    25
    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)
    72
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 85 subjects were screened, of which 78 were enrolled and treated (62 subjects in the guselkumab group and 16 subjects in the placebo group).

    Period 1
    Period 1 title
    Placebo Controlled Period(Week[wk] 0-16)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo SC injection at Weeks 0, 4, and 12.

    Arm title
    Guselkumab
    Arm description
    Subjects received guselkumab 100 mg SC injection at weeks 0, 4 and 12.
    Arm type
    Experimental

    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 injection at weeks 0, 4, and 12.

    Number of subjects in period 1
    Placebo Guselkumab
    Started
    16
    62
    Completed
    13
    61
    Not completed
    3
    1
         Lack of efficacy
    2
    -
         Adverse event, non-fatal
    1
    -
         Lost to follow-up
    -
    1
    Period 2
    Period 2 title
    Active Treatment and Follow up (wk16-40)
    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
    Placebo to Guselkumab
    Arm description
    Subjects who received placebo up to Week 12 during placebo controlled period were then crossed over at Week 16 to receive guselkumab 100 mg SC injection at weeks 16, 20 and 28.
    Arm type
    Experimental

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects who received placebo up to Week 12 during placebo controlled period were crossed over at Week 16 to receive guselkumab 100 mg SC injection at weeks 16, 20 and 28.

    Arm title
    Guselkumab
    Arm description
    Subjects received guselkumab 100 mg SC injection at weeks 20 and 28. Subjects received placebo at Week 16 to maintain the study blind.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo matched with guselkumab 100 mg SC injection at Week 16 to maintain the study blind.

    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 SC injection at weeks 20 and 28.

    Number of subjects in period 2
    Placebo to Guselkumab Guselkumab
    Started
    13
    61
    Completed
    13
    53
    Not completed
    0
    8
         Consent withdrawn by subject
    -
    2
         Unspecified
    -
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period.

    Reporting group title
    Guselkumab
    Reporting group description
    Subjects received guselkumab 100 mg SC injection at weeks 0, 4 and 12.

    Reporting group values
    Placebo Guselkumab Total
    Number of subjects
    16 62 78
    Title for AgeCategorical
    Units: subjects
        Adults (18-64 years)
    14 58 72
        From 65 to 84 years
    2 4 6
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    45.4 ± 15.7 46.2 ± 12.92 -
    Title for Gender
    Units: subjects
        Female
    4 21 25
        Male
    12 41 53

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period.

    Reporting group title
    Guselkumab
    Reporting group description
    Subjects received guselkumab 100 mg SC injection at weeks 0, 4 and 12.
    Reporting group title
    Placebo to Guselkumab
    Reporting group description
    Subjects who received placebo up to Week 12 during placebo controlled period were then crossed over at Week 16 to receive guselkumab 100 mg SC injection at weeks 16, 20 and 28.

    Reporting group title
    Guselkumab
    Reporting group description
    Subjects received guselkumab 100 mg SC injection at weeks 20 and 28. Subjects received placebo at Week 16 to maintain the study blind.

    Primary: Percentage of Subjects who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16

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    End point title
    Percentage of Subjects who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
    End point description
    The IGA documents the investigator's assessment of subjects psoriasis at given time point. Overall lesions graded for induration, erythema, and scaling. Subject's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Subjects who achieved IGA score of cleared (0) or minimal (1) were considered IGA cleared or minimal responders. Non-responder imputation was applied for subjects who met treatment failure rules, as well as for remaining missing data after treatment failure. Subjects who discontinued study drug due to lack of efficacy, an adverse event (AE) of worsening of psoriasis, or who started protocol-prohibited medication during study that could improve psoriasis were considered as treatment failures for study. Full analysis set (FAS) included all randomized subjects who received at least 1 study drug injection. Subjects were analyzed according to assigned treatment to which they were randomized, regardless of treatment they actually received.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    16
    62
    Units: Percentage of subjects
        number (not applicable)
    0
    80.6
    Statistical analysis title
    Statistical Analysis
    Comparison groups
    Placebo v Guselkumab
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Fisher exact
    Confidence interval

    Primary: Percentage of Subjects who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16

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    End point title
    Percentage of Subjects who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
    End point description
    PASI used for assessing, grading severity of psoriatic lesions, their response to therapy. PASI, body divided into 4 regions: head, trunk, upper, lower extremities. Each area was assessed separately for percentage(%) of area involved, which translates to numeric score ranges from 0 (no involvement) to 6 (90 to 100% involvement) and for erythema, induration, scaling, each are rated on a scale of 0 (none) to 4 (severe). PASI produces numeric score ranges from 0 (no visible skin involvement) to 72 (maximal skin involvement of whole body). Higher score indicates more severe disease. PASI 90 represents subjects who achieved at least 90% improvement from baseline in PASI score. Non-responder imputation was applied for subjects who met treatment failure rules, also for remaining missing data after treatment failure. FAS: all randomized subjects received at least 1 study drug injection. Subjects analyzed as per assigned treatment to which they were randomized, regardless treatment received.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    16
    62
    Units: Percentage of subjects
        number (not applicable)
    0
    75.8
    Statistical analysis title
    Statistical Analysis
    Comparison groups
    Placebo v Guselkumab
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Fisher exact
    Confidence interval

    Secondary: Percentage of Subjects who Achieve an IGA Score of Cleared (0) at Week 16

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    End point title
    Percentage of Subjects who Achieve an IGA Score of Cleared (0) at Week 16
    End point description
    The IGA documents the investigator's assessment of subjects psoriasis at given time point. Overall lesions graded for induration, erythema, and scaling. Subject's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Subjects who achieved an IGA score of cleared (0) were considered IGA cleared responders. Non-responder imputation was applied for subjects who met treatment failure rules, as well as for remaining missing data after treatment failure. FAS included all randomized subjects who received at least 1 study drug injection. Subjects were analyzed according to assigned treatment to which they were randomized, regardless of treatment they actually received.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    16
    62
    Units: Percentage of subjects
        number (not applicable)
    0
    56.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieve a PASI 100 Response at Week 16

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    End point title
    Percentage of Subjects who Achieve a PASI 100 Response at Week 16
    End point description
    The PASI assessing, grading severity of psoriatic lesions, their response to therapy. In PASI, the body divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each area was assessed separately % of area involved, which translates to numeric score that ranges from 0(no involvement) to 6(90 to 100% involvement) and for erythema, induration, scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. Higher score indicates more severe disease. Subjects with 100% improvement in PASI from baseline (PASI score=0) were considered PASI 100 responders. Non-responder imputation was applied for subjects who met treatment failure rules, as well as for remaining missing data after treatment failure. FAS: all randomized subjects who received at least 1 study drug injection. Subjects were analyzed according to assigned treatment to which they were randomized, regardless of treatment they actually received.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    16
    62
    Units: Percentage of subjects
        number (not applicable)
    0
    50.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved an IGA Score of Mild or Better (less than or equal to [<=] 2) at Week 16

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    End point title
    Percentage of Subjects who Achieved an IGA Score of Mild or Better (less than or equal to [<=] 2) at Week 16
    End point description
    The IGA documents the investigator's assessment of subjects psoriasis at given time point. Overall lesions graded for induration, erythema, and scaling. Subject's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Subjects who achieved IGA score of cleared (0), minimal (1) or mild (2) were considered IGA mild or better responders. Non-responder imputation was applied for subjects who met treatment failure rules, as well as for remaining missing data after treatment failure. FAS included all randomized subjects who received at least 1 study drug injection. Subjects were analyzed according to assigned treatment to which they were randomized, regardless of treatment they actually received.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    16
    62
    Units: Percentage of subjects
        number (not applicable)
    0
    93.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieve a PASI 50 Response and a PASI 75 Response at Week 16

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    End point title
    Percentage of Subjects who Achieve a PASI 50 Response and a PASI 75 Response at Week 16
    End point description
    PASI used for assessing, grading severity of psoriatic lesions, their response to therapy. PASI, the body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each area was assessed separately for % of area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 to 100% involvement), for erythema, induration, scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. Higher score indicates more severe disease. Subjects with >=50% and >= 75% improvement in PASI from baseline were considered PASI 50, PASI 75 responders. Non-responder imputation was applied for subjects who met treatment failure rules, also for remaining missing data after treatment failure. FAS: all randomized subjects who received at least 1 study drug injection. Subjects were analyzed as per assigned treatment to which they were randomized, regardless of treatment received.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    16
    62
    Units: Percentage of subjects
    number (not applicable)
        PASI 50 responders
    0
    93.5
        PASI 75 responders
    0
    88.7
    No statistical analyses for this end point

    Secondary: Percent Improvement From Baseline in PASI Score at Week 16

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    End point title
    Percent Improvement From Baseline in PASI Score at Week 16
    End point description
    Percent Improvement defined as improvement in PASI from baseline. PASI used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body divided into 4 regions:head,trunk,upper extremities,lower extremities. Each area was assessed separately for % of area involved which translates to numeric score ranges from 0(indicates no involvement) to 6(90 to 100% involvement), and for erythema, induration, and scaling, which are each rated on scale of 0 to 4. PASI produces numeric score ranges from 0(no psoriasis) to 72. Higher score shows more severe disease. Subjects were analyzed according to assigned treatment to which they were randomized, regardless of treatment they received. FAS:all randomized subjects who received at least 1 study drug injection. 'N'(number of subjects analyzed):number of subjects evaluable for this outcome measure. Imputation was applied only for subjects who met treatment failure and their percent improvement was imputed as 0.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    16
    61
    Units: Percent improvement
        arithmetic mean (standard deviation)
    8.72 ± 18.229
    91.53 ± 16.756
    No statistical analyses for this end point

    Secondary: Percent Improvement From Baseline in PASI Score Through Week 40

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    End point title
    Percent Improvement From Baseline in PASI Score Through Week 40
    End point description
    Percent Improvement defined as improvement in PASI from baseline. PASI used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body divided into 4 regions:head,trunk,upper extremities,lower extremities. Each area was assessed separately for % of area involved which translates to numeric score ranges from 0(indicates no involvement) to 6(90 to 100% involvement), and for erythema, induration, and scaling, which are each rated on scale of 0 to 4. PASI produces numeric score ranges from 0(no psoriasis) to 72. Higher score shows more severe disease. Subjects were analyzed according to assigned treatment to which they were randomized, regardless of treatment they received. FAS:all randomized subjects who received at least 1 study drug injection. Here n is number of subjects who were analyzed at specific timepoint. Imputation was applied only for subjects who met treatment failure and their percent improvement was imputed as 0.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, 8, 12, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended every 8 weeks [q8w] dosing interval)
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    16
    62
    Units: Percent improvement
    arithmetic mean (standard deviation)
        Week 4 (n=16,62)
    5.58 ± 13.970
    40.99 ± 26.377
        Week 8 (n=16,62)
    10.45 ± 21.540
    71.76 ± 26.984
        Week 12 (n=16,61)
    13.76 ± 24.143
    84.97 ± 20.520
        Week 20 (n=13,61)
    62.65 ± 20.760
    94.77 ± 13.179
        Week 24 (n=13,59)
    88.74 ± 12.092
    95.89 ± 10.164
        Week 28 (n=13,60)
    95.68 ± 6.162
    96.30 ± 7.504
        Week 32 (n=13,58)
    96.16 ± 5.602
    96.64 ± 7.143
        Week 40 (n=13,55)
    97.70 ± 3.443
    92.47 ± 13.289
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved an IGA Score of cleared (0), cleared (0) or minimal (1) and mild or better (<=2) Through Week 40

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    End point title
    Percentage of Subjects who Achieved an IGA Score of cleared (0), cleared (0) or minimal (1) and mild or better (<=2) Through Week 40
    End point description
    IGA documents investigator's assessment of subjects psoriasis at given time point. Overall lesions graded for induration, erythema, scaling. Subject's psoriasis was assessed as cleared(0), minimal(1), mild(2), moderate(3), or severe(4). Subjects who achieved IGA score of cleared(0) were considered IGA cleared responders. Those who achieved IGA score of cleared(0) or minimal(1) were considered IGA cleared or minimal responders while those achieved IGA score of cleared(0), minimal(1), or mild(2) were considered IGA mild or better responders. Subjects were analyzed as per assigned treatment to which they were randomized, regardless of treatment they received. From week 20, subjects in placebo group, only included subjects who crossed over to receive guselkumab at week 16. It included FAS. n (number analyzed) signify number of subjects who were analyzed at specific timepoint. Non-responder imputation was used to impute missing data or after subjects who met treatment failure criteria.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended q8w dosing interval)
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    16
    62
    Units: Percentage of subjects
    number (not applicable)
        Week 4: IGA of cleared(0) (n=16,62)
    0
    4.8
        Week 4: IGA of cleared(0) or minimal(1) (n=16,62)
    0
    19.4
        Week 4: IGA of mild or better (<=2) (n=16,62)
    0
    54.8
        Week 8: IGA of cleared(0) (n=16,62)
    0
    19.4
        Week 8: IGA of cleared(0) or minimal(1) (n=16,62)
    0
    56.5
        Week 8: IGA of mild or better (<=2) (n=16,62)
    12.5
    85.5
        Week 12: IGA of cleared(0) (n=16,62)
    0
    35.5
        Week 12: IGA of cleared(0) or minimal(1) (n=16,62)
    0
    67.7
        Week 12: IGA of mild or better (<=2) (n=16,62)
    0
    91.9
        Week 20: IGA of cleared(0) (n=13,62)
    0
    67.7
        Week 20: IGA of cleared(0) or minimal(1) (n=13,62)
    46.2
    85.5
        Week 20: IGA of mild or better (<=2) (n=13,62)
    92.3
    93.5
        Week 24: IGA of cleared(0) (n=13,62)
    38.5
    71.0
        Week 24: IGA of cleared(0) or minimal(1) (n=13,62)
    100.0
    87.1
        Week 24: IGA of mild or better (<=2) (n=13,62)
    100.0
    88.7
        Week 28: IGA of cleared(0) (n=13,62)
    61.5
    64.5
        Week 28: IGA of cleared(0) or minimal(1) (n=13,62)
    100.0
    87.1
        Week 28: IGA of mild or better (<=2) (n=13,62)
    100.0
    95.2
        Week 32: IGA of cleared(0) (n=13,62)
    69.2
    66.1
        Week 32: IGA of cleared(0) or minimal(1) (n=13,62)
    92.3
    82.3
        Week 32: IGA of mild or better (<=2) (n=13,62)
    100.0
    100.0
        Week 40: IGA of cleared(0) (n=13,62)
    61.5
    53.2
        Week 40: IGA of cleared(0) or minimal(1) (n=13,62)
    92.3
    71.0
        Week 40:IGA of mild or better (<=2) (n=13,62)
    100.0
    79.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved PASI 100 responses, PASI 90 responses, PASI 75 responses, and PASI 50 responses

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    End point title
    Percentage of Subjects who Achieved PASI 100 responses, PASI 90 responses, PASI 75 responses, and PASI 50 responses
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions and their response to therapy. PASI produces numeric score that can range from 0 (no psoriasis) to 72. Higher score indicates more severe disease. Subjects with 100% improvement in PASI from baseline(PASI score=0) was considered PASI 100 responders. Subjects with >=90%, >=75%, >=50% improvement in PASI from baseline were considered PASI 90, PASI 75, PASI 50 responders. Non-responder imputation was applied for subjects who met treatment failure rules, also for remaining missing data after treatment failure. FAS:all randomized subjects who received at least 1 study drug injection. Subjects were analyzed as per assigned treatment to which they were randomized, regardless of treatment received. Here, n(number analyzed) signifies number of subjects who were analyzed at specific timepoint, for each arm. Non-responder imputation was used to impute missing data or after subjects who met treatment failure criteria.
    End point type
    Secondary
    End point timeframe
    Week 4, 8, 12, 16, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended q8w dosing interval)
    End point values
    Placebo Guselkumab
    Number of subjects analysed
    16
    62
    Units: Percentage of subjects
    number (not applicable)
        Week 4: 100% improvement (n=16,62)
    0
    3.2
        Week 4: >= 90% improvement (n=16,62)
    0
    4.8
        Week 4: >= 75% improvement (n=16,62)
    0
    12.9
        Week 4: >= 50% improvement (n=16,62)
    0
    33.9
        Week 8: 100% improvement (n=16,62)
    0
    16.1
        Week 8: >= 90% improvement (n=16,62)
    0
    33.9
        Week 8: >= 75% improvement (n=16,62)
    0
    56.5
        Week 8: >= 50% improvement (n=16,62)
    6.3
    80.6
        Week 12: 100% improvement (n=16,62)
    0
    30.6
        Week 12: >= 90% improvement (n=16,62)
    0
    54.8
        Week 12: >= 75% improvement (n=16,62)
    0
    77.4
        Week 12: >= 50% improvement (n=16,62)
    12.5
    90.3
        Week 16: 100% improvement (n=16,62)
    0
    50.0
        Week 16: >=90% improvement (n=16,62)
    0
    75.8
        Week 16: >=75% improvement (n=16,62)
    0
    88.7
        Week 16: >=50% improvement (n=16,62)
    0
    93.5
        Week 20: 100% improvement (n=13,62)
    0
    66.1
        Week 20: >=90% improvement (n=13,62)
    7.7
    85.5
        Week 20: >=75% improvement (n=13,62)
    30.8
    91.9
        Week 20: >=50% improvement (n=13,62)
    69.2
    95.2
        Week 24: 100% improvement (n=13,62)
    30.8
    71.0
        Week 24: >=90% improvement (n=13,62)
    61.5
    82.3
        Week 24: >=75% improvement (n=13,62)
    84.6
    88.7
        Week 24: >=50% improvement (n=13,62)
    100.0
    95.2
        Week 28: 100% improvement (n=13,62)
    53.8
    64.5
        Week 28: >=90% improvement (n=13,62)
    84.6
    85.5
        Week 28: >=75% improvement (n=13,62)
    100.0
    95.2
        Week 28: >50% improvement (n=13,62)
    100.0
    96.8
        Week 32: 100% improvement (n=13,62)
    61.5
    64.5
        Week 32: >=90% improvement (n=13,62)
    84.6
    85.5
        Week 32: >=75% improvement (n=13,62)
    100.0
    90.3
        Week 32: >=50% improvement (n=13,62)
    100.0
    93.5
        Week 40: 100% improvement (n=13,62)
    53.8
    53.2
        Week 40: >=90% improvement (n=13,62)
    100.0
    66.1
        Week 40: >=75% improvement (n=13,62)
    100.0
    79.0
        Week 40: >=50% improvement (n=13,62)
    100.0
    79.0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 40
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Placebo (Week 0-16)
    Reporting group description
    Subjects received placebo matched to guselkumab subcutaneous (SC) injection at weeks 0, 4, and 12 during placebo-controlled period.

    Reporting group title
    Guselkumab (Week 0-16)
    Reporting group description
    Subjects received guselkumab 100 mg SC injection at weeks 0, 4, and 12.

    Reporting group title
    Placebo to Guselkumab (Week 16-40)
    Reporting group description
    Subjects who received placebo during placebo controlled period was crossed over to receive guselkumab 100 mg SC injection at weeks 16, 20 and 28.

    Reporting group title
    Guselkumab (Week 16-40)
    Reporting group description
    Subjects received placebo at Week 16, and 100 mg guselkumab at Week 20 and 28.

    Serious adverse events
    Placebo (Week 0-16) Guselkumab (Week 0-16) Placebo to Guselkumab (Week 16-40) Guselkumab (Week 16-40)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 62 (3.23%)
    2 / 13 (15.38%)
    1 / 61 (1.64%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Angina Pectoris
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 62 (0.00%)
    1 / 13 (7.69%)
    0 / 61 (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
    Immune system disorders
    Drug Hypersensitivity
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 62 (0.00%)
    0 / 13 (0.00%)
    1 / 61 (1.64%)
         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
    General disorders and administration site conditions
    Chest Discomfort
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 62 (1.61%)
    0 / 13 (0.00%)
    0 / 61 (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
    Chest Pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 62 (1.61%)
    0 / 13 (0.00%)
    0 / 61 (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
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 62 (0.00%)
    1 / 13 (7.69%)
    0 / 61 (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
    Placebo (Week 0-16) Guselkumab (Week 0-16) Placebo to Guselkumab (Week 16-40) Guselkumab (Week 16-40)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 16 (75.00%)
    38 / 62 (61.29%)
    8 / 13 (61.54%)
    24 / 61 (39.34%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 62 (0.00%)
    1 / 13 (7.69%)
    0 / 61 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Investigations
    Hepatic Enzyme Increased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 62 (0.00%)
    0 / 13 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cardiac disorders
    Left Ventricular Hypertrophy
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 62 (0.00%)
    1 / 13 (7.69%)
    0 / 61 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Productive Cough
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 62 (0.00%)
    1 / 13 (7.69%)
    0 / 61 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 62 (0.00%)
    1 / 13 (7.69%)
    1 / 61 (1.64%)
         occurrences all number
    0
    0
    2
    1
    General disorders and administration site conditions
    Injection Site Bruising
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 62 (3.23%)
    1 / 13 (7.69%)
    1 / 61 (1.64%)
         occurrences all number
    1
    2
    1
    1
    Injection Site Coldness
         subjects affected / exposed
    3 / 16 (18.75%)
    14 / 62 (22.58%)
    2 / 13 (15.38%)
    7 / 61 (11.48%)
         occurrences all number
    3
    21
    2
    7
    Injection Site Erythema
         subjects affected / exposed
    1 / 16 (6.25%)
    7 / 62 (11.29%)
    0 / 13 (0.00%)
    4 / 61 (6.56%)
         occurrences all number
    1
    12
    0
    4
    Injection Site Induration
         subjects affected / exposed
    2 / 16 (12.50%)
    7 / 62 (11.29%)
    1 / 13 (7.69%)
    2 / 61 (3.28%)
         occurrences all number
    3
    8
    1
    2
    Injection Site Oedema
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 62 (0.00%)
    0 / 13 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Injection Site Pain
         subjects affected / exposed
    7 / 16 (43.75%)
    25 / 62 (40.32%)
    3 / 13 (23.08%)
    11 / 61 (18.03%)
         occurrences all number
    12
    50
    4
    14
    Injection Site Pruritus
         subjects affected / exposed
    2 / 16 (12.50%)
    8 / 62 (12.90%)
    1 / 13 (7.69%)
    2 / 61 (3.28%)
         occurrences all number
    2
    9
    1
    2
    Injection Site Swelling
         subjects affected / exposed
    1 / 16 (6.25%)
    7 / 62 (11.29%)
    1 / 13 (7.69%)
    3 / 61 (4.92%)
         occurrences all number
    1
    9
    1
    3
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 62 (1.61%)
    0 / 13 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 62 (0.00%)
    0 / 13 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Depression
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 62 (0.00%)
    0 / 13 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 62 (0.00%)
    0 / 13 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Reproductive system and breast disorders
    Postmenopausal Haemorrhage
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 62 (0.00%)
    0 / 13 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vaginal Cyst
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 62 (0.00%)
    0 / 13 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Urticaria Pressure
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 62 (0.00%)
    1 / 13 (7.69%)
    0 / 61 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 62 (0.00%)
    0 / 13 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    1
    0
    0
    1
    Psoriatic Arthropathy
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 62 (0.00%)
    0 / 13 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    Furuncle
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 62 (0.00%)
    1 / 13 (7.69%)
    0 / 61 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tooth Abscess
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 62 (0.00%)
    0 / 13 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tooth Infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 62 (0.00%)
    0 / 13 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    1
    0
    0
    2
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 16 (0.00%)
    5 / 62 (8.06%)
    0 / 13 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    0
    5
    0
    1
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 16 (0.00%)
    3 / 62 (4.84%)
    1 / 13 (7.69%)
    6 / 61 (9.84%)
         occurrences all number
    0
    3
    1
    8

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Nov 2016
    The overall reason for the amendment is to include the following major changes: 1) The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) assessment was added to the protocol as requested by the US Food and Drug Administration (FDA). 2) Clarification was added that all shampoos used to treat psoriasis must be included in the list of all therapies, other than the study drug, that must be recorded in the subject electronic case report form (eCRF). 3) An exclusion criterion was modified to allow subjects who have completed antiviral treatment for hepatitis C virus to participate.

    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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