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    Clinical Trial Results:
    A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Subjects with Moderate to Severe Hidradenitis Suppurativa

    Summary
    EudraCT number
    		 2018-001176-38
    Trial protocol
    		 FR   DE   NL   DK  
    Global end of trial date
    22 May 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jun 2021
    First version publication date
    03 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO1959HDS2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03628924
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research and Development LLC
    Sponsor organisation address
    920 US, Route 202, P.O. Box 300, Raritan, United States, 08869
    Public contact
    Clinical Registry Group, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research and Development, 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
    19 Jun 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 May 2020
    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 initial efficacy, safety, and tolerability of guselkumab in adult subjects with moderate to severe Hidradenitis Suppurativa (HS).
    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. Safety was evaluated based on adverse events (AEs) and clinical laboratory test results (that is, hematology and serum chemistry).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Sep 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 22
    Country: Number of subjects enrolled
    Germany: 36
    Country: Number of subjects enrolled
    Denmark: 4
    Country: Number of subjects enrolled
    France: 51
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    United States: 61
    Worldwide total number of subjects
    181
    EEA total number of subjects
    98
    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)
    177
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 236 subjects were screened of which 184 subjects were enrolled in the study. Of the 184 subjects, 3 subjects were randomized but did not receive treatment and 181 subjects were randomized and dosed into guselkumab 200 mg and 1200 mg and placebo groups.

    Period 1
    Period 1 title
    Placebo Controlled Period (Week 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 (Week 0 - 16)
    Arm description
    		 Subjects received placebo intravenously (IV) and subcutaneously (SC) at Weeks 0, 4, 8 and an additional SC placebo at Week 12.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo SC at Weeks 0, 4, 8, and 12.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received placebo IV at Weeks 0, 4, and 8.

    Arm title
    		 Guselkumab 200 milligrams (mg) SC (Week 0 - 16)
    Arm description
    		 Subjects received 200 mg guselkumab (Gus) SC at Weeks 0, 4, 8, and 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    CNTO1959
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 200 mg guselkumab SC at Weeks 0, 4, 8, and 12.

    Arm title
    		 Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Arm description
    		 Subjects received 1200 mg guselkumab IV at Weeks 0, 4, and 8, and 200 mg guselkumab SC at Week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    CNTO1959
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received 1200 mg guselkumab IV at Weeks 0, 4, and 8.

    Number of subjects in period 1
    		Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Started
    62
    59
    60
    Completed
    56
    56
    57
    Not completed
    6
    3
    3
         Adverse event, serious fatal
    -
    1
    -
         Lost to follow-up
    2
    -
    -
         Protocol deviation
    1
    2
    1
         Lack of efficacy
    3
    -
    1
         Withdrawal by subject
    -
    -
    1
    Period 2
    Period 2 title
    Active Treatment Period (Week 16-48)
    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 Crossover to Guselkumab 100 mg SC (Week 16 - 48)
    Arm description
    		 At Week 16, subjects receiving placebo during placebo-controlled period were re-randomized to receive 100 mg guselkumab SC at Weeks 16, 20, 28 and 36 and placebo at Weeks 24 and 32. All subjects entered safety follow-up at Week 36 through Week 48.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo matching to guselkumab 100 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At Week 16, subjects receiving placebo during placebo-controlled period were re-randomized to receive 100 mg guselkumab SC at Weeks 16, 20, 28 and 36 and placebo at Weeks 24 and 32.

    Arm title
    		 Placebo Crossover to Guselkumab 200 mg SC (Week 16 - 48)
    Arm description
    		 At Week 16, subjects receiving placebo during placebo-controlled period were re-randomized to receive 200 mg guselkumab SC every 4 weeks (q4w) through Week 36. All subjects entered safety follow-up at Week 36 through Week 48.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo matching to guselkumab 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At Week 16, subjects receiving placebo during placebo-controlled period were re-randomized to receive 200 mg guselkumab SC every 4 weeks (q4w) through Week 36.

    Arm title
    		 Guselkumab 200 mg SC (Week 16 - 48)
    Arm description
    		 Subjects who were receiving 200 mg guselkumab SC during placebo-controlled period, continued to receive 200 mg guselkumab SC q4w through Week 36. All subjects entered safety follow-up at Week 36 through Week 48.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Guselkumab 200 mg
    Investigational medicinal product code
    Other name
    CNTO1959
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects who were receiving 200 mg guselkumab SC during placebo-controlled period, continued to receive 200 mg guselkumab SC q4w through Week 36.

    Arm title
    		 Gus 1200 mg IV Crossover to Gus 200 mg SC (Week 16 - 48)
    Arm description
    		 Subjects who were receiving 1200 mg guselkumab IV during placebo-controlled period switched treatment at Week 12 to receive guselkumab 200 mg SC q4w through Week 36. All subjects entered safety follow-up at Week 36 through Week 48.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Guselkumab 200 mg
    Investigational medicinal product code
    Other name
    CNTO1959
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects who were receiving 1200 mg guselkumab IV during placebo-controlled period switched treatment at Week 12 to receive guselkumab 200 mg SC q4w through Week 36.

    Number of subjects in period 2
    		Placebo Crossover to Guselkumab 100 mg SC (Week 16 - 48) Placebo Crossover to Guselkumab 200 mg SC (Week 16 - 48) Guselkumab 200 mg SC (Week 16 - 48) Gus 1200 mg IV Crossover to Gus 200 mg SC (Week 16 - 48)
    Started
    28
    28
    56
    57
    Completed
    20
    24
    43
    46
    Not completed
    8
    4
    13
    11
         Adverse event, serious fatal
    -
    -
    1
    -
         Adverse event, non-fatal
    1
    -
    1
    4
         Lost to follow-up
    1
    1
    2
    1
         Lack of efficacy
    5
    1
    4
    2
         Protocol deviation
    1
    1
    -
    1
         Withdrawal by subject
    -
    1
    5
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo (Week 0 - 16)
    Reporting group description
    		 Subjects received placebo intravenously (IV) and subcutaneously (SC) at Weeks 0, 4, 8 and an additional SC placebo at Week 12.

    Reporting group title
    Guselkumab 200 milligrams (mg) SC (Week 0 - 16)
    Reporting group description
    		 Subjects received 200 mg guselkumab (Gus) SC at Weeks 0, 4, 8, and 12.

    Reporting group title
    Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Reporting group description
    		 Subjects received 1200 mg guselkumab IV at Weeks 0, 4, and 8, and 200 mg guselkumab SC at Week 12.

    Reporting group values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16) Total
    Number of subjects
    		 62 59 60 181
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 60 57 60 177
        From 65 to 84 years
    		 2 2 0 4
        85 years and over
    		 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.2 ± 11.55 39 ± 12.37 37.2 ± 10.92 -
    Title for Gender
    Units: subjects
        Female
    		 38 32 45 115
        Male
    		 24 27 15 66

    End points

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    End points reporting groups
    Reporting group title
    Placebo (Week 0 - 16)
    Reporting group description
    		 Subjects received placebo intravenously (IV) and subcutaneously (SC) at Weeks 0, 4, 8 and an additional SC placebo at Week 12.

    Reporting group title
    Guselkumab 200 milligrams (mg) SC (Week 0 - 16)
    Reporting group description
    		 Subjects received 200 mg guselkumab (Gus) SC at Weeks 0, 4, 8, and 12.

    Reporting group title
    Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Reporting group description
    		 Subjects received 1200 mg guselkumab IV at Weeks 0, 4, and 8, and 200 mg guselkumab SC at Week 12.
    Reporting group title
    Placebo Crossover to Guselkumab 100 mg SC (Week 16 - 48)
    Reporting group description
    		 At Week 16, subjects receiving placebo during placebo-controlled period were re-randomized to receive 100 mg guselkumab SC at Weeks 16, 20, 28 and 36 and placebo at Weeks 24 and 32. All subjects entered safety follow-up at Week 36 through Week 48.

    Reporting group title
    Placebo Crossover to Guselkumab 200 mg SC (Week 16 - 48)
    Reporting group description
    		 At Week 16, subjects receiving placebo during placebo-controlled period were re-randomized to receive 200 mg guselkumab SC every 4 weeks (q4w) through Week 36. All subjects entered safety follow-up at Week 36 through Week 48.

    Reporting group title
    Guselkumab 200 mg SC (Week 16 - 48)
    Reporting group description
    		 Subjects who were receiving 200 mg guselkumab SC during placebo-controlled period, continued to receive 200 mg guselkumab SC q4w through Week 36. All subjects entered safety follow-up at Week 36 through Week 48.

    Reporting group title
    Gus 1200 mg IV Crossover to Gus 200 mg SC (Week 16 - 48)
    Reporting group description
    		 Subjects who were receiving 1200 mg guselkumab IV during placebo-controlled period switched treatment at Week 12 to receive guselkumab 200 mg SC q4w through Week 36. All subjects entered safety follow-up at Week 36 through Week 48.

    Primary: Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16

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    End point title
    		 Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
    End point description
    HiSCR is defined as at least 50 percent (%) reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline. Full Analysis Set (FAS) included all randomized subjects who received at least one administration of study intervention. Subjects with missing data after applying treatment failure rules were assumed to be non-responders. Subjects who discontinued study intervention due to lack of efficacy or an Adverse event (AE) of worsening of hidradenitis suppurativa (HS), or who started a protocol-prohibited medication or therapy during the study that could improve HS were considered treatment failures.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    62
    59
    60
    Units: percentage of subjects
        number (not applicable)
    38.7
    50.8
    45.0
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo (Week 0 - 16) v Guselkumab 200 milligrams (mg) SC (Week 0 - 16)
    Number of subjects included in analysis
    121
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.166
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Treatment difference
    Point estimate
    12.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.6
         upper limit
    		 29.8
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo (Week 0 - 16) v Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.459
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Treatment difference
    Point estimate
    6.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.3
         upper limit
    		 23.6

    Secondary: Change From Baseline in Subjects Total Abscess and Inflammatory Nodule (AN) Count at Week 16

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    End point title
    		 Change From Baseline in Subjects Total Abscess and Inflammatory Nodule (AN) Count at Week 16
    End point description
    Change from baseline in total AN count at Week 16 was reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions. FAS included all randomized subjects who received at least one administration of study intervention. The analysis was based on observed data after applying treatment failure rules (the change from baseline using observed data or 0 [no improvement] if a subject met treatment failure [TF] criteria).Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    59
    57
    59
    Units: count of abscess and inflammatory nodule
        arithmetic mean (standard deviation)
    -3.2 ± 7.37
    -5.3 ± 9.29
    -5.3 ± 6.53
    No statistical analyses for this end point

    Secondary: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16

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    End point title
    		 Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
    End point description
    DLQI is a simple, compact, and practical questionnaire to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the subject's skin. The subject responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A lower score (that is, negative change score) indicates improvement in the Quality of Life. FAS included all randomized subjects who received at least one administration of study intervention. The analysis was based on observed data after applying treatment failure rules (the change from baseline using observed data or 0 [no improvement] if a subject met TF criteria). Here, N (number of subjects analyzed) signifies subjects who were evaluated for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    59
    56
    57
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.7 ± 5.17
    -3.4 ± 6.81
    -2.5 ± 6.13
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hidradenitis Suppurativa (HS)-Related Pain Symptom Score in the Past 24 Hours Based on Hidradenitis Suppurativa Symptom Diary (HSSD) Questionnaire at Week 16

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    End point title
    		 Change From Baseline in Hidradenitis Suppurativa (HS)-Related Pain Symptom Score in the Past 24 Hours Based on Hidradenitis Suppurativa Symptom Diary (HSSD) Questionnaire at Week 16
    End point description
    HSSD is 7-item patient self-reported questionnaire assesses 5 HS-related symptoms (pain, tenderness, hot skin feeling, odor, and itchiness). Subjects rated severity of each symptom on 0 (no symptom) to 10 (worst possible symptom) scale. All 5 symptoms have recall period of past 7 days, except 2 additional items of pain that is current pain and pain in past 24 hours. Total symptom score ranged from 0 (no symptom) to 10 (worst possible symptom), which is average of 5 individual scale scores that utilize past 7-day recall period. Change from baseline in HR-related pain symptom score based on HSSD was reported. FAS included all randomized subjects who received at least 1 dose of study intervention. Subjects who received analgesic therapy for HS within 1 day of scheduled visit date, were considered TF at that visit (change from baseline using observed data/ 0 [no improvement] if subject met TF criteria). Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    56
    55
    56
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.3 ± 3.17
    -1.6 ± 3.05
    -1.2 ± 2.93
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved at Least 50 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16

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    End point title
    		 Percentage of Subjects Who Achieved at Least 50 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16
    End point description
    Percentage of subjects achieving at least 50 percent reduction in total AN count at Week 16 was reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions. FAS included all randomized subjects who received at least one administration of study intervention. Subjects with missing data after applying treatment failure rules were assumed to be non-responders.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    62
    59
    60
    Units: percentage of subjects
        number (not applicable)
    45.2
    55.9
    51.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved at Least 75 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16

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    End point title
    		 Percentage of Subjects Who Achieved at Least 75 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16
    End point description
    Percentage of subjects achieving at least 75 percent reduction in total AN count at Week 16 was reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions. FAS included all randomized subjects who received at least one administration of study intervention. Subjects with missing data after applying treatment failure rules were assumed to be non-responders.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    62
    59
    60
    Units: percentage of subjects
        number (not applicable)
    30.6
    40.7
    26.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved at Least 90 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16

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    End point title
    		 Percentage of Subjects Who Achieved at Least 90 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16
    End point description
    Percentage of subjects achieving at least 90 percent reduction in total AN count at Week 16 was reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions. FAS included all randomized subjects who received at least one administration of study intervention. Subjects with missing data after applying treatment failure rules were assumed to be non-responders.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    62
    59
    60
    Units: percentage of subjects
        number (not applicable)
    17.7
    22.0
    15.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved 100 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16

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    End point title
    		 Percentage of Subjects Who Achieved 100 Percent Reduction in Total Abscess and Inflammatory Nodule Count at Week 16
    End point description
    Percentage of subjects achieving 100 percent reduction in total AN count at Week 16 was reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions. FAS included all randomized subjects who received at least one administration of study intervention. Subjects with missing data after applying treatment failure rules were assumed to be non-responders.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    62
    59
    60
    Units: percentage of subjects
        number (not applicable)
    14.5
    15.3
    15.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved an Abscess and Inflammatory Nodule Count of 0/1 and AN Count of 0/1/2 at Week 16

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    End point title
    		 Percentage of Subjects Who Achieved an Abscess and Inflammatory Nodule Count of 0/1 and AN Count of 0/1/2 at Week 16
    End point description
    Percentage of subjects who achieved an AN count of 0/1 and AN Count of 0/1/2 at Week 16 were reported. Abscess and inflammatory nodule were counted for the HS affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions. FAS included all randomized subjects who received at least one administration of study intervention. Subjects with missing data after applying treatment failure rules were assumed to be non-responders.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    62
    59
    60
    Units: percentage of subjects
    number (not applicable)
        AN Count of 0/1
    27.4
    30.5
    23.3
        AN Count of 0/1/2
    33.9
    39.0
    31.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Abscess Count of 0 at Week 16 For Subjects With Baseline Abscess Count Greater Than 0

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    End point title
    		 Percentage of Subjects Who Achieved Abscess Count of 0 at Week 16 For Subjects With Baseline Abscess Count Greater Than 0
    End point description
    Percentage of subjects who achieved abscess count of 0 at Week 16 for subjects with baseline abscess count greater than (>) 0 were reported. Population analyzed included FAS subjects with baseline abscess count > 0. Subjects with missing data after applying treatment failure rules were assumed to be non-responders.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    28
    36
    31
    Units: percentage of subjects
        number (not applicable)
    39.3
    63.9
    45.2
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Number of Abscesses at Week 16

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    End point title
    		 Change From Baseline in the Number of Abscesses at Week 16
    End point description
    Change from baseline in number of abscesses at Week 16 was reported. FAS included all randomized subjects who received at least one administration of study intervention. The analysis was based on observed data after applying treatment failure rules (the change from baseline using observed data or 0 (no improvement) if a subject met TF criteria). Here, N (number of subjects analyzed) signifies subjects who were evaluated for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    59
    57
    59
    Units: abscess
        arithmetic mean (standard deviation)
    -0.4 ± 2.72
    -2.1 ± 4.56
    -1.6 ± 3.90
    No statistical analyses for this end point

    Secondary: Change From Baseline in HSSD Symptom Scale Total Score at Week 16

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    End point title
    		 Change From Baseline in HSSD Symptom Scale Total Score at Week 16
    End point description
    HSSD is 7-item patient self-reported questionnaire assesses 5 HS-related symptoms (pain, tenderness, hot skin feeling, odor, and itchiness). Subjects were asked to rate severity of each symptom on 0 to 10 numerical rating scale, with 0 (no symptom) and 10 (worst possible symptom). All 5 symptoms have a recall period of past 7 days, except for 2 additional questions on pain which evaluate current pain and pain in the past 24 hours. A total symptom score, also ranged from 0 (no symptom) to 10 (worst possible symptom), was derived by averaging the 5 individual scale scores that utilize the past 7-day recall period. FAS included all randomized subjects who received at least 1 administration of study intervention. The analysis was based on observed data after applying treatment failure rules (the change from baseline using observed data or 0 (no improvement) if a subject met TF criteria). Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    59
    56
    57
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.19 ± 2.124
    -1.71 ± 2.325
    -0.82 ± 2.148
    No statistical analyses for this end point

    Secondary: Change from Baseline in HSSD Symptom Scale Score (Other Than Pain in the Past 24 Hours) at Week 16

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    End point title
    		 Change from Baseline in HSSD Symptom Scale Score (Other Than Pain in the Past 24 Hours) at Week 16
    End point description
    HSSD - 7-item patient self-reported questionnaire assesses 5 HS-related symptoms (pain, tenderness, hot skin feeling, odor, and itchiness). Subjects rated severity of each symptom on 0 (no symptoms) to 10 (worst possible symptoms) scale. All 5 symptoms have recall period of past 7 days, except 2 additional items of pain which are current pain and pain in past 24 hours. Change from baseline in each individual HSSD component scale (other than pain in past 24 hours) tenderness, hot skin feeling, odor and itchiness symptom, pain, and current pain score were reported. FAS included all subjects who received at least 1 dose of study intervention. Analysis was based on observed data after applying TF rules (change from baseline using observed data or 0 [no improvement] if subject met TF criteria). Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint and 'n' (number of subjects analyzed) signifies subjects evaluated for this endpoint for specified categories.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    59
    56
    57
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Change in HSSD Tenderness Scale Score (n=59,56,57)
    -0.4 ± 2.78
    -2.1 ± 2.93
    -1.3 ± 2.56
        Change in HSSD Hot Skin Feeling Score(n=59,56,57)
    0.1 ± 2.85
    -1.6 ± 3.12
    -0.2 ± 3.16
        Change in HSSD Odor Scale Score (n=59,56,57)
    -0.4 ± 2.73
    -1.9 ± 2.58
    -1.2 ± 2.77
        Change in HSSD Itchiness Scale Score (n=59,56,57)
    0.1 ± 2.82
    -1.1 ± 3.28
    -0.5 ± 2.85
        Change in HSSD Pain Scale Score (n=56,55,56)
    -0.3 ± 2.64
    -1.8 ± 2.86
    -0.9 ± 2.34
        Change in HSSD Current Pain Score (n=56,55,56)
    -0.4 ± 2.71
    -1.5 ± 2.94
    -1.2 ± 2.76
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Draining Fistula Count of 0 at Week 16 for Subjects With Baseline Draining Fistula Count Greater Than 0

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    End point title
    		 Percentage of Subjects Who Achieved Draining Fistula Count of 0 at Week 16 for Subjects With Baseline Draining Fistula Count Greater Than 0
    End point description
    Percentage of subjects who achieved draining fistulas count of 0 at Week 16 for subjects with baseline draining fistula count >0 were reported. Draining fistula were defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation. Population analyzed included FAS subjects with baseline draining fistula count > 0. Subjects with missing data after applying treatment failure rules were assumed to be non-responders.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    41
    42
    39
    Units: percentage of subjects
        number (not applicable)
    36.6
    31.0
    20.5
    No statistical analyses for this end point

    Secondary: Change From Baseline in Number of Draining Fistulas at Week 16

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    End point title
    		 Change From Baseline in Number of Draining Fistulas at Week 16
    End point description
    Change from baseline in number of draining fistulas at Week 16 was reported. Draining fistula are defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation. FAS included all randomized subjects who received at least one administration of study intervention. The analysis was based on observed data after applying treatment failure rules (the change from baseline using observed data or 0 [no improvement] if a subject met TF criteria). Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    59
    57
    59
    Units: fistulas
        arithmetic mean (standard deviation)
    -0.5 ± 2.87
    -1.7 ± 3.77
    -0.8 ± 2.08
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Inflammatory Nodules Count of 0 at Week 16 for Subjects with Baseline Inflammatory Nodule Count Greater Than 0

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    End point title
    		 Percentage of Subjects Who Achieved Inflammatory Nodules Count of 0 at Week 16 for Subjects with Baseline Inflammatory Nodule Count Greater Than 0
    End point description
    Percentage of subjects who achieved inflammatory nodules count of 0 at Week 16 for subjects with baseline inflammatory nodules count >0 were reported. Population analyzed included FAS subjects with baseline inflammatory nodule count > 0. Subjects with missing data after applying treatment failure rules were assumed to be non-responders.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    62
    58
    59
    Units: percentage of subjects
        number (not applicable)
    17.7
    17.2
    18.6
    No statistical analyses for this end point

    Secondary: Change From Baseline in Number of Inflammatory Nodules at Week 16

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    End point title
    		 Change From Baseline in Number of Inflammatory Nodules at Week 16
    End point description
    Change from baseline in number of inflammatory nodules at Week 16 was reported. FAS included all randomized subjects who received at least one administration of study intervention. The analysis was based on observed data after applying treatment failure rules (the change from baseline using observed data or 0 (no improvement) if a subject met TF criteria). Here, N (number of subjects analyzed) signifies subjects who were evaluated for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    59
    57
    59
    Units: inflammatory nodule
        arithmetic mean (standard deviation)
    -2.8 ± 6.96
    -3.2 ± 7.84
    -3.7 ± 4.91
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Hidradenitis Suppurativa-investigator’s Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-Grade Improvement Relative to Baseline at Week 16

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    End point title
    		 Percentage of Subjects With Hidradenitis Suppurativa-investigator’s Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-Grade Improvement Relative to Baseline at Week 16
    End point description
    The HS-IGA documents the investigator’s assessment of the subject’s HS at a given timepoint. The anatomic region with the most severe HS activity at the baseline was evaluated for erythema, drainage, and pain and/or tenderness to palpation for each subject. The subject’s HS is assessed as inactive (0), almost inactive (1), mild activity (2), moderate activity (3), or severe activity (4). A higher score indicates more severe disease. Percentage of subjects with HS-IGA score of inactive (0), almost inactive (1), or mild activity (2) and with at least 2-grade improvement relative to baseline at Week 16 was determined. FAS included all randomized subjects who received at least one administration of study intervention. Subjects with missing data after applying treatment failure rules were assumed to be non-responders.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    62
    59
    60
    Units: percentage of subjects
    number (not applicable)
        HS-IGA scores of inactive (0)
    16.1
    13.6
    13.3
        HS-IGA scores of 0 or almost inactive (1)
    24.2
    28.8
    23.3
        HS-IGA scores of 0, 1, or mild activity (2)
    24.2
    35.6
    31.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With HS-IGA Score of Inactive (0) or Almost Inactive (1) at Week 16 Among Subjects with HS-IGA Score of Moderate Activity (3) or Severe Activity (4) at Baseline

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    End point title
    		 Percentage of Subjects With HS-IGA Score of Inactive (0) or Almost Inactive (1) at Week 16 Among Subjects with HS-IGA Score of Moderate Activity (3) or Severe Activity (4) at Baseline
    End point description
    The HS-IGA documents the investigator’s assessment of the subjects HS at a given timepoint. The anatomic region with the most severe HS activity at the baseline was evaluated for erythema, drainage, and pain and/or tenderness to palpation for each subject. Among subjects with score of moderate activity (3) or severe activity (4) at baseline, the same anatomic site selected for evaluation at the baseline will be re-evaluated at Week 16. The subjects HS is assessed as inactive (0), almost inactive (1), mild activity (2), moderate activity (3), or severe activity (4). A higher score indicates more severe disease. Percentage of subjects with HS-IGA score of inactive (0), almost inactive (1) at Week 16 among subjects with HS-IGA score of 3 or 4 at baseline were reported. Population analyzed included FAS subjects with HS-IGA scores of 3 or 4 at baseline. Subjects with missing data after applying treatment failure rules were assumed to be non-responders.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    62
    59
    60
    Units: percentage of subjects
        number (not applicable)
    27.3
    32.7
    25.0
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 16

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    End point title
    		 Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 16
    End point description
    The HADS comprises of 14 items, seven to assess anxiety (HADS-A), namely items 1, 3, 5, 7, 9, 11, and 13; and seven to assess depression (HADS-D), items 2, 4, 6, 8, 10, 12, and 14. Each item receives a score from 0 to 3 on a Likert Scale. The total score for each HADS-A and HADS-D scale is obtained by adding the individual scores for each item, with the maximum score 21. The presence or absence of depression and anxiety was defined, for each respective scale, based on the following cutoff values: HADS (anxiety): 0-8 equal to (=) no anxiety; >9 = anxiety; HADS (depression): 0-8 = no depression; >9 = depression. FAS included all randomized subjects who received at least one administration of study intervention. The analysis was based on observed data after applying treatment failure rules (the change from baseline using observed data or 0 [no improvement] if a subject met TF criteria). Here, N (number of subjects analyzed) signifies subjects who were evaluated for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    59
    57
    57
    Units: units on a scale
    arithmetic mean (standard deviation)
        HADS-A
    0.0 ± 2.60
    0.0 ± 2.82
    -0.3 ± 2.56
        HADS-D
    0.2 ± 2.48
    -0.6 ± 2.73
    -0.5 ± 2.69
    No statistical analyses for this end point

    Secondary: Change From Baseline in High-Sensitivity C-Reactive Protein (hs-CRP) at Week 16

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    End point title
    		 Change From Baseline in High-Sensitivity C-Reactive Protein (hs-CRP) at Week 16
    End point description
    Change from baseline in hs-CRP at Week 16 was reported. Serum samples were collected and analyzed for hsCRP. Change from Baseline was calculated as: ([hsCRP value at Week 16 minus Baseline value] divided by [Baseline value]). FAS included all randomized subjects who received at least one administration of study intervention. Subjects with missing data after applying treatment failure rules were assumed to be non-responders. Here, N (number of subjects analyzed) signifies subjects who were evaluated for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    52
    51
    52
    Units: milligrams per deciliter
        arithmetic mean (standard deviation)
    -0.308 ± 8.0840
    3.238 ± 19.0716
    -2.828 ± 11.1048
    No statistical analyses for this end point

    Secondary: Number of Subjects with Patient Global Impression of Change (PGIC) of Hidradenitis Suppurativa Severity Scale Score at Week 16

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    End point title
    		 Number of Subjects with Patient Global Impression of Change (PGIC) of Hidradenitis Suppurativa Severity Scale Score at Week 16
    End point description
    The PGIC of HS Severity is a questionnaire that measures subjects perceived change (improvement or deterioration) in severity of their HS. Subjects rated how his/her HS has changed since the beginning of the study using a 7-point scale ranging from 1 which indicates “a lot better now” to 7 which indicates “a lot worse now” with a neutral center point 4 which indicates (“neither better nor worse”). Subjects PGIC of HS Severity at Week 16 were reported. FAS included all randomized subjects who received at least one administration of study intervention. Subjects with missing data after applying treatment failure rules are assumed to be ‘Not improved’. Here, N (number of subjects analyzed) signifies subjects who were evaluated for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Number of subjects analysed
    56
    56
    56
    Units: subjects
    number (not applicable)
        A lot better now
    4
    13
    10
        Moderately better now
    7
    14
    11
        A little better now
    16
    10
    12
        No change
    20
    12
    18
        A little worse now
    3
    2
    4
        Moderately worse now
    5
    1
    1
        A lot worse now
    1
    4
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 48 weeks
    Adverse event reporting additional description
    Safety analysis set included all subjects who received at least 1 dose (complete or partial) of study intervention and subjects were analyzed based on the treatment they actually received, regardless of the treatment groups to which they were assigned.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Placebo (Week 0 - 16)
    Reporting group description
    		 Subjects received placebo intravenously (IV) and subcutaneously (SC) at Weeks 0, 4, 8 and an additional SC placebo at Week 12.

    Reporting group title
    Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16)
    Reporting group description
    		 Subjects received 1200 mg guselkumab IV at Weeks 0, 4, and 8, and 200 mg guselkumab SC at Week 12.

    Reporting group title
    Guselkumab 200 milligrams (mg) SC (Week 0 - 16)
    Reporting group description
    		 Subjects received 200 mg guselkumab SC at Weeks 0, 4, 8, and 12.

    Reporting group title
    Placebo Crossover to Guselkumab 100 mg SC (Week 16 - 48)
    Reporting group description
    		 At Week 16, subjects receiving placebo during placebo-controlled period were re-randomized to receive 100 mg guselkumab SC at Weeks 16, 20, 28 and 36 and placebo at Weeks 24 and 32. All subjects entered safety follow-up at Week 36 through Week 48.

    Reporting group title
    Placebo Crossover to Guselkumab 200 mg SC (Week 16 - 48)
    Reporting group description
    		 At Week 16, subjects receiving placebo during placebo-controlled period were re-randomized to receive 200 mg guselkumab SC every 4 weeks (q4w) through Week 36. All subjects entered safety follow-up at Week 36 through Week 48.

    Reporting group title
    Gus 1200 mg IV Crossover to Gus 200 mg SC (Week 16 - 48)
    Reporting group description
    		 Subjects who were receiving 1200 mg guselkumab IV during placebo-controlled period switched treatment at Week 12 to receive guselkumab 200 mg SC q4w through Week 36. All subjects entered safety follow-up at Week 36 through Week 48.

    Reporting group title
    Guselkumab 200 mg SC (Week 16 - 48)
    Reporting group description
    		 Subjects who were receiving 200 mg guselkumab SC during placebo-controlled period, continued to receive 200 mg guselkumab SC q4w through Week 36. All subjects entered safety follow-up at Week 36 through Week 48.

    Serious adverse events
    		 Placebo (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Placebo Crossover to Guselkumab 100 mg SC (Week 16 - 48) Placebo Crossover to Guselkumab 200 mg SC (Week 16 - 48) Gus 1200 mg IV Crossover to Gus 200 mg SC (Week 16 - 48) Guselkumab 200 mg SC (Week 16 - 48)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 62 (4.84%)
    1 / 60 (1.67%)
    1 / 59 (1.69%)
    3 / 28 (10.71%)
    0 / 28 (0.00%)
    2 / 57 (3.51%)
    3 / 56 (5.36%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Aortic Aneurysm
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 57 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 59 (1.69%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 57 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dysphagia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 57 (1.75%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 57 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 57 (1.75%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small Intestinal Perforation
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 57 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 57 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 57 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Tonsillar Hypertrophy
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 57 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    2 / 28 (7.14%)
    0 / 28 (0.00%)
    0 / 57 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression Suicidal
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 57 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 57 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    1 / 59 (1.69%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 57 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 57 (0.00%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic Shock
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 57 (1.75%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes Mellitus
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 57 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo (Week 0 - 16) Guselkumab 1200 mg IV to Gus 200 mg SC (Week 0 - 16) Guselkumab 200 milligrams (mg) SC (Week 0 - 16) Placebo Crossover to Guselkumab 100 mg SC (Week 16 - 48) Placebo Crossover to Guselkumab 200 mg SC (Week 16 - 48) Gus 1200 mg IV Crossover to Gus 200 mg SC (Week 16 - 48) Guselkumab 200 mg SC (Week 16 - 48)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 62 (35.48%)
    31 / 60 (51.67%)
    28 / 59 (47.46%)
    12 / 28 (42.86%)
    9 / 28 (32.14%)
    28 / 57 (49.12%)
    19 / 56 (33.93%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin Papilloma
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    2 / 28 (7.14%)
    0 / 28 (0.00%)
    0 / 57 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 62 (11.29%)
    2 / 60 (3.33%)
    6 / 59 (10.17%)
    3 / 28 (10.71%)
    0 / 28 (0.00%)
    3 / 57 (5.26%)
    2 / 56 (3.57%)
         occurrences all number
    11
    5
    9
    4
    0
    4
    5
    Migraine
         subjects affected / exposed
    0 / 62 (0.00%)
    3 / 60 (5.00%)
    1 / 59 (1.69%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 57 (0.00%)
    1 / 56 (1.79%)
         occurrences all number
    0
    3
    1
    1
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 62 (3.23%)
    7 / 60 (11.67%)
    2 / 59 (3.39%)
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    2 / 57 (3.51%)
    1 / 56 (1.79%)
         occurrences all number
    2
    7
    2
    0
    3
    3
    1
    Oedema Peripheral
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 60 (3.33%)
    1 / 59 (1.69%)
    2 / 28 (7.14%)
    0 / 28 (0.00%)
    1 / 57 (1.75%)
    0 / 56 (0.00%)
         occurrences all number
    0
    2
    1
    2
    0
    1
    0
    Gastrointestinal disorders
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 62 (3.23%)
    3 / 60 (5.00%)
    1 / 59 (1.69%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    2 / 57 (3.51%)
    2 / 56 (3.57%)
         occurrences all number
    2
    3
    1
    0
    0
    2
    2
    Diarrhoea
         subjects affected / exposed
    6 / 62 (9.68%)
    6 / 60 (10.00%)
    2 / 59 (3.39%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 57 (1.75%)
    4 / 56 (7.14%)
         occurrences all number
    7
    7
    2
    0
    0
    1
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 60 (0.00%)
    4 / 59 (6.78%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    3 / 57 (5.26%)
    1 / 56 (1.79%)
         occurrences all number
    1
    0
    4
    1
    0
    3
    1
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 60 (3.33%)
    1 / 59 (1.69%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    3 / 57 (5.26%)
    0 / 56 (0.00%)
         occurrences all number
    0
    2
    1
    1
    0
    3
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    3 / 57 (5.26%)
    3 / 56 (5.36%)
         occurrences all number
    1
    0
    0
    0
    0
    3
    4
    Erythema
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 60 (1.67%)
    0 / 59 (0.00%)
    2 / 28 (7.14%)
    0 / 28 (0.00%)
    0 / 57 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    0
    0
    Hidradenitis
         subjects affected / exposed
    1 / 62 (1.61%)
    7 / 60 (11.67%)
    3 / 59 (5.08%)
    2 / 28 (7.14%)
    4 / 28 (14.29%)
    4 / 57 (7.02%)
    6 / 56 (10.71%)
         occurrences all number
    1
    9
    4
    2
    4
    6
    8
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 60 (0.00%)
    3 / 59 (5.08%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 57 (1.75%)
    0 / 56 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 62 (4.84%)
    5 / 60 (8.33%)
    1 / 59 (1.69%)
    1 / 28 (3.57%)
    3 / 28 (10.71%)
    0 / 57 (0.00%)
    0 / 56 (0.00%)
         occurrences all number
    4
    6
    1
    1
    6
    0
    0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 60 (3.33%)
    0 / 59 (0.00%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    4 / 57 (7.02%)
    1 / 56 (1.79%)
         occurrences all number
    0
    3
    0
    0
    0
    4
    1
    Influenza
         subjects affected / exposed
    3 / 62 (4.84%)
    3 / 60 (5.00%)
    1 / 59 (1.69%)
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 57 (1.75%)
    1 / 56 (1.79%)
         occurrences all number
    3
    3
    1
    0
    0
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 62 (3.23%)
    9 / 60 (15.00%)
    12 / 59 (20.34%)
    4 / 28 (14.29%)
    8 / 28 (28.57%)
    12 / 57 (21.05%)
    10 / 56 (17.86%)
         occurrences all number
    2
    12
    12
    4
    12
    18
    11
    Upper Respiratory Tract Infection
         subjects affected / exposed
    3 / 62 (4.84%)
    5 / 60 (8.33%)
    3 / 59 (5.08%)
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    3 / 57 (5.26%)
    1 / 56 (1.79%)
         occurrences all number
    3
    5
    4
    1
    0
    3
    1
    Urinary Tract Infection
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 60 (0.00%)
    0 / 59 (0.00%)
    2 / 28 (7.14%)
    0 / 28 (0.00%)
    2 / 57 (3.51%)
    0 / 56 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 May 2019
    The overall rationale for the changes implemented in the protocol amendment was to include an additional urine pregnancy test at Week 48 of the study, increase the percentage of total subjects who are in Hurley Stage III, make necessary corrections to the total blood volume to be collected from each subject during the study, eliminate certain laboratory tests identified as not needed, resolve inconsistencies identified in the duration of continued contraception after the subject receives their last dose, and other minor typographical issues.

    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.
    No notable study limitations were identified by the Sponsor.
    For support, Contact us.
    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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