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    Clinical Trial Results:
    A Phase 3b, Multicenter, Interventional, Randomized, Placebo-controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar non-Pustular Psoriasis

    Summary
    EudraCT number
    		 2018-003206-58
    Trial protocol
    		 FR   DE   ES   GB   IT  
    Global end of trial date
    30 Nov 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Dec 2022
    First version publication date
    16 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO1959PSO3013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03998683
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 G-PLUS: CR108611
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International N.V
    Sponsor organisation address
    30, Turnhoutseweg, Belgium, 2340
    Public contact
    Clinical Registry Group, Janssen-Cilag International N.V, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International N.V, 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
    30 Nov 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to evaluate the efficacy of guselkumab for the treatment of palmoplantar non-pustular 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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Sep 2019
    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
    Germany: 66
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    France: 10
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    Italy: 17
    Worldwide total number of subjects
    117
    EEA total number of subjects
    109
    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)
    104
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 146 subjects were screened, of whom 29 subjects were screen failures. A total of 117 subjects were enrolled and treated in this study.

    Period 1
    Period 1 title
    PHASE IIIB TRIAL (overall period)
    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 a single subcutaneous (SC) injection of placebo matched to guselkumab at Weeks 0, 4, and 12, and guselkumab 100 milligrams (mg) SC injections at Weeks 16, 20, 28, 36, and 44.
    Arm type
    		 Placebo

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

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

    Arm title
    		 Guselkumab
    Arm description
    		 Subjects received a single subcutaneous (SC) injection of guselkumab 100 milligrams (mg) at Weeks 0, 4, 12, 20, 28, 36, and 44 and placebo injection matched to guselkumab at Week 16.
    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
    Single SC injection of placebo matched to guselkumab at Week 16.

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single SC injection of guselkumab 100 mg at Weeks 0, 4, 12, 20, 28, 36 and 44.

    Number of subjects in period 1
    		Placebo Guselkumab
    Started
    39
    78
    Completed
    31
    66
    Not completed
    8
    12
         Consent withdrawn by subject
    3
    3
         Initiated prohibited medication
    2
    -
         Adverse event, non-fatal
    -
    2
         Adverse event, serious non-fatal
    -
    1
         Unspecified
    -
    2
         Lost to follow-up
    1
    2
         Initiated rescue medication
    1
    -
         Lack of efficacy
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received a single subcutaneous (SC) injection of placebo matched to guselkumab at Weeks 0, 4, and 12, and guselkumab 100 milligrams (mg) SC injections at Weeks 16, 20, 28, 36, and 44.

    Reporting group title
    Guselkumab
    Reporting group description
    		 Subjects received a single subcutaneous (SC) injection of guselkumab 100 milligrams (mg) at Weeks 0, 4, 12, 20, 28, 36, and 44 and placebo injection matched to guselkumab at Week 16.

    Reporting group values
    		 Placebo Guselkumab Total
    Number of subjects
    		 39 78 117
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 35 69 104
        From 65 to 84 years
    		 4 9 13
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 47.8 ( 13.14 ) 51.6 ( 13.27 ) -
    Title for Gender
    Units: subjects
        Female
    		 15 42 57
        Male
    		 24 36 60

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received a single subcutaneous (SC) injection of placebo matched to guselkumab at Weeks 0, 4, and 12, and guselkumab 100 milligrams (mg) SC injections at Weeks 16, 20, 28, 36, and 44.

    Reporting group title
    Guselkumab
    Reporting group description
    		 Subjects received a single subcutaneous (SC) injection of guselkumab 100 milligrams (mg) at Weeks 0, 4, 12, 20, 28, 36, and 44 and placebo injection matched to guselkumab at Week 16.

    Primary: Percentage of Subjects who Achieved Palmoplantar Psoriasis Area and Severity Index (ppPASI75) Response at Week 16

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    End point title
    		 Percentage of Subjects who Achieved Palmoplantar Psoriasis Area and Severity Index (ppPASI75) Response at Week 16
    End point description
    ppPASI75 response was defined as improvement of greater than or equal to (>=) 75 percent (%) in ppPASI score from baseline. ppPASI: assessment tool based on PASI to assess severity of 3 symptoms - erythema, pustules/ induration, desquamation/ scale on palms or soles, each on a scale from 0 (none) to 4 (very severe), where higher score indicated more severe disease. Considering non-pustular palmoplantar disease, the score of pustules was set to '0' and thus the ppPASI75 total score was sum of sub-scores (erythema and desquamation) which ranged from 0 to 48, where higher score indicated more severe disease. Full analysis set included all randomised subjects who received at least 1 dose of study intervention and were analysed according to randomised treatment group, regardless of intervention they actually received.
    End point type
    Primary
    End point timeframe
    From baseline up to Week 16
    End point values
    		 Placebo Guselkumab
    Number of subjects analysed
    39
    78
    Units: percentage of subjects
        number (not applicable)
    28.2
    35.9
    Statistical analysis title
    		 Guselkumab versus Placebo
    Statistical analysis description
    Difference in rates between guselkumab and placebo
    Comparison groups
    Placebo v Guselkumab
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.533 [1]
    Method
    		 Fisher exact
    Parameter type
    		 Guselkumab&placebo:Percentage difference
    Point estimate
    7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.5
         upper limit
    		 24.7
    Notes
    [1] - The threshold for statistical significance was 0.05 level.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 56
    Adverse event reporting additional description
    The safety analysis set included all subjects who received one dose of study intervention and completed at least 1 follow-up safety assessment. Subjects were analysed according to the intervention they actually received.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Guselkumab
    Reporting group description
    		 Subjects received Guselkumab 100 mg subcutaneous (SC) injections at Weeks 0, 4, 12, 20, 28, 36, and 44 and placebo injection at Week 16.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo subcutaneous (SC) injections at Weeks 0, 4 and 12, and guselkumab 100 mg SC injections at Weeks 16, 20, 28, 36, and 44

    Serious adverse events
    		 Guselkumab Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 78 (6.41%)
    2 / 39 (5.13%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Humerus Fracture
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Duodenal Ulcer Haemorrhage
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Organising Pneumonia
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Viral Pharyngitis
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes Mellitus
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Guselkumab Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 78 (50.00%)
    10 / 39 (25.64%)
    Investigations
    C-Reactive Protein Increased
         subjects affected / exposed
    0 / 78 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 78 (6.41%)
    0 / 39 (0.00%)
         occurrences all number
    5
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 78 (7.69%)
    4 / 39 (10.26%)
         occurrences all number
    8
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 78 (6.41%)
    0 / 39 (0.00%)
         occurrences all number
    5
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 78 (7.69%)
    1 / 39 (2.56%)
         occurrences all number
    8
    1
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    4 / 78 (5.13%)
    0 / 39 (0.00%)
         occurrences all number
    4
    0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    3 / 78 (3.85%)
    3 / 39 (7.69%)
         occurrences all number
    5
    4
    Arthralgia
         subjects affected / exposed
    7 / 78 (8.97%)
    0 / 39 (0.00%)
         occurrences all number
    8
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    15 / 78 (19.23%)
    3 / 39 (7.69%)
         occurrences all number
    21
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jul 2019
    This amendment was created to provide further clarification on the inclusion, exclusion and withdrawal criteria to provide specificity on the subjects to be included in this study. The frequency of visits for tests and data collection was changed.
    22 Apr 2020
    This amendment was created to incorporate the following changes: The Coronavirus Disease 2019 (COVID-19) pandemic might have an impact on the conduct of this clinical study. In alignment with recent health authority guidance, the sponsor was providing options for study-related subject management in the event of disruption to the conduct of the study.
    18 Jun 2020
    This amendment was created to incorporate the following changes: to revise the sample size of the study. In addition, a COVID-19 pandemic-related exclusion criterion was added, and the guidance for the reporting of adverse events was updated to include combination products.
    16 Jul 2020
    This amendment was created to clarify that subjects who received prior systemic treatment with JAK inhibitors would be excluded from the study.

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

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

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