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    Clinical Trial Results:
    A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Oral Tablet Formulation of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis

    Summary
    EudraCT number
    		 2021-005987-23
    Trial protocol
    		 FR   ES  
    Global end of trial date
    11 Apr 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Apr 2024
    First version publication date
    25 Apr 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    77242113PSO2003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05357755
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 Route 202, South Raritan, New Jersey, United States, 08869
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Apr 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Apr 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to evaluate the efficacy of an oral tablet formulation of JNJ-77242113 compared with placebo in subjects with moderate-to-severe plaque 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
    13 Jun 2022
    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: 13
    Country: Number of subjects enrolled
    Germany: 12
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Poland: 21
    Country: Number of subjects enrolled
    United States: 34
    Worldwide total number of subjects
    89
    EEA total number of subjects
    42
    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)
    84
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 118 subjects were screened, out of which 28 subjects were screen failure. A total of 90 subjects were randomised, out of which 1 subject was inadvertently randomised but never treated. Hence, 89 subjects started the study and received study treatment.

    Period 1
    Period 1 title
    Overall Study (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 with moderate to severe plaque psoriasis, received placebo delayed release tablet orally matching to JNJ-77242113 to maintain the blind once daily (QD) from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo delayed release tablet once daily.

    Arm title
    		 JNJ-77242113 10 mg QD
    Arm description
    		 Subjects with moderate to severe plaque psoriasis, received 10 milligrams (mg) of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-77242113
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received JNJ-77242113 10 mg delayed release tablet once daily.

    Arm title
    		 JNJ-77242113 50 mg QD
    Arm description
    		 Subjects with moderate to severe plaque psoriasis, received 50 mg of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-77242113
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received JNJ-77242113 50 mg delayed release tablet once daily.

    Number of subjects in period 1
    		Placebo JNJ-77242113 10 mg QD JNJ-77242113 50 mg QD
    Started
    24
    31
    34
    Completed
    15
    22
    32
    Not completed
    9
    9
    2
         Consent withdrawn by subject
    7
    6
    1
         Unspecified
    1
    2
    -
         Lost to follow-up
    1
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis, received placebo delayed release tablet orally matching to JNJ-77242113 to maintain the blind once daily (QD) from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose.

    Reporting group title
    JNJ-77242113 10 mg QD
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis, received 10 milligrams (mg) of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose.

    Reporting group title
    JNJ-77242113 50 mg QD
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis, received 50 mg of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose.

    Reporting group values
    		 Placebo JNJ-77242113 10 mg QD JNJ-77242113 50 mg QD Total
    Number of subjects
    		 24 31 34 89
    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)
    		 23 30 31 84
        From 65 to 84 years
    		 1 1 3 5
        85 years and over
    		 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.2 ( 12.78 ) 41.2 ( 12.36 ) 42.2 ( 15.06 ) -
    Title for Gender
    Units: subjects
        Female
    		 8 8 12 28
        Male
    		 16 23 22 61
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 1 1 2 4
        Black or African American
    		 0 1 1 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        White
    		 21 27 30 78
        More than one race
    		 0 0 1 1
        Unknown or Not Reported
    		 2 2 0 4
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 4 1 5 10
        Not Hispanic or Latino
    		 20 29 29 78
        Unknown or Not Reported
    		 0 1 0 1
    Region of Enrollment
    Units: Subjects
        Canada
    		 2 4 7 13
        France
    		 1 2 2 5
        Germany
    		 5 3 4 12
        Poland
    		 5 11 5 21
        Spain
    		 1 1 2 4
        United States
    		 10 10 14 34

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis, received placebo delayed release tablet orally matching to JNJ-77242113 to maintain the blind once daily (QD) from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose.

    Reporting group title
    JNJ-77242113 10 mg QD
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis, received 10 milligrams (mg) of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose.

    Reporting group title
    JNJ-77242113 50 mg QD
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis, received 50 mg of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose.

    Primary: Percentages of Subjects who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index Score (PASI 75) at Week 16

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    End point title
    		 Percentages of Subjects who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index Score (PASI 75) at Week 16
    End point description
    Percentages of subjects who achieved PASI 75 (greater than or equal to [>=] 75% improvement from baseline in PASI) at Week 16 were reported. PASI score: used for assessing and grading the severity of psoriatic lesions and their response to therapy. To calculate PASI scores, the body was divided into 4 regions: head, trunk, upper and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe, 4=very severe) and extent of involvement from 0 (no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. Baseline: the closest measurement taken prior to or at the time of first study intervention administration date. Full analysis set (FAS): all randomised subjects who took at least 1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo JNJ-77242113 10 mg QD JNJ-77242113 50 mg QD
    Number of subjects analysed
    24
    31
    34
    Units: Percentage of subjects
        number (not applicable)
    4.2
    41.9
    73.5
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v JNJ-77242113 50 mg QD
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    JNJ-77242113 10 mg QD v Placebo
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Number of Subjects With Treatment-emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
    End point description
    An adverse event (AE) is any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAE was defined as any adverse event that occurs at or after the initial administration of study intervention. The baseline measurement was defined as the closest measurement taken prior to or at the time of the first study intervention administration date. Data included all TEAEs (both serious and non-serious). The safety analysis set included all randomised subjects who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    From baseline (Week 0) up to 4 weeks after last dose of study drug (up to 20 weeks)
    End point values
    		 Placebo JNJ-77242113 10 mg QD JNJ-77242113 50 mg QD
    Number of subjects analysed
    24
    31
    34
    Units: Subjects
    14
    13
    20
    No statistical analyses for this end point

    Secondary: Percentages of Subjects who Achieved at Least 90% Improvement From Baseline in PASI Score (PASI 90) at Week 16

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    End point title
    		 Percentages of Subjects who Achieved at Least 90% Improvement From Baseline in PASI Score (PASI 90) at Week 16
    End point description
    Percentages of subjects who achieved PASI 90 (>=90% improvement from baseline in PASI) at Week 16 were reported. The PASI score used for assessing and grading the severity of psoriatic lesions and their response to therapy. To calculate PASI scores, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe and 4=very severe) and extent of involvement from 0 (no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of first study intervention administration date. FAS: all randomised subjects who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo JNJ-77242113 10 mg QD JNJ-77242113 50 mg QD
    Number of subjects analysed
    24
    31
    34
    Units: Percentage of subjects
        number (not applicable)
    0
    25.8
    52.9
    Statistical analysis title
    		 Statistical Analysis 6
    Comparison groups
    Placebo v JNJ-77242113 50 mg QD
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 5
    Comparison groups
    Placebo v JNJ-77242113 10 mg QD
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Number of Subjects With Serious TEAEs

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    End point title
    		 Number of Subjects With Serious TEAEs
    End point description
    An AE is any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death, is life threatening, require inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. TEAE was defined as any adverse event that occurs at or after the initial administration of study intervention. The baseline measurement was defined as the closest measurement taken prior to or at the time of the first study intervention administration date. The safety analysis set included all randomised subjects who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    From baseline (Week 0) up to 4 weeks after last dose of study drug (up to 20 weeks)
    End point values
    		 Placebo JNJ-77242113 10 mg QD JNJ-77242113 50 mg QD
    Number of subjects analysed
    24
    31
    34
    Units: Subjects
    0
    0
    2
    No statistical analyses for this end point

    Secondary: Change From Baseline in PASI Total Score at Week 16

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    End point title
    		 Change From Baseline in PASI Total Score at Week 16
    End point description
    Change from baseline in PASI total score at Week 16 was reported. PASI score: used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI scores, the body was divided into 4 regions: head, trunk, upper extremities and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe, 4=very severe) and extent of involvement from 0 (no involvement) to 6 (90% - 100% involvement). PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. Baseline was defined as the closest measurement taken prior to or at the time of first study agent administration date. FAS: all randomised subjects who took at least 1 dose of study intervention. Here, 'N' (number of subjects analysed)= number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo JNJ-77242113 10 mg QD JNJ-77242113 50 mg QD
    Number of subjects analysed
    21
    25
    33
    Units: Units on a score
        arithmetic mean (standard deviation)
    -4.30 ( 6.105 )
    -11.56 ( 9.425 )
    -16.84 ( 8.278 )
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Placebo v JNJ-77242113 50 mg QD
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v JNJ-77242113 10 mg QD
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Percentages of Subjects who Achieved 100% Improvement From Baseline in PASI Score (PASI 100) at Week 16

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    End point title
    		 Percentages of Subjects who Achieved 100% Improvement From Baseline in PASI Score (PASI 100) at Week 16
    End point description
    Percentages of subjects who achieved PASI 100 (100% improvement from baseline in PASI) at Week 16 were reported. The PASI score, used for assessing and grading the severity of psoriatic lesions and their response to therapy. To calculate PASI scores, the body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe and 4=very severe) and extent of involvement from 0 (no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of first study intervention administration date. FAS included all randomised subjects who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo JNJ-77242113 10 mg QD JNJ-77242113 50 mg QD
    Number of subjects analysed
    24
    31
    34
    Units: Percentage of subjects
        number (not applicable)
    0
    9.7
    23.5
    Statistical analysis title
    		 Statistical Analysis 8
    Comparison groups
    Placebo v JNJ-77242113 50 mg QD
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.011
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 7
    Comparison groups
    Placebo v JNJ-77242113 10 mg QD
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.125
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percentages of Subjects who Achieved an Investigator Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16

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    End point title
    		 Percentages of Subjects who Achieved an Investigator Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
    End point description
    Percentages of subjects who achieved an IGA score of cleared (0) or minimal (1) at Week 16 was reported. The IGA documented the investigator’s assessment of the subject’s psoriasis at a given time point. Overall lesions were graded for induration, erythema, and scaling. The subject’s psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score indicated more severe disease. The FAS included all randomised subjects who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo JNJ-77242113 10 mg QD JNJ-77242113 50 mg QD
    Number of subjects analysed
    24
    31
    34
    Units: Percentage of subjects
        number (not applicable)
    4.2
    41.9
    73.5
    Statistical analysis title
    		 Statistical Analysis 10
    Comparison groups
    Placebo v JNJ-77242113 50 mg QD
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 9
    Comparison groups
    Placebo v JNJ-77242113 10 mg QD
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percent Change From Baseline in Psoriasis-Affected Body Surface Area (BSA) at Week 16

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    End point title
    		 Percent Change From Baseline in Psoriasis-Affected Body Surface Area (BSA) at Week 16
    End point description
    Percent change from baseline in psoriasis-affected BSA at Week 16 was reported. BSA was commonly used measure of severity of skin disease. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). BSA was assessed using handprint method where the surface area of the subject’s hand including the palm and all 5 digits was used as a guide to estimate 1% BSA. Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis. The baseline measurement was defined as the closest measurement taken prior to or at the time of the first study intervention administration date. The FAS included all randomised subjects who took at least 1 dose of study intervention. Here, 'N' (number of subjects analysed) refers to the number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo JNJ-77242113 10 mg QD JNJ-77242113 50 mg QD
    Number of subjects analysed
    21
    25
    33
    Units: Percent change
        arithmetic mean (standard deviation)
    -0.9 ( 8.26 )
    -14.9 ( 15.09 )
    -20.1 ( 12.63 )
    Statistical analysis title
    		 Statistical Analysis 14
    Comparison groups
    Placebo v JNJ-77242113 50 mg QD
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 13
    Comparison groups
    Placebo v JNJ-77242113 10 mg QD
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Percentages of Subjects Who Achieved an IGA Score of Cleared (0) at Week 16

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    End point title
    		 Percentages of Subjects Who Achieved an IGA Score of Cleared (0) at Week 16
    End point description
    Percentages of subjects who achieved an IGA score of cleared (0) at Week 16 was reported. The IGA documented the investigator’s assessment of the subject’s psoriasis at a given time point. Overall lesions were graded for induration, erythema, and scaling. The subject’s psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score indicated more severe disease. The FAS included all randomised subjects who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo JNJ-77242113 10 mg QD JNJ-77242113 50 mg QD
    Number of subjects analysed
    24
    31
    34
    Units: Percentage of subjects
        number (not applicable)
    0
    12.9
    29.4
    Statistical analysis title
    		 Statistical Analysis 12
    Comparison groups
    Placebo v JNJ-77242113 50 mg QD
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical Analysis 11
    Comparison groups
    Placebo v JNJ-77242113 10 mg QD
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.071
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All cause mortality: From screening up to 4 weeks after last dose of study drug (up to Week 24); Serious AEs and non-serious AEs: From baseline (Week 0) up to 4 weeks after last dose of study drug (up to Week 20)
    Adverse event reporting additional description
    The safety analysis set included all randomised subjects who took at least 1 dose of study intervention.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis, received placebo delayed release tablet orally matching to JNJ-77242113 to maintain the blind once daily (QD) from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose.

    Reporting group title
    JNJ-77242113 50 mg QD
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis, received 50 mg of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose.

    Reporting group title
    JNJ-77242113 10 mg QD
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis, received 10 milligrams (mg) of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose.

    Serious adverse events
    		 Placebo JNJ-77242113 50 mg QD JNJ-77242113 10 mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 34 (5.88%)
    0 / 31 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Radius Fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 34 (2.94%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 34 (2.94%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo JNJ-77242113 50 mg QD JNJ-77242113 10 mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 24 (41.67%)
    11 / 34 (32.35%)
    7 / 31 (22.58%)
    Investigations
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 34 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    0
    3
    Blood Glucose Increased
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 34 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    0
    2
    Alanine Aminotransferase Increased
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 34 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    0
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 34 (5.88%)
    0 / 31 (0.00%)
         occurrences all number
    0
    3
    0
    General disorders and administration site conditions
    Influenza Like Illness
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 34 (5.88%)
    0 / 31 (0.00%)
         occurrences all number
    0
    2
    0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 34 (2.94%)
    0 / 31 (0.00%)
         occurrences all number
    2
    1
    0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 34 (5.88%)
    0 / 31 (0.00%)
         occurrences all number
    0
    2
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 34 (2.94%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1
    1
    Covid-19
         subjects affected / exposed
    0 / 24 (0.00%)
    3 / 34 (8.82%)
    0 / 31 (0.00%)
         occurrences all number
    0
    3
    0
    Urinary Tract Infection
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 34 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    2
    0
    1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    4 / 24 (16.67%)
    2 / 34 (5.88%)
    1 / 31 (3.23%)
         occurrences all number
    5
    5
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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