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    Clinical Trial Results:
    A Phase 2b Multicenter, Long-Term Extension, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis

    Summary
    EudraCT number
    		 2021-004320-16
    Trial protocol
    		 DE   ES   PL  
    Global end of trial date
    29 Sep 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Oct 2024
    First version publication date
    11 Oct 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    77242113PSO2002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05364554
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 US Highway, Raritan, 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
    29 Sep 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Sep 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 long-term clinical response of JNJ-77242113 treatment 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 Practice and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 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: 34
    Country: Number of subjects enrolled
    Germany: 38
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Japan: 19
    Country: Number of subjects enrolled
    Korea, Republic of: 11
    Country: Number of subjects enrolled
    Poland: 57
    Country: Number of subjects enrolled
    Taiwan: 13
    Country: Number of subjects enrolled
    United States: 39
    Worldwide total number of subjects
    227
    EEA total number of subjects
    108
    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)
    212
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Total of 227 subjects entered study 77242113PSO2002 (long-term extension, LTE) after completing originating study 77242113PSO2001 (EudraCT: 2021-003700-41) Week (W) 16. Pre protocol, data collected from W0 (originating study) through W52 (LTE W36) and from W16 (LTE W0) through W56 (LTE W40) were analysed for efficacy and safety, respectively.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo Then JNJ-77242113 100 mg QD
    Arm description
    		 Subjects originally randomised to placebo in originating study (77242113PSO2001) received orally once daily (QD) dose of JNJ-77242113 100 milligrams (mg) tablet in the morning from Week 0 through Week 36 in this LTE study.
    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 originally randomised to placebo in originating study (77242113PSO2001) received JNJ-77242113 100 mg tablet QD from Week 0 through Week 36 in this LTE study.

    Arm title
    		 JNJ-77242113 25 mg QD
    Arm description
    		 Subjects received orally QD dose of JNJ-77242113 25 mg tablet in the morning from Week 0 through Week 36 in this LTE study.
    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 25 mg QD in the morning from Week 0 through Week 36.

    Arm title
    		 JNJ-77242113 50 mg QD
    Arm description
    		 Subjects received orally QD dose of JNJ-77242113 50 mg tablet in the morning from Week 0 through Week 36 in this LTE study.
    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 (2 tablets of 25 mg) QD in the morning from Week 0 through Week 36.

    Arm title
    		 JNJ-77242113 25 mg BID
    Arm description
    		 Subjects received orally twice daily (BID; morning and evening) dose of JNJ-77242113 25 mg tablet from Week 0 through Week 36 in this LTE study.
    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 25 mg BID (morning and evening) from Week 0 through Week 36.

    Arm title
    		 JNJ-77242113 100 mg QD
    Arm description
    		 Subjects received orally QD dose of JNJ-77242113 100 mg tablet in the morning from Week 0 through Week 36 in this LTE study.
    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 100 mg QD in the morning from Week 0 through Week 36.

    Arm title
    		 JNJ-77242113 100 mg BID
    Arm description
    		 Subjects received orally BID (morning and evening) dose of JNJ-77242113 100 mg tablet from Week 0 through Week 36 in this LTE study.
    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 100 mg BID (morning and evening) from Week 0 through Week 36.

    Number of subjects in period 1
    		Placebo Then JNJ-77242113 100 mg QD JNJ-77242113 25 mg QD JNJ-77242113 50 mg QD JNJ-77242113 25 mg BID JNJ-77242113 100 mg QD JNJ-77242113 100 mg BID
    Started
    35
    35
    39
    40
    40
    38
    Completed
    29
    27
    33
    30
    33
    35
    Not completed
    6
    8
    6
    10
    7
    3
         Unspecified
    1
    2
    2
    1
    2
    1
         Lost to follow-up
    -
    2
    1
    2
    1
    1
         Withdrawal by subject
    5
    4
    3
    7
    4
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo Then JNJ-77242113 100 mg QD
    Reporting group description
    		 Subjects originally randomised to placebo in originating study (77242113PSO2001) received orally once daily (QD) dose of JNJ-77242113 100 milligrams (mg) tablet in the morning from Week 0 through Week 36 in this LTE study.

    Reporting group title
    JNJ-77242113 25 mg QD
    Reporting group description
    		 Subjects received orally QD dose of JNJ-77242113 25 mg tablet in the morning from Week 0 through Week 36 in this LTE study.

    Reporting group title
    JNJ-77242113 50 mg QD
    Reporting group description
    		 Subjects received orally QD dose of JNJ-77242113 50 mg tablet in the morning from Week 0 through Week 36 in this LTE study.

    Reporting group title
    JNJ-77242113 25 mg BID
    Reporting group description
    		 Subjects received orally twice daily (BID; morning and evening) dose of JNJ-77242113 25 mg tablet from Week 0 through Week 36 in this LTE study.

    Reporting group title
    JNJ-77242113 100 mg QD
    Reporting group description
    		 Subjects received orally QD dose of JNJ-77242113 100 mg tablet in the morning from Week 0 through Week 36 in this LTE study.

    Reporting group title
    JNJ-77242113 100 mg BID
    Reporting group description
    		 Subjects received orally BID (morning and evening) dose of JNJ-77242113 100 mg tablet from Week 0 through Week 36 in this LTE study.

    Reporting group values
    		 Placebo Then JNJ-77242113 100 mg QD JNJ-77242113 25 mg QD JNJ-77242113 50 mg QD JNJ-77242113 25 mg BID JNJ-77242113 100 mg QD JNJ-77242113 100 mg BID Total
    Number of subjects
    		 35 35 39 40 40 38 227
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 31 34 38 36 37 36 212
        From 65 to 84 years
    		 4 1 1 4 3 2 15
        85 years and over
    		 0 0 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.3 ( 13.96 ) 45.1 ( 12.43 ) 44.6 ( 9.51 ) 46.1 ( 11.75 ) 43.8 ( 14.03 ) 41.6 ( 11.71 ) -
    Title for Gender
    Units: subjects
        Female
    		 15 9 15 11 10 11 71
        Male
    		 20 26 24 29 30 27 156

    End points

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    End points reporting groups
    Reporting group title
    Placebo Then JNJ-77242113 100 mg QD
    Reporting group description
    		 Subjects originally randomised to placebo in originating study (77242113PSO2001) received orally once daily (QD) dose of JNJ-77242113 100 milligrams (mg) tablet in the morning from Week 0 through Week 36 in this LTE study.

    Reporting group title
    JNJ-77242113 25 mg QD
    Reporting group description
    		 Subjects received orally QD dose of JNJ-77242113 25 mg tablet in the morning from Week 0 through Week 36 in this LTE study.

    Reporting group title
    JNJ-77242113 50 mg QD
    Reporting group description
    		 Subjects received orally QD dose of JNJ-77242113 50 mg tablet in the morning from Week 0 through Week 36 in this LTE study.

    Reporting group title
    JNJ-77242113 25 mg BID
    Reporting group description
    		 Subjects received orally twice daily (BID; morning and evening) dose of JNJ-77242113 25 mg tablet from Week 0 through Week 36 in this LTE study.

    Reporting group title
    JNJ-77242113 100 mg QD
    Reporting group description
    		 Subjects received orally QD dose of JNJ-77242113 100 mg tablet in the morning from Week 0 through Week 36 in this LTE study.

    Reporting group title
    JNJ-77242113 100 mg BID
    Reporting group description
    		 Subjects received orally BID (morning and evening) dose of JNJ-77242113 100 mg tablet from Week 0 through Week 36 in this LTE study.

    Subject analysis set title
    Placebo - JNJ-77242113 100 Milligrams (mg) Once Daily (QD)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects originally randomised to placebo in originating study (77242113PSO2001) received orally QD dose of JNJ-77242113 100 mg tablet in the morning from Week 0 through Week 36 in this LTE study.

    Subject analysis set title
    JNJ-77242113 25 mg QD
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received orally QD dose of JNJ-77242113 25 mg tablet in the morning from Week 0 through Week 36 in this LTE study.

    Subject analysis set title
    JNJ-77242113 50 mg QD
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received orally QD dose of JNJ-77242113 50 mg tablet in the morning from Week 0 through Week 36 in this LTE study.

    Subject analysis set title
    JNJ-77242113 25 mg Twice Daily (BID)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received orally twice daily (BID; morning and evening) dose of JNJ-77242113 25 mg tablet from Week 0 through Week 36 in this LTE study.

    Subject analysis set title
    JNJ-77242113 100 mg QD
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received orally QD dose of JNJ-77242113 100 mg tablet in the morning from Week 0 through Week 36 in this LTE study.

    Subject analysis set title
    JNJ-77242113 100 mg BID
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received orally BID (morning and evening) dose of JNJ-77242113 100 mg tablet from Week 0 through Week 36 in this LTE study.

    Primary: Percentage of Subjects Who Achieved Greater Than or Equal to (>=) 75 Percent (%) Improvement From Baseline in Psoriasis Area Severity Index (PASI) Score (PASI-75) at LTE Week 36

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    End point title
    		 Percentage of Subjects Who Achieved Greater Than or Equal to (>=) 75 Percent (%) Improvement From Baseline in Psoriasis Area Severity Index (PASI) Score (PASI-75) at LTE Week 36 [1]
    End point description
    The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, 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 scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement on scale of 0 (no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. Full analysis set (FAS) included randomised subjects who received at least one dose of study intervention in the originating study (77242113PSO2001) for subjects initially randomised to JNJ-77242113, and subjects who crossed over and received JNJ-77242113 for subjects initially randomised to placebo.
    End point type
    Primary
    End point timeframe
    LTE Week 36
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics was done, no inferential statistical analysis was performed.
    End point values
    		 Placebo - JNJ-77242113 100 Milligrams (mg) Once Daily (QD) JNJ-77242113 25 mg QD JNJ-77242113 50 mg QD JNJ-77242113 25 mg Twice Daily (BID) JNJ-77242113 100 mg QD JNJ-77242113 100 mg BID
    Number of subjects analysed
    35
    43
    43
    41
    43
    42
    Units: Percentage of subjects
        number (not applicable)
    65.7
    48.8
    69.8
    58.5
    65.1
    76.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved at Least 90% Improvement From Baseline in PASI Score (PASI-90) at LTE Week 36

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    End point title
    		 Percentage of Subjects Who Achieved at Least 90% Improvement From Baseline in PASI Score (PASI-90) at LTE Week 36
    End point description
    The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, 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 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range on a scale of 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. FAS: subjects who received at least one dose of study intervention in the originating study (77242113PSO2001) for subjects initially randomised to JNJ-77242113 and who crossed over and received JNJ-77242113 initially randomised to placebo.
    End point type
    Secondary
    End point timeframe
    LTE Week 36
    End point values
    		 Placebo - JNJ-77242113 100 Milligrams (mg) Once Daily (QD) JNJ-77242113 25 mg QD JNJ-77242113 50 mg QD JNJ-77242113 25 mg Twice Daily (BID) JNJ-77242113 100 mg QD JNJ-77242113 100 mg BID
    Number of subjects analysed
    35
    43
    43
    41
    43
    42
    Units: Percentage of subjects
        number (not applicable)
    57.1
    27.9
    41.9
    36.6
    51.2
    64.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved 100% Improvement From Baseline in PASI Score (PASI-100) at LTE Week 36

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    End point title
    		 Percentage of Subjects Who Achieved 100% Improvement From Baseline in PASI Score (PASI-100) at LTE Week 36
    End point description
    The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges on a scale of 0 (no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. Subjects with 100% improvement in PASI from baseline were considered PASI 100 responders. Higher score indicated more severe disease. FAS: subjects who received at least one dose of study intervention in the originating study (77242113PSO2001) for subjects initially randomised to JNJ-77242113 and who crossed over and received JNJ-77242113 initially randomised to placebo.
    End point type
    Secondary
    End point timeframe
    LTE Week 36
    End point values
    		 Placebo - JNJ-77242113 100 Milligrams (mg) Once Daily (QD) JNJ-77242113 25 mg QD JNJ-77242113 50 mg QD JNJ-77242113 25 mg Twice Daily (BID) JNJ-77242113 100 mg QD JNJ-77242113 100 mg BID
    Number of subjects analysed
    35
    43
    43
    41
    43
    42
    Units: Percentage of subjects
        number (not applicable)
    34.3
    14.0
    20.9
    17.1
    25.6
    40.5
    No statistical analyses for this end point

    Secondary: Change From Baseline in PASI Total Score at LTE Week 36 

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    End point title
    		 Change From Baseline in PASI Total Score at LTE Week 36 
    End point description
    The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, 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 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 (indicated 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 more severe disease. FAS: who received at least one dose of study intervention in the originating study (77242113PSO2001) for subjects initially randomised to JNJ-77242113 and who crossed over and received JNJ-77242113 initially randomised to placebo. N (number of subjects analysed) referred to the number of subjects evaluable for this endpoint
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of originating study), LTE Week 36
    End point values
    		 Placebo - JNJ-77242113 100 Milligrams (mg) Once Daily (QD) JNJ-77242113 25 mg QD JNJ-77242113 50 mg QD JNJ-77242113 25 mg Twice Daily (BID) JNJ-77242113 100 mg QD JNJ-77242113 100 mg BID
    Number of subjects analysed
    34
    34
    40
    36
    35
    35
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -14.15 ( 8.068 )
    -13.55 ( 8.232 )
    -14.45 ( 6.878 )
    -13.24 ( 8.981 )
    -15.81 ( 8.908 )
    -18.46 ( 7.892 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at LTE Week 36

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    End point title
    		 Percentage of Subjects Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at LTE Week 36
    End point description
    Percentage of subjects who achieved an IGA score of cleared (0) or minimal (1) at LTE Week 36 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. FAS: who received at least one dose of study intervention in the originating study (77242113PSO2001) for subjects initially randomised to JNJ-77242113 and subjects who crossed over and received JNJ-77242113 initially randomised to placebo.
    End point type
    Secondary
    End point timeframe
    LTE Week 36
    End point values
    		 Placebo - JNJ-77242113 100 Milligrams (mg) Once Daily (QD) JNJ-77242113 25 mg QD JNJ-77242113 50 mg QD JNJ-77242113 25 mg Twice Daily (BID) JNJ-77242113 100 mg QD JNJ-77242113 100 mg BID
    Number of subjects analysed
    35
    43
    43
    41
    43
    42
    Units: Percentage of subjects
        number (not applicable)
    65.7
    37.2
    60.5
    46.3
    60.5
    73.8
    No statistical analyses for this end point

    Secondary: Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at LTE Week 36

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    End point title
    		 Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at LTE Week 36
    End point description
    PSSD, patient-reported outcome questionnaire aimed to measure severity of psoriasis symptoms and signs for treatment benefit assessment. PSSD questionnaire included 11 items:symptoms (itch, pain, stinging, burning and skin tightness) and subject observable signs (skin dryness, cracking, scaling, shedding/flaking, redness and bleeding) using 0 to 10 numerical ratings. Each item severity was rated on 11-point numeric scale ranged from 0(absent) to 10(worst imaginable). Symptom score:by averaging 5 questions and multiplying by 10. PSSD symptom score ranged from 0 to 100, derived from average of symptom scores, where 0=least severe symptom; 100=most severe disease. Higher score=more severe symptom. FAS:who received at least 1 dose of study intervention in originating study (77242113PSO2001) for subjects initially randomised to JNJ-77242113 and who crossed over and received JNJ-77242113 initially randomised to placebo. N (number of subjects analysed)=subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of originating study), LTE Week 36
    End point values
    		 Placebo - JNJ-77242113 100 Milligrams (mg) Once Daily (QD) JNJ-77242113 25 mg QD JNJ-77242113 50 mg QD JNJ-77242113 25 mg Twice Daily (BID) JNJ-77242113 100 mg QD JNJ-77242113 100 mg BID
    Number of subjects analysed
    34
    34
    40
    36
    35
    36
    Units:  Units on a scale
        arithmetic mean (standard deviation)
    -29.5 ( 25.59 )
    -30.1 ( 28.09 )
    -35.2 ( 30.81 )
    -31.2 ( 28.48 )
    -29.4 ( 27.41 )
    -47.7 ( 28.04 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in PSSD Signs Score at LTE Week 36

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    End point title
    		 Change From Baseline in PSSD Signs Score at LTE Week 36
    End point description
    PSSD, patient-reported outcome questionnaire aimed to measure severity of psoriasis symptoms and signs for treatment benefit assessment. PSSD questionnaire included 11 items:symptoms (itch, pain, stinging, burning and skin tightness) and subject observable signs (skin dryness, cracking, scaling, shedding/flaking, redness and bleeding) using 0 to 10 numerical ratings. Each item severity was rated on 11-point numeric scale ranged from 0(absent) to 10(worst imaginable). Symptom score:by averaging 5 questions and multiplying by 10. PSSD symptom score ranged from 0 to 100, derived from average of symptom scores, where 0=least severe symptom; 100=most severe disease. Higher score=more severe symptom. FAS:who received at least 1 dose of study intervention in originating study (77242113PSO2001) for subjects initially randomised to JNJ-77242113 and who crossed over and received JNJ-77242113 initially randomised to placebo. N (number of subjects analysed)=subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of originating study), LTE Week 36
    End point values
    		 Placebo - JNJ-77242113 100 Milligrams (mg) Once Daily (QD) JNJ-77242113 25 mg QD JNJ-77242113 50 mg QD JNJ-77242113 25 mg Twice Daily (BID) JNJ-77242113 100 mg QD JNJ-77242113 100 mg BID
    Number of subjects analysed
    34
    34
    40
    36
    35
    36
    Units:  Units on a scale
        arithmetic mean (standard deviation)
    -42.8 ( 28.65 )
    -35.2 ( 29.02 )
    -39.2 ( 31.64 )
    -36.6 ( 29.16 )
    -43.1 ( 26.87 )
    -53.1 ( 22.03 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved PSSD Symptoms Score Equal (=)0 at LTE Week 36 Among Subjects With a Baseline (Week 0 of the Originating Study) Symptoms Score >=1

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    End point title
    		 Percentage of Subjects Who Achieved PSSD Symptoms Score Equal (=)0 at LTE Week 36 Among Subjects With a Baseline (Week 0 of the Originating Study) Symptoms Score >=1
    End point description
    PSSD, patient-reported outcome questionnaire aimed to measure severity of psoriasis symptoms and signs for treatment benefit assessment. PSSD questionnaire included 11 items:symptoms (itch, pain, stinging, burning and skin tightness) and subject observable signs (skin dryness, cracking, scaling, shedding/flaking, redness and bleeding) using 0 to 10 numerical ratings. Each item severity was rated on 11-point numeric scale: 0(absent) to 10(worst imaginable). Symptom score:by averaging 5 questions and multiplying by 10. PSSD symptom score ranged from 0 to 100,(0=least severe symptom; 100=most severe disease). Higher score=more severe symptom. Analysis population included subjects with baseline PSSD symptom score >=1. FAS:who received at least 1 dose of study intervention in originating study for subjects initially randomised to JNJ-77242113 and who crossed over and received JNJ-77242113 initially randomised to placebo.N (number of subjects analysed)=subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of the Originating Study), LTE Week 36
    End point values
    		 Placebo - JNJ-77242113 100 Milligrams (mg) Once Daily (QD) JNJ-77242113 25 mg QD JNJ-77242113 50 mg QD JNJ-77242113 25 mg Twice Daily (BID) JNJ-77242113 100 mg QD JNJ-77242113 100 mg BID
    Number of subjects analysed
    35
    43
    42
    41
    43
    42
    Units: Percentage of subjects
        number (not applicable)
    34.3
    18.6
    21.4
    17.1
    30.2
    26.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving PSSD Signs Score=0 at Week 36 Among Subjects With a Baseline (Week 0 of the Originating Study) Signs Score >=1

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    End point title
    		 Percentage of Subjects Achieving PSSD Signs Score=0 at Week 36 Among Subjects With a Baseline (Week 0 of the Originating Study) Signs Score >=1
    End point description
    PSSD, patient-reported outcome questionnaire aimed to measure severity of psoriasis symptoms and signs for treatment benefit assessment. PSSD questionnaire included 11 items:symptoms (itch, pain, stinging, burning and skin tightness) and subject observable signs (skin dryness, cracking, scaling, shedding/flaking, redness and bleeding) using 0 to 10 numerical ratings. Each item severity was rated on 11-point numeric scale: 0(absent) to 10(worst imaginable). Symptom score:by averaging 5 questions and multiplying by 10. PSSD symptom score ranged from 0 to 100,(0=least severe symptom; 100=most severe disease). Higher score=more severe symptom. Analysis population included subjects with baseline PSSD sign score >=1. FAS:who received at least 1 dose of study intervention in originating study for subjects initially randomised to JNJ-77242113 and who crossed over and received JNJ-77242113 initially randomised to placebo. N (number of subjects analysed)=subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of the Originating Study), LTE Week 36
    End point values
    		 Placebo - JNJ-77242113 100 Milligrams (mg) Once Daily (QD) JNJ-77242113 25 mg QD JNJ-77242113 50 mg QD JNJ-77242113 25 mg Twice Daily (BID) JNJ-77242113 100 mg QD JNJ-77242113 100 mg BID
    Number of subjects analysed
    35
    43
    43
    41
    43
    42
    Units: Percentage of subjects
        number (not applicable)
    22.9
    16.3
    11.6
    12.2
    14.0
    16.7
    No statistical analyses for this end point

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

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    End point title
    		 Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) 
    End point description
    An AE was any untoward medical occurrence in a clinical investigation where subjects administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. A SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. TEAE was defined as any AE that occurs after receiving the treatment in originating study (77242113PSO2001) and analysed from Week 16 (LTE Week 0) up to Week 56 (LTE Week 40) in this LTE study (77242113PSO2002). Long-term extension (LTE) safety analysis set included randomised subjects in study 77242113PSO2001 who entered the LTE study 77242113PSO2002 and received at least one dose of study intervention (including a partial dose) during the 77242113PSO2002 study period.
    End point type
    Secondary
    End point timeframe
    From Week 16 (LTE Week 0) up to Week 56 (LTE Week 40)
    End point values
    		 Placebo Then JNJ-77242113 100 mg QD JNJ-77242113 25 mg QD JNJ-77242113 50 mg QD JNJ-77242113 25 mg BID JNJ-77242113 100 mg QD JNJ-77242113 100 mg BID
    Number of subjects analysed
    35
    35
    39
    40
    40
    38
    Units: Subjects
        TEAE
    23
    18
    19
    27
    27
    19
        TESAE
    1
    0
    2
    3
    2
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Week 16 (LTE Week 0) up to Week 56 (LTE Week 40)
    Adverse event reporting additional description
    Safety analysis were based on LTE safety analysis set which included randomised subjects in study 77242113PSO2001 who entered the LTE study 77242113PSO2002 and received at least one dose of study intervention (including a partial dose) during the 77242113PSO2002 study period.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Placebo Then JNJ-77242113 100 mg QD
    Reporting group description
    		 Subjects originally randomised to placebo in originating study (77242113PSO2001) received orally once daily (QD) dose of JNJ-77242113 100 milligrams (mg) tablet in the morning from Week 0 through Week 36 in this LTE study.

    Reporting group title
    JNJ-77242113 25 mg QD
    Reporting group description
    		 Subjects received orally QD dose of JNJ-77242113 25 mg tablet in the morning from Week 0 through Week 36 in this LTE study.

    Reporting group title
    JNJ-77242113 100 mg QD
    Reporting group description
    		 Subjects received orally QD dose of JNJ-77242113 100 mg tablet in the morning from Week 0 through Week 36 in this LTE study.

    Reporting group title
    JNJ-77242113 25 mg BID
    Reporting group description
    		 Subjects received orally twice daily (BID; morning and evening) dose of JNJ-77242113 25 mg tablet from Week 0 through Week 36 in this LTE study.

    Reporting group title
    JNJ-77242113 100 mg BID
    Reporting group description
    		 Subjects received orally BID (morning and evening) dose of JNJ-77242113 100 mg tablet from Week 0 through Week 36 in this LTE study.

    Reporting group title
    JNJ-77242113 50 mg QD
    Reporting group description
    		 Subjects received orally QD dose of JNJ-77242113 50 mg tablet in the morning from Week 0 through Week 36 in this LTE study.

    Serious adverse events
    		 Placebo Then JNJ-77242113 100 mg QD JNJ-77242113 25 mg QD JNJ-77242113 100 mg QD JNJ-77242113 25 mg BID JNJ-77242113 100 mg BID JNJ-77242113 50 mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    2 / 40 (5.00%)
    3 / 40 (7.50%)
    1 / 38 (2.63%)
    2 / 39 (5.13%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine Leiomyoma
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 38 (2.63%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    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
    Injury, poisoning and procedural complications
    Ligament Injury
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary Artery Disease
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    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
    Ventricular Dysfunction
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular Accident
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    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
    General disorders and administration site conditions
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    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
    Respiratory, thoracic and mediastinal disorders
    Tonsillar Hypertrophy
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral Disc Protrusion
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    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
    Foot Deformity
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Then JNJ-77242113 100 mg QD JNJ-77242113 25 mg QD JNJ-77242113 100 mg QD JNJ-77242113 25 mg BID JNJ-77242113 100 mg BID JNJ-77242113 50 mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 35 (40.00%)
    13 / 35 (37.14%)
    20 / 40 (50.00%)
    17 / 40 (42.50%)
    15 / 38 (39.47%)
    15 / 39 (38.46%)
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 35 (2.86%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 38 (5.26%)
    1 / 39 (2.56%)
         occurrences all number
    2
    1
    0
    0
    2
    1
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 38 (5.26%)
    1 / 39 (2.56%)
         occurrences all number
    2
    1
    0
    0
    2
    1
    Injury, poisoning and procedural complications
    Meniscus Injury
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    3
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    1 / 38 (2.63%)
    1 / 39 (2.56%)
         occurrences all number
    1
    0
    1
    2
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    3 / 40 (7.50%)
    3 / 40 (7.50%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    2
    3
    3
    0
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    1
    0
    2
    0
    0
    1
    Infections and infestations
    Covid-19
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 35 (2.86%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    3 / 38 (7.89%)
    3 / 39 (7.69%)
         occurrences all number
    2
    1
    2
    1
    3
    3
    Bronchitis
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 38 (0.00%)
    3 / 39 (7.69%)
         occurrences all number
    1
    1
    0
    1
    0
    3
    Sinusitis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 38 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    0
    2
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    9 / 35 (25.71%)
    3 / 35 (8.57%)
    11 / 40 (27.50%)
    6 / 40 (15.00%)
    5 / 38 (13.16%)
    7 / 39 (17.95%)
         occurrences all number
    11
    3
    11
    8
    7
    9
    Influenza
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    1 / 40 (2.50%)
    3 / 40 (7.50%)
    1 / 38 (2.63%)
    1 / 39 (2.56%)
         occurrences all number
    1
    0
    1
    3
    1
    1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    4 / 35 (11.43%)
    6 / 35 (17.14%)
    2 / 40 (5.00%)
    3 / 40 (7.50%)
    4 / 38 (10.53%)
    3 / 39 (7.69%)
         occurrences all number
    4
    10
    2
    4
    4
    3
    Urinary Tract Infection
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 35 (2.86%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    2 / 38 (5.26%)
    1 / 39 (2.56%)
         occurrences all number
    3
    2
    0
    1
    2
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Apr 2022
    The purpose of this amendment was to include toxicology data, updates to the study intervention dosing instructions to include a fasting requirement, and updates to the analysis strategy regarding discontinuations due to Corona Virus disease-2019 (COVID-19) (intercurrent event number 3) to a Treatment Policy strategy.

    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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