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

    Summary
    EudraCT number
    		 2021-003700-41
    Trial protocol
    		 ES  
    Global end of trial date
    16 Dec 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Dec 2023
    First version publication date
    30 Dec 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    77242113PSO2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05223868
    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
    20 Jan 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Dec 2022
    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 dose response of JNJ-77242113 at Week 16 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
    03 Feb 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: 35
    Country: Number of subjects enrolled
    Germany: 47
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Japan: 20
    Country: Number of subjects enrolled
    Korea, Republic of: 11
    Country: Number of subjects enrolled
    Poland: 60
    Country: Number of subjects enrolled
    Taiwan: 13
    Country: Number of subjects enrolled
    United States: 50
    Worldwide total number of subjects
    255
    EEA total number of subjects
    123
    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)
    236
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 255 subjects were randomised and treated in the study. After Week 16 subjects who were not enrolled in long term extension (LTE) study (NCT05364554) were followed up for safety up to 4 weeks after the last dose of the study drug.

    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 2 tablets of placebo matching to JNJ-77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in long term extension (LTE) study were followed up for safety up to 4 weeks after the last dose of the study drug.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo tablets, 2 in the morning and 1 in the evening daily.

    Arm title
    		 JNJ-77242113 25 mg QD + Placebo
    Arm description
    		 Subjects with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 1 placebo tablet in the morning and 1 in the evening.

    Investigational medicinal product name
    JNJ-77242113
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received JNJ-77242113 25 mg tablet once daily.

    Arm title
    		 JNJ-77242113 50 mg QD + Placebo
    Arm description
    		 Subjects with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 1 placebo tablet in the evening.

    Investigational medicinal product name
    JNJ-77242113
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received JNJ-77242113 25 mg 2 tablets once daily.

    Arm title
    		 JNJ-77242113 25 mg BID + Placebo
    Arm description
    		 Subjects with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo tablet in the morning.

    Investigational medicinal product name
    JNJ-77242113
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received JNJ-77242113 25 mg tablet twice daily.

    Arm title
    		 JNJ-77242113 100 mg QD + Placebo
    Arm description
    		 Subjects with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-77242113
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received JNJ-77242113 100 mg tablet once daily.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 1 placebo tablet in the morning and 1 in the evening.

    Arm title
    		 JNJ-77242113 100 mg BID + Placebo
    Arm description
    		 Subjects with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo tablet in the morning.

    Investigational medicinal product name
    JNJ-77242113
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received JNJ-77242113 100 mg tablet twice daily.

    Number of subjects in period 1
    		Placebo JNJ-77242113 25 mg QD + Placebo JNJ-77242113 50 mg QD + Placebo JNJ-77242113 25 mg BID + Placebo JNJ-77242113 100 mg QD + Placebo JNJ-77242113 100 mg BID + Placebo
    Started
    43
    43
    43
    41
    43
    42
    Completed
    36
    36
    40
    40
    41
    38
    Not completed
    7
    7
    3
    1
    2
    4
         Unspecified
    -
    2
    -
    -
    1
    1
         Lost to follow-up
    1
    3
    -
    -
    -
    1
         Withdrawal by subject
    6
    2
    3
    1
    1
    2

    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 2 tablets of placebo matching to JNJ-77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in long term extension (LTE) study were followed up for safety up to 4 weeks after the last dose of the study drug.

    Reporting group title
    JNJ-77242113 25 mg QD + Placebo
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug.

    Reporting group title
    JNJ-77242113 50 mg QD + Placebo
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug.

    Reporting group title
    JNJ-77242113 25 mg BID + Placebo
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug.

    Reporting group title
    JNJ-77242113 100 mg QD + Placebo
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug.

    Reporting group title
    JNJ-77242113 100 mg BID + Placebo
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug.

    Reporting group values
    		 Placebo JNJ-77242113 25 mg QD + Placebo JNJ-77242113 50 mg QD + Placebo JNJ-77242113 25 mg BID + Placebo JNJ-77242113 100 mg QD + Placebo JNJ-77242113 100 mg BID + Placebo Total
    Number of subjects
    		 43 43 43 41 43 42 255
    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)
    		 38 42 40 37 39 40 236
        From 65 to 84 years
    		 5 1 3 4 4 2 19
        85 years and over
    		 0 0 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.9 ( 14.7 ) 44.5 ( 12.72 ) 45.1 ( 11.08 ) 45.7 ( 11.91 ) 44.7 ( 14.11 ) 42 ( 11.34 ) -
    Title for Gender
    Units: subjects
        Female
    		 18 11 16 11 11 12 79
        Male
    		 25 32 27 30 32 30 176

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis received 2 tablets of placebo matching to JNJ-77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in long term extension (LTE) study were followed up for safety up to 4 weeks after the last dose of the study drug.

    Reporting group title
    JNJ-77242113 25 mg QD + Placebo
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug.

    Reporting group title
    JNJ-77242113 50 mg QD + Placebo
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug.

    Reporting group title
    JNJ-77242113 25 mg BID + Placebo
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug.

    Reporting group title
    JNJ-77242113 100 mg QD + Placebo
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug.

    Reporting group title
    JNJ-77242113 100 mg BID + Placebo
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug.

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

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    End point title
    		 Percentage of Subjects Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 16 [1]
    End point description
    Percentage of subjects who achieved PASI-75 score (greater than or equal to [>=] 75 percent [%] improvement from baseline in PASI) at Week 16 were reported. 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 from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. Full analysis set (FAS) included all randomised subjects who received at least 1 administration of study intervention.
    End point type
    Primary
    End point timeframe
    Baseline, Week 16
    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: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Placebo JNJ-77242113 25 mg QD + Placebo JNJ-77242113 50 mg QD + Placebo JNJ-77242113 25 mg BID + Placebo JNJ-77242113 100 mg QD + Placebo JNJ-77242113 100 mg BID + Placebo
    Number of subjects analysed
    43
    43
    43
    41
    43
    42
    Units: Percentage of subjects
        number (not applicable)
    9.3
    37.2
    58.1
    51.2
    65.1
    78.6
    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. 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 from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. FAS included all randomised subjects who received at least 1 administration of study intervention. Here 'N' (number of subjects analysed) referred 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 25 mg QD + Placebo JNJ-77242113 50 mg QD + Placebo JNJ-77242113 25 mg BID + Placebo JNJ-77242113 100 mg QD + Placebo JNJ-77242113 100 mg BID + Placebo
    Number of subjects analysed
    40
    37
    41
    40
    42
    39
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -3.59 ( 9.436 )
    -12.76 ( 8.050 )
    -14.56 ( 6.528 )
    -12.73 ( 8.021 )
    -13.99 ( 8.653 )
    -17.44 ( 8.356 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved at Least 90% Improvement From Baseline in PASI (PASI-90) at Week 16

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    End point title
    		 Percentage of Subjects Who Achieved at Least 90% Improvement From Baseline in PASI (PASI-90) at Week 16
    End point description
    Percentage of subjects who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Week 16 were reported. 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 from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. FAS included all randomised subjects who received at least 1 administration of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo JNJ-77242113 25 mg QD + Placebo JNJ-77242113 50 mg QD + Placebo JNJ-77242113 25 mg BID + Placebo JNJ-77242113 100 mg QD + Placebo JNJ-77242113 100 mg BID + Placebo
    Number of subjects analysed
    43
    43
    43
    41
    43
    42
    Units: Percentage of subjects
        number (not applicable)
    2.3
    25.6
    51.2
    26.8
    46.5
    59.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved at Least 100% Improvement From Baseline in PASI (PASI-100) at Week 16

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    End point title
    		 Percentage of Subjects Who Achieved at Least 100% Improvement From Baseline in PASI (PASI-100) at Week 16
    End point description
    Percentage of subjects who achieved PASI-100 score (>=100% improvement from baseline in PASI) at Week 16 were reported. 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 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 (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 greater severity of psoriasis. FAS included all randomised subjects who received at least 1 administration of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo JNJ-77242113 25 mg QD + Placebo JNJ-77242113 50 mg QD + Placebo JNJ-77242113 25 mg BID + Placebo JNJ-77242113 100 mg QD + Placebo JNJ-77242113 100 mg BID + Placebo
    Number of subjects analysed
    43
    43
    43
    41
    43
    42
    Units: Percentage of subjects
        number (not applicable)
    0
    11.6
    25.6
    9.8
    23.3
    40.5
    No statistical analyses for this end point

    Secondary: Percentage 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
    		 Percentage of Subjects Who Achieved an Investigator Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
    End point description
    Percentage 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. FAS included all randomised subjects who received at least 1 administration of study intervention.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo JNJ-77242113 25 mg QD + Placebo JNJ-77242113 50 mg QD + Placebo JNJ-77242113 25 mg BID + Placebo JNJ-77242113 100 mg QD + Placebo JNJ-77242113 100 mg BID + Placebo
    Number of subjects analysed
    43
    43
    43
    41
    43
    42
    Units: Percentage of subjects
        number (not applicable)
    11.6
    39.5
    58.1
    51.2
    62.8
    64.3
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Subjects Who Achieved an IGA Score of Cleared (0) at Week 16
    End point description
    Percentage 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. FAS included all randomised subjects who received at least 1 administration of study intervention.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Placebo JNJ-77242113 25 mg QD + Placebo JNJ-77242113 50 mg QD + Placebo JNJ-77242113 25 mg BID + Placebo JNJ-77242113 100 mg QD + Placebo JNJ-77242113 100 mg BID + Placebo
    Number of subjects analysed
    43
    43
    43
    41
    43
    42
    Units: Percentage of subjects
        number (not applicable)
    0
    16.3
    34.9
    14.6
    27.9
    45.2
    No statistical analyses for this end point

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

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    End point title
    		 Percent Change From Baseline in Body Surface Area (BSA) at Week 16
    End point description
    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 hand print 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. FAS included all randomised subjects who received at least 1 administration 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 25 mg QD + Placebo JNJ-77242113 50 mg QD + Placebo JNJ-77242113 25 mg BID + Placebo JNJ-77242113 100 mg QD + Placebo JNJ-77242113 100 mg BID + Placebo
    Number of subjects analysed
    40
    37
    41
    40
    42
    39
    Units: Percent change
        arithmetic mean (standard deviation)
    -2.4 ( 16.51 )
    -11.9 ( 10.00 )
    -15.3 ( 11.41 )
    -13.3 ( 11.08 )
    -14.6 ( 14.03 )
    -21.0 ( 13.74 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 16

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    End point title
    		 Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at Week 16
    End point description
    Change from baseline in PSSD symptoms scores at Week 16 was reported. PSSD was a patient-reported outcome (PRO) questionnaire designed to measure severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and subject observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Severity of each item was rated on 11-point numeric scale ranging from 0 (absent) to 10 (worst imaginable). Two sub scores each ranging from 0 (least severe symptom) to 100 (most severe symptom) were derived. Higher score indicated more severe disease. FAS: all randomised subjects who received at least 1 administration of study intervention. '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 25 mg QD + Placebo JNJ-77242113 50 mg QD + Placebo JNJ-77242113 25 mg BID + Placebo JNJ-77242113 100 mg QD + Placebo JNJ-77242113 100 mg BID + Placebo
    Number of subjects analysed
    40
    37
    41
    40
    42
    39
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -0.8 ( 29.59 )
    -35.8 ( 29.22 )
    -36.7 ( 29.95 )
    -34.0 ( 29.19 )
    -29.4 ( 28.28 )
    -44.0 ( 31.22 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in PSSD Signs Score at Week 16

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    End point title
    		 Change From Baseline in PSSD Signs Score at Week 16
    End point description
    Change from baseline in PSSD sign scores at Week 16 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and subject observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. The severity of each item was rated on 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). Two sub scores each ranging from 0 (least severe sign) to 100 (most severe sign) were derived. Higher score indicated more severe disease. FAS: all randomised subjects who received at least 1 administration of study intervention. '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 25 mg QD + Placebo JNJ-77242113 50 mg QD + Placebo JNJ-77242113 25 mg BID + Placebo JNJ-77242113 100 mg QD + Placebo JNJ-77242113 100 mg BID + Placebo
    Number of subjects analysed
    40
    37
    41
    40
    42
    39
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -6.2 ( 22.38 )
    -38.6 ( 27.55 )
    -42.7 ( 28.70 )
    -41.8 ( 27.78 )
    -41.9 ( 28.65 )
    -51.1 ( 26.01 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved PSSD Symptoms Score Equal to (=) 0 at Week 16 Among Subjects With a Baseline Symptoms Score Greater Than or Equal to (>=) 1

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    End point title
    		 Percentage of Subjects Who Achieved PSSD Symptoms Score Equal to (=) 0 at Week 16 Among Subjects With a Baseline Symptoms Score Greater Than or Equal to (>=) 1
    End point description
    The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and subject observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. The severity of each item was rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). Two sub scores each ranging from 0 (indicated least severe symptom) to 100 (indicated most severe symptom) were derived. A higher score indicated more severe disease. FAS included all randomised subjects who received at least 1 administration 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 25 mg QD + Placebo JNJ-77242113 50 mg QD + Placebo JNJ-77242113 25 mg BID + Placebo JNJ-77242113 100 mg QD + Placebo JNJ-77242113 100 mg BID + Placebo
    Number of subjects analysed
    43
    43
    42
    41
    43
    42
    Units: Percentage of subjects
        number (not applicable)
    0
    16.3
    23.8
    17.1
    27.9
    26.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved PSSD Sign Score = 0 at Week 16 Among Subjects With a Baseline Sign Score >=1

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    End point title
    		 Percentage of Subjects Who Achieved PSSD Sign Score = 0 at Week 16 Among Subjects With a Baseline Sign Score >=1
    End point description
    The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and subject observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. The severity of each item was rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). Two sub scores each ranging from 0 (indicated least severe sign) to 100 (indicated most severe sign) were derived. A higher score indicated more severe disease. FAS included all randomised subjects who received at least 1 administration of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo JNJ-77242113 25 mg QD + Placebo JNJ-77242113 50 mg QD + Placebo JNJ-77242113 25 mg BID + Placebo JNJ-77242113 100 mg QD + Placebo JNJ-77242113 100 mg BID + Placebo
    Number of subjects analysed
    43
    43
    43
    41
    43
    42
    Units: Percentage of subjects
        number (not applicable)
    0
    2.3
    14.0
    9.8
    16.3
    14.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved a Dermatological Life Quality Index (DLQI) of 0 or 1 at Week 16 Among Subjects With Baseline DLQI Score Greater Than (>) 1

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    End point title
    		 Percentage of Subjects Who Achieved a Dermatological Life Quality Index (DLQI) of 0 or 1 at Week 16 Among Subjects With Baseline DLQI Score Greater Than (>) 1
    End point description
    The DLQI was a dermatology specific health-related quality of life (HRQoL) instrument designed to assess the impact of the disease on a subject's HRQoL. It was a 10-item questionnaire that assesses HRQoL over the past week and in addition to evaluating overall HRQoL, could be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Each question was scored on a 4-point scale of 0 to 3 (0 = not at all, 1 = a little; 2 = a lot; or 3 = very much, where higher score indicated more impact on QoL). The total score was sum of scores from all 10 questions and it ranged from 0 (not at all) to 30 (very much), with a higher score indicating greater impact on HRQoL. FAS included all randomised subjects who received at least 1 administration of study intervention. Here 'N' (number of subjects analysed) referred 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 25 mg QD + Placebo JNJ-77242113 50 mg QD + Placebo JNJ-77242113 25 mg BID + Placebo JNJ-77242113 100 mg QD + Placebo JNJ-77242113 100 mg BID + Placebo
    Number of subjects analysed
    41
    43
    43
    40
    43
    41
    Units: Percentage of subjects
        number (not applicable)
    2.4
    27.9
    37.2
    30.0
    55.8
    43.9
    No statistical analyses for this end point

    Secondary: Change From Baseline in Domain Scores of the Patient-Reported Outcomes Measurement Information System (PROMIS-29) at Week 16

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    End point title
    		 Change From Baseline in Domain Scores of the Patient-Reported Outcomes Measurement Information System (PROMIS-29) at Week 16
    End point description
    The PROMIS-29, a 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance and ability to participate in social roles and activities) with 4 questions. The questions were ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often and 5= always). Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain). Norm-based scores have been calculated for each domain on PROMIS measures, score of 50 represents mean or average of reference population. Score of 60 means that person is one standard deviation above reference population. On symptom-oriented domains (anxiety, depression, fatigue, pain interference and sleep disturbance), higher scores represent worse symptomatology. On function-oriented domains (physical functioning and social role), higher scores represent better functioning. FAS was analysed. 'N'= number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo JNJ-77242113 25 mg QD + Placebo JNJ-77242113 50 mg QD + Placebo JNJ-77242113 25 mg BID + Placebo JNJ-77242113 100 mg QD + Placebo JNJ-77242113 100 mg BID + Placebo
    Number of subjects analysed
    40
    37
    41
    40
    42
    39
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Physical Function
    -1.04 ( 5.929 )
    2.30 ( 6.060 )
    5.81 ( 6.896 )
    4.55 ( 7.789 )
    3.10 ( 7.325 )
    5.81 ( 8.408 )
        Anxiety
    -2.36 ( 7.971 )
    -3.98 ( 8.789 )
    -5.27 ( 8.026 )
    -5.27 ( 6.787 )
    -4.70 ( 8.570 )
    -8.31 ( 9.693 )
        Depression
    -1.01 ( 6.238 )
    -3.09 ( 8.709 )
    -3.23 ( 6.576 )
    -1.96 ( 6.569 )
    -2.62 ( 7.465 )
    -3.67 ( 8.912 )
        Fatigue
    -0.76 ( 5.469 )
    -2.44 ( 10.983 )
    -1.50 ( 7.801 )
    -3.09 ( 8.676 )
    -2.98 ( 7.818 )
    -3.75 ( 8.409 )
        Sleep Disturbance
    0.14 ( 6.099 )
    -1.89 ( 5.859 )
    -3.45 ( 7.947 )
    -4.36 ( 6.041 )
    -1.04 ( 5.995 )
    -3.19 ( 5.705 )
        Social Roles and Activities
    0.99 ( 8.393 )
    4.31 ( 9.035 )
    4.82 ( 8.511 )
    5.39 ( 10.908 )
    5.78 ( 7.538 )
    7.73 ( 9.607 )
        Pain Interference
    0.09 ( 7.819 )
    -6.79 ( 9.038 )
    -7.41 ( 9.867 )
    -7.18 ( 7.956 )
    -3.98 ( 7.889 )
    -9.56 ( 8.668 )
        Pain Intensity
    0.7 ( 2.89 )
    -2.6 ( 2.94 )
    -2.7 ( 3.25 )
    -2.6 ( 3.25 )
    -1.7 ( 3.00 )
    -3.3 ( 3.01 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved at Least a 5-point Improvement From Baseline in Each PROMIS-29 Domain at Week 16

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    End point title
    		 Percentage of Subjects Who Achieved at Least a 5-point Improvement From Baseline in Each PROMIS-29 Domain at Week 16
    End point description
    PROMIS-29, 29-item generic HRQoL survey, assesses each 7 PROMIS domains (depression; anxiety; physical function; pain interference; fatigue; sleep disturbance and ability to participate in social roles and activities) with 4 questions. The questions were ranked on 5-point Likert Scale (1=never, 2=rarely, 3=sometimes, 4=often and 5= always). Pain intensity was rated on 11-point scale (0=no pain; 10=worst imaginable pain). Norm-based scores have been calculated for each domain on PROMIS measures, score of 50 represents mean or average of reference population. Score of 60 means that person is one standard deviation above reference population. On symptom-oriented domains (anxiety, depression, fatigue, pain interference and sleep disturbance), higher scores represent worse symptomatology. On function-oriented domains (physical functioning and social role), higher scores represent better functioning. FAS: all randomised subjects who received at least 1 administration of study intervention.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Placebo JNJ-77242113 25 mg QD + Placebo JNJ-77242113 50 mg QD + Placebo JNJ-77242113 25 mg BID + Placebo JNJ-77242113 100 mg QD + Placebo JNJ-77242113 100 mg BID + Placebo
    Number of subjects analysed
    43
    43
    43
    41
    43
    42
    Units: Percentage of subjects
    number (not applicable)
        Physical Function
    11.6
    23.3
    41.9
    36.6
    37.2
    40.5
        Anxiety
    30.2
    32.6
    44.2
    53.7
    41.9
    54.8
        Depression
    23.3
    27.9
    34.9
    26.8
    32.6
    35.7
        Fatigue
    18.6
    20.9
    23.3
    41.5
    25.6
    42.9
        Sleep Disturbance
    16.3
    23.3
    32.6
    43.9
    23.3
    38.1
        Social Roles and Activities
    23.3
    30.2
    46.5
    56.1
    44.2
    57.1
        Pain Interference
    20.9
    46.5
    55.8
    51.2
    41.9
    64.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Treatment-emergent Adverse Event (TEAEs) and Serious TEAEs

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    End point title
    		 Percentage of Subjects With Treatment-emergent Adverse Event (TEAEs) and Serious TEAEs
    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 event that occurs at or after the initial administration of study agent. The safety analyses set included all randomised subjects who received at least 1 administration 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 25 mg QD + Placebo JNJ-77242113 50 mg QD + Placebo JNJ-77242113 25 mg BID + Placebo JNJ-77242113 100 mg QD + Placebo JNJ-77242113 100 mg BID + Placebo
    Number of subjects analysed
    43
    43
    43
    41
    43
    42
    Units: Percentage of subjects
    number (not applicable)
        TEAEs
    51.2
    46.5
    60.5
    48.8
    44.2
    61.9
        Serious TEAEs
    0
    0
    2.3
    0
    4.7
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline (Week 0) up to 4 weeks after last dose of study drug (up to 20 weeks)
    Adverse event reporting additional description
    The safety analyses set included all randomised subjects who received at least 1 administration 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 2 tablets of placebo matching to JNJ-77242113 in morning and 1 tablet in the evening to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in long term extension (LTE) study were followed up for safety up to 4 weeks after the last dose of the study drug.

    Reporting group title
    JNJ-77242113 25 mg QD + Placebo
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis received JNJ-77242113 25 milligrams (mg) once daily (QD) and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug.

    Reporting group title
    JNJ-77242113 100 mg BID + Placebo
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis received JNJ-77242113 100 mg BID in morning and evening along with a matching placebo in morning to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug.

    Reporting group title
    JNJ-77242113 25 mg BID+ Placebo
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis received JNJ-77242113 25 mg twice daily (BID) in morning and evening along with a matching placebo in the morning to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug.

    Reporting group title
    JNJ-77242113 100 mg QD + Placebo
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis received JNJ-77242113 100 mg QD and matching placebo in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug.

    Reporting group title
    JNJ-77242113 50 mg QD + Placebo
    Reporting group description
    		 Subjects with moderate to severe plaque psoriasis received JNJ-77242113 50 mg QD (2*25 mg tablets) in morning followed by matching placebo in the evening to maintain the blind from Week 0 through Week 16. Subjects who were not enrolled in LTE study were followed up for safety up to 4 weeks after the last dose of the study drug.

    Serious adverse events
    		 Placebo JNJ-77242113 25 mg QD + Placebo JNJ-77242113 100 mg BID + Placebo JNJ-77242113 25 mg BID+ Placebo JNJ-77242113 100 mg QD + Placebo JNJ-77242113 50 mg QD + Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    2 / 43 (4.65%)
    1 / 43 (2.33%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Psychiatric disorders
    Suicide Attempt
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (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
    Infections and infestations
    Covid-19
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 43 (2.33%)
    0 / 43 (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
    Infected Cyst
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    1 / 43 (2.33%)
         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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo JNJ-77242113 25 mg QD + Placebo JNJ-77242113 100 mg BID + Placebo JNJ-77242113 25 mg BID+ Placebo JNJ-77242113 100 mg QD + Placebo JNJ-77242113 50 mg QD + Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 43 (23.26%)
    10 / 43 (23.26%)
    10 / 42 (23.81%)
    12 / 41 (29.27%)
    8 / 43 (18.60%)
    15 / 43 (34.88%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 43 (0.00%)
    1 / 42 (2.38%)
    1 / 41 (2.44%)
    3 / 43 (6.98%)
    1 / 43 (2.33%)
         occurrences all number
    1
    0
    1
    2
    3
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 43 (4.65%)
    1 / 42 (2.38%)
    2 / 41 (4.88%)
    1 / 43 (2.33%)
    4 / 43 (9.30%)
         occurrences all number
    1
    2
    2
    2
    1
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 43 (2.33%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    3 / 43 (6.98%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    1
    0
    3
    1
    Infections and infestations
    Covid-19
         subjects affected / exposed
    5 / 43 (11.63%)
    5 / 43 (11.63%)
    4 / 42 (9.52%)
    8 / 41 (19.51%)
    2 / 43 (4.65%)
    3 / 43 (6.98%)
         occurrences all number
    5
    5
    4
    8
    2
    3
    Nasopharyngitis
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 43 (2.33%)
    2 / 42 (4.76%)
    3 / 41 (7.32%)
    1 / 43 (2.33%)
    8 / 43 (18.60%)
         occurrences all number
    2
    1
    3
    3
    1
    9
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 43 (2.33%)
    3 / 43 (6.98%)
    2 / 42 (4.76%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    4
    2
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Nov 2021
    The overall reason for the amendment was to clarify stratification and to clarify the contraceptive appendix.
    12 Jan 2022
    The overall reason for the amendment was to update the study intervention dosing instructions and to update the analysis strategy regarding discontinuations due to 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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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