Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 2b, Multicenter, Double-blind, Active-controlled, Randomized Study to Investigate the Efficacy and Safety of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection

    Summary
    EudraCT number
    		 2019-000622-22
    Trial protocol
    		 GB   FR   DE   CZ   ES   BE   IT  
    Global end of trial date
    26 Apr 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 May 2023
    First version publication date
    12 May 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CR108608
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 Route 202 South, 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
    26 Apr 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Apr 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of this trial was to establish the dose-response relationship for antiviral activity of 3 doses of JNJ-73763989 + NA and to evaluate the efficacy of combination regimens of JNJ-73763989 + NA (with and without JNJ-56136379) and of JNJ-56136379+NA.
    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
    02 Aug 2019
    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
    Belgium: 19
    Country: Number of subjects enrolled
    Brazil: 4
    Country: Number of subjects enrolled
    Canada: 20
    Country: Number of subjects enrolled
    China: 6
    Country: Number of subjects enrolled
    Czechia: 27
    Country: Number of subjects enrolled
    Germany: 16
    Country: Number of subjects enrolled
    Spain: 22
    Country: Number of subjects enrolled
    France: 22
    Country: Number of subjects enrolled
    United Kingdom: 12
    Country: Number of subjects enrolled
    Hong Kong: 11
    Country: Number of subjects enrolled
    Italy: 30
    Country: Number of subjects enrolled
    Japan: 61
    Country: Number of subjects enrolled
    Korea, Republic of: 10
    Country: Number of subjects enrolled
    Malaysia: 18
    Country: Number of subjects enrolled
    Poland: 37
    Country: Number of subjects enrolled
    Russian Federation: 62
    Country: Number of subjects enrolled
    Thailand: 23
    Country: Number of subjects enrolled
    Turkey: 49
    Country: Number of subjects enrolled
    United States: 21
    Worldwide total number of subjects
    470
    EEA total number of subjects
    173
    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)
    462
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Out of 471 randomised subjects, only 470 subjects were analysed and treated with 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
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA
    Arm description
    		 Subjects received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks. Subjects were followed up to Week 96.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-73763989
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received JNJ-73763989 100 mg as subcutaneous (SC) injection up to 48 weeks.

    Investigational medicinal product name
    Nucleos(t)ide Analog (NA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received NA treatment (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) orally up to 48 weeks.

    Investigational medicinal product name
    JNJ-56136379
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received JNJ-56136379 250 milligrams (mg) orally up to 48 weeks.

    Arm title
    		 Arm 2: JNJ-73763989 (200mg) + Placebo + NA
    Arm description
    		 Subjects received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablets orally once daily up to 48 weeks. Subjects were followed-up to Week 96.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-73763989
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received JNJ-73763989 200 mg as SC injection up to 48 weeks.

    Investigational medicinal product name
    Nucleos(t)ide Analog (NA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received NA treatment (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) orally up to 48 weeks.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo matching to JNJ-56136379 orally up to 48 weeks.

    Arm title
    		 Arm 3: JNJ-73763989 (100 mg) + Placebo + NA
    Arm description
    		 Subjects received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablets orally once daily up to 48 weeks. Subjects were followed-up to Week 96.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nucleos(t)ide Analog (NA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received NA treatment (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) orally up to 48 weeks.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo matching to JNJ-56136379 orally up to 48 weeks.

    Investigational medicinal product name
    JNJ-73763989
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received JNJ-73763989 100 mg as SC injection up to 48 weeks.

    Arm title
    		 Arm 4: JNJ-73763989 (40 mg) + Placebo + NA
    Arm description
    		 Subjects received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks. Subjects were followed-up to Week 96.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-73763989
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received JNJ-73763989 40 mg as SC injection up to 48 weeks.

    Investigational medicinal product name
    Nucleos(t)ide Analog (NA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received NA treatment (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) orally up to 48 weeks.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo matching to JNJ-56136379 orally up to 48 weeks.

    Arm title
    		 Arm 5: Placebo + JNJ-56136379 + NA
    Arm description
    		 Subjects received placebo matching to JNJ-73763989 as SC injection and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks. Subjects were followed-up to Week 96.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo matching to JNJ-73763989 as SC injection up to 48 weeks.

    Investigational medicinal product name
    Nucleos(t)ide Analog (NA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received NA treatment (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) orally up to 48 weeks.

    Investigational medicinal product name
    JNJ-56136379
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a fixed dose of JNJ-56136379 250 mg tablet orally up to 48 weeks.

    Arm title
    		 Arm 6: Placebo + Placebo + NA
    Arm description
    		 Subjects received placebo matching to JNJ-73763989 as SC injection and placebo matching to JNJ-56136379 tablet orally along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks. Subjects were followed-up to Week 96.
    Arm type
    		 other

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo matching to JNJ-73763989 SC injection up to 48 weeks.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo matching to JNJ-56136379 orally up to 48 weeks.

    Investigational medicinal product name
    Nucleos(t)ide Analog (NA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) orally up to 48 weeks.

    Number of subjects in period 1
    		Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Started
    95
    96
    93
    93
    48
    45
    Completed
    92
    90
    90
    85
    45
    45
    Not completed
    3
    6
    3
    8
    3
    0
         Physician decision
    -
    1
    -
    -
    -
    -
         Lost to follow-up
    -
    1
    2
    1
    1
    -
         Withdrawal by subject
    3
    4
    1
    7
    2
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA
    Reporting group description
    		 Subjects received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks. Subjects were followed up to Week 96.

    Reporting group title
    Arm 2: JNJ-73763989 (200mg) + Placebo + NA
    Reporting group description
    		 Subjects received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablets orally once daily up to 48 weeks. Subjects were followed-up to Week 96.

    Reporting group title
    Arm 3: JNJ-73763989 (100 mg) + Placebo + NA
    Reporting group description
    		 Subjects received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablets orally once daily up to 48 weeks. Subjects were followed-up to Week 96.

    Reporting group title
    Arm 4: JNJ-73763989 (40 mg) + Placebo + NA
    Reporting group description
    		 Subjects received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks. Subjects were followed-up to Week 96.

    Reporting group title
    Arm 5: Placebo + JNJ-56136379 + NA
    Reporting group description
    		 Subjects received placebo matching to JNJ-73763989 as SC injection and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks. Subjects were followed-up to Week 96.

    Reporting group title
    Arm 6: Placebo + Placebo + NA
    Reporting group description
    		 Subjects received placebo matching to JNJ-73763989 as SC injection and placebo matching to JNJ-56136379 tablet orally along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks. Subjects were followed-up to Week 96.

    Reporting group values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA Total
    Number of subjects
    		 95 96 93 93 48 45 470
    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)
    		 94 95 89 93 46 45 462
        From 65 to 84 years
    		 1 1 4 0 2 0 8
        85 years and over
    		 0 0 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.8 ( 10.72 ) 42.9 ( 10.9 ) 43 ( 11.3 ) 42.2 ( 10.92 ) 43.9 ( 9.8 ) 43.8 ( 9.99 ) -
    Title for Gender
    Units: subjects
        Female
    		 24 35 38 32 11 20 160
        Male
    		 71 61 55 61 37 25 310

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA
    Reporting group description
    		 Subjects received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir [ETV] monohydrate 0.5 mg, tenofovir disoproxil fumarate [TDF] 300 mg, or tenofovir alafenamide [TAF] 25 mg) tablet orally once daily up to 48 weeks. Subjects were followed up to Week 96.

    Reporting group title
    Arm 2: JNJ-73763989 (200mg) + Placebo + NA
    Reporting group description
    		 Subjects received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablets orally once daily up to 48 weeks. Subjects were followed-up to Week 96.

    Reporting group title
    Arm 3: JNJ-73763989 (100 mg) + Placebo + NA
    Reporting group description
    		 Subjects received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablets orally once daily up to 48 weeks. Subjects were followed-up to Week 96.

    Reporting group title
    Arm 4: JNJ-73763989 (40 mg) + Placebo + NA
    Reporting group description
    		 Subjects received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks. Subjects were followed-up to Week 96.

    Reporting group title
    Arm 5: Placebo + JNJ-56136379 + NA
    Reporting group description
    		 Subjects received placebo matching to JNJ-73763989 as SC injection and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks. Subjects were followed-up to Week 96.

    Reporting group title
    Arm 6: Placebo + Placebo + NA
    Reporting group description
    		 Subjects received placebo matching to JNJ-73763989 as SC injection and placebo matching to JNJ-56136379 tablet orally along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks. Subjects were followed-up to Week 96.

    Primary: Percentage of Subjects Meeting the Nucleos(t)ide Analog (NA) Treatment Completion Criteria at Week 48

    		 Close Top of page
    End point title
    		 Percentage of Subjects Meeting the Nucleos(t)ide Analog (NA) Treatment Completion Criteria at Week 48
    End point description
    Percentage of subject meeting the NA treatment completion criteria at Week 48 was reported. NA completion criteria: subjects had alanine transaminase (ALT) less than (<) 3*upper limit of normal range (ULN); subjects had hepatitis B virus deoxyribonucleic acid (HBV DNA) < lower limit of quantification (LLOQ); subjects had hepatitis B e antigen (HBeAg)-negative; subjects had hepatitis B surface antigen (HBsAg) <10 international units per millilitre (IU/mL). Modified Intent-to-Treat (mITT) analysis set included all subjects who were randomised in the study and received at least one dose of study treatment. Here, 'N' (number of subject analysed) signifies number of subjects who were evaluable for this endpoint excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44.
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    89
    90
    90
    87
    45
    45
    Units: Percentage of subject
        number (confidence interval 90%)
    9.4 (4.36 to 14.36)
    19.1 (12.76 to 27.06)
    16.3 (10.33 to 23.99)
    5.5 (2.19 to 11.21)
    0.0 (0.00 to 6.05)
    2.2 (0.11 to 10.11)
    Statistical analysis title
    		 NA versus JNJ-56136379+NA
    Comparison groups
    Arm 6: Placebo + Placebo + NA v Arm 5: Placebo + JNJ-56136379 + NA
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.848
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Difference of proportions
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -5.97
         upper limit
    		 1.38
    Statistical analysis title
    		 NA versus JNJ3989 (100mg)+JNJ6379+NA
    Comparison groups
    Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA v Arm 6: Placebo + Placebo + NA
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.027
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Difference of proportions
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 13.68
    Statistical analysis title
    		 JNJ-73763989+JNJ-56136379+NA V/S JNJ-56136379+NA
    Comparison groups
    Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA v Arm 5: Placebo + JNJ-56136379 + NA
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.917
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Difference of proportions
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 4.16
         upper limit
    		 14.07
    Statistical analysis title
    		 JNJ-73763989+JNJ-56136379+NA V/S JNJ-73763989+NA
    Comparison groups
    Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA v Arm 3: JNJ-73763989 (100 mg) + Placebo + NA
    Number of subjects included in analysis
    179
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.917
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Difference of proportions
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -14.67
         upper limit
    		 1.25

    Secondary: Percentage of Subjects with Adverse Events (AE)

    		 Close Top of page
    End point title
    		 Percentage of Subjects with Adverse Events (AE)
    End point description
    An AE was any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Safety analysis set included all subjects who received at least one dose of any of the study treatments. Here, 'n' (number analysed) represents number of subjects evaluable at the specified timepoints.
    End point type
    Secondary
    End point timeframe
    DB: Up to 48 weeks, F-U: Week 48 up to Week 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    95
    96
    93
    93
    48
    45
    Units: Percentage of subjects
    number (not applicable)
        Double blind (DB) (n=95,96,93,93,48,45)
    71.6
    64.6
    71.0
    74.2
    85.4
    66.7
        Follow-up (F-U) Phase (n=92,95,91,90,47,45)
    46.7
    42.1
    54.9
    45.6
    55.3
    31.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Serious Adverse Events (SAE)

    		 Close Top of page
    End point title
    		 Percentage of Subjects with Serious Adverse Events (SAE)
    End point description
    SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important. Safety analysis set included all subjects who received at least one dose of any of the study treatments. Here, 'n' (number analysed) represents number of subjects evaluable at the specified category.
    End point type
    Secondary
    End point timeframe
    DB: Up to 48 weeks, F-U: Week 48 up to Week 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    95
    96
    93
    93
    48
    45
    Units: Percentage of subjects
    number (not applicable)
        DB Phase (n=95,96,93,93,48,45)
    2.1
    3.1
    2.2
    1.1
    4.2
    0
        Follow-up Phase (n=92,95,91,90,47,45)
    3.3
    5.3
    3.3
    1.1
    2.1
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Abnormalities in Clinical Laboratory Tests

    		 Close Top of page
    End point title
    		 Percentage of Subjects with Abnormalities in Clinical Laboratory Tests
    End point description
    Percentage of subjects with abnormalities in clinical laboratory tests were reported. Abnormality was determined at the investigator's discretion. Safety analysis set included all subjects who received at least one dose of any of the study treatments. Here, 'N' (number of subject analysed) signifies number of subjects who were evaluable for this endpoint and 'n' (number analysed) represents number of subjects evaluable at the specified category. AL: Abnormal low; AH: Abnormal high; M.C: Mean corpuscular; GGT: Gamma Glutamyl Transferase; E.C: Epithelial cells. Here, '99999' indicated that data was not available due to less number of subjects.
    End point type
    Secondary
    End point timeframe
    DB: Up to 48 weeks, F-U: Week 48 up to Week 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    95
    96
    93
    93
    48
    45
    Units: Percentage of subjects
    number (not applicable)
        DB:Basophils AL (n=93,94,93,92,48,45)
    0
    0
    0
    0
    0
    0
        DB:Basophils AH (n=93,94,93,92,48,45)
    1.1
    2.1
    1.1
    2.2
    2.1
    0
        F-U:Basophils AL (n=93,92,90,87,46,44)
    0
    0
    0
    0
    0
    0
        F-U:Basophils AH (n=93,92,90,87,46,44)
    2.2
    0
    1.1
    0
    0
    0
        DB:Eosinophils AL (n=93,94,93,92,48,45)
    0
    0
    0
    0
    0
    0
        DB:Eosinophils AH (n=93,94,93,92,48,45)
    3.2
    0
    1.1
    3.3
    14.6
    2.2
        F-U:Eosinophils AL (n=93,92,90,87,46,44)
    0
    0
    0
    0
    0
    0
        F-U:Eosinophils AH (n=93,92,90,87,46,44)
    1.1
    1.1
    1.1
    1.1
    2.2
    0
        DB:Ery. M.C HGB Conc. AL (n=93,94,93,92,48,45)
    10.8
    13.8
    26.9
    14.1
    16.7
    22.2
        DB:Ery. M.C HGB Conc. AH (n=93,94,93,92,48,45)
    0
    0
    0
    0
    0
    0
        F-U:Ery. M.C HGB Conc. AL (n=93,92,90,87,46,44)
    13.0
    17.4
    24.4
    18.4
    13.0
    22.7
        F-U:Ery. M.C HGB Conc. AH (n=93,92,90,87,46,44)
    0
    0
    0
    0
    0
    0
        DB:Ery. M.C Hemoglobin AL (n=93,94,93,92,48,45)
    3.2
    4.3
    7.5
    6.5
    6.3
    11.1
        DB:Ery. M.C Hemoglobin AH (n=93,94,93,92,48,45)
    7.5
    1.1
    1.1
    1.1
    6.3
    2.2
        F-U::Ery. M.C Hemoglobin AL (n=93,92,90,87,46,44)
    7.5
    8.7
    6.7
    8.0
    2.2
    6.8
        F-U::Ery. M.C Hemoglobin AH (n=93,92,90,87,46,44)
    4.3
    1.1
    0
    1.1
    2.2
    2.3
        DB:Ery. M.C Volume AL (n=93,94,93,92,48,45)
    3.2
    4.3
    7.5
    6.5
    6.3
    8.9
        DB:Ery. M.C Volume AH (n=93,94,93,92,48,45)
    29.0
    19.1
    15.1
    16.3
    29.2
    13.3
        F-U:Ery. M.C Volume AL (n=93,92,90,87,46,44)
    4.3
    6.5
    7.8
    6.9
    2.2
    4.5
        F-U:Ery. M.C Volume AH (n=93,92,90,87,46,44)
    16.3
    12.0
    13.3
    13.8
    19.6
    9.1
        DB:Erythrocytes AL (n=93,94,93,92,48,45)
    20.4
    14.9
    24.7
    15.2
    27.1
    22.2
        DB:Erythrocytes AH (n=93,94,93,92,48,45)
    0
    0
    3.2
    3.3
    0
    2.2
        F-U:Erythrocytes AL (n=93,92,90,87,46,44)
    18.3
    13.0
    21.1
    19.5
    21.7
    13.6
        F-U:Erythrocytes AH (n=93,92,90,87,46,44)
    0
    0
    1.1
    3.4
    0
    0
        DB:Hematocrit AL(n=93,94,93,92,48,45)
    7.5
    10.6
    14.0
    8.7
    10.4
    13.3
        DB:Hematocrit AH (n=93,94,93,92,48,45)
    1.1
    0
    1.1
    0
    2.1
    2.2
        F-U:Hematocrit AL (n=93,92,90,87,46,44)
    6.5
    13.0
    10.0
    11.5
    13.0
    11.4
        F-U: Hematocrit AH (n=93,92,90,87,46,44)
    1.1
    1.1
    0
    0
    0
    0
        DB:Lymphocytes Atypical AL (n=5,6,2,4,2,2)
    0
    0
    0
    0
    0
    0
        DB:Lymphocytes Atypical AH (n=5,6,2,4,2,2)
    80.0
    100.0
    100.0
    100.0
    100.0
    100.0
        F-U:Lymphocytes Atypical AL (n=2,4,1,0,2,0)
    0
    0
    0
    99999
    0
    99999
        F-U:Lymphocytes Atypical AH (n=2,4,1,0,2,0)
    100.0
    100.0
    100.0
    99999
    100.0
    99999
        DB:Lymphocyte Atypical/Leukocyte AL(n=5,6,2,4,2,1)
    0
    0
    0
    0
    0
    0
        DB:Lymphocyte Atypical/Leukocyte AH(n=5,6,2,4,2,1)
    80.0
    100.0
    100.0
    100.0
    100.0
    100.0
        F-U:LymphocyteAtypical/Leukocyte AL(n=2,4,1,0,1,0)
    0
    0
    0
    99999
    0
    99999
        F-U:LymphocyteAtypical/Leukocyte AH(n=2,4,1,0,1,0)
    100.0
    100.0
    100.0
    99999
    100.0
    99999
        F-U:Metamyelocytes AL(n=1,0,0,0,0,0)
    0
    99999
    99999
    99999
    99999
    99999
        F-U:Metamyelocytes AH (n=1,0,0,0,0,0)
    100.0
    99999
    99999
    99999
    99999
    99999
        DB:Monocytes AL (n=93,94,93,92,48,45)
    10.8
    12.8
    5.4
    5.4
    4.2
    8.9
        DB:Monocytes AH (n=93,94,93,92,48,45)
    1.1
    2.1
    0
    0
    6.3
    0
        F-U:Monocytes AL (n=93,92,90,87,46,44)
    4.3
    7.6
    7.8
    1.1
    4.3
    0
        F-U:Monocytes AH (n=93,92,90,87,46,44)
    0
    1.1
    1.1
    0
    0
    0
        F-U:Myelocytes AL (n=1,0,1,0,0,0)
    0
    99999
    0
    99999
    99999
    99999
        F-U:Myelocytes AH (n=1,0,1,0,0,0)
    100.0
    99999
    100.0
    99999
    99999
    99999
        DB:Neutrophils, Segmented AL (n=93,94,93,92,48,45)
    36.6
    24.5
    23.7
    25.0
    35.4
    33.3
        DB:Neutrophils, Segmented AH (n=93,94,93,92,48,45)
    5.4
    4.3
    6.5
    6.5
    4.2
    4.4
        F-U:Neutrophils,Segmented AL(n=93,92,90,87,46,44)
    30.1
    23.9
    18.9
    26.4
    17.4
    20.5
        F-U:Neutrophils,Segmented AH(n=93,92,90,87,46,44)
    3.2
    4.3
    2.2
    2.3
    4.3
    0
        DB:Reticulocytes AL (n=91,92,91,89,46,45)
    34.1
    27.2
    26.4
    24.7
    41.3
    37.8
        DB:Reticulocytes AH (n=91,92,91,89,46,45)
    4.4
    0
    0
    2.2
    0
    2.2
        F-U:Reticulocytes AL (n=92,92,90,86,46,44)
    27.2
    32.6
    24.4
    20.9
    30.4
    13.6
        F-U:Reticulocytes AH (n=92,92,90,86,46,44)
    3.3
    4.3
    4.4
    1.2
    0
    2.3
        DB:Serum Alpha Fetoprotein AL(n=87,91,88,89,46,43)
    0
    0
    0
    0
    0
    0
        DB:Serum Alpha Fetoprotein AH(n=87,91,88,89,46,43)
    1.1
    3.3
    0
    0
    0
    0
        F-U:Serum AlphaFetoprotein AL(n=89,85,85,86,46,45)
    0
    0
    0
    0
    0
    0
        F-U:Serum AlphaFetoprotein AH(n=89,85,85,86,46,45)
    1.1
    2.4
    0
    1.2
    0
    0
        F-U:Serum Chloride AL (n=94,94,90,88,46,45)
    0
    0
    0
    0
    0
    0
        F-U:Serum Chloride AH (n=94,94,90,88,46,45)
    1.1
    2.1
    1.1
    0
    0
    0
        DB:Serum GGT AL(n=93,96,93,93,48,45)
    1.1
    3.1
    5.4
    8.6
    2.1
    8.9
        DB:Serum GGT AH(n=93,96,93,93,48,45)
    10.8
    3.1
    3.2
    2.2
    6.3
    4.4
        F-U:Serum GGT AL(n=94,94,90,88,46,45)
    1.1
    3.2
    3.3
    9.1
    8.7
    4.4
        F-U:Serum GGT AH(n=94,94,90,88,46,45)
    4.3
    2.1
    6.7
    3.4
    4.3
    0
        DB:Serum HDL Cholesterol AL(n=93,96,93,93,48.45)
    6.5
    18.8
    24.7
    28.0
    8.3
    37.8
        DB:Serum HDL Cholesterol AH(n=93,96,93,93,48.45)
    50.5
    15.6
    11.8
    6.5
    41.7
    8.9
        F-U:Serum HDL Cholesterol AL(n=94,94,90,88,46,45)
    18.1
    20.2
    15.6
    28.4
    19.6
    17.8
        F-U:Serum HDL Cholesterol AH(n=94,94,90,88,46,45)
    23.4
    12.8
    10.0
    8.0
    19.6
    2.2
        DB:Indirect Bilirubin AL(n=93,96,93,93,48,45)
    0
    0
    0
    0
    0
    0
        DB:Indirect Bilirubin AH(n=93,96,93,93,48,45)
    7.5
    3.1
    4.3
    6.5
    8.3
    2.2
        F-U:Indirect Bilirubin AL(n=92,94,90,88,46,45)
    0
    0
    0
    0
    0
    0
        F-U:Indirect Bilirubin AH(n=92,94,90,88,46,45)
    6.5
    1.1
    2.2
    8.0
    6.5
    2.2
        DB:Lactate Dehydrogenase AL(n=93,94,93,92,48,45)
    0
    0
    0
    0
    0
    0
        DB:Lactate Dehydrogenase AH(n=93,94,93,92,48,45)
    9.7
    11.7
    3.2
    8.7
    14.6
    4.4
        F-U:Lactate Dehydrogenase AL(n=92,94,90,88,46,45)
    0
    0
    0
    0
    0
    0
        F-U:Lactate Dehydrogenase AH(n=92,94,90,88,46,45)
    6.5
    7.4
    7.8
    9.1
    13.0
    6.7
        DB:Serum Protein AL(n=93,96,93,93,48,45)
    5.4
    3.1
    0
    0
    2.1
    0
        DB:Serum Protein AH(n=93,96,93,93,48,45)
    2.2
    3.1
    4.3
    3.2
    7
    6.7
        F-U:Serum Protein AL(n=94,94,90,88,46,45)
    0
    0
    0
    0
    0
    0
        F-U:Serum Protein AH(n=94,94,90,88,46,45)
    4.3
    1.1
    2.2
    2.3
    2.2
    2.2
        DB:Urea Nitrogen AL (n=93,96,93,93,48,45)
    6.50
    0
    0
    0
    0
    0
        DB:Urea Nitrogen AH (n=93,96,93,93,48,45)
    6.5
    4.2
    3.2
    5.4
    6.3
    6.7
        F-U:Urea Nitrogen AL (n=94,94,90,88,46,45)
    0
    0
    0
    0
    0
    0
        F-U:Urea Nitrogen AH (n=94,94,90,88,46,45)
    6.4
    4.3
    2.2
    1.1
    8.7
    0
        DB:Urine Granular Casts AL(n=1,0,0,1,0,0)
    0
    99999
    99999
    0
    99999
    99999
        DB:Urine Granular Casts AH(n=1,0,0,1,0,0)
    100.0
    99999
    99999
    100.0
    99999
    99999
        DB:Urine Hyaline Casts AL(n=3,5,3,4,2,6)
    0
    0
    0
    0
    0
    0
        DB:Urine Hyaline Casts AH(n=3,5,3,4,2,6)
    100.0
    60.0
    100.0
    100.0
    100.0
    100.0
        F-U:Urine Hyaline Casts AL(n=1,0,0,0,0,0)
    0
    99999
    99999
    99999
    99999
    99999
        F-U:Urine Hyaline Casts AH(n=1,0,0,0,0,0)
    100.0
    99999
    99999
    99999
    99999
    99999
        DB:Urine Leukocytes AL(n=47,48,42,39,21,22)
    0
    0
    0
    0
    0
    0
        DB:Urine Leukocytes AH(n=47,48,42,39,21,22)
    8.5
    6.3
    9.5
    2.6
    9.5
    9.1
        F-U:Urine Leukocytes AL(n=8,7,9,11,4,0)
    0
    0
    0
    0
    0
    99999
        F-U:Urine Leukocytes AH(n=8,7,9,11,4,0)
    0
    0
    0
    0
    25.0
    99999
        DB:Urine Specific Gravity AL(n=61,61,53,54,29,25)
    1.6
    0
    3.8
    3.7
    0
    0
        DB:Urine Specific Gravity AH(n=61,61,53,54,29,25)
    1.6
    11.5
    1.9
    5.6
    3.4
    24.0
        F-U:Urine Specific Gravity AL(n=17,15,18,15,8,0))
    5.9
    0
    5.6
    0
    0
    99999
        F-U:Urine Specific Gravity AH(n=17,15,18,15,8,0))
    5.9
    0
    0
    0
    0
    99999
        DB:Urine Squamous Epithelial cellAL(n=1,3,4,2,2,2)
    0
    0
    0
    0
    0
    0
        DB:Urine Squamous Epithelial cellAH(n=1,3,4,2,2,2)
    100.0
    66.7
    75.0
    50.0
    50.0
    50.0
        DB:Urine T.E Cells AL(n=0,1,1,2,1,1)
    99999
    0
    0
    0
    0
    0
        DB:Urine Transitinoal E.C AH(n=0,1,1,2,1,1)
    99999
    100.0
    100.0
    100.0
    100.0
    100.0
        DB:Urine Tubular E.C AL(n=0,0,0,1,0,0)
    99999
    99999
    99999
    0
    99999
    99999
        DB:Urine Tubular E.C AH (n=0,0,0,1,0,0)
    99999
    99999
    99999
    100.0
    99999
    99999
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Abnormalities in Electrocardiogram (ECG)

    		 Close Top of page
    End point title
    		 Percentage of Subjects with Abnormalities in Electrocardiogram (ECG)
    End point description
    Percentage of subjects with abnormalities in ECG parameters (heart rate, PR interval, QRS duration, and QTcF interval) were reported. Abnormality criteria: Heart rate abnormally low (AL): <45 beats per minute (bpm); Hear rate abnormally high (AH):>=120 bpm; PR interval AH:>220 msec; QRS duration AH:>120 msec; QTcF borderline prolonged (BP) QT: 450 msec to <=480 msec. Safety analysis set included all subjects who received at least one dose of any of the study treatments. Here, 'N' (number of subject analysed) signifies number of subjects who were evaluable for this endpoint and 'n' (number analysed) represents number of subjects evaluable at the specified timepoints. PP: Pathologically prolonged.
    End point type
    Secondary
    End point timeframe
    DB: Up to 48 weeks, F-U: Wek 48 up to Week 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    93
    95
    91
    92
    47
    45
    Units: Percentage of subjects
    number (not applicable)
        DB: Heart Rate AL (n=93,95,91,92,47,45
    0
    2.1
    1.1
    3.3
    0
    0
        DB: Heart Rate AH (n=93,95,91,92,47,45
    0
    0
    0
    0
    0
    0
        F-U: Heart Rate AL (n=92,84,83,84,46,1)
    0
    0
    0
    0
    2.2
    0
        F-U: Heart Rate AH (n=92,84,93,84,46,1)
    0
    0
    0
    0
    0
    0
        DB: PR interval AH (n=93,95,91,92,47,45)
    1.1
    0
    3.3
    1.1
    4.3
    2.2
        F-U: PR interval AH (n=92,84,83,84,46,1)
    0
    0
    1.2
    0
    0
    0
        DB: QRS duration AH (n=93,95,91,92,47,45)
    2.2
    1.1
    1.1
    0
    0
    2.2
        F-U: QRS duration AH (n=92,84,83,84,46,1)
    2.2
    0
    0
    0
    0
    0
        DB: QTcF interval BP-QT(n=93,95,91,92,47,45)
    2.2
    2.1
    3.3
    1.1
    0
    2.2
        DB:QTcF interval prolonged QT(n=93,95,91,92,47,45)
    0
    0
    0
    0
    0
    0
        DB: QTcF interval PP-QT(n=93,95,91,92,47,45)
    0
    0
    0
    0
    0
    0
        F-U: QTcF interval BP-QT (n=92,84,83,84,46,1)
    1.1
    0
    2.4
    1.2
    0
    0
        F-U:QTcF interval prolonged QT(n=92,84,83,84,46,1)
    0
    0
    0
    0
    0
    0
        F-U: QTcF interval PP-QT (n=92,84,83,84,46,1)
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Abnormalities in Vital Signs

    		 Close Top of page
    End point title
    		 Percentage of Subjects with Abnormalities in Vital Signs
    End point description
    Percentage of subjects with abnormalities in vital signs parameters (pulse rate, diastolic and systolic blood pressure) were reported. Abnormality criteria: Pulse rate AL:<=45 bpm; Systolic blood pressure (SBP) AL: <=90 millimeters of mercury (mmHg), mild:>140 mmHg - <160 mmHg; moderate:>=160 mmHg - <180 mmHg; Diastolic blood pressure (DBP): AL: <=150 mmHg; mild:>90 mmHg - <100 mmHg; moderate: >=100 mmHg - <110 mmHg; severe:>=110 mmHg. Abnormality was determined at the investigator's discretion. Safety analysis set included all subjects who received at least one dose of any of the study treatments. Here, 'N' (number of subject analysed) signifies number of subjects who were evaluable for this endpoint and 'n' (number analysed) represented number of subjects evaluable at the specified category.
    End point type
    Secondary
    End point timeframe
    DB: Up to 48 weeks, F-U: Week 48 up to Week 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    94
    96
    93
    93
    48
    45
    Units: Percentage of subjects
    number (not applicable)
        DB:Pulse rate AL (n=93,96,93,93,48,45)
    1.1
    4.2
    2.2
    2.2
    0
    0
        DB:Pulse rate AH (n=93,96,93,93,48,45)
    0
    2.1
    1.1
    2.2
    0
    0
        FU:Pulse rate AL (n=94,94,90,88,46,45)
    1.1
    0
    1.1
    2.3
    0
    0
        FU:Pulse rate AH (n=94,94,90,88,46,45)
    0
    0
    0
    1.1
    0
    0
        DB: DBP AL (n=93,96,93,93,48,45)
    4.3
    1.0
    4.3
    4.3
    0
    2.2
        DB: DBP mild (n=93,96,93,93,48,45)
    20.4
    18.8
    12.9
    14.0
    0
    6.7
        DB: DBP moderate (n=93,96,93,93,48,45)
    4.3
    4.2
    3.2
    3.2
    0
    0
        DB: DBP severe (n=93,96,93,93,48,45)
    0
    0
    0
    1.1
    0
    0
        FU: DBP AL (n=94,94,90,88,46,45)
    1.1
    1.1
    0
    1.1
    0
    0
        FU: DBP mild (n=94,94,90,88,46,45)
    10.16
    10.16
    4.4
    12.5
    0
    8.9
        FU: DBP moderate (n=94,94,90,88,46,45)
    1.1
    2.1
    4.4
    1.1
    0
    0
        DB: SBP AL(n=93,96,93,93,48,45)
    0
    6.3
    2.2
    6.5
    0
    4.4
        DB: SBP mild (n=93,96,93,93,48,45)
    23.7
    18.8
    12.9
    22.6
    0
    17.8
        DB: SBP moderate (n=93,96,93,93,48,45)
    4.3
    3.1
    4.3
    2.2
    0
    2.2
        FU: SBP AL (n=94,94,90,88,46,45)
    3.2
    2.1
    1.1
    4.5
    0
    0
        FU: SBP mild (n=94,94,90,88,46,45)
    12.8
    12.8
    11.1
    10.2
    0
    4.4
        FU: SBP moderate (n=94,94,90,88,46,45)
    0
    2.1
    2.2
    2.1
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBsAg Seroclearance 24 Weeks After Completion of all Study Intervention at Week 48

    		 Close Top of page
    End point title
    		 Percentage of Subjects with HBsAg Seroclearance 24 Weeks After Completion of all Study Intervention at Week 48
    End point description
    Percentage of subjects with HBsAg seroclearance 24 weeks after completion of all study intervention at week 48 were reported. HBsAg Seroclearance was defined as HBsAg <LLOQ. Responder was defined as a subject who achieved functional cure at Week 72 if the subject met the criteria for stopping NA treatment at Week 48, had HBsAg seroclearance at Week 72. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment. Here, 'N' (number of subject analysed) signifies number of subjects who were evaluable for this endpoint excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44.
    End point type
    Secondary
    End point timeframe
    Week 72
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    85
    83
    82
    83
    46
    45
    Units: Percentage of subjects
        number (confidence interval 90%)
    0.0 (0.00 to 3.46)
    0.0 (0.00 to 3.54)
    0.0 (0.00 to 3.59)
    0.0 (0.00 to 3.54)
    0.0 (0.00 to 6.30)
    2.2 (0.11 to 10.11)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBsAg Seroclearance 48 Weeks After Completion of all Study Intervention at Week 48.

    		 Close Top of page
    End point title
    		 Percentage of Subjects with HBsAg Seroclearance 48 Weeks After Completion of all Study Intervention at Week 48.
    End point description
    Percentage of subjects with HBsAg seroclearance 48 weeks after completion of all study intervention at Week 48 were reported. HBsAg Seroclearance was defined as HBsAg <LLOQ. A responder was defined as a subject who achieved HBsAg seroclearance at Week 96 if the subject completed 48 weeks of treatment, met the criteria for stopping NA treatment at Week 48, did not require NA re-treatment between Week 48 and Week 96, and had HBsAg seroclearance at Week 96. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    94
    94
    92
    91
    48
    45
    Units: Percentage of subjects
        number (confidence interval 90%)
    0.0 (0.00 to 3.14)
    1.1 (0.05 to 4.95)
    0.0 (0.00 to 3.20)
    0.0 (0.00 to 3.24)
    0.0 (0.00 to 6.05)
    2.2 (0.11 to 10.11)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBV DNA <LLOQ 24 and 48 Weeks After Completion of all Study Intervention at Week 48

    		 Close Top of page
    End point title
    		 Percentage of Subjects with HBV DNA <LLOQ 24 and 48 Weeks After Completion of all Study Intervention at Week 48
    End point description
    Percentage of subject who completed all study intervention at week 48 and reached HBV DNA <LLOQ at follow-up weeks 24 and 48 were reported. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, 'N' (number of subject analysed) signifies number of subjects who were evaluable for this endpoint and 'n' (number analyzed) represents number of subjects evaluable at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Weeks 72 and 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    94
    94
    92
    91
    48
    45
    Units: Percentage of subjects
    number (confidence interval 90%)
        F-U: Week 72 (n=94,94,92,91,48,45)
    5.3 (2.12 to 10.86)
    16.0 (10.10 to 23.50)
    7.6 (3.63 to 13.82)
    1.1 (0.06 to 5.11)
    0.0 (0.00 to 6.05)
    4.4 (0.80 to 13.34)
        FU: Week 96 (n=94,94,92,91,48,45)
    6.4 (2.82 to 12.21)
    9.6 (5.09 to 16.11)
    5.4 (2.17 to 11.09)
    1.1 (0.06 to 5.11)
    2.1 (0.11 to 9.51)
    0.0 (0.00 to 6.44)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Meeting the NA Treatment Completion Criteria

    		 Close Top of page
    End point title
    		 Percentage of Subjects Meeting the NA Treatment Completion Criteria
    End point description
    Percentage of subjects meeting the NA treatment completion criteria was reported. NA completion criteria: subjects had ALT 3*ULN; subjects had HBV DNA <LLOQ; subjects was HBeAg-negative; subjects had HBsAg <10 IU/mL. A responder was defined as a subject who stopped NA at Week 48 and met the NA treatment completion criteria at any time during the follow-up phase, regardless of the treatment duration. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44.
    End point type
    Secondary
    End point timeframe
    Week 48 up to Week 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    94
    94
    92
    91
    48
    45
    Units: Percentage of subjects
        number (confidence interval 90%)
    11.7 (6.70 to 18.63)
    26.6 (19.21 to 35.12)
    16.3 (10.33 to 23.99)
    4.4 (1.52 to 9.78)
    0.0 (0.00 to 6.05)
    2.2 (0.11 to 10.11)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84 and 96

    		 Close Top of page
    End point title
    		 Percentage of Subjects with HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84 and 96
    End point description
    Percentage of subjects with HBsAg seroclearance after completion of NA treatment at Weeks 60, 84 and 96 were reported. A responder was defined as a subject who achieved HBsAg seroclearance at Week 96 if the subject completed 48 weeks of treatment, met the criteria for stopping NA treatment at Week 48, did not require NA re-treatment between Week 48 and Week 96, and had HBsAg seroclearance at Week 96. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, 'n' (number analysed) represented number of subjects evaluable at the specified timepoints. Here, '99999' indicated that data was not available as no subject was analysed.
    End point type
    Secondary
    End point timeframe
    Weeks 60, 84 and 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    94
    94
    92
    91
    48
    45
    Units: Percentage of of subjects
    number (confidence interval 90%)
        Week 96 (n=94,94,92,9148,45)
    0.0 (0.00 to 3.14)
    1.1 (0.05 to 4.95)
    0.0 (0.00 to 3.20)
    0.0 (0.00 to 3.24)
    0.0 (0.00 to 6.05)
    2.2 (0.11 to 10.11)
        Week 60 (n=9,22,18,5,0,1)
    0.0 (0.00 to 28.31)
    9.1 (1.64 to 25.95)
    0.0 (0.00 to 15.33)
    0.0 (0.00 to 45.07)
    99999 (99999 to 99999)
    0.0 (0.00 to 95.00)
        Week 84 (n=10,22,14,5,0,1)
    0.0 (0.00 to 25.89)
    9.1 (1.64 to 25.95)
    0.0 (0.00 to 19.26)
    0.0 (0.00 to 45.07)
    99999 (99999 to 99999)
    100.0 (5.0 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Required NA Re-treatment During Follow-up

    		 Close Top of page
    End point title
    		 Percentage of Subjects who Required NA Re-treatment During Follow-up
    End point description
    Percentage of subjects who required NA re-treatment during follow-up were reported. Responder was defined as a subject who met the criteria for NA re-treatment at any time during follow-up, for those subjects who met the NA treatment completion criteria at any time during the study and actually stopped NA treatment. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44.
    End point type
    Secondary
    End point timeframe
    Week 48 up to Week 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    94
    94
    92
    91
    48
    45
    Units: Percentage of subjects
        number (confidence interval 90%)
    1.1 (0.05 to 4.95)
    1.1 (0.05 to 4.95)
    2.2 (0.39 to 6.69)
    0.0 (0.00 to 3.24)
    0.0 (0.00 to 6.05)
    0.0 (0.00 to 6.44)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Flares

    		 Close Top of page
    End point title
    		 Percentage of Subjects with Flares
    End point description
    Percentage of subjects with flare (virologic, biochemical, and clinical) was reported. Virologic flare: confirmed HBV DNA >peak threshold; biochemical Flare: confirmed ALT and/or AST increase of 3*ULN and 3*nadir; clinical flare: confirmed HBV DNA >peak threshold and confirmed ALT and/or AST increase of 3*ULN and 3*nadir. Virologic and clinical flare was assessed only for those subjects who were off-treatment and had HBV DNA<LLOQ at the last observed time point on all study treatments and biochemical flares was identified on treatment and off treatment, respectively. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, 'n' (number analysed) represents number of subjects evaluable at the specified category.
    End point type
    Secondary
    End point timeframe
    Follow-up phase (Week 48 up to Week 96)
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    94
    94
    92
    91
    48
    45
    Units: Percentage of subjects
    number (confidence interval 90%)
        Biochemical: On NA (n=94,94,92,91,48,45
    0.0 (0.00 to 3.14)
    0.0 (0.00 to 3.14)
    0.0 (0.00 to 3.20)
    0.0 (0.00 to 3.24)
    2.1 (0.11 to 9.51)
    0.0 (0.00 to 6.44)
        Biochemical: Off NA (n=33,40,40,18,10,10)
    0.0 (0.00 to 8.68)
    2.5 (1.13 to 11.32)
    0.0 (0.00 to 7.22)
    0.0 (0.00 to 14.59)
    0.0 (0.00 to 25.89)
    0.0 (0.00 to 25.89)
        Virologic HBVDNA>200:Off NA(n=30,37,37,14,9,10)
    13.3 (4.69 to 27.96)
    24.3 (13.32 to 38.61)
    21.6 (11.24 to 35.64)
    14.3 (2.60 to 38.54)
    0.0 (0.00 to 28.31)
    0.0 (0.00 to 25.89)
        Virologic HBVDNA>2000:Off NA(n=30,37,37,14,9,10)
    3.3 (0.17 to 14.86)
    2.7 (0.14 to 12.19)
    8.1 (2.25 to 19.64)
    7.1 (0.37 to 29.67)
    0.0 (0.00 to 28.21)
    10.0 (0.51 to 39.42)
        Virologic HBVDNA>20000:Off NA(n=30,37,37,14,9,10)
    3.0 (0.17 to 14.86)
    2.7 (0.14 to 12.19)
    5.4 (0.97 to 16.05)
    0.0 (0.00 to 19.26)
    0.0 (0.00 to 8.31)
    0.0 (0.00 to 25.89)
        Clinical HBVDNA>200:Off NA(n=30,37,37,14,9,10)
    0.0 (0.00 to 9.50)
    0.0 (0.00 to 7.78)
    0.0 (0.00 to 7.78)
    0.0 (0.00 to 19.26)
    0.0 (0.00 to 28.31)
    0.0 (0.00 to 25.89)
        Clinical HBVDNA>2000:Off NA(n=30,37,37,14,9,10)
    0.0 (0.00 to 9.50)
    0.0 (0.00 to 7.78)
    0.0 (0.00 to 7.78)
    0.0 (0.00 to 19.26)
    0.0 (0.00 to 28.31)
    0.0 (0.00 to 25.89)
        Clinical HBVDNA>20000:Off NA(n=30,37,37,14,9,10)
    0.0 (0.00 to 9.50)
    2.7 (0.14 to 12.19)
    0.0 (0.00 to 7.78)
    0.0 (0.00 to 19.26)
    0.0 (0.00 to 28.31)
    0.0 (0.00 to 25.89)
    No statistical analyses for this end point

    Secondary: Number of Subjects with (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker

    		 Close Top of page
    End point title
    		 Number of Subjects with (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker
    End point description
    Number of subjects with (sustained) reduction, suppression and/or seroclearance considering single and multiple marker was reported. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, 'n' (number analysed) represents number of subjects evaluable at the specified timepoints.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24, 36 and 48
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    94
    94
    92
    91
    48
    45
    Units: Subjects
        Week 12 (n=94,94,92,91,48,45)
    10
    25
    17
    5
    1
    1
        Week 24 (n=94,94,92,91,48,45)
    10
    24
    16
    5
    1
    1
        Week 36 (n=94,94,92,91,48,45)
    9
    23
    18
    5
    1
    1
        Week 48 (n=94,94,92,91,48,45)
    10
    23
    18
    5
    1
    1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBsAg Seroconversion

    		 Close Top of page
    End point title
    		 Percentage of Subjects with HBsAg Seroconversion
    End point description
    HBsAg seroconversion was defined as achieving HBsAg seroclearance (HBsAg (quantitative) <LLOQ) together with an appearance of anti-HBs antibodies (baseline anti-HBs antibodies [quantitative] <LLOQ and a post-baseline assessment greater than or equal to [>=] LLOQ). mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, 'N' (number of subject analysed) signifies number of subjects who were evaluable for this endpoint and 'n' (number analysed) represents number of subjects evaluable at the specified timepoints.
    End point type
    Secondary
    End point timeframe
    Week 48, Follow-up Weeks 60, 72, and 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    87
    89
    83
    85
    45
    42
    Units: Percentage of subjects
    number (not applicable)
        DB: Week 48 (n=86,89,83,85,44,42)
    0.0
    1.1
    0.0
    0.0
    0.0
    0.0
        F-U: Week 60 (n=85,83,78,81,45,41)
    0.0
    0.0
    0.0
    0.0
    0.0
    0.0
        F-U: Week 72 (n=83,82,76,82,45,42)
    0.0
    0.0
    1.3
    0.0
    0.0
    2.4
        F-U: Week 96 (n=87,81,80,80,42,42)
    0.0
    1.2
    0.0
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBeAg Seroconversion

    		 Close Top of page
    End point title
    		 Percentage of Subjects with HBeAg Seroconversion
    End point description
    HBeAg seroconversion was defined as achieving HBeAg seroclearance (HBeAg [quantitative] <LLOQ) together with an appearance of anti-HBe antibodies (baseline anti-HBe antibodies [qualitative] with a “negative” result and a post-baseline assessment with “positive” result. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, 'N' (number of subject analysed) signifies number of subjects who were evaluable for this endpoint and 'n' (number analysed) represents number of subjects evaluable at the specified timepoints.
    End point type
    Secondary
    End point timeframe
    Week 48, Follow-up Weeks 60, 72, and 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    25
    28
    23
    25
    14
    11
    Units: Percentage of subjects
    number (not applicable)
        DB: Week 48 (n=25, 28, 23, 24, 13, 11)
    4.0
    3.6
    8.7
    0
    0
    18.2
        F-U: Week 60 (n=23, 27, 22, 23, 14, 10)
    4.3
    7.4
    4.5
    0
    0
    20.0
        F-U: Week 72 (n=24, 27, 22, 25, 14, 11)
    4.2
    3.7
    9.1
    0
    0
    18.2
        F-U: Week 96 (n=25, 27, 23, 24, 13, 11)
    8.0
    14.8
    13.0
    4.2
    7.7
    18.2
    No statistical analyses for this end point

    Secondary: Change From Baseline in HBsAg Levels

    		 Close Top of page
    End point title
    		 Change From Baseline in HBsAg Levels
    End point description
    Change from baseline in HBsAg levels was reported. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, 'n' (number analysed) represents number of subjects evaluable at the specified category. Log IU/mL: Log international units per millilitre
    End point type
    Secondary
    End point timeframe
    DB: Baseline, Weeks 12, 24, 48; F-U: Weeks 60, 72, 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    94
    94
    92
    91
    48
    45
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        DB: Baseline (n=94,94,92,91,48,45)
    3.66 ( 0.691 )
    3.83 ( 0.721 )
    3.70 ( 0.778 )
    3.81 ( 0.678 )
    3.63 ( 0.681 )
    3.83 ( 0.714 )
        DB: Week 12 (n=92,92,86,88,45,45)
    -0.96 ( 0.533 )
    -1.51 ( 0.790 )
    -1.24 ( 0.646 )
    -0.82 ( 0.361 )
    -0.01 ( 0.286 )
    -0.07 ( 0.244 )
        DB: Week 24 (n=91,92,88,88,45,44)
    -1.52 ( 0.582 )
    -2.22 ( 0.768 )
    -1.84 ( 0.612 )
    -1.26 ( 0.430 )
    -0.05 ( 0.356 )
    -0.12 ( 0.350 )
        DB: Week 48 (n=87,91,88,86,45,44)
    -1.76 ( 0.643 )
    -2.58 ( 0.996 )
    -2.09 ( 0.665 )
    -1.50 ( 0.470 )
    -0.07 ( 0.354 )
    -0.22 ( 0.854 )
        F-U: Week 60 (n=87,85,84,83,46,1)
    -1.59 ( 0.613 )
    -2.21 ( 0.975 )
    -1.75 ( 0.699 )
    -1.22 ( 0.456 )
    -0.12 ( 0.367 )
    -0.21 ( 0.747 )
        F-U: Week 72 (n=85,83,82,84,46,45)
    -1.38 ( 0.630 )
    -1.85 ( 0.927 )
    -1.50 ( 0.783 )
    -1.01 ( 0.487 )
    -0.15 ( 0.366 )
    -0.26 ( 1.032 )
        F-U: Week 96 (n=89,82,85,82,44,45)
    -1.04 ( 0.634 )
    -1.39 ( 0.895 )
    -1.15 ( 0.744 )
    -0.74 ( 0.497 )
    -0.14 ( 0.360 )
    -0.25 ( 1.031 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in HBeAg Levels

    		 Close Top of page
    End point title
    		 Change From Baseline in HBeAg Levels
    End point description
    Change from baseline in HBeAg levels was reported. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, 'N' (number of subject analysed) signifies number of subjects who were evaluable for this endpoint and 'n' (number analysed) represents number of subjects evaluable at the specified timepoints. log10 IU/mL: Log10 international units per millilitre
    End point type
    Secondary
    End point timeframe
    DB: Baseline, Weeks 12, 24, 48; F-U: Weeks 60, 72, 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    27
    30
    25
    30
    15
    13
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        DB: Baseline (n=27,30,25,30,15,13)
    1.22 ( 1.494 )
    1.60 ( 1.449 )
    1.68 ( 1.540 )
    1.26 ( 1.318 )
    0.81 ( 1.261 )
    1.03 ( 1.435 )
        DB: Week 12 (n=27,27,23,29,13,10)
    -0.82 ( 0.746 )
    -0.90 ( 0.629 )
    -0.95 ( 0.502 )
    -0.44 ( 0.273 )
    -0.60 ( 0.652 )
    -0.32 ( 0.425 )
        DB: Week 24 (n=27,29,25,30,,13,13)
    -1.00 ( 0.880 )
    -1.17 ( 0.832 )
    -1.12 ( 0.636 )
    -0.54 ( 0.372 )
    -0.77 ( 0.817 )
    -0.59 ( 0.782 )
        DB: Week 48 (n=26,28,24,27,14,13)
    -1.43 ( 1.194 )
    -1.50 ( 1.142 )
    -1.53 ( 0.999 )
    -0.78 ( 0.550 )
    -0.84 ( 0.876 )
    -0.96 ( 1.325 )
        F-U: Week 60 (n=25,27,24,27,15,12
    -1.40 ( 1.253 )
    -1.61 ( 1.168 )
    -1.32 ( 0.763 )
    -0.83 ( 0.600 )
    -0.87 ( 0.874 )
    -1.03 ( 1.384 )
        F-U: Week 72 (n=25,27,23,28,15,13)
    -1.50 ( 1.276 )
    -1.67 ( 1.303 )
    -1.44 ( 1.000 )
    -0.80 ( 0.687 )
    -0.95 ( 0.891 )
    -0.97 ( 1.361 )
        F-U: Week 96 (n=26,27,24,26,14,13)
    -1.55 ( 1.334 )
    -1.58 ( 1.325 )
    -1.43 ( 1.092 )
    -0.84 ( 0.710 )
    -1.21 ( 1.104 )
    -1.07 ( 1.357 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in HBV DNA Levels

    		 Close Top of page
    End point title
    		 Change from Baseline in HBV DNA Levels
    End point description
    Change from baseline in HBV DNA levels were reported. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, 'N' (number of subject analysed) signifies number of subjects who were evaluable for this endpoint and 'n' (number analysed) represents number of subjects evaluable at the specified category.
    End point type
    Secondary
    End point timeframe
    DB: Baseline, Weeks 12, 24, 48; F-U: Weeks 60, 72, 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    33
    35
    33
    33
    18
    16
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        DB: Baseline (n=33,35,33,33,18,16)
    5.97 ( 1.989 )
    6.64 ( 1.972 )
    6.34 ( 1.778 )
    6.10 ( 1.916 )
    6.48 ( 2.008 )
    6.39 ( 1.922 )
        DB: Week 12 (n=32,34,33,31,16,16)
    -4.13 ( 1.267 )
    -3.90 ( 1.221 )
    -3.83 ( 1.079 )
    -3.72 ( 1.008 )
    -4.28 ( 1.052 )
    -3.64 ( 1.365 )
        DB: Week 24 (n=32,33,32,31,16,16)
    -4.59 ( 1.532 )
    -5.03 ( 1.441 )
    -4.68 ( 1.199 )
    -4.53 ( 1.273 )
    -5.08 ( 1.566 )
    -4.34 ( 1.457 )
        DB: Week 48 (n=30,32,32,30,15,16)
    -4.85 ( 1.896 )
    -5.28 ( 1.663 )
    -5.18 ( 1.669 )
    -4.86 ( 1.605 )
    -5.71 ( 1.578 )
    -4.68 ( 1.970 )
        F-U: Week 60 (n=31,32,28,31,17,16)
    -4.85 ( 1.910 )
    -5.39 ( 1.673 )
    -5.27 ( 1.759 )
    -4.95 ( 1.602 )
    -5.40 ( 1.808 )
    -4.67 ( 2.028 )
        F-U: Week 72 (n=30,31,29,31,17,16)
    -4.97 ( 1.912 )
    -5.40 ( 1.849 )
    -5.25 ( 1.727 )
    -5.04 ( 1.606 )
    -5.49 ( 1.845 )
    -4.81 ( 1.903 )
        F-U: Week 96 (n=31,30,29,28,17,16)
    -4.96 ( 2.010 )
    -5.45 ( 1.948 )
    -5.18 ( 2.004 )
    -5.06 ( 1.693 )
    -5.63 ( 1.827 )
    -4.95 ( 1.963 )
    No statistical analyses for this end point

    Secondary: Time to Achieve HBsAg Seroclearance

    		 Close Top of page
    End point title
    		 Time to Achieve HBsAg Seroclearance
    End point description
    Time to HBsAg seroclearance (defined as HBsAg level <LLOQ) was defined as the number of days between the date of first study treatment intake and the date of the first occurrence of HBsAg seroclearance. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, '99999' indicated that data was not evaluable due to less number of events.
    End point type
    Secondary
    End point timeframe
    Up to Week 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    94
    94
    92
    91
    48
    45
    Units: Hours
        median (confidence interval 90%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Time to Achieve HBeAg Seroclearance

    		 Close Top of page
    End point title
    		 Time to Achieve HBeAg Seroclearance
    End point description
    Time to HBeAg seroclearance (defined as HBeAg level <LLOQ) was defined as the number of days between the date of first study treatment intake and the date of the first occurrence of HBeAg seroclearance. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, '99999' indicated that data was not evaluable due to less number of events. Here, 'N' (number of subject analysed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Up to Week 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    27
    30
    25
    30
    15
    13
    Units: Hour
        median (confidence interval 90%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBsAg Value <100 IU/mL

    		 Close Top of page
    End point title
    		 Percentage of Subjects with HBsAg Value <100 IU/mL
    End point description
    Percentage of subjects with HBsAg value <100 IU/mL was reported. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, 'n' (number analysed) represents number of subjects evaluable at the specified timepoints.
    End point type
    Secondary
    End point timeframe
    DB: Baseline, Weeks 12, 24, 48; F-U: Weeks 60, 72, 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    94
    94
    92
    91
    48
    45
    Units: Percentage of subjects
    number (not applicable)
        DB: Baseline (n=94,94,92,92,48,45)
    0
    1.1
    1.1
    0
    0
    0
        DB: Week 12 (n=92,92,86,88,45,45)
    19.6
    33.7
    30.2
    15.9
    0
    0
        DB: Week 24 (n=91,92,88,88,45,44)
    42.9
    65.2
    59.1
    25.0
    0
    0
        DB: Week 48 (n=87,91,88,86,45,44)
    57.5
    74.7
    69.3
    36.0
    0
    2.3
        F-U: Week 60 (n=87,85,84,83,46,45)
    54.0
    61.2
    56.0
    22.9
    0
    2.2
        F-U: Week 72 (n=85,83,82,84,46,45)
    43.5
    47.0
    37.8
    14.3
    0
    2.2
        F-U: Week 96 (n=89,82,85,82,44,45)
    21.3
    35.4
    28.2
    9.8
    0
    2.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBsAg Value >1 log10 IU/mL Reduction from Baseline

    		 Close Top of page
    End point title
    		 Percentage of Subjects with HBsAg Value >1 log10 IU/mL Reduction from Baseline
    End point description
    Percentage of subjects with HBsAg value >1 log10 IU/mL reduction from baseline was reported. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, 'N' (number of subject analysed) signifies number of subjects who were evaluable for this endpoint and 'n' (number analysed) represents number of subjects evaluable at the specified timepoints.
    End point type
    Secondary
    End point timeframe
    DB: Baseline, Weeks 12, 24, 48; F-U: Weeks 60, 72, 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    92
    92
    88
    88
    46
    45
    Units: Percentage of subjects
    number (not applicable)
        DB: Week 12 (n=92,92,86,88,45,45)
    40.2
    72.8
    60.5
    27.3
    2.2
    0
        DB: Week 24 (n=91,92,88,88,45,44)
    84.6
    97.8
    93.2
    71.6
    4.4
    4.5
        DB: Week 48 (n=87,91,88,86,45,44)
    93.1
    97.8
    97.7
    82.6
    4.4
    4.5
        F-U: Week 60 (n=87,85,84,83,46,45)
    86.2
    94.1
    90.5
    67.5
    4.3
    4.4
        F-U: Week 72 (n=85,83,82,84,46,45)
    71.8
    84.4
    73.2
    46.6
    4.3
    6.7
        F-U: Week 96 (n=89,82,85,82,44,45)
    41.6
    63.4
    49.4
    20.7
    4.5
    4.4
    No statistical analyses for this end point

    Secondary: Percentage of HBeAg-positive Subjects with HBeAg Levels <LLOQ

    		 Close Top of page
    End point title
    		 Percentage of HBeAg-positive Subjects with HBeAg Levels <LLOQ
    End point description
    Percentage of HBeAg-positive subjects with HBeAg levels <LLOQ was reported. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, 'N' (number of subject analysed) signifies number of subjects who were evaluable for this endpoint and 'n' (number analysed) represents number of subjects evaluable at the specified timepoints.
    End point type
    Secondary
    End point timeframe
    DB: Weeks 12, 24, 48; F-U: Weeks 60, 72, 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    27
    29
    25
    30
    15
    13
    Units: Percentage of subjects
    number (not applicable)
        DB: Week 12 (n=27,27,23,29,13,10)
    7.4
    3.7
    17.4
    6.9
    7.7
    0
        DB: Week 24 (n=27,29,25,30,13,13)
    7.4
    3.4
    16.0
    6.7
    7.7
    0
        DB: Week 48 (n=26,28,24,27,14,13)
    19.2
    7.1
    20.8
    11.1
    7.1
    15.4
        F-U: Week 60 (n=25,27,24,27,15,12)
    12.0
    11.1
    16.7
    7.4
    6.7
    16.7
        F-U: Week 72 (n=25,27,23,28,15,13)
    8.0
    11.1
    21.7
    10.7
    6.7
    15.4
        F-U: Week 96 (n=26,27,24,26,14,13)
    15.4
    14.8
    20.8
    11.5
    21.4
    15.4
    No statistical analyses for this end point

    Secondary: Percentage of HBeAg-positive Subjects with HBeAg Levels >1 log10 IU/mL

    		 Close Top of page
    End point title
    		 Percentage of HBeAg-positive Subjects with HBeAg Levels >1 log10 IU/mL
    End point description
    Percentage of HBeAg-positive subjects with HBeAg levels >1 log10 IU/mL was reported. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, 'N' (number of subject analysed) signifies number of subjects who were evaluable for this endpoint and 'n' (number analysed) represents number of subjects evaluable at the specified timepoints.
    End point type
    Secondary
    End point timeframe
    DB: Weeks 12, 24, 48; F-U: Weeks 60, 72, 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    27
    29
    25
    30
    15
    13
    Units: Percentage of subjects
    number (not applicable)
        DB: Week 12 (n=27,27,23,29,13,10)
    33.3
    33.3
    39.1
    3.4
    23.1
    10.0
        DB: Week 24 (n=27,29,25,30,13,13)
    44.4
    48.3
    60.0
    10.0
    30.8
    23.1
        DB: Week 48 (n=26,28,24,27,14,13)
    50.0
    53.6
    66.7
    25.9
    35.7
    30.8
        F-U: Week 60 (n=25,27,24,27,15,12)
    52.0
    63.3
    62.5
    37.0
    40.0
    33.3
        F-U: Week 72 (n=25,27,23,28,15,13)
    56.0
    59.3
    65.2
    35.7
    40.0
    30.8
        F-U: Week 96 (n=26,27,24,26,14,13)
    53.8
    59.3
    58.3
    42.3
    42.9
    30.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBV DNA Levels <LLOQ

    		 Close Top of page
    End point title
    		 Percentage of Subjects with HBV DNA Levels <LLOQ
    End point description
    Percentage of subjects with HBV DNA levels <LLOQ was reported. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, 'N' (number of subject analysed) signifies number of subjects who were evaluable for this endpoint and 'n' (number analyzed) represents number of subjects evaluable at the specified timepoints.
    End point type
    Secondary
    End point timeframe
    DB: Weeks 12, 24, 48; F-U: Weeks 60, 72, 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    91
    92
    88
    88
    46
    45
    Units: Percentage of subjects
    number (not applicable)
        DB: Week 12 (n=92,92,86,88,45,45)
    78.3
    71.7
    76.7
    70.5
    73.3
    75.6
        DB: Week 24 (n=91,92,88,88,45,44)
    84.6
    80.4
    81.8
    83.0
    80.0
    77.3
        DB: Week 48 (n=88,91,88,87,45,45)
    92.0
    85.7
    86.4
    90.8
    95.6
    93.3
        F-U: Week 60 (n=88,85,83,85,46,45)
    88.6
    85.9
    79.5
    85.9
    93.5
    93.3
        F-U: Week 72 (n=86,85,83,84,46,45)
    89.5
    81.2
    81.9
    86.9
    95.7
    91.1
        F-U: Week 96 (n=89,82,85,80,44,45)
    94.4
    75.6
    80.0
    87.5
    95.5
    93.3
    No statistical analyses for this end point

    Secondary: Mean Decrease from Baseline in ALT at EOT (Week 48) in Subjects With Elevated ALT at Baseline

    		 Close Top of page
    End point title
    		 Mean Decrease from Baseline in ALT at EOT (Week 48) in Subjects With Elevated ALT at Baseline
    End point description
    Mean decrease from baseline in ALT at EOT (Week 48) in subjects With elevated ALT at baseline was reported. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment. Here, 'N' (number of subject analysed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    35
    32
    37
    34
    19
    18
    Units: Units per liter (U/L)
        arithmetic mean (standard deviation)
    -72.77 ( 106.851 )
    -65.47 ( 110.213 )
    -37.51 ( 63.468 )
    -42.53 ( 41.767 )
    -17.68 ( 272.44 )
    -49.28 ( 85.374 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with ALT Normalization

    		 Close Top of page
    End point title
    		 Percentage of Subjects with ALT Normalization
    End point description
    Percentage of subjects with ALT normalization was reported. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment. Here, 'N' (number of subject analysed) signifies number of subjects who were evaluable for this endpoint and 'n' (number analysed) represents number of subjects evaluable at the specified timepoints.
    End point type
    Secondary
    End point timeframe
    DB: Baseline, Weeks 12, 24, 48; F-U: Weeks 60, 72, 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    36
    32
    37
    34
    19
    18
    Units: Percentage of subjects
    number (not applicable)
        DB: Week 12 On-treatment (n=35,31,36,31,16,17)
    54.3
    41.9
    58.3
    64.5
    56.3
    47.1
        DB: Week 24 On-treatment (n=34,30,36,33,17,18)
    61.8
    43.3
    69.4
    78.8
    76.5
    55.6
        DB: Week 48 On-treatment (n=33,30,35,31,16,17)
    60.6
    46.7
    65.7
    83.9
    87.5
    58.8
        F-U: Week 60 On-treatment (n=33,28,33,33,18,18)
    0
    3.6
    12.1
    0
    0
    5.6
        F-U: Week 72 On-treatment (n=32,28,33,33,18,18)
    0
    3.6
    12.1
    0
    0
    5.6
        F-U: Week 96 On-treatment (n=33,26,34,30,18,18)
    21.2
    11.5
    35.3
    10.0
    16.7
    11.1
        F-U: Week 60 Off-treatment (n=33,28,33,33,18,18)
    0
    3.6
    12.1
    0
    0
    5.6
        F-U: Week 72 Off-treatment (n=32,28,33,33,18,18)
    0
    3.6
    12.1
    0
    0
    5.6
        F-U: Week 96 Off-treatment (n=33,26,34,30,18,18)
    21.2
    11.5
    35.3
    10.0
    16.7
    11.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Virologic Breakthrough

    		 Close Top of page
    End point title
    		 Percentage of Subjects with Virologic Breakthrough
    End point description
    Virologic breakthrough was defined as having a confirmed on-treatment HBV DNA increase by >1 log10 from nadir (that is, lowest value during treatment) or a confirmed HBV DNA level >200 IU/mL in subjects who had on-treatment HBV DNA level below the LLOQ. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44.
    End point type
    Secondary
    End point timeframe
    Up to Week 48
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    94
    94
    92
    91
    48
    45
    Units: Percentage of subjects
        number (confidence interval 90%)
    2.1 (0.38 to 6.55)
    2.1 (0.38 to 6.55)
    2.2 (0.39 to 6.69)
    2.2 (0.39 to 6.76)
    0.0 (0.00 to 6.05)
    2.2 (0.11 to 10.11)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Undetectable HBV DNA Levels After Re-start of NA Treatment During Follow-up

    		 Close Top of page
    End point title
    		 Percentage of Subjects with Undetectable HBV DNA Levels After Re-start of NA Treatment During Follow-up
    End point description
    Percentage of subjects with undetectable HBV DNA levels after re-start of NA treatment during follow-up was reported. mITT analysis set included all subjects who were randomised in the study and received at least one dose of study treatment excluding those subjects impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44.
    End point type
    Secondary
    End point timeframe
    Week 48 up to Week 96
    End point values
    		 Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 6: Placebo + Placebo + NA
    Number of subjects analysed
    94
    94
    92
    91
    48
    45
    Units: Percentage of subjects
        number (confidence interval 90%)
    1.1 (0.05 to 4.95)
    1.1 (0.05 to 4.95)
    1.1 (0.06 to 5.05)
    0.0 (0.00 to 3.24)
    0.0 (0.00 to 6.05)
    0.0 (0.00 to 6.44)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to 150 weeks
    Adverse event reporting additional description
    Safety analysis set included all subjects who received at least one dose of any of the study treatments.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Arm 6: Placebo + Placebo + NA
    Reporting group description
    		 Subjects received placebo matching to JNJ-73763989 as SC injection and placebo matching to JNJ-56136379 tablet orally along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally up to 48 weeks.

    Reporting group title
    Arm 5: Placebo + JNJ-56136379 + NA
    Reporting group description
    		 Subjects received placebo matching to JNJ-73763989 as SC injection and a fixed dose of JNJ-56136379 250 mg tablet orally along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally up to 48 weeks.

    Reporting group title
    Arm 2: JNJ-73763989 (200mg) + Placebo + NA
    Reporting group description
    		 Subjects received JNJ-73763989 200 mg as SC injection along with placebo matching to JNJ-56136379 tablet orally and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablets orally up to 48 weeks.

    Reporting group title
    Arm 3: JNJ-73763989 (100 mg) + Placebo + NA
    Reporting group description
    		 Subjects received JNJ-73763989 100 mg as SC injection along with placebo matching to JNJ-56136379 tablet orally and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablets orally up to 48 weeks.

    Reporting group title
    Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 + NA
    Reporting group description
    		 Subjects received JNJ-73763989 100 mg as subcutaneous (SC) injection along JNJ-56136379 250 milligrams (mg) orally and Nucleos(t)ide Analog (NA) (either Entecavir [ETV] monohydrate 0.5 mg, Tenofovir disoproxil fumarate [TDF] 300 mg, or Tenofovir alafenamide [TAF] 25 mg) tablet orally up to 48 weeks.

    Reporting group title
    Arm 4: JNJ-73763989 (40 mg) + Placebo + NA
    Reporting group description
    		 Subjects received JNJ-73763989 40 mg as SC injection along with placebo matching to JNJ-56136379 tablet orally and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally up to 48 weeks.

    Serious adverse events
    		 Arm 6: Placebo + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 45 (0.00%)
    3 / 48 (6.25%)
    8 / 96 (8.33%)
    7 / 93 (7.53%)
    5 / 95 (5.26%)
    2 / 93 (2.15%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 95 (1.05%)
    0 / 93 (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
    Alanine Aminotransferase Increased
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 95 (1.05%)
    0 / 93 (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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine Leiomyoma
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    2 / 95 (2.11%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 96 (1.04%)
    0 / 93 (0.00%)
    0 / 95 (0.00%)
    0 / 93 (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
    Hepatocellular Carcinoma
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 96 (1.04%)
    0 / 93 (0.00%)
    0 / 95 (0.00%)
    0 / 93 (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
    Injury, poisoning and procedural complications
    Fracture Displacement
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 95 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia Fracture
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 96 (0.00%)
    1 / 93 (1.08%)
    0 / 95 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    Multiple Injuries
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 96 (1.04%)
    0 / 93 (0.00%)
    0 / 95 (0.00%)
    0 / 93 (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
    Ligament Rupture
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 96 (0.00%)
    2 / 93 (2.15%)
    0 / 95 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    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 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 95 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Myoclonus
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 96 (0.00%)
    1 / 93 (1.08%)
    0 / 95 (0.00%)
    0 / 93 (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
    Eye disorders
    Retinal Detachment
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 96 (0.00%)
    1 / 93 (1.08%)
    0 / 95 (0.00%)
    0 / 93 (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
    Gastrointestinal disorders
    Melaena
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 95 (0.00%)
    1 / 93 (1.08%)
         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
    Gastric Ulcer
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 96 (1.04%)
    0 / 93 (0.00%)
    0 / 95 (0.00%)
    0 / 93 (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
    Gastric Polyps
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 96 (0.00%)
    1 / 93 (1.08%)
    0 / 95 (0.00%)
    0 / 93 (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
    Hepatobiliary disorders
    Gallbladder Cholesterolosis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 96 (1.04%)
    0 / 93 (0.00%)
    0 / 95 (0.00%)
    0 / 93 (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
    Cholecystitis Chronic
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 96 (1.04%)
    0 / 93 (0.00%)
    0 / 95 (0.00%)
    0 / 93 (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
    Renal and urinary disorders
    Renal Colic
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 95 (1.05%)
    0 / 93 (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
    Urinary Incontinence
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 95 (0.00%)
    1 / 93 (1.08%)
         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
    Musculoskeletal and connective tissue disorders
    Intervertebral Disc Protrusion
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 96 (1.04%)
    0 / 93 (0.00%)
    0 / 95 (0.00%)
    0 / 93 (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
    Rhabdomyolysis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 96 (1.04%)
    0 / 93 (0.00%)
    0 / 95 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cystitis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 95 (1.05%)
    0 / 93 (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
    Covid-19 Pneumonia
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 95 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Covid-19
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 95 (1.05%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    Appendicitis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 96 (0.00%)
    1 / 93 (1.08%)
    0 / 95 (0.00%)
    0 / 93 (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
    Pneumocystis Jirovecii Pneumonia
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 96 (1.04%)
    0 / 93 (0.00%)
    0 / 95 (0.00%)
    0 / 93 (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
    Urinary Tract Infection
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 96 (1.04%)
    0 / 93 (0.00%)
    0 / 95 (0.00%)
    0 / 93 (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
    		 Arm 6: Placebo + Placebo + NA Arm 5: Placebo + JNJ-56136379 + NA Arm 2: JNJ-73763989 (200mg) + Placebo + NA Arm 3: JNJ-73763989 (100 mg) + Placebo + NA Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 + NA Arm 4: JNJ-73763989 (40 mg) + Placebo + NA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 45 (55.56%)
    36 / 48 (75.00%)
    60 / 96 (62.50%)
    63 / 93 (67.74%)
    62 / 95 (65.26%)
    50 / 93 (53.76%)
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 48 (6.25%)
    4 / 96 (4.17%)
    1 / 93 (1.08%)
    6 / 95 (6.32%)
    1 / 93 (1.08%)
         occurrences all number
    1
    5
    6
    1
    9
    1
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 48 (6.25%)
    2 / 96 (2.08%)
    0 / 93 (0.00%)
    3 / 95 (3.16%)
    2 / 93 (2.15%)
         occurrences all number
    1
    6
    2
    0
    3
    3
    Glomerular Filtration Rate Decreased
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 48 (6.25%)
    2 / 96 (2.08%)
    5 / 93 (5.38%)
    11 / 95 (11.58%)
    5 / 93 (5.38%)
         occurrences all number
    1
    5
    2
    6
    16
    6
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 48 (2.08%)
    4 / 96 (4.17%)
    1 / 93 (1.08%)
    5 / 95 (5.26%)
    1 / 93 (1.08%)
         occurrences all number
    2
    1
    4
    1
    6
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 45 (15.56%)
    5 / 48 (10.42%)
    16 / 96 (16.67%)
    19 / 93 (20.43%)
    13 / 95 (13.68%)
    14 / 93 (15.05%)
         occurrences all number
    9
    7
    27
    29
    20
    22
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 45 (6.67%)
    2 / 48 (4.17%)
    3 / 96 (3.13%)
    3 / 93 (3.23%)
    3 / 95 (3.16%)
    3 / 93 (3.23%)
         occurrences all number
    4
    3
    3
    5
    4
    3
    Neutropenia
         subjects affected / exposed
    0 / 45 (0.00%)
    3 / 48 (6.25%)
    1 / 96 (1.04%)
    0 / 93 (0.00%)
    0 / 95 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    0
    3
    1
    0
    0
    0
    General disorders and administration site conditions
    Injection Site Pain
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 96 (0.00%)
    7 / 93 (7.53%)
    2 / 95 (2.11%)
    2 / 93 (2.15%)
         occurrences all number
    0
    1
    0
    38
    6
    11
    Pyrexia
         subjects affected / exposed
    2 / 45 (4.44%)
    5 / 48 (10.42%)
    7 / 96 (7.29%)
    4 / 93 (4.30%)
    4 / 95 (4.21%)
    4 / 93 (4.30%)
         occurrences all number
    3
    8
    7
    4
    5
    4
    Fatigue
         subjects affected / exposed
    3 / 45 (6.67%)
    6 / 48 (12.50%)
    3 / 96 (3.13%)
    5 / 93 (5.38%)
    8 / 95 (8.42%)
    7 / 93 (7.53%)
         occurrences all number
    3
    8
    3
    5
    9
    8
    Asthenia
         subjects affected / exposed
    4 / 45 (8.89%)
    4 / 48 (8.33%)
    6 / 96 (6.25%)
    5 / 93 (5.38%)
    3 / 95 (3.16%)
    3 / 93 (3.23%)
         occurrences all number
    5
    4
    10
    9
    3
    3
    Gastrointestinal disorders
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 45 (4.44%)
    3 / 48 (6.25%)
    5 / 96 (5.21%)
    2 / 93 (2.15%)
    3 / 95 (3.16%)
    3 / 93 (3.23%)
         occurrences all number
    3
    3
    5
    4
    3
    4
    Abdominal Pain
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 48 (2.08%)
    0 / 96 (0.00%)
    5 / 93 (5.38%)
    2 / 95 (2.11%)
    5 / 93 (5.38%)
         occurrences all number
    2
    1
    0
    5
    2
    5
    Nausea
         subjects affected / exposed
    1 / 45 (2.22%)
    6 / 48 (12.50%)
    7 / 96 (7.29%)
    6 / 93 (6.45%)
    4 / 95 (4.21%)
    6 / 93 (6.45%)
         occurrences all number
    1
    6
    9
    6
    7
    7
    Diarrhoea
         subjects affected / exposed
    2 / 45 (4.44%)
    3 / 48 (6.25%)
    4 / 96 (4.17%)
    11 / 93 (11.83%)
    5 / 95 (5.26%)
    7 / 93 (7.53%)
         occurrences all number
    2
    5
    4
    11
    5
    8
    Hepatobiliary disorders
    Hepatic Steatosis
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    2 / 96 (2.08%)
    5 / 93 (5.38%)
    1 / 95 (1.05%)
    3 / 93 (3.23%)
         occurrences all number
    0
    0
    2
    8
    1
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 45 (6.67%)
    2 / 48 (4.17%)
    7 / 96 (7.29%)
    3 / 93 (3.23%)
    6 / 95 (6.32%)
    3 / 93 (3.23%)
         occurrences all number
    3
    2
    7
    4
    7
    4
    Oropharyngeal Pain
         subjects affected / exposed
    1 / 45 (2.22%)
    4 / 48 (8.33%)
    2 / 96 (2.08%)
    4 / 93 (4.30%)
    3 / 95 (3.16%)
    1 / 93 (1.08%)
         occurrences all number
    1
    5
    2
    4
    3
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 45 (0.00%)
    3 / 48 (6.25%)
    2 / 96 (2.08%)
    3 / 93 (3.23%)
    5 / 95 (5.26%)
    0 / 93 (0.00%)
         occurrences all number
    0
    3
    2
    3
    6
    0
    Alopecia
         subjects affected / exposed
    1 / 45 (2.22%)
    2 / 48 (4.17%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    5 / 95 (5.26%)
    0 / 93 (0.00%)
         occurrences all number
    1
    4
    0
    0
    5
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 48 (6.25%)
    4 / 96 (4.17%)
    6 / 93 (6.45%)
    6 / 95 (6.32%)
    7 / 93 (7.53%)
         occurrences all number
    1
    3
    4
    6
    6
    7
    Back Pain
         subjects affected / exposed
    1 / 45 (2.22%)
    4 / 48 (8.33%)
    6 / 96 (6.25%)
    9 / 93 (9.68%)
    7 / 95 (7.37%)
    8 / 93 (8.60%)
         occurrences all number
    3
    5
    9
    11
    7
    13
    Myalgia
         subjects affected / exposed
    3 / 45 (6.67%)
    4 / 48 (8.33%)
    6 / 96 (6.25%)
    8 / 93 (8.60%)
    6 / 95 (6.32%)
    4 / 93 (4.30%)
         occurrences all number
    3
    5
    7
    8
    9
    4
    Infections and infestations
    Covid-19
         subjects affected / exposed
    6 / 45 (13.33%)
    6 / 48 (12.50%)
    12 / 96 (12.50%)
    11 / 93 (11.83%)
    8 / 95 (8.42%)
    11 / 93 (11.83%)
         occurrences all number
    6
    6
    12
    11
    9
    11
    Nasopharyngitis
         subjects affected / exposed
    1 / 45 (2.22%)
    4 / 48 (8.33%)
    6 / 96 (6.25%)
    12 / 93 (12.90%)
    9 / 95 (9.47%)
    8 / 93 (8.60%)
         occurrences all number
    1
    6
    6
    12
    10
    10
    Rhinitis
         subjects affected / exposed
    0 / 45 (0.00%)
    3 / 48 (6.25%)
    1 / 96 (1.04%)
    1 / 93 (1.08%)
    1 / 95 (1.05%)
    2 / 93 (2.15%)
         occurrences all number
    0
    3
    1
    1
    2
    2
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 45 (2.22%)
    3 / 48 (6.25%)
    4 / 96 (4.17%)
    5 / 93 (5.38%)
    2 / 95 (2.11%)
    3 / 93 (3.23%)
         occurrences all number
    1
    3
    4
    8
    2
    3

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Nov 2019
    The main purpose of this amendment-1 was to add liver ultrasound with increased risk for hepatocellular carcinoma (HCC), a timeframe of 30 days prior to screening was added for the use of contraception by female subjects of childbearing potential, exclusion criteria as well as the description of the unblinding procedure were updated, breast cancer resistance protein (BCRP) inhibitors were added as disallowed concomitant medications, and description on control of the Type 1 error rate for multiple testing was updated.
    27 Jan 2020
    The main purpose of this amendment-2 was to include the following main changes: based on a nonclinical finding from the preliminary results of the 3-month combination toxicity study with JNJ-56136379 and JNJ-73763989 in the rat, hematologic abnormalities were included as an event of special interest, to trigger a mandatory higher visit frequency with unscheduled visits in case of significant on-treatment reduction in hematologic parameters, and treatment discontinuation criteria were included in relation to hematological abnormalities as precautionary measure.
    30 Sep 2021
    The main purpose of this amendment-3 was to include the following main changes: after a severe alanine aminotransferase (ALT) flare in a virologically suppressed hepatitis B e antigen (HBeAg)-negative subject randomised to the control arm in the REEF-2 (73763989PAHPB2002) study, a new nucleos(t)ide analog (NA) re-treatment criterion was added for subjects who discontinued NA treatment at Week 48 or during the follow-up phase; in addition, more frequent monitoring for participants who discontinued NA treatment was included.
    24 Nov 2021
    The main purpose of this amendment-4 was to include the additional changes to the criteria for posttreatment monitoring and for NA re-treatment for subjects discontinued NA treatment, to further protect the safety of study subjects.

    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.

    European Medicines Agency © 1995-Mon May 05 14:20:48 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA