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    Clinical Trial Results:
    A Phase 2 Open-label Trial to Evaluate Safety, Efficacy, Tolerability, and Pharmacodynamics of a Combination of JNJ-73763989, Nucleos(t)ide Analogs, and a PD-1 Inhibitor in Chronic Hepatitis B Patients

    Summary
    EudraCT number
    		 2021-005132-33
    Trial protocol
    		 FR   ES   IT  
    Global end of trial date
    31 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jun 2025
    First version publication date
    01 Jun 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    73763989PAHPB2008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05275023
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 Route 202, Raritan,, NJ, 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
    31 May 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to evaluate the efficacy of the study intervention, based on hepatitis B surface antigen (HBsAg) levels at follow-up (FU) Week 24.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practice and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jun 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    Türkiye: 9
    Country: Number of subjects enrolled
    Taiwan: 7
    Country: Number of subjects enrolled
    Canada: 5
    Worldwide total number of subjects
    37
    EEA total number of subjects
    14
    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)
    37
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 37 subjects were enrolled in the study.

    Period 1
    Period 1 title
    Intervention Phase: Week 0 to Week 24
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA)
    Arm description
    		 In intervention phase (IP), subjects received a loading dose of JNJ-73763989 (JNJ-3989) 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, subjects received a single dose of nivolumab 0.3 milligrams per kilogram (mg/kg) as intravenous (IV) infusion. Subjects also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide [TAF] 25 mg or entecavir [ETV] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, subjects were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to follow up (FU) Week 48 (up to Week 72).
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-73763989
    Investigational medicinal product code
    Other name
    JNJ-3989
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use, Subdermal use
    Dosage and administration details
    Subjects received JNJ-3989 200 mg QW from Week 0 up to Week 3 followed by Q4W from Week 4 until Week 24.

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received nivolumab 0.3 mg/kg once at Week 16.

    Investigational medicinal product name
    NA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) QD from Week 0 up to Week 24.

    Arm title
    		 JNJ-3989 + Nivolumab (3 infusions) + NA
    Arm description
    		 In IP, subjects received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, subjects received of nivolumab 0.3 mg/kg as IV infusion. Subjects also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, subjects were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-73763989
    Investigational medicinal product code
    Other name
    JNJ-3989
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received JNJ-3989 200 mg QW from Week 0 up to Week 3 followed by Q4W from Week 4 until Week 24.

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received nivolumab 0.3 mg/kg once at Week 16, 20, 24.

    Investigational medicinal product name
    NA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) QD from Week 0 up to Week 24.

    Number of subjects in period 1
    		JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA) JNJ-3989 + Nivolumab (3 infusions) + NA
    Started
    18
    19
    Completed
    18
    19
    Period 2
    Period 2 title
    FU Phase: FU Week 1 to FU Week 48
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg)
    Arm description
    		 After Week 24, subjects were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
    Arm type
    		 Experimental

    Investigational medicinal product name
    NA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects continued to receive NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) QD up to follow-up Week 48 (Week 72).

    Arm title
    		 NA(tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg)
    Arm description
    		 After Week 24, subjects were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
    Arm type
    		 Experimental

    Investigational medicinal product name
    NA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects continued to receive NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) QD up to follow-up Week 48 (Week 72).

    Number of subjects in period 2
    		NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) NA(tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg)
    Started
    18
    19
    Completed
    18
    19

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA)
    Reporting group description
    		 In intervention phase (IP), subjects received a loading dose of JNJ-73763989 (JNJ-3989) 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, subjects received a single dose of nivolumab 0.3 milligrams per kilogram (mg/kg) as intravenous (IV) infusion. Subjects also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide [TAF] 25 mg or entecavir [ETV] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, subjects were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to follow up (FU) Week 48 (up to Week 72).

    Reporting group title
    JNJ-3989 + Nivolumab (3 infusions) + NA
    Reporting group description
    		 In IP, subjects received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, subjects received of nivolumab 0.3 mg/kg as IV infusion. Subjects also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, subjects were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).

    Reporting group values
    		 JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA) JNJ-3989 + Nivolumab (3 infusions) + NA Total
    Number of subjects
    		 18 19
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.7 ( 7.75 ) 47.9 ( 5.05 ) -
    Gender categorical
    Units: Subjects
        Male
    		 15 15 30
        Female
    		 3 4 7
    Age Categorical
    Units: Subjects
        <=18 years
    		 0 0 0
        Between 18 and 65 years
    		 18 19 37
        >=65 years
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    JNJ-73763989 (JNJ-3989) + Nivolumab (1 infusion) + NA
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    In intervention phase (IP), subjects received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, subjects received a single dose of nivolumab 0.3 mg/kg as IV infusion. Subjects also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide [TAF] 25 mg or entecavir [ETV] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, subjects were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).

    Subject analysis set title
    JNJ-3989 + Nivolumab (3 infusions) + NA
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    In IP, subjects received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, subjects received 3 doses of nivolumab 0.3 mg/kg as IV infusion. Subjects also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, subjects were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).

    Subject analysis sets values
    		 JNJ-73763989 (JNJ-3989) + Nivolumab (1 infusion) + NA JNJ-3989 + Nivolumab (3 infusions) + NA
    Number of subjects
    18
    19
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Male
    0
    0
        Female
    0
    0
    Age Categorical
    Units: Subjects
        <=18 years
    0
    0
        Between 18 and 65 years
    0
    0
        >=65 years
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA)
    Reporting group description
    		 In intervention phase (IP), subjects received a loading dose of JNJ-73763989 (JNJ-3989) 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, subjects received a single dose of nivolumab 0.3 milligrams per kilogram (mg/kg) as intravenous (IV) infusion. Subjects also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide [TAF] 25 mg or entecavir [ETV] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, subjects were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to follow up (FU) Week 48 (up to Week 72).

    Reporting group title
    JNJ-3989 + Nivolumab (3 infusions) + NA
    Reporting group description
    		 In IP, subjects received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, subjects received of nivolumab 0.3 mg/kg as IV infusion. Subjects also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, subjects were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
    Reporting group title
    NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg)
    Reporting group description
    		 After Week 24, subjects were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).

    Reporting group title
    NA(tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg)
    Reporting group description
    		 After Week 24, subjects were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).

    Subject analysis set title
    JNJ-73763989 (JNJ-3989) + Nivolumab (1 infusion) + NA
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    In intervention phase (IP), subjects received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, subjects received a single dose of nivolumab 0.3 mg/kg as IV infusion. Subjects also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide [TAF] 25 mg or entecavir [ETV] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, subjects were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).

    Subject analysis set title
    JNJ-3989 + Nivolumab (3 infusions) + NA
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    In IP, subjects received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, subjects received 3 doses of nivolumab 0.3 mg/kg as IV infusion. Subjects also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, subjects were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).

    Primary: Percentage of Subjects Who Achieved Hepatitis B Surface Antigen (HBsAg) Seroclearance at Follow-up (FU) Week 24

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    End point title
    		 Percentage of Subjects Who Achieved Hepatitis B Surface Antigen (HBsAg) Seroclearance at Follow-up (FU) Week 24 [1]
    End point description
    Percentage of subjects who achieved HBsAg seroclearance at FU Week 24 were reported. Seroclearance of HBsAg was defined as a (quantitative) HBsAg level less than (<) lower limit of quantification (LLOQ) (0.05 international unit per millilitres [IU/mL]). Full analysis set (FAS) included all subjects who were randomly assigned to an intervention arm in this intervention-specific appendix (ISA) and received at least 1 dose of study intervention within this ISA.
    End point type
    Primary
    End point timeframe
    At FU Week 24
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) NA(tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg)
    Number of subjects analysed
    18
    19
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Experienced Treatment-emergent Adverse Events (TEAEs) of Special Interest

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    End point title
    		 Percentage of Subjects Who Experienced Treatment-emergent Adverse Events (TEAEs) of Special Interest
    End point description
    An AE was any untoward medical occurrence in a subject participating in a clinical study that does not necessarily had a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment-emergent. AEs of interest were significant AEs that are judged to be of special interest because of clinical importance, known class effects or based on nonclinical signals. Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
    End point type
    Secondary
    End point timeframe
    IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
    End point values
    		 JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA) JNJ-3989 + Nivolumab (3 infusions) + NA
    Number of subjects analysed
    18
    19
    Units: Percentage of subjects
    number (not applicable)
        IP
    11.1
    5.3
        FU Phase
    0
    5.3
    No statistical analyses for this end point

    Secondary: Number of Subjects with TEAEs by Severity

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    End point title
    		 Number of Subjects with TEAEs by Severity
    End point description
    Number of subjects with TEAEs by severity were reported. An AE was any untoward medical occurrence in a subject participating in a clinical study that did not necessarily had a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment-emergent. Severity of AE were graded by using Division of Acquired Immunodeficiency Syndrome (DAIDS) grading scale that ranges from Grade 1 to Grade 5. Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicated a potentially life-threatening event, Grade 5 indicated death. Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
    End point type
    Secondary
    End point timeframe
    IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
    End point values
    		 JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA) JNJ-3989 + Nivolumab (3 infusions) + NA
    Number of subjects analysed
    18
    19
    Units: Subjects
        IP: Grade 1
    5
    7
        IP: Grade 2
    1
    5
        IP: Grade 3
    0
    0
        IP: Grade 4
    0
    0
        IP: Grade 5
    0
    0
        FU Phase: Grade 1
    7
    6
        FU Phase: Grade 2
    1
    2
        FU Phase: Grade 3
    0
    0
        FU Phase: Grade 4
    0
    0
        FU Phase: Grade 5
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Immune Related TEAEs

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    End point title
    		 Number of Subjects with Immune Related TEAEs
    End point description
    Number of subjects with immune related TEAEs were reported. An AE was any untoward medical occurrence in a subject participating in a clinical study that did not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment-emergent. Immune-related AEs (irAEs) were alanine aminotransferase/alanine aminotransferase (ALT/AST) elevations including immune-related hepatic AEs, infusion-related reaction (IRRs) and other irAEs (including gastrointestinal AEs, neurological AEs, pulmonary AEs, renal AEs, endocrinopathies, rash, uveitis and visual complaints, lipase/amylase elevations, and infection), hematological abnormalities and injection site reactions. Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
    End point type
    Secondary
    End point timeframe
    IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
    End point values
    		 JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA) JNJ-3989 + Nivolumab (3 infusions) + NA
    Number of subjects analysed
    18
    19
    Units: Subjects
        IP
    0
    0
        FU Phase
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects with Abnormalities in Vital Signs

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    End point title
    		 Number of Subjects with Abnormalities in Vital Signs
    End point description
    Number of subjects with abnormalities in vital signs measurements (including pulse rate: abnormally low: less than or equal to [<=45 bpm], abnormally high: greater than or equal to [>=]120 bpm; diastolic blood pressure [BP]: abnormally low: <=50 millimetres of mercury (mmHg), mild: >90 to <100 mmHg, moderate: >=100 to <110 mmHg, and severe: >=110 mmHg; systolic BP: abnormally low: <=90 mmHg, mild: >140 to <160 mmHg, moderate: >=160 to <180 mmHg, and severe: >=180 mmHg) were reported. Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
    End point type
    Secondary
    End point timeframe
    IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
    End point values
    		 JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA) JNJ-3989 + Nivolumab (3 infusions) + NA
    Number of subjects analysed
    18
    19
    Units: Subjects
        IP: Pulse: Abnormally Low
    0
    0
        IP: Pulse: Abnormally High
    0
    0
        IP: Diastolic BP: Abnormally Low
    0
    0
        IP: Diastolic BP: Mild
    0
    1
        IP: Diastolic BP: Moderate
    0
    1
        IP: Diastolic BP: Severe
    0
    1
        IP: Systolic BP: Abnormally low
    2
    2
        IP: Systolic BP: Mild
    2
    1
        IP: Systolic BP: Moderate
    0
    1
        IP: Systolic BP: Severe
    0
    0
        FU Phase: Pulse: Abnormally low
    0
    0
        FU Phase: Pulse: Abnormally high
    0
    0
        FU Phase: Diastolic BP: Abnormally low
    0
    1
        FU Phase: Diastolic BP: Mild
    1
    1
        FU Phase: Diastolic BP: Moderate
    0
    1
        FU Phase: Diastolic BP: Severe
    0
    0
        FU Phase: Systolic BP: Abnormally low
    0
    0
        FU Phase: Systolic BP: Mild
    2
    2
        FU Phase: Systolic BP: Moderate
    0
    0
        FU Phase: Systolic BP: Severe
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Abnormalities in 12-lead Electrocardiogram (ECGs)

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    End point title
    		 Number of Subjects with Abnormalities in 12-lead Electrocardiogram (ECGs)
    End point description
    Number of subjects with abnormalities in 12-lead ECGs: heart rate (abnormally low: <45 beats per minute [bpm], abnormally high: greater than or equal [>=]120 bpm), PR interval (abnormally high: greater than [>] 220 millisecond [msec]), QRS interval (abnormally high: >=120 msec), QTc interval Fridericia (Borderline prolonged QT: 450< QTc <=480 msec; Prolonged QT: 480 < QTc <=500; Pathologically prolonged (PP) QT: QTc >500), were reported. Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA. Here, ‘n’ (number analysed) refers to number of subjects evaluable at specified parameter.
    End point type
    Secondary
    End point timeframe
    IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
    End point values
    		 JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA) JNJ-3989 + Nivolumab (3 infusions) + NA
    Number of subjects analysed
    18
    19
    Units: Subjects
        IP:Heart rate: Abnormally low (n=18,19)
    0
    0
        IP: Heart rate: Abnormally high (n=18,19)
    0
    0
        IP: PR interval: Abnormally high (n=18,19)
    1
    0
        IP: QRS interval: Abnormally high (n=18,19)
    0
    0
        IP:QTc interval: Borderline prolonged QT(n=18,19)
    0
    1
        IP: QTc interval: prolonged QT (n=18,19)
    0
    0
        IP: QTc interval: PP QT (n=18,19)
    0
    0
        FU Ph: Heart rate: Abnormally low (n=18,18)
    0
    0
        FU Ph: Heart rate: Abnormally high (n=18,18)
    0
    0
        FU Ph: PR interval: Abnormally high (n=18,18)
    0
    0
        FU Ph: QRS interval: Abnormally high (n=18,18)
    0
    0
        FU:QTc interval Borderline prolonged QT(n=18,18)
    0
    1
        FU Ph: QTc interval: prolonged QT(n=18,18)
    0
    0
        FU Ph:QTc interval: PP QT (n=18,18)
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Abnormalities in Clinical Laboratory Parameters: Hematology

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    End point title
    		 Percentage of Subjects with Abnormalities in Clinical Laboratory Parameters: Hematology
    End point description
    Percentage of subjects with abnormalities in hematology parameters (including basophils/Leukocytes high, erythrocytes mean corpuscular volume (EMCV) high, erythrocytes high and low, lymphocytes/leukocytes high and low, monocytes/leukocytes high and low, neutrophils, segmented+band form high and low, reticulocytes/erythrocytes high and low, basophils/leukocytes, eosinophils/leukocytes high, erythrocyte mean corpuscular hemoglobin (EMCH) low, reticulocytes/erythrocytes high and low, lymphocytes atypical/leukocytes high, lymphocytes atypical high, hematocrit high, monocytes low and high) were reported. Abnormalities with at least 1 subject is included. Low and high categorization depend on investigator's discretion. Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA. Here, ‘n’ (number analysed) refers to number of subjects evaluable at specified parameter. n=0 indicates that there was no evaluable subject for specified parameter.
    End point type
    Secondary
    End point timeframe
    IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
    End point values
    		 JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA) JNJ-3989 + Nivolumab (3 infusions) + NA
    Number of subjects analysed
    18
    19
    Units: Percentage of Subjects
    number (not applicable)
        IP:Basophils/Leukocytes:High(n=18,19)
    11.1
    42.1
        IP: EMCV:High (n=18,19)
    16.7
    0
        IP: Erythrocytes: Low (n=18,19)
    16.7
    26.3
        IP: Erythrocytes: High (n=18,19)
    0
    5.3
        IP:Lymphocytes/Leukocytes:Low(n=18,19)
    0
    5.3
        IP:Lymphocytes/Leukocytes: High(n=18,19)
    11.1
    5.3
        IP:Monocytes/Leukocytes:Low (n=18,19)
    0
    5.3
        IP:Monocytes/Leukocytes:High (n=18,19)
    0
    5.3
        IP:Neutrophils, Segmented+Band Form:Low (n=18,19)
    22.2
    26.3
        IP:Neutrophils, Segmented+Band Form:High(n=18,19)
    11.1
    10.5
        IP: Reticulocytes/Erythrocytes: Low (n=18,19)
    0
    10.5
        IP: Reticulocytes/Erythrocytes: High (n=18,19)
    0
    10.5
        FU Ph: Basophils/Leukocytes: High (n=18,19)
    11.1
    5.3
        FU Ph:Eosinophils/Leukocytes:High (n=18,19)
    0
    15.8
        FU Ph: EMCH Low (n=18,19)
    5.6
    0
        FU Ph: EMCV: High (n=18,19)
    27.8
    15.8
        FU Ph: Erythrocyte: Low (n=18,19)
    11.1
    21.1
        FU Ph: Erythrocyte: High (n=18,19)
    0
    5.3
        FU Ph:Lymphocytes/Leukocytes:Low (n=18,19)
    11.1
    5.3
        FU Ph:Lymphocytes/Leukocytes:High (n=18,19)
    22.2
    5.3
        FU Ph:Monocytes/Leukocytes: Low (n=18,19)
    0
    10.5
        FU Ph:Monocytes/Leukocytes: High (n=18,19)
    5.6
    15.8
        FU:Neutrophils, Segmented+Band Form:Low(n=18,19)
    38.9
    31.6
        FU:Neutrophils,Segmented+Band Form:High(n=18,19)
    11.1
    0
        FU Ph: Reticulocytes/Erythrocytes: Low (n=18,19)
    16.7
    42.1
        FU Ph:Reticulocytes/Erythrocytes: High(n=18,19)
    0
    5.3
        FU Ph:Lymphocytes Atypical/Leukocyte:High(n=0,1)
    0
    100
        FU Ph: Lymphocytes Atypical: High (n=0,1)
    0
    100
        FU Ph: Hematocrit: High (n=18, 19)
    5.6
    0
        FU Ph: Monocytes: Low (n=18, 19)
    5.6
    10.5
        FU Ph: Monocytes: High (n=18, 19)
    5.6
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Abnormalities in Physical Examinations

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    End point title
    		 Number of Subjects with Abnormalities in Physical Examinations
    End point description
    Number of subjects with abnormalities in physical examinations were reported. Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
    End point type
    Secondary
    End point timeframe
    IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
    End point values
    		 JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA) JNJ-3989 + Nivolumab (3 infusions) + NA
    Number of subjects analysed
    18
    19
    Units: Subjects
        IP
    0
    2
        FU Phase
    2
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects with Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry

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    End point title
    		 Number of Subjects with Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
    End point description
    Number of subjects with abnormalities in clinical chemistry parameters (including C reactive protein high, cystatin C low and high, gamma glutamyl transferase low, high density lipoprotein (HDL) cholesterol low and high, indirect bilirubin high, lactate dehydrogenase high, protein high, thyrotropin low and high, free thyroxine high, free triiodothyronine low and high, and urea nitrogen high), were reported. Abnormalities with at least 1 subject is included. Low and high categorization depend on investigator's discretion. Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA. Here, ‘n’ (number analysed) signifies number of subjects analysed at each specified timepoint.
    End point type
    Secondary
    End point timeframe
    IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
    End point values
    		 JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA) JNJ-3989 + Nivolumab (3 infusions) + NA
    Number of subjects analysed
    18
    19
    Units: Subjects
        IP: C Reactive Protein: High (n=18,19)
    3
    2
        IP: Cystatin C: Low (n=18,19)
    2
    1
        IP: Cystatin C: High (n=18,19)
    1
    1
        IP:Gamma Glutamyl Transferase:Low (n=18,19)
    4
    4
        IP: HDL Cholesterol: Low (n=18,19)
    6
    3
        IP: HDL Cholesterol: High (n=18,19)
    3
    4
        IP: Indirect Bilirubin: High (n=18,19)
    1
    0
        IP: Lactate Dehydrogenase: High (n=18,19)
    2
    2
        IP: Protein: High (n=18,19)
    1
    0
        IP: Thyrotropin: Low (n=18,19)
    2
    0
        IP: Thyrotropin: High (n=18,19)
    1
    0
        IP: Thyroxine, Free : High (n=18,19)
    3
    1
        IP: Triiodothyronine, Free : Low (n=18,19)
    0
    1
        IP: Triiodothyronine, Free: High (n=18,19)
    5
    4
        IP: Urea Nitrogen: High (n=18,19)
    1
    2
        FU Phase: Chloride: Low (n=18,19)
    0
    1
        FU Phase: Cystatin C: Low (n=18,19)
    1
    0
        FU Phase: Cystatin C: High (n=18,19)
    2
    3
        FU Ph:Gamma Glutamyl Transferase:Low(n=18,19)
    0
    1
        FU Phase: HDL Cholesterol: Low (n=18,19)
    6
    2
        FU Phase: HDL Cholesterol: High (n=18,19)
    2
    4
        FU Phase: Indirect Bilirubin: High (n=17,18)
    1
    0
        FU Phase: Lactate Dehydrogenase: High (n=18,19)
    2
    2
        FU Phase: Protein: High (n=18,19)
    1
    1
        FU Phase: Thyrotropin: Low (n=18,19)
    1
    0
        FU Phase: Thyrotropin: High (n=18,19)
    1
    1
        FU Phase: Thyroxine, Free: Low (n=18,19)
    1
    1
        FU Phase: Thyroxine, Free: High (n=18,19)
    2
    0
        FU Phase: Triiodothyronine, Free: High (n=18,19)
    6
    3
        FU Phase: Urea Nitrogen: High (n=18,19)
    1
    1
        FU Phase: C Reactive Protein: High (n=18,19)
    2
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels

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    End point title
    		 Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
    End point description
    Change from baseline in HBsAg levels were reported. International units per millilitres=IU/mL. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study. FAS included all subjects who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'n' (number analysed) signifies number of subjects analysed at each specified timepoints.
    End point type
    Secondary
    End point timeframe
    IP: Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, and End of Study Intervention (EOSI; Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and End of Study (EOS)
    End point values
    		 JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA) JNJ-3989 + Nivolumab (3 infusions) + NA
    Number of subjects analysed
    18
    19
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        IP: Baseline (n=18,19)
    3.25 ( 0.472 )
    3.14 ( 0.542 )
        IP: Week 1 (n=18,19)
    -0.19 ( 0.185 )
    -0.17 ( 0.135 )
        IP: Week 2 (n=18,19)
    -0.26 ( 0.293 )
    -0.31 ( 0.330 )
        IP: Week 3 (n=18,19)
    -0.34 ( 0.335 )
    -0.44 ( 0.405 )
        IP: Week 4 (n=18,19)
    -0.40 ( 0.400 )
    -0.52 ( 0.525 )
        IP: Week 8 (n=18,19)
    -0.80 ( 0.576 )
    -0.87 ( 0.695 )
        IP: Week 12 (n=18,19)
    -1.32 ( 0.513 )
    -1.41 ( 0.687 )
        IP: Week 16 (n=18,19)
    -1.77 ( 0.361 )
    -1.84 ( 0.548 )
        IP: Week 20 (n=18,19)
    -1.97 ( 0.376 )
    -2.07 ( 0.549 )
        IP: EOSI (Week 24) (n=18,19)
    -2.01 ( 0.385 )
    -2.10 ( 0.563 )
        FU Phase: Week 4 (n=6,7)
    -1.93 ( 0.515 )
    -1.98 ( 0.590 )
        FU Phase: Week 8 (n=18,19)
    -1.99 ( 0.417 )
    -2.12 ( 0.613 )
        FU Phase: Week 12 (n=17,16)
    -1.93 ( 0.393 )
    -1.99 ( 0.574 )
        FU Phase: Week 16 (n=18,19)
    -1.85 ( 0.420 )
    -2.01 ( 0.648 )
        FU Phase: Week 20 (n=18,19)
    -1.77 ( 0.418 )
    -2.02 ( 0.584 )
        FU Phase: Week 24 (n=18,19)
    -1.70 ( 0.507 )
    -1.85 ( 0.616 )
        FU Phase: Week 32 (n=18,19)
    -1.64 ( 0.616 )
    -1.75 ( 0.606 )
        FU Phase: Week 40 (n=18,19)
    -1.38 ( 0.568 )
    -1.69 ( 0.904 )
        FU Phase: Week 48 (n=17,16)
    -1.23 ( 0.527 )
    -1.54 ( 0.929 )
        FU Phase: EOS (n=18,19)
    -1.26 ( 0.530 )
    -1.54 ( 0.929 )
    No statistical analyses for this end point

    Secondary: Number of Subjects with Abnormalities in Clinical Laboratory Parameters: Urinalysis

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    End point title
    		 Number of Subjects with Abnormalities in Clinical Laboratory Parameters: Urinalysis
    End point description
    Number of subjects with abnormalities in clinical chemistry parameters (including specific gravity high and urine hyaline casts high) were reported. Abnormalities with at least 1 subject is included. Low and high categorization depend on investigator's discretion. Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA. Here, N (number of subjects analysed) signifies number of subjects analysed for this endpoint and 'n' (number analysed) signifies number of subjects analysed at each specified timepoint.
    End point type
    Secondary
    End point timeframe
    IP: Week 0 up to Week 24: FU Phase: FU Week 1 up to FU Week 48
    End point values
    		 JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA) JNJ-3989 + Nivolumab (3 infusions) + NA
    Number of subjects analysed
    9
    11
    Units: Subjects
        IP: Specific Gravity: High (n=9,11)
    2
    0
        IP: Urine Hyaline Casts: High (n=1,1)
    1
    1
        FU Phase: Specific Gravity: High (n=8,7)
    1
    1
        FU Phase: Urine Hyaline Casts: High (n=2,2)
    2
    2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Change in HBsAg Levels Below/Above Different Cut-offs Over Time

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    End point title
    		 Percentage of Subjects with Change in HBsAg Levels Below/Above Different Cut-offs Over Time
    End point description
    Percentage of subjects with change in HBsAg levels below/above different cut-offs (<0.05 IU/mL, <1 U/mL, <10 IU/mL, <100 IU/mL , <1000 IU/mL) over time were reported. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study. FAS included all subjects who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'n' (number analysed) signifies number of subjects analysed at each specified timepoints.
    End point type
    Secondary
    End point timeframe
    IP: Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, and EOSI (Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48)
    End point values
    		 JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA) JNJ-3989 + Nivolumab (3 infusions) + NA
    Number of subjects analysed
    18
    19
    Units: Percentage of subjects
    number (not applicable)
        IP: Baseline: HBsAg < 0.05 IU/mL (n=18,19)
    0
    0
        IP: Baseline: HBsAg <1 IU/mL (n=18,19)
    0
    0
        IP: Baseline: HBsAg <10 IU/mL (n=18,19)
    0
    0
        IP: Baseline: HBsAg <100 IU/mL (n=18,19)
    0
    0
        IP: Baseline: HBsAg <1000 IU/mL (n=18,19)
    38.9
    42.1
        IP: Week 1: HBsAg <0.05 IU/mL (n=18,19)
    0
    0
        IP: Week 1: HBsAg <1 IU/mL (n=18,19)
    0
    0
        IP: Week 1: HBsAg <10 IU/mL (n=18,19)
    0
    0
        IP: Week 1: HBsAg <100 IU/mL (n=18,19)
    0
    10.5
        IP: Week 1: HBsAg <1000 IU/mL (n=18,19)
    44.4
    57.9
        IP: Week 2: HBsAg <0.05 IU/mL (n=18,19)
    0
    0
        IP: Week 2: HBsAg <1 IU/mL (n=18,19)
    0
    0
        IP: Week 2: HBsAg <10 IU/mL (n=18,19)
    0
    0
        IP: Week 2: HBsAg <100 IU/mL (n=18,19)
    5.6
    15.8
        IP: Week 2: HBsAg <1000 IU/mL (n=18,19)
    38.9
    63.2
        IP: Week 3: HBsAg <0.05 IU/mL (n=18,19)
    0
    0
        IP: Week 3: HBsAg <1 IU/mL (n=18,19)
    0
    0
        IP: Week 3: HBsAg <10 IU/mL (n=18,19)
    0
    0
        IP: Week 3: HBsAg <100 IU/mL (n=18,19)
    11.1
    15.8
        IP: Week 3: HBsAg <1000 IU/mL (n=18,19)
    50.0
    63.2
        IP: Week 4: HBsAg <0.05 IU/mL (n=18,19)
    0
    0
        IP: Week 4: HBsAg <1 IU/mL (n=18,19)
    0
    0
        IP: Week 4: HBsAg <10 IU/mL (n=18,19)
    0
    0
        IP: Week 4: HBsAg <100 IU/mL (n=18,19)
    11.1
    15.8
        IP: Week 4: HBsAg <1000 IU/mL (n=18,19)
    61.1
    73.7
        IP: Week 8: HBsAg <0.05 IU/mL (n=18,19)
    0
    0
        IP: Week 8: HBsAg <1 IU/mL (n=18,19)
    0
    0
        IP: Week 8: HBsAg <10 IU/mL (n=18,19)
    0
    10.5
        IP: Week 8: HBsAg <100 IU/mL (n=18,19)
    27.8
    42.1
        IP: Week 8: HBsAg <1000 IU/mL (n=18,19)
    66.7
    78.9
        IP: Week 12: HBsAg <0.05 IU/mL (n=18,19)
    0
    0
        IP: Week 12: HBsAg <1 IU/mL (n=18,19)
    0
    5.3
        IP: Week 12: HBsAg <10 IU/mL (n=18,19)
    11.1
    15.8
        IP: Week 12: HBsAg <100 IU/mL (n=18,19)
    55.6
    68.4
        IP: Week 12: HBsAg <1000 IU/mL (n=18,19)
    100.0
    94.7
        IP: Week 16: HBsAg <0.05 IU/mL (n=18,19)
    0
    0
        IP: Week 16: HBsAg <1 IU/mL (n=18,19)
    0
    5.3
        IP: Week 16: HBsAg <10 IU/mL (n=18,19)
    16.7
    21.1
        IP: Week 16: HBsAg <100 IU/mL (n=18,19)
    83.3
    89.5
        IP: Week 16: HBsAg <1000 IU/mL (n=18,19)
    100.0
    100.0
        IP: Week 20: HBsAg <0.05 IU/mL (n=18,19)
    0
    0
        IP: Week 20: HBsAg <1 IU/mL (n=18,19)
    0
    5.3
        IP: Week 20: HBsAg <10 IU/mL (n=18,19)
    22.2
    42.1
        IP: Week 20: HBsAg <100 IU/mL (n=18,19)
    83.3
    94.7
        IP: Week 20: HBsAg <1000 IU/mL (n=18,19)
    100.0
    100.0
        IP:EOSI (Week 24): HBsAg <0.05 IU/mL (n=18,19)
    0
    0
        IP: EOSI (Week 24): HBsAg <1 IU/mL (n=18,19)
    0
    5.3
        IP: EOSI (Week 24): HBsAg <10 IU/mL (n=18,19)
    33.3
    52.6
        IP: EOSI (Week 24): HBsAg <100 IU/mL (n=18,19)
    88.9
    94.7
        IP: EOSI (Week 24): HBsAg <1000 IU/mL (n=18,19)
    100.0
    100.0
        FU Phase: Week 4: HBsAg <0.05 IU/mL (n=6,7)
    0
    0
        FU Phase: Week 4: HBsAg <1 IU/mL (n=6,7)
    0
    0
        FU Phase: Week 4: HBsAg <10 IU/mL (n=6,7)
    16.7
    57.1
        FU Phase: Week 4: HBsAg <100 IU/mL (n=6,7)
    83.3
    85.7
        FU Phase: Week 4: HBsAg <1000 IU/mL (n=6,7)
    100.0
    100.0
        FU Phase: Week 8: HBsAg <0.05 IU/mL (n=18,19)
    0
    0
        FU Phase: Week 8: HBsAg <1 IU/mL(n=18,19)
    0
    10.5
        FU Phase: Week 8: HBsAg <10 IU/mL(n=18,19)
    33.3
    52.6
        FU Phase: Week 8: HBsAg <100 IU/mL(n=18,19)
    88.9
    94.7
        FU Phase: Week 8: HBsAg <1000 IU/mL(n=18,19)
    100.0
    100.0
        FU Phase: Week 12: HBsAg <0.05 IU/mL(n=17,16)
    0
    0
        FU Phase: Week 12: HBsAg <1 IU/mL(n=17,16)
    0
    0
        FU Phase: Week 12: HBsAg <10 IU/mL(n=17,16)
    29.4
    50.0
        FU Phase: Week 12: HBsAg <100 IU/mL(n=17,16)
    88.2
    93.8
        FU Phase: Week 12: HBsAg <1000 IU/mL(n=17,16)
    100.0
    100.0
        FU Phase: Week 16: HBsAg <0.05 IU/mL(n=18,19)
    0
    0
        FU Phase: Week 16: HBsAg <1 IU/mL(n=18,19)
    0
    5.3
        FU Phase: Week 16: HBsAg <10 IU/mL(n=18,19)
    22.2
    47.4
        FU Phase: Week 16: HBsAg <100 IU/mL(n=18,19)
    83.3
    94.7
        FU Phase: Week 16: HBsAg <1000 IU/mL(n=18,19)
    100.0
    100.0
        FU Phase: Week 20: HBsAg <0.05 IU/mL(n=18,17)
    0
    0
        FU Phase: Week 20: HBsAg <1 IU/mL(n=18,17)
    0
    0
        FU Phase: Week 20: HBsAg <10 IU/mL(n=18,17)
    22.2
    52.9
        FU Phase: Week 20: HBsAg <100 IU/mL(n=18,17)
    83.3
    100.0
        FU Phase: Week 20: HBsAg <1000 IU/mL(n=18,17)
    94.4
    100.0
        FU Phase: Week 24: HBsAg <0.05 IU/mL(n=18,19)
    0
    0
        FU Phase: Week 24: HBsAg <1 IU/mL(n=18,19)
    0
    0
        FU Phase: Week 24: HBsAg <10 IU/mL(n=18,19)
    16.7
    42.1
        FU Phase: Week 24: HBsAg <100 IU/mL(n=18,19)
    72.2
    84.2
        FU Phase: Week 24: HBsAg <1000 IU/mL(n=18,19)
    88.9
    94.7
        FU Phase: Week 32: HBsAg <0.05 IU/mL(n=18,19)
    0
    0
        FU Phase: Week 32: HBsAg <1 IU/mL(n=18,19)
    5.6
    0
        FU Phase: Week 32: HBsAg <10 IU/mL(n=18,19)
    16.7
    26.3
        FU Phase: Week 32: HBsAg <100 IU/mL(n=18,19)
    72.2
    78.9
        FU Phase: Week 32: HBsAg <1000 IU/mL(n=18,19)
    88.9
    94.7
        FU Phase: Week 40: HBsAg <0.05 IU/mL(n=18,19)
    0
    5.3
        FU Phase: Week 40: HBsAg <1 IU/mL(n=18,19)
    0
    5.3
        FU Phase: Week 40: HBsAg <10 IU/mL(n=18,19)
    11.1
    15.8
        FU Phase: Week 40: HBsAg <100 IU/mL(n=18,19)
    66.7
    78.9
        FU Phase: Week 40: HBsAg <1000 IU/mL(n=18,19)
    88.9
    89.5
        FU Phase: Week 48: HBsAg <0.05 IU/mL(n=17,19)
    0
    5.3
        FU Phase: Week 48: HBsAg <1 IU/mL(n=17,19)
    0
    5.3
        FU Phase: Week 48: HBsAg <10 IU/mL(n=17,19)
    11.8
    15.8
        FU Phase: Week 48: HBsAg <100 IU/mL(n=17,19)
    64.7
    78.9
        FU Phase: Week 48: HBsAg <1000 IU/mL(n=17,19)
    82.4
    89.5
        FU Phase: EOS: HBsAg <0.05 IU/mL(n=18,19)
    0
    5.3
        FU Phase: EOS: HBsAg <1 IU/mL(n=18,19)
    0
    5.3
        FU Phase: EOS: HBsAg <10 IU/mL(n=18,19)
    11.1
    15.8
        FU Phase: EOS: HBsAg <100 IU/mL(n=18,19)
    66.7
    78.9
        FU Phase: EOS: HBsAg <1000 IU/mL(n=18,19)
    83.3
    89.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With HBsAg With Seroconversion

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    End point title
    		 Percentage of Subjects With HBsAg With Seroconversion
    End point description
    Percentage of subjects with HBsAg seroconversion were reported. Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance and appearance of anti-HBs antibodies (baseline anti-HBs antibodies <LLOQ and a post-baseline assessment >=LLOQ). FAS included all subjects who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'N' (number of subjects analysed) signifies number of subjects analysed for this endpoint and 'n' (number analysed) signifies number of subjects analysed at each specified timepoint.
    End point type
    Secondary
    End point timeframe
    IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48
    End point values
    		 JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA) JNJ-3989 + Nivolumab (3 infusions) + NA
    Number of subjects analysed
    17
    19
    Units: Percentage of subjects
    number (not applicable)
        IP Phase (n=17,19)
    0
    0
        FU Phase (n=17,18)
    0
    5.6
    No statistical analyses for this end point

    Secondary: Percentage of Subejcts With HBsAg Seroclearance

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    End point title
    		 Percentage of Subejcts With HBsAg Seroclearance
    End point description
    Percentage of subjects with HBsAg seroclearance were reported. Seroclearance of HBsAg was defined as a HBsAg level <lower limit of quantification (LLOQ) (0.05 IU/mL). FAS included all subjects who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA.
    End point type
    Secondary
    End point timeframe
    IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48
    End point values
    		 JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA) JNJ-3989 + Nivolumab (3 infusions) + NA
    Number of subjects analysed
    18
    19
    Units: Percentage of subjects
    number (not applicable)
        IP
    0
    0
        FU Phase
    0
    5.3
    No statistical analyses for this end point

    Secondary: Time to Achieve HBsAg Seroclearance

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    End point title
    		 Time to Achieve HBsAg Seroclearance [2]
    End point description
    Time to achieve HBsAg seroclearance was reported. Seroclearance of HBsAg was defined as a (quantitative) HBsAg level <LLOQ (0.05 IU/mL). FAS included all subjects who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. 99999 signifies that median and upper limit could not be estimated due to insufficient number of subjects with events. Data could not be collected and analysed as no subject had event in arm JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA).
    End point type
    Secondary
    End point timeframe
    Week 0 up to FU Week 48 (up to Week 72)
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    		 JNJ-3989 + Nivolumab (3 infusions) + NA
    Number of subjects analysed
    1
    Units: Days
        median (full range (min-max))
    99999 (450 to 99999)
    No statistical analyses for this end point

    Secondary: Time to Achieve HBsAg Seroconversion

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    End point title
    		 Time to Achieve HBsAg Seroconversion [3]
    End point description
    Time to achieve HBsAg seroconversion were reported. Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance and appearance of anti-HBs antibodies (baseline anti-HBs antibodies <LLOQ and a post-baseline assessment >=LLOQ). FAS included all subjects who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. 99999 signifies that median and upper limit could not be estimated due to insufficient number of subjects with events. Data could not be collected and analysed as no subject had event in arm JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA).
    End point type
    Secondary
    End point timeframe
    Week 0 up to FU Week 48 (up to Week 72)
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    		 JNJ-3989 + Nivolumab (3 infusions) + NA
    Number of subjects analysed
    1
    Units: Days
        median (full range (min-max))
    99999 (505 to 99999)
    No statistical analyses for this end point

    Secondary: Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time

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    End point title
    		 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time
    End point description
    HBV DNA levels over time were reported. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study. FAS included all subjects who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'n' (number analysed) signifies number of subjects analysed at each specified timepoint.
    End point type
    Secondary
    End point timeframe
    IP: Baseline, Weeks 2, 4, 8, 12, 16, 20 and EOSI (Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48)
    End point values
    		 JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA) JNJ-3989 + Nivolumab (3 infusions) + NA
    Number of subjects analysed
    18
    19
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        IP: Baseline (n=18,19)
    0.83 ( 0.220 )
    0.80 ( 0.200 )
        IP: Week 2 (n=18,19)
    0.87 ( 0.260 )
    0.72 ( 0.109 )
        IP: Week 4 (n=18,19)
    0.83 ( 0.220 )
    0.85 ( 0.228 )
        IP: Week 8 (n=18,19)
    0.88 ( 0.239 )
    0.82 ( 0.216 )
        IP: Week 12 (n=18,19)
    0.88 ( 0.239 )
    0.82 ( 0.216 )
        IP: Week 16 (n=18,19)
    0.91 ( 0.244 )
    0.82 ( 0.216 )
        IP: Week 20 (n=18,19)
    0.86 ( 0.231 )
    0.80 ( 0.200 )
        IP: EOSI (Week 24) (n=18,19)
    0.96 ( 0.281 )
    0.77 ( 0.179 )
        FU Phase: Week 4 (n=18,19)
    0.83 ( 0.220 )
    0.90 ( 0.288 )
        FU Phase: Week 8 (n=18,19)
    0.83 ( 0.220 )
    0.80 ( 0.200 )
        FU Phase: Week 12 (n=17,18)
    0.93 ( 0.257 )
    0.91 ( 0.244 )
        FU Phase: Week 16 (n=18,19)
    0.78 ( 0.183 )
    0.85 ( 0.228 )
        FU Phase: Week 20 (n=18,17)
    0.86 ( 0.231 )
    0.90 ( 0.242 )
        FU Phase: Week 24 (n=18,19)
    0.86 ( 0.231 )
    0.87 ( 0.236 )
        FU Phase: Week 32 (n=18,19)
    0.88 ( 0.239 )
    0.75 ( 0.150 )
        FU Phase: Week 40 (n=18,19)
    0.91 ( 0.244 )
    0.85 ( 0.228 )
        FU Phase: Week 48 (n=17,19)
    0.84 ( 0.224 )
    0.82 ( 0.216 )
        FU Phase: EOS (n=18,19)
    0.83 ( 0.220 )
    0.82 ( 0.216 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time

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    End point title
    		 Percentage of Subjects With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
    End point description
    Percentage of subjects with HBV DNA level below/above different cut-offs over time were reported. HBV DNA cut offs: <LLOQ target detected (TD): that is, traces of HBV DNA were detected/found but were too low to be quantified; <LLOQ target not detected (TND): that is, no traces of HBV DNA were detected/found. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study. The LLOQ for HBV DNA was 20 IU/mL. As indicated in the data table, the sum of percentage values of each sub-categories within the specific timepoints “IP: Week 2” and “FU Phase: Week 4”, shows a slight deviation from 100% due to rounding. FAS included all subjects who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'n' (number analysed) signifies number of subjects analysed at each specified timepoint.
    End point type
    Secondary
    End point timeframe
    IP: Baseline, Weeks 2, 4, 8, 12, 16, 20, and EOSI (Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48)
    End point values
    		 JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA) JNJ-3989 + Nivolumab (3 infusions) + NA
    Number of subjects analysed
    18
    19
    Units: Percentage of subjects
    number (not applicable)
        IP: Baseline: HBV DNA < LLOQ TND(n=18,19)
    72.2
    78.9
        IP: Baseline: HBV DNA < LLOQ TD(n=18,19)
    27.8
    21.1
        IP: Week 2: HBV DNA < LLOQ TND(n=18,19)
    66.7
    94.7
        IP: Week 2: HBV DNA < LLOQ TD(n=18,19)
    27.8
    5.3
        IP: Week 2: HBV DNA>LLOQ(n=18,19)
    5.6
    0
        IP: Week 4: HBV DNA < LLOQ TND(n=18,19)
    72.2
    68.4
        IP: Week 4: HBV DNA < LLOQ TD(n=18,19)
    27.8
    31.6
        IP: Week 8: HBV DNA < LLOQ TND(n=18,19)
    61.1
    73.7
        IP: Week 8: HBV DNA < LLOQ TD(n=18,19)
    38.9
    26.3
        IP: Week 12: HBV DNA < LLOQ TND(n=18,19)
    61.1
    73.7
        IP: Week 12: HBV DNA < LLOQ TD(n=18,19)
    38.9
    26.3
        IP: Week 16: HBV DNA <LLOQ TND(n=18,19)
    55.6
    73.7
        IP: Week 16: HBV DNA <LLOQ TD(n=18,19)
    44.4
    26.3
        IP: Week 20: HBV DNA <LLOQ TND(n=18,19)
    66.7
    78.9
        IP: Week 20: HBV DNA <LLOQ TD(n=18,19)
    33.3
    21.1
        IP: EOSI (Week 24): HBV DNA <LLOQ TND(n=18,19)
    50.0
    84.2
        IP: EOSI (Week 24): HBV DNA <LLOQ TD(n=18,19)
    38.9
    15.8
        IP: EOSI(Week 24): HBV DNA > LLOQ(n=18,19)
    11.1
    0
        FU Phase: Week 4: HBV DNA <LLOQ TND(n=18,19)
    72.2
    63.2
        FU Phase: Week 4: HBV DNA <LLOQ TD(n=18,19)
    27.8
    31.6
        FU Phase: Week 4: HBV DNA > LLOQ(n=18,19)
    0
    5.3
        FU Phase: Week 8: HBV DNA <LLOQ TND(n=18,19)
    72.2
    78.9
        FU Phase: Week 8: HBV DNA <LLOQ TD(n=18,19)
    27.8
    21.1
        FU Phase: Week 12: HBV DNA <LLOQ TND(n=17,18)
    52.9
    55.6
        FU Phase: Week 12: HBV DNA <LLOQ TD(n=17,18)
    41.2
    44.4
        FU Phase: Week 12: HBV DNA > LLOQ(n=18,19)
    5.9
    0
        FU Phase: Week 16: HBV DNA <LLOQ TND(n=18,19)
    83.3
    68.4
        FU Phase: Week 16: HBV DNA <LLOQ TD(n=18,19)
    16.7
    31.6
        FU Phase: Week 20: HBV DNA <LLOQ TND(n=18,17)
    66.7
    58.8
        FU Phase: Week 20: HBV DNA <LLOQ TD(n=18,17)
    33.3
    41.2
        FU Phase: Week 24: HBV DNA <LLOQ TND(n=18,19)
    66.7
    63.2
        FU Phase: Week 24: HBV DNA <LLOQ TD(n=18,19)
    33.3
    36.8
        FU Phase: Week 32: HBV DNA <LLOQ TND(n=18,19)
    61.1
    89.5
        FU Phase: Week 32: HBV DNA <LLOQ TD(n=18,19)
    38.9
    10.5
        FU Phase:Week 40:HBV DNA <LLOQ TND(n=18,19)
    55.6
    68.4
        FU Phase: Week 40: HBV DNA <LLOQ TD(n=18,19)
    44.4
    31.6
        FU Phase: Week 48: HBV DNA <LLOQ TND(n=17,19)
    70.6
    73.7
        FU Phase: Week 48: HBV DNA <LLOQ TD(n=17,19)
    29.4
    26.3
        FU Phase: EOS: HBV DNA <LLOQ TND(n=18,19)
    72.2
    73.7
        FU Phase: EOS: HBV DNA <LLOQ TD(n=18,19)
    27.8
    26.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Hepatitis B e Antigen (HBeAg) Level Below/above Different Cut-offs Over Time

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    End point title
    		 Percentage of Subjects with Hepatitis B e Antigen (HBeAg) Level Below/above Different Cut-offs Over Time
    End point description
    Percentage of subjects with HBeAg level below/above different cut-offs over time were reported. HBeAg cut-offs: <LLOQ (0.11 IU/mL). EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study. FAS included all subjects who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'n' (number analysed) signifies number of subjects analysed at each specified timepoint. 99999 signifies no subject was analysed at that timepoint.
    End point type
    Secondary
    End point timeframe
    IP: Baseline, Weeks 2, 4, 8, 12, 20, and EOSI (Week 24); FU Phase: FU Weeks 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48)
    End point values
    		 JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA) JNJ-3989 + Nivolumab (3 infusions) + NA
    Number of subjects analysed
    18
    19
    Units: Percentage of subjects
    number (not applicable)
        IP: Baseline (n=18,19)
    100.0
    94.7
        IP: Week 2 (n=0,1)
    99999
    100.0
        IP: Week 4 (n=0,1)
    99999
    100.0
        IP: Week 8(n=0,1)
    99999
    100.0
        IP: Week 12(n=18,19)
    100.0
    100.0
        IP: Week 20(n=0,1)
    99999
    100.0
        IP: EOSI (Week 24)(n=18,19)
    100.0
    100.0
        FU Phase: Week 12 (n=16,16)
    100.0
    100.0
        FU Phase: Week 16 (n=0,1)
    99999
    100.0
        FU Phase: Week 24 (n=18,18)
    100.0
    100.0
        FU Phase: Week 32 (n=0,1)
    99999
    100.0
        FU Phase: Week 40: (n=1,0)
    100.0
    99999
        FU Phase: Week 48 (n=17,17)
    94.1
    100.0
        FU Phase: EOS: (n=18,19)
    94.4
    100.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Virologic Breakthrough

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    End point title
    		 Percentage of Subjects with Virologic Breakthrough
    End point description
    Percentage of subjects with virologic breakthrough (confirmed on-treatment HBV DNA increase by >1 log10 IU/mL from nadir in subjects who did not have on-treatment HBV DNA level below LLOQ or a confirmed on-treatment HBV DNA level >200 IU/mL in subjects who had on-treatment HBV DNA level below LLOQ) were reported. FAS included all subjects who were randomly assigned to an intervention arm in this intervention-specific appendix (ISA) and received at least 1 dose of study intervention within this ISA.
    End point type
    Secondary
    End point timeframe
    IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48
    End point values
    		 JNJ-3989 + Nivolumab (1 infusion) + Nucleos(t)ide Analog (NA) JNJ-3989 + Nivolumab (3 infusions) + NA
    Number of subjects analysed
    18
    19
    Units: Percentage of subjects
    number (not applicable)
        IP
    0
    0
        FU Phase
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
    Adverse event reporting additional description
    Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    IP: JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
    Reporting group description
    		 In intervention phase (IP), subjects received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, subjects received a single dose of nivolumab 0.3 mg/kg as intravenous (IV) infusion. Subjects also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide [TAF] 25 mg or entecavir [ETV] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24.

    Reporting group title
    FU: JNJ-3989 + Nivolumab (3 infusions) + NA
    Reporting group description
    		 After Week 24, subjects were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).

    Reporting group title
    FU: JNJ-3989 + Nivolumab (1 infusion) + NA
    Reporting group description
    		 After Week 24, subjects were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).

    Reporting group title
    IP: JNJ-3989 + Nivolumab (3 infusions) + NA
    Reporting group description
    		 In IP, subjects received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, subjects received of nivolumab 0.3 mg/kg as IV infusion. Subjects also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24.

    Serious adverse events
    		 IP: JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA FU: JNJ-3989 + Nivolumab (3 infusions) + NA FU: JNJ-3989 + Nivolumab (1 infusion) + NA IP: JNJ-3989 + Nivolumab (3 infusions) + NA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IP: JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA FU: JNJ-3989 + Nivolumab (3 infusions) + NA FU: JNJ-3989 + Nivolumab (1 infusion) + NA IP: JNJ-3989 + Nivolumab (3 infusions) + NA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 18 (33.33%)
    8 / 19 (42.11%)
    8 / 18 (44.44%)
    12 / 19 (63.16%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Injection Site Erythema
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Asthenia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Chills
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Immune system disorders
    Drug Hypersensitivity
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Reproductive system and breast disorders
    Cystocele
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Intermenstrual Bleeding
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    1
    1
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Productive Cough
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Anxiety
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Investigations
    Lipase Increased
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Amylase Increased
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Cervical Radiculopathy
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Headache
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    0
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Eye disorders
    Ocular Hyperaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Conjunctival Haemorrhage
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal Pain Upper
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal Tenderness
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dental Caries
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Oesophagitis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 19 (10.53%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    2
    0
    1
    Oral Pain
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Toothache
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Skin Hyperpigmentation
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pollakiuria
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Renal Cyst
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Pain in Extremity
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Periarthritis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Muscular Weakness
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    0
    1
    Muscle Spasms
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Intervertebral Disc Protrusion
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Arthralgia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    2
    Candida Infection
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Influenza
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    1 / 19 (5.26%)
         occurrences all number
    1
    0
    1
    1
    Laryngopharyngitis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Covid-19
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    3 / 19 (15.79%)
         occurrences all number
    1
    0
    1
    3
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Pharyngitis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    1
    1
    Oral Herpes
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    0
    0
    1
    Viral Infection
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Urethritis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Vitamin D Deficiency
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Decreased Appetite
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
         occurrences all number
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jun 2022
    The purpose of this amendment was to allow inclusion of subjects with low titers of auto antibodies, to remove certain procedures, to implement changes regarding immune-related gastro-intestinal adverse event management based on Health Authority feedback and clarifications of sampling collection.
    28 Mar 2023
    The purpose of this amendment was that due to difficult recruitment a strategic decision was taken to not extend further enrollment beyond the planned enrollment period and continue the study with a reduced sample size.
    30 Jun 2023
    The main purpose of this amendment was the discontinuation of programmed cell death protein receptor-1 inhibitor (nivolumab) as study intervention as of 20 June 2023 as an urgent safety measure (USM).

    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.
    Per protocol amendment 2 (28 Mar 2023), due to difficulties in recruitment, further subjects enrollment was stopped. Hence, pharmacokinetic assessments were not performed due to change in planned analysis.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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