Trial Outcomes & Findings for A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection (NCT NCT04129554)

Last Updated: 2025-02-04

Results Overview

Percentage of participants with HBsAg seroclearance at Week 72 (24 weeks after completion of all study interventions at Week 48) without restarting NA treatment was reported. Seroclearance at Week 72 of the treatment defined as a confirmed loss of HBsAg at Week 72. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

130 participants

Primary outcome timeframe

Week 72

Results posted on

2025-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Overall Study STARTED	85	45
Overall Study COMPLETED	81	40
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Overall Study Withdrawal by Subject	4	3
Overall Study Other	0	2

Baseline Characteristics

A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=85 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) n=45 Participants Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.	Total n=130 Participants Total of all reporting groups
Age, Continuous	45.3 years STANDARD_DEVIATION 10.1 • n=5 Participants	47.4 years STANDARD_DEVIATION 10.55 • n=7 Participants	46 years STANDARD_DEVIATION 10.27 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	16 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	29 Participants n=7 Participants	87 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	3 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=5 Participants	41 Participants n=7 Participants	107 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	17 Participants n=5 Participants	8 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	56 Participants n=5 Participants	30 Participants n=7 Participants	86 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment BELGIUM	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment FRANCE	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment GERMANY	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment ITALY	17 Participants n=5 Participants	5 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment POLAND	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment SPAIN	18 Participants n=5 Participants	7 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment UNITED KINGDOM	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 72

Population: Modified intent-to-treat (mITT) included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=79 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) n=39 Participants Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 72 Without Restarting NA Treatment	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: From screening up to Week 102

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug.

An adverse event (AE) was any untoward medical occurrence in a clinical study participant who was administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAE was defined as the AEs occurring after first administration of study intervention (or worsened since then).

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=85 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) n=45 Participants Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	85.9 Percentage of participants	80.0 Percentage of participants

SECONDARY outcome

Timeframe: From screening up to 102 weeks

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug.

An AE was any untoward medical occurrence in a clinical study participant who was administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAE was defined as the AEs occurring after first administration of study intervention (or worsened since then). SAEs included any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the off spring of a study participant.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=85 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) n=45 Participants Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs)	3.5 Percentage of participants	8.9 Percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: mITT included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of subjects analyzed) signifies participants who were evaluable for this outcome measure.

Percentage of participants with hepatitis B surface antigen (HBsAg) seroclearance at Week 48 was reported. Seroclearance at Week 48 of the treatment defined as a confirmed loss of HBsAg at Week 48. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=76 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) n=41 Participants Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Percentage of Participants With HBsAg Seroclearance at Week 48	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Week 48

Percentage of participants with HBV DNA \<LLOQ (20 international units per milliliters \[IU/mL\]) at Week 48 was reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=75 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) n=41 Participants Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Less Than (<) Lower Limit of Quantification (LLOQ) at Week 48	97.3 Percentage of participants	100 Percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: mITT included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic.

Percentage of participants with HBsAg seroclearance at Week 96 (48 weeks after stopping all study interventions at Week 48 without restarting NA treatment) was reported. Seroclearance at Week 96 of the treatment defined as a confirmed loss of HBsAg at Week 96. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result. Missing values were imputed by last observation carried forward (LOCF).

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=84 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) n=44 Participants Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Percentage of Participants With HBsAg Seroclearance at Week 96 (48 Weeks After Stopping All Study Interventions at Week 48 Without Restarting NA Treatment)	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 96

Population: mITT included all participants, who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of participants analyzed) included participants with blood marker data.

Percentage of participants with (sustained) reduction, suppression, and/or seroclearance considering single and multiple markers (such as hepatitis B surface antigen \[HBsAg\] and HBV DNA) (HBsAg \>= lower limit of quantification \[LLOQ\] and HBV DNA\<2000 IU/mL; HBsAg \>= LLOQ and LLOQ \<= HBV DNA \< 2000 IU/mL) off-treatment was reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=71 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) n=28 Participants Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Percentage of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance HBsAg>=LLOQ and HBVDNA<2000 IU/mL	23.9 Percentage of participants	3.6 Percentage of participants
Percentage of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance HBsAg>=LLOQ and LLOQ<=HBV DNA <2000 IU/mL	64.8 Percentage of participants	64.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 96

Percentage of participants with HBsAg seroconversion were reported. HBsAg seroconversion was defined as HBsAg seroclearance together with appearance of anti-hepatitis B surface (HBs) or anti-hepatitis e (HBe) antibodies, respectively.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=81 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) n=39 Participants Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Percentage of Participants With HBsAg Seroconversion at Week 96	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 48, 72, and 96

Population: mITT included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number evaluable) signifies number of participants analyzed at each specified timepoints.

Change from baseline in HBsAg values was reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=81 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) n=41 Participants Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Change From Baseline in HBsAg Values at Weeks 48, 72, and 96 Week 48	-1.89 log10 IU/mL Standard Deviation 0.522	-0.06 log10 IU/mL Standard Deviation 0.082
Change From Baseline in HBsAg Values at Weeks 48, 72, and 96 Week 72	-1.76 log10 IU/mL Standard Deviation 0.658	-0.25 log10 IU/mL Standard Deviation 0.563
Change From Baseline in HBsAg Values at Weeks 48, 72, and 96 Week 96	-1.46 log10 IU/mL Standard Deviation 0.661	-0.49 log10 IU/mL Standard Deviation 0.783

SECONDARY outcome

Timeframe: Baseline (Day 1), Weeks 48, 72, and 96

Population: mITT included as all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of participants analyzed) signifies that no participants were available for change from baseline HBV DNA analysis because all participants were virologically suppressed, thereby planned data collection and analysis was not performed and thus, no data was reported for this outcome measure.

Change from baseline in HBV DNA values was reported. Participants were considered as virologically suppressed if they were on stable HBV treatment (receiving NA treatment \[ETV, TDF, or TAF)\] for at least 24 months prior to screening and were on the same dose of NA treatment regimen for at least 3 months at the time of screening, and had serum HBV DNA less than (\<)60 IU/mL on 2 sequential measurements at least 6 months and had documented alanine aminotransferase values \<2.0\* upper limit of normal on 2 sequential measurements at least 6 months apart.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 96

Population: mITT included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Time to achieve first HBsAg seroclearance 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.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=83 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) n=44 Participants Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Time to Achieve First HBsAg Seroclearance	NA Days Here, NA indicates that median and full range for the first occurrence of HBsAg seroclearance after first intake of study treatment was not estimable because of less number of events.	NA Days Here, NA indicates that median and full range for the first occurrence of HBsAg seroclearance after first intake of study treatment was not estimable because of less number of events.

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 96

Percentage of participants with reduction of \>1 log10 in HBsAg Levels IU/mL from baseline was reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=81 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) n=40 Participants Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Percentage of Participants With Reduction of More Than (>) 1 log10 IU/mL in HBsAg Levels From Baseline	81.5 Percentage of participants	12.5 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 48, 72, and 96

Population: mITT included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Percentage of participants with HBsAg Levels \<100 IU/mL at Weeks 48, 72, and 96 was reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=81 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) n=41 Participants Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Percentage of Participants With HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96 Week 48	71.1 Percentage of participants	2.4 Percentage of participants
Percentage of Participants With HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96 Week 72	67.1 Percentage of participants	10.3 Percentage of participants
Percentage of Participants With HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96 Week 96	46.9 Percentage of participants	15.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 96

Percentage of Participants with HBV DNA levels \<LLOQ (20 IU/mL) was reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=71 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) n=28 Participants Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Percentage of Participants With HBV DNA Levels Less Than (<) LLOQ From Baseline up to Week 96 (End of Study)	23.9 Percentage of participants	3.6 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 96

Population: mITT included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Percentage of participants with flares (virologic, biochemical and clinical flares) was reported. Biochemical flare was defined as confirmed alanine transaminase flare and/or aspartate aminotransferase flare \>=3\*upper limit of normal and \>=3\*nadir. The start of a confirmed virologic flare was defined as the first date of two consecutive visits with HBV DNA \>200 IU/mL. The end date of the same confirmed virologic flare was defined as the first date when HBV DNA value returns to less than or equal to (\<=)200 IU/mL or the date of NA treatment restart, whichever comes first. Clinical flare was defined as participants with both virologic and biochemical flare.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=77 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) n=41 Participants Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Percentage of Participants With Flares Virologic Flare (HBV DNA >20000 - =<100000 IU/mL)	8.0 Percentage of participants	10.0 Percentage of participants
Percentage of Participants With Flares Virologic Flare (HBV DNA >100000 IU/mL)	2.7 Percentage of participants	27.5 Percentage of participants
Percentage of Participants With Flares Alanine Transaminase Flare	3.9 Percentage of participants	19.5 Percentage of participants
Percentage of Participants With Flares Aspartate Aminotransferase Flare	1.3 Percentage of participants	14.6 Percentage of participants
Percentage of Participants With Flares Clinical Flare: HBV DNA > 200 - =<2000IU/mL	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Flares Clinical Flare: HBV DNA > 2000 - =<20000IU/mL	1.3 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Flares Clinical Flare: HBV DNA > 20000 - =<100000IU/mL	1.3 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Flares Clinical Flare: HBV DNA > 100000 IU/mL	1.3 Percentage of participants	27.5 Percentage of participants
Percentage of Participants With Flares Virologic Flare (HBV DNA > 200 - =<2000 IU/mL)	38.7 Percentage of participants	25.0 Percentage of participants
Percentage of Participants With Flares Virologic Flare (HBV DNA>2000 - =< 20000 IU/mL)	24.0 Percentage of participants	30.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 48

Population: mITT included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic.

Percentage of participants with virologic breakthrough defined as confirmed on-treatment HBV DNA increase by more than (\>) 1 log10 IU/mL from nadir level or confirmed on treatment level \>200 IU/mL in participants who had HBV DNA level below \<LLOQ of the HBV DNA assay was reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=84 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) n=44 Participants Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Percentage of Participants With Virologic Breakthrough	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Week 96

Population: mITT included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Percentage of participants requiring NA re-treatment (either ETV, TDF, or TAF) during follow-up was reported.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=77 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) n=41 Participants Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Percentage of Participants Requiring NA Re-Treatment During Follow-up	9.1 Percentage of participants	26.8 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 96

Population: mITT included all participants who were randomized in the study and received at least one dose of study intervention excluding those participants impacted by the pandemic. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Correlation coefficient between on-treatment HBsAg change from baseline with on-treatment HBV blood markers and baseline characteristics was reported at different timepoints (against age, baseline NA treatment duration, HBsAg value at baseline, HBsAg values at Weeks 24 and 48).

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=79 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) n=39 Participants Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline Characteristics Age	0.2860 correlation coefficient	0.1746 correlation coefficient
Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline Characteristics Baseline NA treatment duration	0.2381 correlation coefficient	0.4324 correlation coefficient
Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline Characteristics HBsAg value at baseline	-0.9970 correlation coefficient	-0.5923 correlation coefficient
Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline Characteristics HBsAg at Week 24	0.9983 correlation coefficient	0.7120 correlation coefficient
Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline Characteristics HBsAg at Week 48	0.9982 correlation coefficient	0.8065 correlation coefficient

SECONDARY outcome

Timeframe: Predose at Weeks 4, 8, 12, and 16

Population: Pharmacokinetic (PK) analysis set included all participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. NA (nucleos\[t\]ide analog) was tenofovir disoproxil fumarate (TDF).

C(predose) was defined as the observed plasma concentration of JNJ-73763976 (a molecule of JNJ-73763989) at predose of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=18 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Observed Plasma Concentration at Predose (C[Predose]) of JNJ-73763976 (Molecule of JNJ-73763989)	NA nanogram/milliliter (ng/mL) Standard Deviation NA Here, NA indicated that data was below quantification limit (\<2.1 ng/mL).	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose

Population: PK analysis set included participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. NA was TDF. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure.

Cmax was defined as the maximum observed concentration of JNJ-73763976 (molecule of JNJ-73763989). PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=18 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763976 (Molecule of JNJ-73763989)	1111 ng/mL Standard Deviation 716 • Interval 716.0 to	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose

Population: PK analysis set included participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. NA was TDF.

tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-73763976 (molecule of JNJ-73763989). PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=18 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763976 (Molecule of JNJ-73763989)	6.00 Hour Full Range 1.00 • Interval 1.0 to 10.0	—

SECONDARY outcome

Timeframe: 24 hours postdose at Weeks 4, 8, 12, and 16

Population: PK analysis set included participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

C(24h) was defined as the observed plasma concentration of JNJ-73763976 (a molecule of JNJ-73763989) at 24 h postdose of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=18 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Observed Plasma Concentration at 24 Hour Postdose (C[24h]) of JNJ-73763976 (Molecule of JNJ-73763989)	275 ng/mL Standard Deviation 161 • Interval 161.0 to	—

SECONDARY outcome

Timeframe: 0 to 24 hours postdose at Weeks 4, 8, 12, and 16

Population: PK analysis set included participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

AUC(0-24h) was defined as the area under the concentration of JNJ-73763976 (a molecule of JNJ-73763989) versus time curve from time 0 to 24 hours of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=17 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-73763976 (Molecule of JNJ-73763989)	17833 nanogramhour/milliliter (ngh/mL) Standard Deviation 9670 • Interval 9670.0 to	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose

Population: PK analysis set included participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

Cmax(Dose Normalized) was defined as the maximum observed concentration of JNJ-73763976 (a molecule of JNJ-73763989) dose normalized to 1 mg. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=18 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763976 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (Cmax[Dose Normalized])	8.34 ng/mL/mg Standard Deviation 5.37 • Interval 5.37 to	—

SECONDARY outcome

Timeframe: 0 to 24 hours post-dose at Weeks 4, 8, 12, and 16

Population: PK analysis set included participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

AUC(\[0-24h\], Dose Normalized) was defined as the area under the concentration of JNJ-73763976 (molecule of JNJ-73763989) versus time curve from time 0 to 24 hours of JNJ-73763989 dose normalized to 1 mg. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=17 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours of JNJ-73763976 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (AUC[0-24h], Dose Normalized)	134 ng*h/mL/mg Standard Deviation 72.5 • Interval 72.5 to	—

SECONDARY outcome

Timeframe: Predose at Weeks 4, 8, 12, and 16

Population: PK analysis set was defined as participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analyzed) signifies number of participants analyzed at each specified outcome measure. NA was TDF.

C(predose) was defined as the observed plasma concentration of JNJ-73763924 (a molecule of JNJ-73763989) at predose of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=18 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Observed Plasma Concentration at Predose (C[Predose]) of JNJ-73763924 (Molecule of JNJ-73763989)	NA ng/mL Standard Deviation NA Here, NA indicates that mean and standard deviation could not be estimated as data was below quantification limit (\<2.1 ng/mL).	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose

Population: PK analysis set included participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

Cmax was defined as the maximum concentration of JNJ-73763924 (molecule of JNJ-73763989). PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=18 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763924 (Molecule of JNJ-73763989)	222 ng/mL Standard Deviation 142 • Interval 142.0 to	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose

Population: PK analysis set included participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-73763924 (molecule of JNJ-73763989). PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=18 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763924 (Molecule of JNJ-73763989)	5.07 Hour Full Range 1.00 • Interval 1.0 to 8.03	—

SECONDARY outcome

Timeframe: 24 hours postdose at Weeks 4, 8, 12, and 16

Population: PK analysis set included participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

C(24h) was defined as the observed plasma concentration of JNJ-73763924 (molecule of JNJ-73763989) at 24 h postdose of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=17 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Observed Plasma Concentration at 24 Hour Postdose (C[24h]) of JNJ-73763924 (Molecule of JNJ-73763989)	35.0 ng/mL Standard Deviation 25.5 • Interval 25.5 to	—

SECONDARY outcome

Timeframe: 0 to 24 hours postdose at Weeks 4, 8, 12, and 16

Population: PK analysis set included participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

AUC(0-24h) was defined as the area under the concentration of JNJ-73763924 (molecule of JNJ-73763989) versus time curve from time 0 to 24 hour of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=17 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hour (AUC[0-24h]) of JNJ-73763924 (Molecule of JNJ-73763989)	3386 ng*h/mL Standard Deviation 1930 • Interval 1930.0 to	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose

Population: PK analysis set included participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

Cmax(Dose Normalized) was defined as the maximum observed analyte concentration of JNJ-73763924 (molecule of JNJ-73763989) dose normalized to 1 mg. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=18 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763924 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (Cmax[Dose Normalized])	3.33 nanogram/milliliter/milligram (ng/mL/mg) Standard Deviation 2.14 • Interval 2.14 to	—

SECONDARY outcome

Timeframe: 0 to 24 hours postdose at Weeks 4, 8, 12, and 16

Population: PK analysis set included participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

AUC(\[0-24h\], Dose Normalized) was defined as the area under the analyte concentration JNJ-73763924 (a molecule of JNJ-73763989) versus time curve from time 0 to 24 hours of JNJ-73763989 dose normalized to 1 mg. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=17 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours of JNJ-73763924 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (AUC[0-24h], Dose Normalized)	50.8 ng*h/mL/mg Standard Deviation 28.9 • Interval 28.9 to	—

SECONDARY outcome

Timeframe: Predose at Weeks 4, 8, 12, and 16

C(predose) was defined as the observed plasma concentration at predose of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=12 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Observed Plasma Concentration at Predose (C[Predose]) of JNJ-56136379	10812 ng/mL Standard Deviation 2430 • Interval 2430.0 to	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose

Population: PK analysis set included participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

Cmax was defined as the maximum observed concentration of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=12 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Maximum Observed Analyte Concentration (Cmax) of JNJ-56136379	14754 ng/mL Standard Deviation 4318 • Interval 4318.0 to	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose

Population: PK analysis set included participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=12 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-56136379	4.00 Hour Full Range 0.0 • Interval 0.0 to 24.17	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose

Population: PK analysis set included participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

Ctau was defined as the observed or predicted concentration at the end of a dosing interval of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=11 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Observed or Predicted Concentration at the End of a Dosing Interval (Ctau) of JNJ-56136379	12763 ng/mL Standard Deviation 4959 • Interval 4959.0 to	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose

Population: PK analysis set included participants who have received at least 1 dose of any of the study interventions and have at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. NA was TDF.

AUCtau was defined as the area under the analyte concentration versus time curve during a dosing interval at steady state of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=12 Participants Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Area Under the Analyte Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCtau) of JNJ-56136379	282458 ng*h/mL Standard Deviation 79118 • Interval 79118.0 to	—

Adverse Events

Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA

Serious events: 3 serious events

Other events: 71 other events

Deaths: 0 deaths

Arm 2: Nucleos(t)Ide Analog (NA)

Serious events: 4 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA n=85 participants at risk Participants received JNJ-73763989 200 mg subcutaneous (SC) injection, once every 4 weeks (q4w), along with JNJ-56136379 250 mg tablet once daily (qd) and NA treatment orally (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) qd up to 48 weeks.	Arm 2: Nucleos(t)Ide Analog (NA) n=45 participants at risk Participants received matching placebo for JNJ-73763989 by SC injection q4w, along with matching placebo for JNJ-56136379 qd and NA treatment orally (either ETV, TDF or TAF) qd up to 48 weeks.
Ear and labyrinth disorders Vertigo	0.00% 0/85 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.	2.2% 1/45 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.
General disorders Pyrexia	1.2% 1/85 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.	0.00% 0/45 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.
Hepatobiliary disorders Subacute Hepatic Failure	0.00% 0/85 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.	2.2% 1/45 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.
Infections and infestations Covid-19	1.2% 1/85 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.	0.00% 0/45 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.
Infections and infestations Cytomegalovirus Infection Reactivation	1.2% 1/85 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.	0.00% 0/45 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.
Infections and infestations Hepatitis B Reactivation	0.00% 0/85 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.	2.2% 1/45 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Radius Fracture	0.00% 0/85 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.	2.2% 1/45 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral Disc Disorder	0.00% 0/85 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.	2.2% 1/45 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	1.2% 1/85 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.	0.00% 0/45 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Cancer	1.2% 1/85 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.	0.00% 0/45 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular Carcinoma	0.00% 0/85 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.	2.2% 1/45 • Up to Week 102 (including 6 weeks of screening) The safety analysis set included all participants who received at least 1 dose of study drug.

Other adverse events

Additional Information

Study Director

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER