Trial Outcomes & Findings for A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection (NCT NCT04667104)

NCT ID: NCT04667104

Last Updated: 2024-07-03

Results Overview

Percentage of participants with a reduction of at least 2 log10IU/mL in HBsAg levels from baseline to Week 24 were reported. A responder was defined as a participant with reduction of at least 2 log10 IU/mL in HBsAg levels from baseline at Week 24.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

48 participants

Primary outcome timeframe

From Baseline (Day 1) to Week 24

Results posted on

2024-07-03

Participant Flow

At Week 12, participants were assessed for pegylated interferon alpha 2a (PegIFN-alpha2a) eligibility criteria and those who did not meet the criteria continued in Treatment Period 1 (TP 1) until Week 24 and those who met the criteria entered Treatment Period 2 (TP 2). After Week 12, one participant continued with TP1 regimen during TP2 until Week 24. As of Protocol Amendment 3, JNJ-56136379 was stopped immediately as study drug and study continued with JNJ-73763989, PegIFN alpha 2a \& NA only.

Participant milestones

Participant milestones
Measure
TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA
Participants received a single dose of JNJ-73763989 (JNJ-3989) 200 milligrams (mg) as a subcutaneous injection (SC) every 4 weeks (Q4W) along with JNJ-56136379 (JNJ-6379) 250 mg tablet once daily (QD) and nucleos(t)ide analog (NA) treatment (either entecavir\[ETV\] 0.5 mg, tenofovir disoproxil fumarate\[TDF\] 245 mg, or tenofovir alafenamide\[TAF\] 25 mg) QD up to 12 weeks in TP 1. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after protocol amendment 3, received JNJ-3989 + PegIFN-alpha 2a + NA only. Participants were assessed for eligibility criteria for PegIFN-alpha 2a at Week 12. Participants who met the criteria entered TP 2.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
TP 1: From Week 1 to Week 12
STARTED
48
0
0
TP 1: From Week 1 to Week 12
COMPLETED
48
0
0
TP 1: From Week 1 to Week 12
NOT COMPLETED
0
0
0
TP 2: From Week 12 to Week 24
STARTED
0
48
0
TP 2: From Week 12 to Week 24
COMPLETED
0
48
0
TP 2: From Week 12 to Week 24
NOT COMPLETED
0
0
0
FU:Week 24 to FU Week 48 (i.e.Week 72.4)
STARTED
0
0
48
FU:Week 24 to FU Week 48 (i.e.Week 72.4)
COMPLETED
0
0
47
FU:Week 24 to FU Week 48 (i.e.Week 72.4)
NOT COMPLETED
0
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA
Participants received a single dose of JNJ-73763989 (JNJ-3989) 200 milligrams (mg) as a subcutaneous injection (SC) every 4 weeks (Q4W) along with JNJ-56136379 (JNJ-6379) 250 mg tablet once daily (QD) and nucleos(t)ide analog (NA) treatment (either entecavir\[ETV\] 0.5 mg, tenofovir disoproxil fumarate\[TDF\] 245 mg, or tenofovir alafenamide\[TAF\] 25 mg) QD up to 12 weeks in TP 1. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after protocol amendment 3, received JNJ-3989 + PegIFN-alpha 2a + NA only. Participants were assessed for eligibility criteria for PegIFN-alpha 2a at Week 12. Participants who met the criteria entered TP 2.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
FU:Week 24 to FU Week 48 (i.e.Week 72.4)
Other
0
0
1

Baseline Characteristics

A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA
n=48 Participants
Participants received a single dose of JNJ-73763989 (JNJ-3989) 200 milligrams (mg) as a subcutaneous injection (SC) every 4 weeks (Q4W) along with JNJ-56136379 (JNJ-6379) 250 mg tablet once daily (QD) and nucleos(t)ide analog (NA) treatment (either entecavir\[ETV\] 0.5 mg, tenofovir disoproxil fumarate\[TDF\] 245 mg, or tenofovir alafenamide\[TAF\] 25 mg) QD up to 12 weeks in TP 1. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after protocol amendment 3, received JNJ-3989 + PegIFN-alpha 2a + NA only. Participants were assessed for eligibility criteria for PegIFN-alpha 2a at Week 12. Participants who met the criteria entered TP 2.
Age, Continuous
44.6 years
STANDARD_DEVIATION 1.47 • n=5 Participants
Age, Customized
Children (2-11 years)
0 Participants
n=5 Participants
Age, Customized
Adolescents (12-17 years)
0 Participants
n=5 Participants
Age, Customized
Adults (18-64 years)
48 Participants
n=5 Participants
Age, Customized
From 65 to 84 years
0 Participants
n=5 Participants
Age, Customized
85 years and over
0 Participants
n=5 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
Sex: Female, Male
Male
40 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
48 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
34 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
14 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: From Baseline (Day 1) to Week 24

Population: Full Analysis Set (FAS) included all participants who were enrolled and who received at least 1 dose of study intervention within this intervention-specific appendix (ISA). Data for this outcome measure was planned to be collected and analyzed for specified arm only.

Percentage of participants with a reduction of at least 2 log10IU/mL in HBsAg levels from baseline to Week 24 were reported. A responder was defined as a participant with reduction of at least 2 log10 IU/mL in HBsAg levels from baseline at Week 24.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Percentage of Participants With a Reduction of at Least 2 log10 International Unit/Millilitres (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels From Baseline to Week 24
64.6 percentage of participants
90% Confidence Interval 51.73 • Interval 51.73 to 76.02

SECONDARY outcome

Timeframe: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.

Percentage of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were AEs with onset during the intervention period or follow-up period or that were a consequence of a pre-existing condition that had worsened since baseline.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
n=48 Participants
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability
52.1 percentage of participants
87.5 percentage of participants
60.4 percentage of participants

SECONDARY outcome

Timeframe: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were AEs with onset during the intervention period or follow-up period or that were a consequence of a pre-existing condition that had worsened since baseline. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
n=48 Participants
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Percentage of Participants With Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
0 percentage of participants
2.1 percentage of participants
8.3 percentage of participants

SECONDARY outcome

Timeframe: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.

Number of participants with clinically significant abnormalities in vital signs (pulse rate, and blood pressure \[systolic and diastolic\]) were reported.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
n=48 Participants
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Number of Participants With Clinically Significant Abnormalities in Vital Signs as a Measure of Safety and Tolerability
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this endpoint and "n"(number analyzed) signifies number of participants analyzed at specified timepoints.

Number of participants with clinically significant abnormalities in laboratory findings (including hematology, blood biochemistry, and urinalysis) were reported. Only parameters in which any participant had abnormality are reported below.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
n=48 Participants
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Treatment-emergent (TE)-Grade 3 ALT elevations
1 Participants
1 Participants
1 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
TE-Grade 3 total bilirubin elevations
0 Participants
0 Participants
1 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
TE-Grade 3 direct bilirubin elevations
0 Participants
0 Participants
2 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Treatment-emergent-High serum indirect bilirubin
0 Participants
0 Participants
3 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Renal complications-eGFR Decreases
0 Participants
0 Participants
0 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Hematology-low absolute neutrophil count Grade 1
1 Participants
13 Participants
2 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Hematology-low absolute neutrophil count Grade 2
0 Participants
2 Participants
1 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Hematology-low absolute neutrophil count Grade 3
0 Participants
3 Participants
0 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Hematology-low absolute neutrophil count Grade 4
0 Participants
1 Participants
0 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Hematology-low absolute lymphocyte count Grade 1
1 Participants
1 Participants
0 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Hematology-low absolute lymphocyte count Grade 2
1 Participants
3 Participants
0 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Hematology-low absolute lymphocyte count Grade 3
0 Participants
3 Participants
2 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Hematology-low absolute lymphocyte count Grade 4
0 Participants
1 Participants
1 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Hematology-decreased platelets of Grade 1
0 Participants
20 Participants
8 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Hematology-decreased platelets of Grade 2
0 Participants
5 Participants
0 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Hematology-low hemoglobin Grade 2
0 Participants
0 Participants
1 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Hematology-low WBC count of Grade 1
0 Participants
14 Participants
5 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Hematology-low WBC count of Grade 2
0 Participants
6 Participants
1 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Hematology-low WBC count of Grade 3
0 Participants
2 Participants
0 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Chemistry-LDL cholesterol Grade 3
2 Participants
1 Participants
2 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Chemistry-eGFR creatinine low Grade 3 elevation
1 Participants
0 Participants
0 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Chemistry-eGFR Cystatin C low Grade 3 elevation
0 Participants
1 Participants
2 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Chemistry-Grade 3 elevations in triglycerides
0 Participants
2 Participants
0 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Chemistry-Grade 3 elevation amylase
0 Participants
0 Participants
1 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Chemistry-Grade 3 elevation direct bilirubin high
0 Participants
0 Participants
2 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Chemistry-lipaseGrade 4 elevation
0 Participants
0 Participants
1 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Urinalysis-Grade 1 glycosuria
0 Participants
0 Participants
1 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Urinalysis-Grade 1 hematuria
0 Participants
1 Participants
1 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Urinalysis-Grade 2 hematuria
1 Participants
1 Participants
1 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Urinalysis-Grade 1 proteinuria
2 Participants
5 Participants
4 Participants
Number of Participants With Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
Urinalysis-Grade 2 proteinuria
1 Participants
1 Participants
1 Participants

SECONDARY outcome

Timeframe: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to Week 28

Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.

Number of participants with clinically significant abnormalities in 12- lead ECGs (heart rate, PR, QRS and QT corrected \[QTc\]) were reported.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
n=48 Participants
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs) as a Measure of Safety and Tolerability
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24

Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Data for this outcome measure was not planned to be collected and analyzed for Follow-Up Period as pre-specified in protocol.

Number of participants with clinically significant abnormalities in physical examination were reported.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Number of Participants With Clinically Significant Abnormalities in Physical Examination as a Measure of Safety and Tolerability
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24

Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Data for this outcome measure was planned to be collected and analyzed at TP 1 and TP 2 for participants with diabetes/hypertension only. Since no subject had diabetes/hypertension hence data for this OM was not collected and analyzed as pre-specified in protocol.

Number of participants with abnormalities in Ophthalmic examination were planned to be reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Week 24 (EOSI)

Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Data for this outcome measure was not planned to be collected and analyzed for Treatment Period 1 and Follow-Up period as pre-specified in protocol.

Percentage of participants meeting the protocol-defined NA treatment completion criteria at EOSI were reported. NA treatment completion criteria are defined based on laboratory results at Week 24 were; HBsAg \<10 IU/mL; HBeAg-negative; HBV DNA \<20 IU/mL, that is, lower limit of quantification(LLOQ); alanine aminotransferase(ALT) \<3\*ULN.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Percentage of Participants Meeting the Protocol-defined Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at End of Study Intervention (EOSI)
31.3 percentage of participants

SECONDARY outcome

Timeframe: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

Percentage of participants with HBeAg levels below different cut-offs were reported. The cut-offs for HBeAg levels were as followed:\< 100 IU/mL, \< 10 IU/mL, \< 1 IU/mL, \< LLOQ (0.11 IU/mL).

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=11 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=11 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
n=11 Participants
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs
< 100 IU/mL
100.0 percentage of participants
100.0 percentage of participants
100.0 percentage of participants
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs
< LLOQ (0.11 IU/mL)
36.4 percentage of participants
27.3 percentage of participants
27.3 percentage of participants
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs
< 1 IU/mL
90.9 percentage of participants
100.0 percentage of participants
81.8 percentage of participants
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Levels Below Different Cut-offs
< 10 IU/mL
100.0 percentage of participants
100.0 percentage of participants
100.0 percentage of participants

SECONDARY outcome

Timeframe: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA.

Percentage of participants with HBsAg levels below different cut-offs were reported. The cut-offs for HBsAg level were: \<1000 IU/mL, \<100 IU/mL, \<10 IU/mL, \<1 IU/mL, \<LLOQ (0.05 IU/mL).

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
n=48 Participants
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Percentage of Participants With HBsAg Levels Below Different Cut-offs
<LLOQ (0.05 IU/mL)
0 percentage of participants
2.1 percentage of participants
2.1 percentage of participants
Percentage of Participants With HBsAg Levels Below Different Cut-offs
<1 IU/mL
4.2 percentage of participants
6.3 percentage of participants
2.1 percentage of participants
Percentage of Participants With HBsAg Levels Below Different Cut-offs
<10 IU/mL
12.5 percentage of participants
47.9 percentage of participants
4.2 percentage of participants
Percentage of Participants With HBsAg Levels Below Different Cut-offs
<100 IU/mL
58.3 percentage of participants
91.7 percentage of participants
27.1 percentage of participants
Percentage of Participants With HBsAg Levels Below Different Cut-offs
<1000 IU/mL
89.6 percentage of participants
97.9 percentage of participants
68.8 percentage of participants

SECONDARY outcome

Timeframe: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA.

Percentage of participants with HBV DNA levels below cut-offs were reported. The cut-offs for HBV DNA were as follows: \<LLOQ (=20 IU/mL) target detected or not detected, \< LLOQ target not detected, and \< LLOQ target detected, \<60 IU/mL, \<100 IU/mL, \<200 IU/mL, \<1000 IU/mL, \<2000 IU/mL, \<20000 IU/mL.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
n=48 Participants
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs
< LLOQ for target detected and not detected
95.8 percentage of participants
75.0 percentage of participants
81.3 percentage of participants
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs
< LLOQ for target not detected
52.1 percentage of participants
27.1 percentage of participants
54.2 percentage of participants
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs
< LLOQ for target detected
43.8 percentage of participants
47.9 percentage of participants
27.1 percentage of participants
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs
< 60 IU/mL
100.0 percentage of participants
89.6 percentage of participants
83.3 percentage of participants
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs
< 100 IU/mL
100.0 percentage of participants
95.8 percentage of participants
83.3 percentage of participants
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs
< 200 IU/mL
100.0 percentage of participants
97.9 percentage of participants
85.4 percentage of participants
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs
< 1000 IU/mL
100.0 percentage of participants
100.0 percentage of participants
89.6 percentage of participants
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs
< 2000 IU/mL
100.0 percentage of participants
100.0 percentage of participants
93.8 percentage of participants
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below Different Cut-offs
< 20000 IU/mL
100.0 percentage of participants
100.0 percentage of participants
97.9 percentage of participants

SECONDARY outcome

Timeframe: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

Percentage of participants with ALT levels below \>=3\*ULN cut-off were reported.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=3 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=3 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
n=3 Participants
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Percentage of Participants With ALT Levels Greater Than or Equal to (>=) 3*ULN
33.3 percentage of participants
33.3 percentage of participants
66.7 percentage of participants

SECONDARY outcome

Timeframe: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

Percentage of participants with HBeAg seroconversion were reported. Seroconversion of HBeAg is defined as having achieved HBeAg seroclearance (as HBeAg level \<LLOQ \[0.11 IU/mL\]) and appearance of anti-HBe antibodies, defined as baseline anti-HBe antibodies with a negative result and a post-baseline assessment with positive result.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=11 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=11 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
n=11 Participants
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Percentage of Participants With HBeAg Seroconversion
0 percentage of participants
10.0 percentage of participants
20.0 percentage of participants

SECONDARY outcome

Timeframe: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

Percentage of participants with HBsAg seroconversion were reported. Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance (defined as HBsAg \<LLOQ \[0.05 IU/mL\]) and appearance of anti-HBs antibodies.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=45 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=46 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
n=46 Participants
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Percentage of Participants With HBsAg Seroconversion
0 percentage of participants
0 percentage of participants
0 percentage of participants

SECONDARY outcome

Timeframe: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Baseline (Day 1) up to Week 24; Follow-Up: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA.

Change from baseline over time in HBsAg levels were reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study agent.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
n=48 Participants
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Change From Baseline Over Time in HBsAg Levels
-1.43 log10 IU/mL
Standard Error 0.070 • Interval 0.07 to
-2.18 log10 IU/mL
Standard Error 0.084 • Interval 0.084 to
-0.71 log10 IU/mL
Standard Error 0.092 • Interval 0.092 to

SECONDARY outcome

Timeframe: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Baseline (Day 1) up to Week 24; Follow-Up: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

Change from baseline over time in HBeAg levels were reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study agent.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=11 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=11 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
n=11 Participants
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Change From Baseline Over Time in HBeAg Levels
-0.68 log10 IU/mL
Standard Error 0.087 • Interval 0.087 to
-0.72 log10 IU/mL
Standard Error 0.106 • Interval 0.106 to
-0.53 log10 IU/mL
Standard Error 0.112 • Interval 0.112 to

SECONDARY outcome

Timeframe: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Baseline (Day 1) up to Week 24; Follow-Up: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA.

Change from baseline over time in HBV DNA levels were reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study agent.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
n=48 Participants
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Change From Baseline Over Time in HBV DNA Levels
0.03 log10 IU/mL
Standard Error 0.032
0.28 log10 IU/mL
Standard Error 0.059
0.36 log10 IU/mL
Standard Error 0.145

SECONDARY outcome

Timeframe: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Data for this endpoint was planned to be collected and analyzed in a single arm.

Time to first occurrence of HBsAg seroclearance were reported in median time. Time to first occurrence of the HBsAg seroclearance was defined as the number of days between the date of first study intervention intake and the date of first occurrence of the HBsAg seroclearance.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Time to First Occurrence of HBsAg Seroclearance
NA weeks
NA indicates that median \[range\] data were not estimable as at least 50% participants did not reach HBsAg seroclearance.

SECONDARY outcome

Timeframe: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here "N" (number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed in a single arm.

Time to first occurrence of HBeAg seroclearance were reported in median time. Time to first occurrence of the HBeAg seroclearance is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBeAg seroclearance.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=11 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Time to First Occurrence of HBeAg Seroclearance
14.1 weeks
Interval 4.1 to 72.4

SECONDARY outcome

Timeframe: From Baseline (Day 1) up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Data for this endpoint was planned to be collected and analyzed in a single arm.

Time to first occurrence of HBV DNA \< LLOQ (20 IU/mL) were reported in median time. Time to first occurrence of the HBV DNA \< LLOQ is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBV DNA \< LLOQ.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Time to First Occurrence of HBV DNA < LLOQ
4.1 weeks
Interval 2.9 to 32.3

SECONDARY outcome

Timeframe: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

Percentage of Participants with virologic breakthrough were reported. It was defined as confirmed on-treatment (the time period during which the participant received any of the study treatments) HBV DNA increase by \>1 log10 IU/mL from nadir or confirmed on-treatment HBV DNA level \>200 IU/mL in participants who had HBV DNA level \<LLOQ (20 IU/mL) of the HBV DNA assay. Confirmed means that the criteria were fulfilled at 2 or more consecutive time points or at the last observed time point.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
n=38 Participants
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Percentage of Participants With Virologic Breakthrough
0 percentage of participants
0 percentage of participants
0 percentage of participants

SECONDARY outcome

Timeframe: At Week 48 (24 weeks after completion of all study interventions at Week 24)

Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Data for this outcome measure was planned to be collected and analyzed for Follow-Up Period only as pre-specified in protocol.

Percentage of participants with HBsAg seroclearance at Week 48 (i.e., 24 weeks after completion of all study interventions at Week 24) without re-starting NA treatment were reported. HBsAg seroclearance was defined as \[quantitative\] HBsAg \<LLOQ (0.05 IU/mL).

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Percentage of Participants With HBsAg Seroclearance at Week 48 Without Re-starting NA Treatment
0 percentage of participants

SECONDARY outcome

Timeframe: At Week 48 (24 weeks after completion of all study interventions at Week 24)

Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for Follow-Up Period only as pre specified in protocol.

Percentage of participants with HBV DNA \<LLOQ (20 IU/mL) at Week 48 (that is, 24 weeks after completion of all study interventions at Week 24) without re-starting NA treatment were reported.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=10 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Percentage of Participants With HBV DNA < LLOQ at Week 48 Without Re-starting NA Treatment
30.0 percentage of participants

SECONDARY outcome

Timeframe: Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and "n"(number analyzed) signifies number of participants analyzed at specified categories. No participant was available for the analysis where "n=0".

Percentage of participants with biochemical flares were reported. On-treatment biochemical flare was defined as confirmed ALT and/or AST \>=3\*ULN and \>=3\*nadir, while the participant received any of the study interventions. Off-treatment biochemical flare was defined as confirmed ALT and/or AST =3\*ULN and =3\*nadir, while the participants did not receive any of the study interventions (Off treatment, including NA).

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
n=48 Participants
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Percentage of Participants With Biochemical Flares
On-Treatment
0 percentage of participants
Interval 0.0 to 6.05
4.2 percentage of participants
Interval 0.75 to 12.54
0 percentage of participants
Interval 0.0 to 7.58
Percentage of Participants With Biochemical Flares
Off-Treatment
0 percentage of participants
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for Follow-Up period only as pre-specified in protocol.

Percentage of participants with virologic flares were reported. Virologic flare was defined as confirmed HBV DNA \>peak threshold (lowest peak to qualify as virologic flare was HBV DNA \>200 IU/mL) in participants who were off-treatment. Off-treatment was defined as the time period after stopping all study treatments (including NA) and had HBV DNA \<LLOQ (20 IU/mL) at the last observed time point on all study interventions.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=15 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Percentage of Participants With Virologic Flares
33.3 percentage of participants
90% Confidence Interval 14.17 • Interval 14.17 to 57.74

SECONDARY outcome

Timeframe: Follow-Up Period: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)

Population: FAS included all participants who were enrolled and who received at least 1 dose of study intervention within this ISA. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for Follow-up Period only as pre-specified in protocol.

Number of participants requiring NA re-treatment based on failure in NA treatment completion criteria (HBsAg \<10 IU/mL, and HBeAg-negative, and HBV DNA \< LLOQ (20 IU/mL), and ALT \<3\*ULN) were reported.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=15 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Number of Participants Requiring NA Re-treatment
4 Participants

SECONDARY outcome

Timeframe: Treatment Period 1: Day 1 Week 1; Treatment Period 2: Day 1, Week 12

Population: Pharmacokinetics(PK) analysis set included participants who received at least 1 dose of study intervention and had at least 1 valid blood sample drawn for PK analysis. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for TP1 and TP2 only as specified in protocol.

The maximum observed plasma concentrations (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) were reported.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=5 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=5 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)
JNJ-73763976
1338 nanograms/milliliters (ng/mL)
Standard Deviation 971
928 nanograms/milliliters (ng/mL)
Standard Deviation 692
Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)
JNJ-73763924
271 nanograms/milliliters (ng/mL)
Standard Deviation 197
185 nanograms/milliliters (ng/mL)
Standard Deviation 130

SECONDARY outcome

Timeframe: Treatment Period 1: Day 1 Week 1; Treatment Period 2: Day 1, Week 12

Population: PK Analysis Set included all participants who received at least 1 dose of study intervention and had at least 1 valid blood sample drawn for PK analysis. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for TP 1 and TP 2 as pre-specified in protocol.

Plasma concentration 24 hours (C24h) after administration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) were reported.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=5 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=5 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)
JNJ-73763924
38.7 ng/mL
Standard Deviation 16.2
57.4 ng/mL
Standard Deviation 15.9
Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)
JNJ-73763976
309 ng/mL
Standard Deviation 145
390 ng/mL
Standard Deviation 162

SECONDARY outcome

Timeframe: Treatment Period 1: Day 1, Week 1; Treatment Period 2: Day 1, Week 12

Population: PK analysis set included all participants who received at least 1 dose of study intervention and had at least 1 valid blood sample drawn for PK analysis. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for TP1 and TP2 as pre-specified in protocol.

Time to reach maximum observed plasma concentration (Cmax) (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) were reported.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=5 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=5 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)
JNJ-73763976
5.50 hours
Interval 2.0 to 6.2
6.00 hours
Interval 2.0 to 23.58
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)
JNJ-73763924
2.00 hours
Interval 1.0 to 6.0
4.02 hours
Interval 0.5 to 7.72

SECONDARY outcome

Timeframe: Treatment Period 1: Day 1, Week 1; Treatment Period 2: Day 1, Week 12

Population: PK analysis set: participants who received at least 1 dose of study intervention and had at least 1 valid blood sample drawn for PK analysis. Here "N" (number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for TP1 and TP2 as specified in protocol.

Area under the plasma concentration versus time curve from time 0 to 24 hours (AUC\[0-24\]h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) were reported.

Outcome measures

Outcome measures
Measure
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=5 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=5 Participants
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hour (AUC[0-24]h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)
JNJ-73763976
18635 ng*h/mL
Standard Deviation 10983
13580 ng*h/mL
Standard Deviation 8598
Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hour (AUC[0-24]h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)
JNJ-73763924
3342 ng*h/mL
Standard Deviation 1919
2466 ng*h/mL
Standard Deviation 1432

Adverse Events

TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA

Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths

TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA

Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths

Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)

Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA
n=48 participants at risk
Participants received a single dose of JNJ-73763989 (JNJ-3989) 200 milligrams (mg) as a subcutaneous injection (SC) every 4 weeks (Q4W) along with JNJ-56136379 (JNJ-6379) 250 mg tablet once daily (QD) and nucleos(t)ide analog (NA) treatment (either entecavir\[ETV\] 0.5 mg, tenofovir disoproxil fumarate\[TDF\] 245 mg, or tenofovir alafenamide\[TAF\] 25 mg) QD up to 12 weeks in TP 1. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after protocol amendment 3, received JNJ-3989 + PegIFN-alpha 2a + NA only. Participants were assessed for eligibility criteria for PegIFN-alpha 2a at Week 12. Participants who met the criteria entered TP 2.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 participants at risk
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
n=48 participants at risk
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Hepatobiliary disorders
Cholelithiasis
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
2.1%
1/48 • Number of events 1 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Hepatobiliary disorders
Hepatic Mass
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
2.1%
1/48 • Number of events 1 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Infections and infestations
Urinary Tract Infection
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
2.1%
1/48 • Number of events 1 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
2.1%
1/48 • Number of events 1 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Renal and urinary disorders
Hydronephrosis
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
2.1%
1/48 • Number of events 1 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Renal and urinary disorders
Nephrolithiasis
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
2.1%
1/48 • Number of events 1 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Renal and urinary disorders
Ureterolithiasis
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
2.1%
1/48 • Number of events 1 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Reproductive system and breast disorders
Prostatitis
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
2.1%
1/48 • Number of events 1 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.

Other adverse events

Other adverse events
Measure
TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA
n=48 participants at risk
Participants received a single dose of JNJ-73763989 (JNJ-3989) 200 milligrams (mg) as a subcutaneous injection (SC) every 4 weeks (Q4W) along with JNJ-56136379 (JNJ-6379) 250 mg tablet once daily (QD) and nucleos(t)ide analog (NA) treatment (either entecavir\[ETV\] 0.5 mg, tenofovir disoproxil fumarate\[TDF\] 245 mg, or tenofovir alafenamide\[TAF\] 25 mg) QD up to 12 weeks in TP 1. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after protocol amendment 3, received JNJ-3989 + PegIFN-alpha 2a + NA only. Participants were assessed for eligibility criteria for PegIFN-alpha 2a at Week 12. Participants who met the criteria entered TP 2.
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
n=48 participants at risk
Participants who met the eligibility criteria for PegIFN-alpha2a (Participants who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg) QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (QIW) during TP 2. Participants enrolled until Protocol Amendment 3, also received single dose of JNJ-56136379 250 mg orally as part of their study intervention. Participants enrolled after Protocol Amendment 3, received JNJ-73763989 + PegIFN alpha 2a + NA only.
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
n=48 participants at risk
At Week 24, prior to follow-up period, all participants stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Participants who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen \[HBsAg\] \<10 international units/millilitre \[IU/mL\], and hepatitis B e antigen \[HBeAg\]-negative, and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] \<20 IU/mL \<lower limit of quantification \[LLOQ\], and alanine aminotransferase \[ALT\] \<3\*Upper limit of normal \[ULN\]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Participants who did not meet NA completion criteria continued NA treatment during the follow-up period up to follow-up Week 48 (with window period of +/- 4 days that is up to Week 72.4).
Blood and lymphatic system disorders
Leukopenia
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
6.2%
3/48 • Number of events 4 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
8.3%
4/48 • Number of events 6 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
8.3%
4/48 • Number of events 5 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
2.1%
1/48 • Number of events 1 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Gastrointestinal disorders
Diarrhoea
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
6.2%
3/48 • Number of events 3 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
General disorders
Fatigue
6.2%
3/48 • Number of events 3 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
10.4%
5/48 • Number of events 5 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
2.1%
1/48 • Number of events 1 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
General disorders
Influenza Like Illness
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
12.5%
6/48 • Number of events 7 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
General disorders
Injection Site Erythema
2.1%
1/48 • Number of events 1 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
14.6%
7/48 • Number of events 10 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
General disorders
Pyrexia
4.2%
2/48 • Number of events 2 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
31.2%
15/48 • Number of events 18 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
4.2%
2/48 • Number of events 2 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Infections and infestations
Covid-19
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
2.1%
1/48 • Number of events 1 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
27.1%
13/48 • Number of events 13 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Infections and infestations
Nasopharyngitis
2.1%
1/48 • Number of events 1 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
2.1%
1/48 • Number of events 1 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
6.2%
3/48 • Number of events 3 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Infections and infestations
Upper Respiratory Tract Infection
2.1%
1/48 • Number of events 1 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
6.2%
3/48 • Number of events 7 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Investigations
Alanine Aminotransferase Increased
2.1%
1/48 • Number of events 2 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
6.2%
3/48 • Number of events 4 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Investigations
Neutrophil Count Decreased
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
8.3%
4/48 • Number of events 7 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Metabolism and nutrition disorders
Decreased Appetite
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
10.4%
5/48 • Number of events 5 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
8.3%
4/48 • Number of events 4 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Musculoskeletal and connective tissue disorders
Myalgia
4.2%
2/48 • Number of events 2 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
18.8%
9/48 • Number of events 9 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Nervous system disorders
Dizziness
2.1%
1/48 • Number of events 1 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
6.2%
3/48 • Number of events 3 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
0.00%
0/48 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Nervous system disorders
Headache
6.2%
3/48 • Number of events 4 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
8.3%
4/48 • Number of events 4 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
6.2%
3/48 • Number of events 3 • Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to follow-up Week 48 (with window period of +/- 4 days, that is Week 72.4)
Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.

Additional Information

Clinical Registry Group

Janssen Research & Development, LLC

Phone: 844-434-4210

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