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.
COMPLETED
PHASE2
48 participants
From Baseline (Day 1) to Week 24
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
| 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
| 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
| 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 24Population: 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
| 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
| 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
| 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
| 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
| 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 28Population: 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
| 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 24Population: 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
| 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 24Population: 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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 12Population: 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
| 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 12Population: 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
| 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 12Population: 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
| 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 12Population: 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
| 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
TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
Follow-Up (FU) Period-nucleos(t)Ide Analog (NA)
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
| 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
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