Trial Outcomes & Findings for An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants (NCT NCT05275023)

NCT ID: NCT05275023

Last Updated: 2025-04-25

Results Overview

Percentage of participants who achieved HBsAg seroclearance at FU Week 24 were reported. Seroclearance of HBsAg was defined as a (quantitative) HBsAg level less than (\<) lower limit of quantification (LLOQ) (0.05 international unit per milliliters \[IU/mL\]).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

37 participants

Primary outcome timeframe

At FU Week 24

Results posted on

2025-04-25

Participant Flow

Participant milestones

Participant milestones
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + Nucleos(t)Ide Analog (NA)
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 milligrams per kilogram (mg/kg) as intravenous (IV) infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to follow up (FU) Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Intervention Phase: Week 0 to Week 24
STARTED
18
19
Intervention Phase: Week 0 to Week 24
COMPLETED
18
19
Intervention Phase: Week 0 to Week 24
NOT COMPLETED
0
0
FU Phase: FU Week 1 to FU Week 48
STARTED
18
19
FU Phase: FU Week 1 to FU Week 48
COMPLETED
18
19
FU Phase: FU Week 1 to FU Week 48
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
n=18 Participants
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=19 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Total
n=37 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
18 Participants
n=5 Participants
19 Participants
n=7 Participants
37 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
4 Participants
n=7 Participants
7 Participants
n=5 Participants
Sex: Female, Male
Male
15 Participants
n=5 Participants
15 Participants
n=7 Participants
30 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
5 Participants
n=7 Participants
5 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
18 Participants
n=5 Participants
14 Participants
n=7 Participants
32 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
7 Participants
n=5 Participants
7 Participants
n=7 Participants
14 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
White
11 Participants
n=5 Participants
11 Participants
n=7 Participants
22 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
CANADA
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Region of Enrollment
FRANCE
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
Region of Enrollment
ITALY
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Region of Enrollment
SPAIN
2 Participants
n=5 Participants
5 Participants
n=7 Participants
7 Participants
n=5 Participants
Region of Enrollment
TAIWAN
3 Participants
n=5 Participants
4 Participants
n=7 Participants
7 Participants
n=5 Participants
Region of Enrollment
TURKEY
6 Participants
n=5 Participants
3 Participants
n=7 Participants
9 Participants
n=5 Participants
Region of Enrollment
UNITED KINGDOM
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
AgeContinuous
40.7 years
STANDARD_DEVIATION 7.75 • n=5 Participants
47.9 years
STANDARD_DEVIATION 5.05 • n=7 Participants
44.4 years
STANDARD_DEVIATION 7.38 • n=5 Participants

PRIMARY outcome

Timeframe: At FU Week 24

Population: Full analysis set (FAS) included all participants who were randomly assigned to an intervention arm in this intervention-specific appendix (ISA) and received at least 1 dose of study intervention within this ISA.

Percentage of participants who achieved HBsAg seroclearance at FU Week 24 were reported. Seroclearance of HBsAg was defined as a (quantitative) HBsAg level less than (\<) lower limit of quantification (LLOQ) (0.05 international unit per milliliters \[IU/mL\]).

Outcome measures

Outcome measures
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
n=18 Participants
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=19 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Percentage of Participants Who Achieved Hepatitis B Surface Antigen (HBsAg) Seroclearance at Follow-up (FU) Week 24
0 Percentage of participants
0 Percentage of participants

SECONDARY outcome

Timeframe: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

Population: Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA.

An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily had a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment emergent. AEs of interest were significant AEs that are judged to be of special interest because of clinical importance, known class effects or based on nonclinical signals.

Outcome measures

Outcome measures
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
n=18 Participants
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=19 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) of Special Interest
IP
11.1 Percentage of participants
5.3 Percentage of participants
Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) of Special Interest
FU Phase
0 Percentage of participants
5.3 Percentage of participants

SECONDARY outcome

Timeframe: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

Population: Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA.

Number of participants with TEAEs by severity were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that did not necessarily had a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment emergent. Severity of AE were graded by using Division of Acquired Immunodeficiency Syndrome (DAIDS) grading scale that ranges from Grade 1 to Grade 5. Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicated a potentially life-threatening event, Grade 5 indicated death.

Outcome measures

Outcome measures
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
n=18 Participants
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=19 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Number of Participants With TEAEs by Severity
IP: Grade 1
5 Participants
7 Participants
Number of Participants With TEAEs by Severity
IP: Grade 2
1 Participants
5 Participants
Number of Participants With TEAEs by Severity
IP: Grade 3
0 Participants
0 Participants
Number of Participants With TEAEs by Severity
IP: Grade 4
0 Participants
0 Participants
Number of Participants With TEAEs by Severity
IP: Grade 5
0 Participants
0 Participants
Number of Participants With TEAEs by Severity
FU Phase: Grade 1
7 Participants
6 Participants
Number of Participants With TEAEs by Severity
FU Phase: Grade 2
1 Participants
2 Participants
Number of Participants With TEAEs by Severity
FU Phase: Grade 3
0 Participants
0 Participants
Number of Participants With TEAEs by Severity
FU Phase: Grade 4
0 Participants
0 Participants
Number of Participants With TEAEs by Severity
FU Phase: Grade 5
0 Participants
0 Participants

SECONDARY outcome

Timeframe: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

Population: Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA.

Number of participants with immune related TEAEs were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that did not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Any AE occurring at or after the initial administration of study intervention was considered to be treatment emergent. Immune-related AEs (irAEs) were alanine aminotransferase/alanine aminotransferase (ALT/AST) elevations including immune-related hepatic AEs, infusion-related reaction (IRRs) and other irAEs (including gastrointestinal AEs, neurological AEs, pulmonary AEs, renal AEs, endocrinopathies, rash, uveitis and visual complaints, lipase/amylase elevations, and infection), hematological abnormalities and injection site reactions.

Outcome measures

Outcome measures
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
n=18 Participants
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=19 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Number of Participants With Immune Related TEAEs
IP
0 Participants
0 Participants
Number of Participants With Immune Related TEAEs
FU Phase
0 Participants
1 Participants

SECONDARY outcome

Timeframe: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

Population: Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA.

Number of participants with abnormalities in vital signs measurements (including pulse rate: abnormally low: less than or equal to \[\<=\] 45 beats per minute \[bpm\], abnormally high: greater than or equal to \[\>=\] 120 bpm; diastolic blood pressure \[BP\]: abnormally low: \<=50 millimeters of mercury \[mmHg\], mild: \>90 to \<100 mmHg, moderate: \>=100 to \<110 mmHg, and severe: \>=110 mmHg; systolic BP: abnormally low: \<=90 mmHg, mild: \>140 to \<160 mmHg, moderate: \>=160 to \<180 mmHg, and severe: \>=180 mmHg) were reported.

Outcome measures

Outcome measures
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
n=18 Participants
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=19 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Number of Participants With Abnormalities in Vital Signs
IP: Pulse: Abnormally Low
0 Participants
0 Participants
Number of Participants With Abnormalities in Vital Signs
IP: Pulse: Abnormally High
0 Participants
0 Participants
Number of Participants With Abnormalities in Vital Signs
IP: Diastolic BP: Abnormally Low
0 Participants
0 Participants
Number of Participants With Abnormalities in Vital Signs
IP: Diastolic BP: Mild
0 Participants
1 Participants
Number of Participants With Abnormalities in Vital Signs
IP: Diastolic BP: Moderate
0 Participants
1 Participants
Number of Participants With Abnormalities in Vital Signs
IP: Diastolic BP: Severe
0 Participants
1 Participants
Number of Participants With Abnormalities in Vital Signs
IP: Systolic BP: Abnormally low
2 Participants
2 Participants
Number of Participants With Abnormalities in Vital Signs
IP: Systolic BP: Mild
2 Participants
1 Participants
Number of Participants With Abnormalities in Vital Signs
IP: Systolic BP: Moderate
0 Participants
1 Participants
Number of Participants With Abnormalities in Vital Signs
IP: Systolic BP: Severe
0 Participants
0 Participants
Number of Participants With Abnormalities in Vital Signs
FU Phase: Pulse: Abnormally low
0 Participants
0 Participants
Number of Participants With Abnormalities in Vital Signs
FU Phase: Pulse: Abnormally high
0 Participants
0 Participants
Number of Participants With Abnormalities in Vital Signs
FU Phase: Diastolic BP: Abnormally low
0 Participants
1 Participants
Number of Participants With Abnormalities in Vital Signs
FU Phase: Diastolic BP: Mild
1 Participants
1 Participants
Number of Participants With Abnormalities in Vital Signs
FU Phase: Diastolic BP: Moderate
0 Participants
1 Participants
Number of Participants With Abnormalities in Vital Signs
FU Phase: Diastolic BP: Severe
0 Participants
0 Participants
Number of Participants With Abnormalities in Vital Signs
FU Phase: Systolic BP: Abnormally low
0 Participants
0 Participants
Number of Participants With Abnormalities in Vital Signs
FU Phase: Systolic BP: Mild
2 Participants
2 Participants
Number of Participants With Abnormalities in Vital Signs
FU Phase: Systolic BP: Moderate
0 Participants
0 Participants
Number of Participants With Abnormalities in Vital Signs
FU Phase: Systolic BP: Severe
0 Participants
0 Participants

SECONDARY outcome

Timeframe: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

Population: Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) refers to number of participants evaluable at specified parameter.

Number of participants with abnormalities in 12-lead ECGs: heart rate (abnormally low: \<45 beats per minute \[bpm\], abnormally high: greater than or equal \[\>=\] 120 bpm), PR interval (abnormally high: greater than \[\>\] 220 millisecond \[msec\]), QRS interval (abnormally high: \>=120 msec), QTc interval Fridericia (Borderline prolonged QT: 450\< QTc \<=480 msec; Prolonged QT: 480 \< QTc \<=500; Pathologically prolonged QT: QTc \>500) were reported.

Outcome measures

Outcome measures
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
n=18 Participants
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=19 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs)
IP: QTc interval: Pathologically prolonged QT
0 Participants
0 Participants
Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs)
FU Phase: Heart rate: Abnormally low
0 Participants
0 Participants
Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs)
FU Phase: Heart rate: Abnormally high
0 Participants
0 Participants
Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs)
FU Phase: PR interval: Abnormally high
0 Participants
0 Participants
Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs)
FU Phase: QRS interval: Abnormally high
0 Participants
0 Participants
Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs)
FU Phase: QTc interval Borderline prolonged QT
0 Participants
1 Participants
Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs)
FU Phase: QTc interval: prolonged QT
0 Participants
0 Participants
Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs)
FU Phase:QTc interval: Pathologically prolonged QT
0 Participants
0 Participants
Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs)
IP: Heart rate: Abnormally low
0 Participants
0 Participants
Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs)
IP: Heart rate: Abnormally high
0 Participants
0 Participants
Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs)
IP: PR interval: Abnormally high
1 Participants
0 Participants
Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs)
IP: QRS interval: Abnormally high
0 Participants
0 Participants
Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs)
IP: QTc interval: Borderline prolonged QT
0 Participants
1 Participants
Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs)
IP: QTc interval: prolonged QT
0 Participants
0 Participants

SECONDARY outcome

Timeframe: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

Population: Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA.

Number of participants with abnormalities in physical examinations were reported.

Outcome measures

Outcome measures
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
n=18 Participants
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=19 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Number of Participants With Abnormalities in Physical Examinations
IP
0 Participants
2 Participants
Number of Participants With Abnormalities in Physical Examinations
FU Phase
2 Participants
1 Participants

SECONDARY outcome

Timeframe: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

Population: Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) refers to number of participants evaluable at specified parameter. n=0 indicates that there was no evaluable participant for specified parameter.

Percentage of participants with abnormalities in hematology parameters (including basophils/Leukocytes high, erythrocytes mean corpuscular volume high, erythrocytes high and low, lymphocytes/leukocytes high and low, monocytes/leukocytes high and low, neutrophils, segmented+band form high and low, reticulocytes/erythrocytes high and low, basophils/leukocytes, eosinophils/leukocytes high, erythrocyte mean corpuscular hemoglobin low, reticulocytes/erythrocytes high and low, lymphocytes atypical/leukocytes high, lymphocytes atypical high, hematocrit high, monocytes low and high) were reported. Abnormalities with at least 1 participant is included. Low and high categorization depend on investigator's discretion.

Outcome measures

Outcome measures
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
n=18 Participants
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=19 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
IP: Basophils/Leukocytes: High
11.1 Percentage of participants
42.1 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
IP: Erythrocytes Mean Corpuscular Volume: High
16.7 Percentage of participants
0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
IP: Erythrocytes: Low
16.7 Percentage of participants
26.3 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
IP: Erythrocytes: High
0 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
IP: Lymphocytes/Leukocytes: Low
0 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
IP: Lymphocytes/Leukocytes: High
11.1 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
IP: Monocytes/Leukocytes: Low
0 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
IP: Monocytes/Leukocytes: High
0 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
IP: Neutrophils, Segmented+Band Form: Low
22.2 Percentage of participants
26.3 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
IP: Neutrophils, Segmented+Band Form: High
11.1 Percentage of participants
10.5 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
IP: Reticulocytes/Erythrocytes: Low
0 Percentage of participants
10.5 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
IP: Reticulocytes/Erythrocytes: High
0 Percentage of participants
10.5 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
FU Phase: Basophils/Leukocytes: High
11.1 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
FU Phase: Eosinophils/Leukocytes: High
0 Percentage of participants
15.8 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
FU Phase: Erythrocyte Mean Corpuscular Hemoglobin: Low
5.6 Percentage of participants
0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
FU Phase: Erythrocyte Mean Corpuscular Volume: High
27.8 Percentage of participants
15.8 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
FU Phase: Erythrocyte: Low
11.1 Percentage of participants
21.1 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
FU Phase: Erythrocyte: High
0 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
FU Phase: Lymphocytes/Leukocytes: Low
11.1 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
FU Phase: Lymphocytes/Leukocytes: High
22.2 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
FU Phase: Monocytes/Leukocytes: Low
0 Percentage of participants
10.5 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
FU Phase: Monocytes/Leukocytes: High
5.6 Percentage of participants
15.8 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
FU Phase: Neutrophils, Segmented + Band Form: Low
38.9 Percentage of participants
31.6 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
FU Phase: Neutrophils, Segmented + Band Form: High
11.1 Percentage of participants
0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
FU Phase: Reticulocytes/Erythrocytes: Low
16.7 Percentage of participants
42.1 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
FU Phase: Reticulocytes/Erythrocytes: High
0 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
FU Phase: Lymphocytes Atypical/Leukocytes: High
100 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
FU Phase: Lymphocytes Atypical: High
100 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
FU Phase: Hematocrit: High
5.6 Percentage of participants
0 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
FU Phase: Monocytes: Low
5.6 Percentage of participants
10.5 Percentage of participants
Percentage of Participants With Abnormalities in Clinical Laboratory Parameters: Hematology
FU Phase: Monocytes: High
5.6 Percentage of participants
0 Percentage of participants

SECONDARY outcome

Timeframe: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

Population: Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoint.

Number of participants with abnormalities in clinical chemistry parameters (including C reactive protein high, cystatin C low and high, gamma glutamyl transferase low, high density lipoprotein \[HDL\] cholesterol low and high, indirect bilirubin high, lactate dehydrogenase high, protein high, thyrotropin low and high, free thyroxine high, free triiodothyronine low and high, and urea nitrogen high) were reported. Abnormalities with at least 1 participant is included. Low and high categorization depend on investigator's discretion.

Outcome measures

Outcome measures
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
n=18 Participants
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=19 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
IP: C Reactive Protein: High
3 Participants
2 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
IP: Cystatin C: Low
2 Participants
1 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
IP: Cystatin C: High
1 Participants
1 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
IP: Gamma Glutamyl Transferase: Low
4 Participants
4 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
IP: HDL Cholesterol: Low
6 Participants
3 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
IP: HDL Cholesterol: High
3 Participants
4 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
IP: Indirect Bilirubin: High
1 Participants
0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
IP: Lactate Dehydrogenase: High
2 Participants
2 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
IP: Protein: High
1 Participants
0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
IP: Thyrotropin: Low
2 Participants
0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
IP: Thyrotropin: High
1 Participants
0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
IP: Free Thyroxine: High
3 Participants
1 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
IP: Triiodothyronine, Free: Low
0 Participants
1 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
IP: Triiodothyronine, Free: High
5 Participants
4 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
IP: Urea Nitrogen: High
1 Participants
2 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
FU Phase: C Reactive Protein: High
2 Participants
0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
FU Phase: Chloride: Low
0 Participants
1 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
FU Phase: Cystatin C: Low
1 Participants
0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
FU Phase: Cystatin C: High
2 Participants
3 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
FU Phase: Gamma Glutamyl Transferase: Low
0 Participants
1 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
FU Phase: HDL Cholesterol: Low
6 Participants
2 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
FU Phase: HDL Cholesterol: High
2 Participants
4 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
FU Phase: Indirect Bilirubin: High
1 Participants
0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
FU Phase: Lactate Dehydrogenase: High
2 Participants
2 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
FU Phase: Protein: High
1 Participants
1 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
FU Phase: Thyrotropin: Low
1 Participants
0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
FU Phase: Thyrotropin: High
1 Participants
1 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
FU Phase: Free Thyroxine: Low
1 Participants
1 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
FU Phase: Free Thyroxine: High
2 Participants
0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
FU Phase: Free Triiodothyronine: High
6 Participants
3 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Clinical Chemistry
FU Phase: Urea Nitrogen: High
1 Participants
1 Participants

SECONDARY outcome

Timeframe: IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

Population: Safety analysis set included all participants who received at least 1 dose of study intervention within this ISA. Here, N (number of participants analyzed) signifies number of participants analyzed for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at each specified category.

Number of participants with abnormalities in clinical laboratory parameters (including specific gravity high and urine hyaline casts high) were reported. Abnormalities with at least 1 participant is included. Low and high categorization depend on investigator's discretion.

Outcome measures

Outcome measures
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
n=9 Participants
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=11 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Urinalysis
IP: Specific Gravity: High
2 Participants
0 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Urinalysis
IP: Urine Hyaline Casts: High
1 Participants
1 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Urinalysis
FU Phase: Specific Gravity: High
1 Participants
1 Participants
Number of Participants With Abnormalities in Clinical Laboratory Parameters: Urinalysis
FU Phase: Urine Hyaline Casts: High
2 Participants
2 Participants

SECONDARY outcome

Timeframe: IP: Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, and End of Study Intervention (EOSI; Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48)

Population: FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints.

Change from baseline in HBsAg levels were reported. International units per milliliters=IU/mL. End of Study Intervention (EOSI) was the last post-baseline visit in study intervention period. End of study (EOS) was the last visit in the study.

Outcome measures

Outcome measures
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
n=18 Participants
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=19 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
IP: Baseline
3.25 log10 IU/mL
Standard Deviation 0.472
3.14 log10 IU/mL
Standard Deviation 0.542
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
IP: Week 1
-0.19 log10 IU/mL
Standard Deviation 0.185
-0.17 log10 IU/mL
Standard Deviation 0.135
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
IP: Week 2
-0.26 log10 IU/mL
Standard Deviation 0.293
-0.31 log10 IU/mL
Standard Deviation 0.330
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
IP: Week 3
-0.34 log10 IU/mL
Standard Deviation 0.335
-0.44 log10 IU/mL
Standard Deviation 0.405
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
IP: Week 4
-0.40 log10 IU/mL
Standard Deviation 0.400
-0.52 log10 IU/mL
Standard Deviation 0.525
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
IP: Week 8
-0.80 log10 IU/mL
Standard Deviation 0.576
-0.87 log10 IU/mL
Standard Deviation 0.695
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
IP: Week 12
-1.32 log10 IU/mL
Standard Deviation 0.513
-1.41 log10 IU/mL
Standard Deviation 0.687
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
IP: Week 16
-1.77 log10 IU/mL
Standard Deviation 0.361
-1.84 log10 IU/mL
Standard Deviation 0.548
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
IP: Week 20
-1.97 log10 IU/mL
Standard Deviation 0.376
-2.07 log10 IU/mL
Standard Deviation 0.549
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
IP: EOSI (Week 24)
-2.01 log10 IU/mL
Standard Deviation 0.385
-2.10 log10 IU/mL
Standard Deviation 0.563
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
FU Phase: Week 4
-1.93 log10 IU/mL
Standard Deviation 0.515
-1.98 log10 IU/mL
Standard Deviation 0.590
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
FU Phase: Week 8
-1.99 log10 IU/mL
Standard Deviation 0.417
-2.12 log10 IU/mL
Standard Deviation 0.613
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
FU Phase: Week 12
-1.93 log10 IU/mL
Standard Deviation 0.393
-1.99 log10 IU/mL
Standard Deviation 0.574
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
FU Phase: Week 16
-1.85 log10 IU/mL
Standard Deviation 0.420
-2.01 log10 IU/mL
Standard Deviation 0.648
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
FU Phase: Week 20
-1.77 log10 IU/mL
Standard Deviation 0.418
-2.02 log10 IU/mL
Standard Deviation 0.584
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
FU Phase: Week 24
-1.70 log10 IU/mL
Standard Deviation 0.507
-1.85 log10 IU/mL
Standard Deviation 0.616
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
FU Phase: Week 32
-1.64 log10 IU/mL
Standard Deviation 0.616
-1.75 log10 IU/mL
Standard Deviation 0.606
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
FU Phase: Week 40
-1.38 log10 IU/mL
Standard Deviation 0.568
-1.69 log10 IU/mL
Standard Deviation 0.904
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
FU Phase: Week 48
-1.23 log10 IU/mL
Standard Deviation 0.527
-1.54 log10 IU/mL
Standard Deviation 0.929
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
FU Phase: EOS
-1.26 log10 IU/mL
Standard Deviation 0.530
-1.54 log10 IU/mL
Standard Deviation 0.929

SECONDARY outcome

Timeframe: IP: Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, and EOSI (Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48)

Population: FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints.

Percentage of participants with change in HBsAg levels below/above different cut-offs (\<0.05 IU/mL, \<1 U/mL, \<10 IU/mL, \<100 IU/mL , \<1000 IU/mL) over time were reported. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study.

Outcome measures

Outcome measures
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
n=18 Participants
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=19 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: EOS: HBsAg <1 IU/mL
0 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Baseline: HBsAg < 0.05 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Baseline: HBsAg <1 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Baseline: HBsAg <10 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Baseline: HBsAg <100 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Baseline: HBsAg <1000 IU/mL
38.9 Percentage of participants
42.1 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 1: HBsAg <0.05 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 1: HBsAg <1 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 1: HBsAg <10 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 1: HBsAg <100 IU/mL
0 Percentage of participants
10.5 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 1: HBsAg <1000 IU/mL
44.4 Percentage of participants
57.9 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 2: HBsAg <0.05 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 2: HBsAg <1 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 2: HBsAg <10 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 2: HBsAg <100 IU/mL
5.6 Percentage of participants
15.8 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 2: HBsAg <1000 IU/mL
38.9 Percentage of participants
63.2 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 3: HBsAg <0.05 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 3: HBsAg <1 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 3: HBsAg <10 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 3: HBsAg <100 IU/mL
11.1 Percentage of participants
15.8 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 3: HBsAg <1000 IU/mL
50.0 Percentage of participants
63.2 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 4: HBsAg <0.05 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 4: HBsAg <1 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 4: HBsAg <10 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 4: HBsAg <100 IU/mL
11.1 Percentage of participants
15.8 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 4: HBsAg <1000 IU/mL
61.1 Percentage of participants
73.7 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 8: HBsAg <0.05 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 8: HBsAg <1 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 8: HBsAg <10 IU/mL
0 Percentage of participants
10.5 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 8: HBsAg <100 IU/mL
27.8 Percentage of participants
42.1 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 8: HBsAg <1000 IU/mL
66.7 Percentage of participants
78.9 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 12: HBsAg <0.05 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 12: HBsAg <1 IU/mL
0 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 12: HBsAg <10 IU/mL
11.1 Percentage of participants
15.8 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 12: HBsAg <100 IU/mL
55.6 Percentage of participants
68.4 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 12: HBsAg <1000 IU/mL
100.0 Percentage of participants
94.7 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 16: HBsAg <0.05 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 16: HBsAg <1 IU/mL
0 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 16: HBsAg <10 IU/mL
16.7 Percentage of participants
21.1 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 16: HBsAg <100 IU/mL
83.3 Percentage of participants
89.5 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 16: HBsAg <1000 IU/mL
100.0 Percentage of participants
100.0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 20: HBsAg <0.05 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 20: HBsAg <1 IU/mL
0 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 20: HBsAg <10 IU/mL
22.2 Percentage of participants
42.1 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 20: HBsAg <100 IU/mL
83.3 Percentage of participants
94.7 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: Week 20: HBsAg <1000 IU/mL
100.0 Percentage of participants
100.0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: EOSI (Week 24): HBsAg <0.05 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: EOSI (Week 24): HBsAg <1 IU/mL
0 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: EOSI (Week 24): HBsAg <10 IU/mL
33.3 Percentage of participants
52.6 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: EOSI (Week 24): HBsAg <100 IU/mL
88.9 Percentage of participants
94.7 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
IP: EOSI (Week 24): HBsAg <1000 IU/mL
100.0 Percentage of participants
100.0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 4: HBsAg <0.05 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 4: HBsAg <1 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 4: HBsAg <10 IU/mL
16.7 Percentage of participants
57.1 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 4: HBsAg <100 IU/mL
83.3 Percentage of participants
85.7 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 4: HBsAg <1000 IU/mL
100.0 Percentage of participants
100.0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 8: HBsAg <0.05 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 8: HBsAg <1 IU/mL
0 Percentage of participants
10.5 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 8: HBsAg <10 IU/mL
33.3 Percentage of participants
52.6 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 8: HBsAg <100 IU/mL
88.9 Percentage of participants
94.7 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 8: HBsAg <1000 IU/mL
100.0 Percentage of participants
100.0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 12: HBsAg <0.05 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 12: HBsAg <1 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 12: HBsAg <10 IU/mL
29.4 Percentage of participants
50.0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 12: HBsAg <100 IU/mL
88.2 Percentage of participants
93.8 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 12: HBsAg <1000 IU/mL
100.0 Percentage of participants
100.0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 16: HBsAg <0.05 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 16: HBsAg <1 IU/mL
0 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 16: HBsAg <10 IU/mL
22.2 Percentage of participants
47.4 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 16: HBsAg <100 IU/mL
83.3 Percentage of participants
94.7 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 16: HBsAg <1000 IU/mL
100.0 Percentage of participants
100.0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 20: HBsAg <0.05 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 20: HBsAg <1 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 20: HBsAg <10 IU/mL
22.2 Percentage of participants
52.9 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 20: HBsAg <100 IU/mL
83.3 Percentage of participants
100.0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 20: HBsAg <1000 IU/mL
94.4 Percentage of participants
100.0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 24: HBsAg <0.05 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 24: HBsAg <1 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 24: HBsAg <10 IU/mL
16.7 Percentage of participants
42.1 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 24: HBsAg <100 IU/mL
72.2 Percentage of participants
84.2 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 24: HBsAg <1000 IU/mL
88.9 Percentage of participants
94.7 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 32: HBsAg <0.05 IU/mL
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 32: HBsAg <1 IU/mL
5.6 Percentage of participants
0 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 32: HBsAg <10 IU/mL
16.7 Percentage of participants
26.3 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 32: HBsAg <100 IU/mL
72.2 Percentage of participants
78.9 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 32: HBsAg <1000 IU/mL
88.9 Percentage of participants
94.7 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 40: HBsAg <0.05 IU/mL
0 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 40: HBsAg <1 IU/mL
0 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 40: HBsAg <10 IU/mL
11.1 Percentage of participants
15.8 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 40: HBsAg <100 IU/mL
66.7 Percentage of participants
78.9 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 40: HBsAg <1000 IU/mL
88.9 Percentage of participants
89.5 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 48: HBsAg <0.05 IU/mL
0 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 48: HBsAg <1 IU/mL
0 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 48: HBsAg <10 IU/mL
11.8 Percentage of participants
15.8 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 48: HBsAg <100 IU/mL
64.7 Percentage of participants
78.9 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: Week 48: HBsAg <1000 IU/mL
82.4 Percentage of participants
89.5 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: EOS: HBsAg <0.05 IU/mL
0 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: EOS: HBsAg <10 IU/mL
11.1 Percentage of participants
15.8 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: EOS: HBsAg <100 IU/mL
66.7 Percentage of participants
78.9 Percentage of participants
Percentage of Participants With Change in HBsAg Levels Below/Above Different Cut-offs Over Time
FU Phase: EOS: HBsAg <1000 IU/mL
83.3 Percentage of participants
89.5 Percentage of participants

SECONDARY outcome

Timeframe: IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48

Population: FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA.

Percentage of participants with HBsAg seroclearance were reported. Seroclearance of HBsAg was defined as a HBsAg level \<lower limit of quantification (LLOQ) (0.05 IU/mL).

Outcome measures

Outcome measures
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
n=18 Participants
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=19 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Percentage of Participants With HBsAg Seroclearance
IP
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With HBsAg Seroclearance
FU Phase
0 Percentage of participants
5.3 Percentage of participants

SECONDARY outcome

Timeframe: IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48

Population: FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'N' (number of participants analyzed) signifies number of participants analyzed for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed for specified categories.

Percentage of participants with HBsAg seroconversion were reported. Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance and appearance of anti-HBs antibodies (baseline anti-HBs antibodies \<LLOQ and a post-baseline assessment \>=LLOQ).

Outcome measures

Outcome measures
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
n=17 Participants
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=19 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Percentage of Participants With HBsAg Seroconversion
IP Phase
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With HBsAg Seroconversion
FU Phase
0 Percentage of participants
5.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 0 up to FU Week 48 (up to Week 72)

Population: FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. N=0 signifies that data could not be collected and analyzed as no participant had event.

Time to achieve HBsAg seroclearance was reported. Seroclearance of HBsAg was defined as a (quantitative) HBsAg level \<LLOQ (0.05 IU/mL).

Outcome measures

Outcome measures
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=1 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Time to Achieve HBsAg Seroclearance
NA Days
Interval 450.0 to
Here, 'NA' signifies that median and upper limit could not be estimated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Week 0 up to FU Week 48 (up to Week 72)

Population: FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, N=0 signifies that data could not be collected and analyzed as no participant had event.

Time to achieve HBsAg seroconversion were reported. Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance and appearance of anti-HBs antibodies (baseline anti-HBs antibodies \<LLOQ and a post-baseline assessment \>=LLOQ).

Outcome measures

Outcome measures
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=1 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Time to Achieve HBsAg Seroconversion
NA Days
Interval 505.0 to
Here, 'NA' signifies that median and upper limit could not be estimated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: IP: Baseline, Weeks 2, 4, 8, 12, 16, 20 and EOSI (Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48)

Population: FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints.

HBV DNA levels over time were reported. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study.

Outcome measures

Outcome measures
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
n=18 Participants
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=19 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time
IP: Baseline
0.83 log10 IU/mL
Standard Deviation 0.220
0.80 log10 IU/mL
Standard Deviation 0.200
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time
IP: Week 2
0.87 log10 IU/mL
Standard Deviation 0.260
0.72 log10 IU/mL
Standard Deviation 0.109
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time
IP: Week 4
0.83 log10 IU/mL
Standard Deviation 0.220
0.85 log10 IU/mL
Standard Deviation 0.228
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time
IP: Week 8
0.88 log10 IU/mL
Standard Deviation 0.239
0.82 log10 IU/mL
Standard Deviation 0.216
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time
IP: Week 12
0.88 log10 IU/mL
Standard Deviation 0.239
0.82 log10 IU/mL
Standard Deviation 0.216
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time
IP: Week 16
0.91 log10 IU/mL
Standard Deviation 0.244
0.82 log10 IU/mL
Standard Deviation 0.216
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time
IP: Week 20
0.86 log10 IU/mL
Standard Deviation 0.231
0.80 log10 IU/mL
Standard Deviation 0.200
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time
IP: EOSI (Week 24)
0.96 log10 IU/mL
Standard Deviation 0.281
0.77 log10 IU/mL
Standard Deviation 0.179
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time
FU Phase: Week 4
0.83 log10 IU/mL
Standard Deviation 0.220
0.90 log10 IU/mL
Standard Deviation 0.288
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time
FU Phase: Week 8
0.83 log10 IU/mL
Standard Deviation 0.220
0.80 log10 IU/mL
Standard Deviation 0.200
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time
FU Phase: Week 12
0.93 log10 IU/mL
Standard Deviation 0.257
0.91 log10 IU/mL
Standard Deviation 0.244
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time
FU Phase: Week 16
0.78 log10 IU/mL
Standard Deviation 0.183
0.85 log10 IU/mL
Standard Deviation 0.228
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time
FU Phase: Week 20
0.86 log10 IU/mL
Standard Deviation 0.231
0.90 log10 IU/mL
Standard Deviation 0.242
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time
FU Phase: Week 24
0.86 log10 IU/mL
Standard Deviation 0.231
0.87 log10 IU/mL
Standard Deviation 0.236
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time
FU Phase: Week 32
0.88 log10 IU/mL
Standard Deviation 0.239
0.75 log10 IU/mL
Standard Deviation 0.150
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time
FU Phase: Week 40
0.91 log10 IU/mL
Standard Deviation 0.244
0.85 log10 IU/mL
Standard Deviation 0.228
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time
FU Phase: Week 48
0.84 log10 IU/mL
Standard Deviation 0.224
0.82 log10 IU/mL
Standard Deviation 0.216
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Over Time
FU Phase: EOS
0.83 log10 IU/mL
Standard Deviation 0.220
0.82 log10 IU/mL
Standard Deviation 0.216

SECONDARY outcome

Timeframe: IP: Baseline, Weeks 2, 4, 8, 12, 16, 20, and EOSI (Week 24); FU Phase: FU Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48)

Population: FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoint.

Percentage of participants with HBV DNA level below/above different cut-offs over time were reported. HBV DNA cut offs: \<LLOQ target detected (TD): that is, traces of HBV DNA were detected/found but were too low to be quantified; \<LLOQ target not detected (TND): that is, no traces of HBV DNA were detected/found. EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study. The LLOQ for HBV DNA was 20 IU/mL. As indicated in the data table, the sum of percentage values of each sub-categories within the specific timepoints "IP: Week 2" and "FU Phase: Week 4", shows a slight deviation from 100% due to rounding.

Outcome measures

Outcome measures
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
n=18 Participants
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=19 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
IP: Week 2: HBV DNA < LLOQ TD
27.8 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
IP: Week 2: HBV DNA > LLOQ
5.6 Percentage of participants
0 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
IP: Baseline: HBV DNA < LLOQ TND
72.2 Percentage of participants
78.9 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
IP: Baseline: HBV DNA < LLOQ TD
27.8 Percentage of participants
21.1 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
IP: Week 2: HBV DNA < LLOQ TND
66.7 Percentage of participants
94.7 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
IP: Week 4: HBV DNA < LLOQ TND
72.2 Percentage of participants
68.4 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
IP: Week 4: HBV DNA < LLOQ TD
27.8 Percentage of participants
31.6 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
IP: Week 8: HBV DNA < LLOQ TND
61.1 Percentage of participants
73.7 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
IP: Week 8: HBV DNA < LLOQ TD
38.9 Percentage of participants
26.3 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
IP: Week 12: HBV DNA < LLOQ TND
61.1 Percentage of participants
73.7 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
IP: Week 12: HBV DNA < LLOQ TD
38.9 Percentage of participants
26.3 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
IP: Week 16: HBV DNA <LLOQ TND
55.6 Percentage of participants
73.7 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
IP: Week 16: HBV DNA <LLOQ TD
44.4 Percentage of participants
26.3 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
IP: Week 20: HBV DNA <LLOQ TND
66.7 Percentage of participants
78.9 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
IP: Week 20: HBV DNA <LLOQ TD
33.3 Percentage of participants
21.1 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
IP: EOSI(Week 24): HBV DNA <LLOQ TND
50.0 Percentage of participants
84.2 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
IP: EOSI(Week 24): HBV DNA <LLOQ TD
38.9 Percentage of participants
15.8 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
IP: EOSI(Week 24): HBV DNA > LLOQ
11.1 Percentage of participants
0 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 4: HBV DNA <LLOQ TND
72.2 Percentage of participants
63.2 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 4: HBV DNA <LLOQ TD
27.8 Percentage of participants
31.6 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 4: HBV DNA > LLOQ
0 Percentage of participants
5.3 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 8: HBV DNA <LLOQ TND
72.2 Percentage of participants
78.9 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 8: HBV DNA <LLOQ TD
27.8 Percentage of participants
21.1 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 12: HBV DNA <LLOQ TND
52.9 Percentage of participants
55.6 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 12: HBV DNA <LLOQ TD
41.2 Percentage of participants
44.4 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 12: HBV DNA > LLOQ
5.9 Percentage of participants
0 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 16: HBV DNA <LLOQ TND
83.3 Percentage of participants
68.4 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 16: HBV DNA <LLOQ TD
16.7 Percentage of participants
31.6 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 20: HBV DNA <LLOQ TND
66.7 Percentage of participants
58.8 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 20: HBV DNA <LLOQ TD
33.3 Percentage of participants
41.2 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 24: HBV DNA <LLOQ TND
66.7 Percentage of participants
63.2 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 24: HBV DNA <LLOQ TD
33.3 Percentage of participants
36.8 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 32: HBV DNA <LLOQ TND
61.1 Percentage of participants
89.5 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 32: HBV DNA <LLOQ TD
38.9 Percentage of participants
10.5 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 40: HBV DNA <LLOQ TND
55.6 Percentage of participants
68.4 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 40: HBV DNA <LLOQ TD
44.4 Percentage of participants
31.6 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 48: HBV DNA <LLOQ TND
70.6 Percentage of participants
73.7 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 48: HBV DNA <LLOQ TD
29.4 Percentage of participants
26.3 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: EOS: HBV DNA <LLOQ TND
72.2 Percentage of participants
73.7 Percentage of participants
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Level Below/Above Different Cut-offs Over Time
FU Phase: EOS: HBV DNA <LLOQ TD
27.8 Percentage of participants
26.3 Percentage of participants

SECONDARY outcome

Timeframe: IP: Baseline, Weeks 2, 4, 8, 12, 20, and EOSI (Week 24); FU Phase: FU Weeks 12, 16, 20, 24, 32, 40, 48, and EOS (last visit at FU Week 48)

Population: FAS included all participants who were randomly assigned to an intervention arm in this ISA and received at least 1 dose of study intervention within this ISA. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoint. Here, n=0 signifies no participant was analyzed at specified timepoint.

Percentage of participants with HBeAg level below/above different cut-offs over time were reported. HBeAg cut-offs: \<LLOQ (0.11 IU/mL). EOSI was the last post-baseline visit in study intervention period. EOS was the last visit in the study.

Outcome measures

Outcome measures
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
n=18 Participants
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=19 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time
IP: Baseline
100.0 Percentage of participants
94.7 Percentage of participants
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time
IP: Week 2
100 Percentage of participants
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time
IP: Week 4
100.0 Percentage of participants
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time
IP: Week 8
100.0 Percentage of participants
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time
IP: Week 12
100.0 Percentage of participants
100.0 Percentage of participants
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time
IP: Week 20
100.0 Percentage of participants
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time
IP: EOSI (Week 24)
100.0 Percentage of participants
100.0 Percentage of participants
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 12
100.0 Percentage of participants
100.0 Percentage of participants
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 16
100.0 Percentage of participants
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 24
100.0 Percentage of participants
100.0 Percentage of participants
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 32
100.0 Percentage of participants
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 40
100.0 Percentage of participants
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time
FU Phase: Week 48
94.1 Percentage of participants
100.0 Percentage of participants
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Level Below/Above Different Cut-offs Over Time
FU Phase: EOS
94.4 Percentage of participants
100.0 Percentage of participants

SECONDARY outcome

Timeframe: IP: Week 0 to Week 24; FU Phase: FU Week 1 up to FU Week 48

Population: FAS included all participants who were randomly assigned to an intervention arm in this intervention-specific appendix (ISA) and received at least 1 dose of study intervention within this ISA.

Percentage of participants with virologic breakthrough (confirmed on-treatment HBV DNA increase by \>1 log10 IU/mL from nadir in participants who did not have on-treatment HBV DNA level below LLOQ or a confirmed on-treatment HBV DNA level \>200 IU/mL in participants who had on-treatment HBV DNA level below LLOQ) were reported.

Outcome measures

Outcome measures
Measure
JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
n=18 Participants
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
JNJ-3989 + Nivolumab (3 Infusions) + NA
n=19 Participants
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24. After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Percentage of Participants With Virologic Breakthrough
IP
0 Percentage of participants
0 Percentage of participants
Percentage of Participants With Virologic Breakthrough
FU Phase
0 Percentage of participants
0 Percentage of participants

Adverse Events

IP: JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

IP: JNJ-3989 + Nivolumab (3 Infusions) + NA

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

FU: JNJ-3989 + Nivolumab (1 Infusion) + NA

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

FU: JNJ-3989 + Nivolumab (3 Infusions) + NA

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
IP: JNJ-73763989 (JNJ-3989) + Nivolumab (1 Infusion) + NA
n=18 participants at risk
In intervention phase (IP), participants received a loading dose of JNJ-3989 200 milligrams (mg) as subcutaneous (SC) injection once weekly (QW) for first 4 weeks starting from Week 0 up to Week 3 followed by single dose once every 4 weeks (Q4W) from Week 4 up to Week 24. At Week 16, participants received a single dose of nivolumab 0.3 mg/kg as intravenous (IV) infusion. Participants also received NA (either tenofovir disoproxil 245 mg or tenofovir alafenamide \[TAF\] 25 mg or entecavir \[ETV\] 0.5 mg) tablet orally once daily (QD) from Week 0 up to Week 24.
IP: JNJ-3989 + Nivolumab (3 Infusions) + NA
n=19 participants at risk
In IP, participants received a loading dose of JNJ-3989 200 mg as SC injection QW for first 4 weeks starting from Week 0 up to Week 3 followed by single dose Q4W from Week 4 up to Week 24. At Weeks 16, 20 and 24, participants received of nivolumab 0.3 mg/kg as IV infusion. Participants also received NA (either tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD from Week 0 up to Week 24.
FU: JNJ-3989 + Nivolumab (1 Infusion) + NA
n=18 participants at risk
After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
FU: JNJ-3989 + Nivolumab (3 Infusions) + NA
n=19 participants at risk
After Week 24, participants were followed up for safety for 48 weeks during which they continued to receive NA (tenofovir disoproxil 245 mg or TAF 25 mg or ETV 0.5 mg) tablet orally QD up to FU Week 48 (up to Week 72).
Blood and lymphatic system disorders
Anaemia
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Cardiac disorders
Palpitations
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Endocrine disorders
Hyperthyroidism
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Eye disorders
Conjunctival Haemorrhage
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Eye disorders
Ocular Hyperaemia
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Gastrointestinal disorders
Abdominal Pain Upper
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Gastrointestinal disorders
Abdominal Tenderness
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Gastrointestinal disorders
Dental Caries
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Gastrointestinal disorders
Diarrhoea
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Gastrointestinal disorders
Dyspepsia
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
10.5%
2/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Gastrointestinal disorders
Gastritis
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Gastrointestinal disorders
Haemorrhoids
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Gastrointestinal disorders
Nausea
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Gastrointestinal disorders
Oesophagitis
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Gastrointestinal disorders
Oral Pain
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Gastrointestinal disorders
Toothache
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Gastrointestinal disorders
Vomiting
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
General disorders
Asthenia
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
General disorders
Chills
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
General disorders
Fatigue
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
General disorders
Injection Site Erythema
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
General disorders
Pyrexia
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Hepatobiliary disorders
Cholelithiasis
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Immune system disorders
Drug Hypersensitivity
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Infections and infestations
Bronchitis
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Infections and infestations
Candida Infection
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Infections and infestations
Conjunctivitis
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Infections and infestations
Covid-19
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
15.8%
3/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Infections and infestations
Influenza
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Infections and infestations
Laryngopharyngitis
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Infections and infestations
Nasopharyngitis
11.1%
2/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Infections and infestations
Oral Herpes
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Infections and infestations
Pharyngitis
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Infections and infestations
Respiratory Tract Infection
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Infections and infestations
Urethritis
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Infections and infestations
Urinary Tract Infection
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Infections and infestations
Viral Infection
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Investigations
Amylase Increased
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Investigations
Lipase Increased
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Metabolism and nutrition disorders
Decreased Appetite
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Metabolism and nutrition disorders
Vitamin D Deficiency
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Musculoskeletal and connective tissue disorders
Muscle Spasms
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Musculoskeletal and connective tissue disorders
Muscular Weakness
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Musculoskeletal and connective tissue disorders
Pain in Extremity
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Musculoskeletal and connective tissue disorders
Periarthritis
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Nervous system disorders
Cervical Radiculopathy
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Nervous system disorders
Headache
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Psychiatric disorders
Anxiety
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Psychiatric disorders
Insomnia
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Renal and urinary disorders
Nephrolithiasis
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Renal and urinary disorders
Pollakiuria
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Renal and urinary disorders
Renal Cyst
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Reproductive system and breast disorders
Cystocele
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Reproductive system and breast disorders
Intermenstrual Bleeding
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Respiratory, thoracic and mediastinal disorders
Cough
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Respiratory, thoracic and mediastinal disorders
Productive Cough
5.6%
1/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
Vascular disorders
Hypertension
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
5.3%
1/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/18 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.
0.00%
0/19 • IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Safety analysis set included all subjects who received at least 1 dose of study intervention within this ISA.

Additional Information

Executive Medical Director

Janssen Research & Development, LLC

Phone: 844-434-4210

Results disclosure agreements

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

Restriction type: OTHER