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 \[IU/mL\]).
COMPLETED
PHASE2
37 participants
At FU Week 24
2025-04-25
Participant Flow
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
| 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 24Population: 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
| 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 48Population: 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
| 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 48Population: 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
| 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 48Population: 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
| 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 48Population: 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
| 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 48Population: 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
| 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 48Population: 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
| 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 48Population: 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
| 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 48Population: 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
| 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 48Population: 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
| 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
| 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
| 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 48Population: 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
| 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 48Population: 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
| 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
| 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
| 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
| 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
| 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
| 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 48Population: 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
| 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
IP: JNJ-3989 + Nivolumab (3 Infusions) + NA
FU: JNJ-3989 + Nivolumab (1 Infusion) + NA
FU: JNJ-3989 + Nivolumab (3 Infusions) + NA
Serious adverse events
Adverse event data not reported
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
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