Hepatitis B, Chronic
Conditions
Brief summary
The purpose of this study is to establish the dose-response relationship for antiviral activity of 3 dose levels of JNJ-73763989+nucleos(t)ide analog (NA) and to evaluate the efficacy of combination regimens of JNJ-73763989+NA (with and without JNJ-56136379) and of JNJ-56136379+NA.
Detailed description
Hepatitis B virus (HBV) is a small deoxyribonucleic acid virus that specifically infects the human liver. The acute phase of infection is either followed by an immune controlled state or progresses to chronic hepatitis B. The worldwide estimated prevalence of chronic HBV infection is about 292 million people affected. Hepatitis B surface antigen (HBsAg) seroclearance is currently considered to be associated with the most thorough suppression of HBV replication (termed functional cure). With current available NA treatment strategies, rate of HBsAg seroclearance remains very low (around 3 percent \[%\]) even under long-term treatment. Also, with the persistently high global prevalence of HBV-associated mortality, there is a medical need for more effective finite treatment options that lead to sustained HBsAg seroclearance. JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic HBV infection via ribonucleic acid interference mechanism. JNJ-56136379 is an orally administered capsid assembly modulator that is being developed for the treatment of chronic HBV infection. The aim of the study is to evaluate efficacy as measured by proportion of participants who completed 48-week study intervention and qualified for stopping NA treatment at Week 48. The study includes: Screening phase (4 weeks), Double-blind study intervention phase (from Day 1 up to Week 48), and Follow-up phase (48 weeks after end of investigational intervention with a maximum duration of 96 weeks). The duration of individual study participation will be between 100 and 150 weeks. Safety and tolerability (including adverse events \[AEs\] and Serious AEs, laboratory assessments, electrocardiogram \[ECG\], vital signs, physical examination), efficacy (including HBsAg seroclearance), and pharmacokinetics will be assessed throughout the study.
Interventions
DRUGJNJ-73763989
JNJ-73763989 will be administered as medium dose (Arms 1 and 3), high dose (Arm 2), and low dose (Arm 4) as subcutaneous injection.
Placebo for JNJ-73763989 will be administered as subcutaneous injection.
DRUGJNJ-56136379
JNJ-56136379 tablets will be administered orally.
Placebo for JNJ-56136379 tablets will be administered orally.
DRUGNucleos(t)ide Analog (NA)
NA treatment that is either of ETV, TDF or TAF tablets will be administered orally.
Sponsors
Janssen Sciences Ireland UC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Medically stable based on physical examination, medical history, vital signs, electrocardiogram (ECG) at screening * Chronic hepatitis B virus (HBV) infection with documentation at least 6 months prior to screening * Hepatitis B surface antigen (HBsAg) greater than (\>) 100 International Units per Milliliter (IU/mL) at screening * Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m\^2), extremes included * Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential * Liver fibrosis stage 0-2 (Metavir) or Fibroscan less than (\<) 9 Kilopascal (kPa) at screening
Exclusion criteria
* Evidence of infection with hepatitis A, C, D or E virus infection or evidence of human immunodeficiency, virus type 1 (HIV-1) or HIV-2 infection at screening * History or evidence of clinical signs/symptoms of hepatic decompensation including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices or any laboratory abnormalities indicating a reduced liver function as defined in the protocol * Evidence of liver disease of non-HBV etiology * Signs of hepatocellular carcinoma (HCC) * Significant laboratory abnormalities as defined in the protocol at screening * Participants with a history of malignancy within 5 years before screening * Abnormal sinus rhythm or ECG parameters at screening as defined in the protocol * History of or current cardiac arrhythmia or history or clinical evidence of significant or unstable cardiac disease * Participants with any current or previous illness for which, in the opinion of the investigator and/or sponsor, participation would not be in the best interest of the participant * History of or current clinically significant skin disease or drug rash * Participants with known allergies, hypersensitivity, or intolerance to JNJ-3989 and JNJ 6379 or their excipients or excipients of the placebo content * Contraindications to the use of entecavir (ETV), tenofovir disoproxil fumarate (TDF), or tenofovir alafenamide (TAF) per local prescribing information * Participants who have taken any therapies disallowed per protocol * Female participants who are pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention * Male participants who plan to father a child while enrolled * Participants who had or planned major surgery, (example, requiring general anesthesia) or who have received an organ transplant * Vulnerable participants (example, incarcerated individuals, individuals under a legal protection measure)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Meeting the Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at Week 48 | Week 48 | Percentage of participants meeting the NA treatment completion criteria at Week 48 were reported. A participant was defined as a responder in meeting the NA treatment completion criteria at Week 48, if the following criteria were met based on the clinical laboratory tests performed at Week 44: participants had alanine transaminase (ALT) less than (\<) 3\*upper limit of normal range (ULN); had hepatitis B virus deoxyribonucleic acid (HBV DNA) \< lower limit of quantification (LLOQ); was hepatitis B e antigen (HBeAg)-negative; had hepatitis B surface antigen (HBsAg) \<10 international units per milliliter (IU/mL). Multiple Imputation using a longitudinal multiple regression model was applied to impute missing data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Follow-up Phase 1: Percentage of Participants With TEAEs | From Week 48 up to Week 96 | An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment. |
| Follow-up Phase 2: Percentage of Participants With TEAEs | From Week 48 up to Week 96 | An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment. |
| Follow-up Phase 3: Percentage of Participants With TEAEs | From Week 48 up to Week 96 | An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment. |
| Extended Follow-up Phase: Percentage of Participants With TEAEs | Extended Follow up Week 1 to extended follow up Week 48 | An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment. |
| Double-blind Phase: Percentage of Participants With Serious Adverse Events (SAEs) | Baseline up to Week 48 | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important. |
| Time to Achieve HBeAg Seroclearance | Baseline (Day 1) up to Week 96 | Time to HBeAg seroclearance (defined as HBeAg level \<LLOQ \[0.11 IU/mL\]) was defined as the number of days between the date of first study treatment intake and the date of the first occurrence of HBeAg seroclearance. |
| Percentage of Participants With HBsAg Levels <100 IU/mL | Baseline, Weeks 12, 24, 48, 60, 72, 96 | Percentage of participants with HBsAg levels \<100 IU/mL was reported. |
| Follow-up Phase 1: Percentage of Participants With SAEs | From Week 48 up to Week 96 | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important. |
| Follow-up Phase 2: Percentage of Participants With SAEs | From Week 48 up to Week 96 | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important. |
| Follow-up Phase 3: Percentage of Participants With SAEs | From Week 48 up to Week 96 | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important. |
| Extended Follow-up Phase: Percentage of Participants With SAEs | Extended Follow up Week 1 to extended follow up Week 48 | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important. |
| Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96 | Percentage of participants with abnormalities in clinical laboratory tests (hematology: Abnormally low \[AL\] and Abnormally high \[AH\] basophils, eosinophils, erthrocytes mean corpuscular hemoglobin concentration, erthrocytes mean corpuscular heamoglobin, erthrocytes mean corpuscular volume, erthrocytes, hematocrit, lymphocytes atypical, metamyelocytes, monocytes, myelocytes, neutrophils, segmented, reticulocytes) were reported. Abnormality was determined at the investigator's discretion. Here, M.C: Mean corpuscular. Participants with abnormally low or high values were reported. |
| Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | Double blind (DB) phase: Baseline up to Week 48, Follow up (FU) phase: Week 48 up to Week 96 | Percentage of participants with abnormalities in clinical laboratory tests (Chemistry: abnormally high and serum alpha fetoprotein, serum chloride, Serum gamma glutamyl tranferase \[GGT\], Serum high density cholesterol \[HDL\] Cholesterol, Indirect Bilirubin, Lactate Dehydrogenase, Serum Protein, Urea Nitrogen) were reported. Abnormality was determined at the investigator's discretion. Participants with abnormally low or high values were reported. |
| Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | Double blind (DB) phase: Baseline up to Week 48, Follow up (FU) phase: Week 48 up to Week 96 | Percentage of participants with abnormalities in clinical laboratory tests(Urinalysis: abnormally high and low urine granular casts, urine hyaline casts, Urine Leukocytes,Urine Specific Gravity,Urine Squamous Epithelial cell, Urine T.E Cells, Urine Transitinoal erythrocyte count \[E.C\],Urine Tubular erthrocyte count ) were reported. Abnormality was determined at the investigator's discretion. Participants with abnormally low or high values were reported. |
| Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96 | Percentage of participants with abnormalities in ECG parameters (heart rate, PR interval, QRS duration, and QTcF interval) were reported. Abnormality criteria: Heart rate abnormally low (AL): \<45 beats per minute (bpm); PR interval AH:\>220 msec; QRS duration AH:\>120 msec; QTcF borderline prolonged (BP) QT: 450 msec to \<=480 msec. Participants with abnormally low or high values were reported. |
| Percentage of Participants With Abnormalities in Vital Signs | Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96 | Percentage of participants with abnormalities in vital signs parameters (pulse rate, diastolic and systolic blood pressure) were reported. Abnormality criteria: Pulse rate AL:\<=45 bpm; Systolic blood pressure (SBP) AL: \<=90 millimeters of mercury (mmHg), mild:\>140 mmHg to \<160 mmHg; moderate:\>=160 mmHg to \<180 mmHg; Diastolic blood pressure (DBP): AL: \<=150 mmHg; mild:\>90 mmHg to \<100 mmHg; moderate: \>=100 mmHg to \<110 mmHg; severe:\>=110 mmHg. Abnormality was determined at the investigator's discretion. Participants with abnormally low or high values were reported. |
| Percentage of Participants With HBsAg Seroclearance 24 Weeks After Completion of All Study Intervention at Week 48 | Week 72 | Percentage of participants with HBsAg seroclearance 24 weeks after completion of all study intervention at Week 48 were reported. HBsAg seroclearance was defined as HBsAg (less than \[\<\] lower limit of quantification LLOQ \[0.05 IU/mL\]). Responder was defined as a participant who achieved functional cure at Week 72. A participant was defined as having achieved functional cure at Week 72 if he/she: had met the criteria for stopping NA treatment at Week 48 and stopped treatment; had HBsAg seroclearance at Week 72 (that is, 24 weeks after stopping all study interventions); did not require NA re-treatment between Weeks 48 and 72. Multiple Imputation using a longitudinal multiple regression model was applied to impute missing data. |
| Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Weeks 12, 24, 48, 60, 72, 96 | Percentage of participants with HBsAg levels \>1 log10 IU/mL reduction from baseline was reported. |
| Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Weeks 12, 24, 48, 60, 72, 96 | Percentage of HBeAg-positive participants with HBeAg levels \<LLOQ were reported. |
| Double-blind Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | Baseline up to Week 48 | An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment. |
| Percentage of Participants With HBV DNA <LLOQ 24 and 48 Weeks After Completion of All Study Intervention at Week 48 | Weeks 72 and 96 | Percentage of participants with HBV DNA \<LLOQ at 24 and 48 weeks after completion of all study intervention at Week 48 were reported. A responder was defined as a participant who achieved HBV DNA \<LLOQ 24 and 48 weeks after stopping all study treatments at any time during the study and without restarting NA treatment thereafter. |
| Percentage of Participants Meeting the NA Treatment Completion Criteria During Follow-up | Week 48 up to Week 96 | Percentage of participants meeting the NA treatment completion criteria during follow-up were reported. A participant was defined as a responder in meeting the NA treatment completion criteria at Week 48, if the following criteria were met based on the clinical laboratory tests performed at Week 44: participants had alanine transaminase (ALT) less than (\<) 3\*upper limit of normal range (ULN); had hepatitis B virus deoxyribonucleic acid (HBV DNA) \< lower limit of quantification (LLOQ); was hepatitis B e antigen (HBeAg)-negative; had hepatitis B surface antigen (HBsAg) \<10 international units per milliliter (IU/mL). A responder was defined as a participant who stopped NA at Week 48 and met the NA treatment completion criteria at any time during the follow-up phase, regardless of the treatment duration. |
| Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96 | Weeks 60, 84, and 96 | Percentage of participants with HBsAg seroclearance after completion of NA treatment at Weeks 60, 84, and 96 were reported. Seroclearance of HBsAg was defined as HBsAg level \<LLOQ (0.05 IU/mL). For Week 60: a responder was defined as a participant who achieved HBsAg seroclearance 12 weeks off treatment if the subject achieved HBsAg seroclearance 12 weeks after stopping; for Week 84:A responder was defined as a participant who achieved HBsAg seroclearance 36 weeks off-treatment if the participant achieved HBsAg seroclearance 36 weeks after stopping all study treatments; for Week 96:A responder was defined as a participant who achieved HBsAg seroclearance at Week 96 if the participant completed 48 weeks of treatment, met the criteria for stopping NA treatment at Week 48, did not require NA re-treatment between Week 48 and Week 96, and had HBsAg seroclearance at Week 96. |
| Percentage of Participants Who Required NA Re-treatment During Follow-up | Week 48 up to Week 96 | Percentage of participants who required NA re-treatment during follow-up were reported. Responder was defined as a participant who met the criteria for NA re-treatment at any time during follow-up, for those participants who met the NA treatment completion criteria at any time during the study and actually stopped NA treatment. NA re-treatment criteria: (1) Re-start NA treatment immediately with signs of decreasing liver function based on laboratory findings (eg, International Normalized Ratio \[INR\], direct bilirubin) or clinical assessment (eg, ascites, hepatic encephalopathy). (2) Immediately with an HBV DNA value of \>100,000 IU/mL (irrespective of confirmation and/or ALT increase). (3) With confirmed post-treatment HBeAg seroreversion (HBeAg positive after it was negative at NA completion) (4) With confirmed\* post-treatment increases in HBV DNA \>2,000 IU/mL and ALT \>5x ULN (5) With confirmed\* post-treatment increases in HBV DNA \>20,000 IU/mL. |
| Percentage of Participants With Flares | Follow-up phase (Week 48 up to Week 96) | Percentage of participants with flares (virologic, biochemical, and clinical) were reported. Virologic flare: confirmed HBV DNA \>peak threshold ( 20,000 IU/mL 2,000 IU/mL and 200 IU/mL); biochemical Flare: confirmed ALT and/or AST increase of 3\*ULN and 3\*nadir; clinical flare: confirmed HBV DNA \>peak threshold and confirmed ALT and/or AST increase of 3\*ULN and 3\*nadir. Virologic and clinical flare was assessed only for those participants who were off-treatment and had HBV DNA\<LLOQ at the last observed time point on all study treatments and biochemical flares was identified on treatment and off treatment, respectively. Each virologic flare was categorized based on the confirmed (i.e., two consecutive values) peak HBV DNA above any of the three thresholds within the start and end date of that flare as follows: 20,000 IU/mL 2,000 IU/mL and 200 IU/mL. A participant was defined as off-treatment failure if he/she required NA re-treatment after stopping all study interventions. |
| Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Weeks 12, 24, 36 and 48 | Number of participants with (sustained) reduction considering multiple markers were reported. HBV DNA results \<LLOQ were reported as: (a) target detected, that is, traces of HBV DNA were detected/found but were too low to be quantified, or (b) target not detected, that is, no traces of HBV DNA were detected/found. LLOQ value for HBV DNA was 20 IU/mL. |
| Percentage of Participants With HBsAg Seroconversion | Weeks 48, 60, 72, and 96 | HBsAg seroconversion was defined as achieving HBsAg seroclearance (HBsAg \[quantitative\] \<LLOQ \[0.05 IU/mL\]) together with an appearance of anti-HBs antibodies (baseline anti-HBs antibodies \[quantitative\] \<LLOQ and a post-baseline assessment greater than or equal to \[\>=\] LLOQ). |
| Percentage of Participants With HBeAg Seroconversion | Weeks 48, 60, 72, and 96 | HBeAg seroconversion was defined as achieving HBeAg seroclearance (HBeAg \[quantitative\] \<LLOQ) together with an appearance of anti-HBe antibodies (baseline anti-HBe antibodies \[qualitative\] with a negative result and a post-baseline assessment with positive result. |
| Change From Baseline in HBsAg Levels | Baseline, Weeks 12, 24, 48, 60, 72, 96 | Change from baseline in HBsAg levels was reported. |
| Change From Baseline in HBeAg Levels | Baseline, Weeks 12, 24, 48, 60, 72, 96 | Change from baseline in HBeAg levels was reported. |
| Change From Baseline in HBV DNA Levels | Baseline, Weeks 12, 24, 48, 60, 72, 96 | Change from baseline in HBV DNA levels were reported. |
| Time to Achieve HBsAg Seroclearance | Baseline (Day 1) up to Week 96 | Time to HBsAg seroclearance (defined as HBsAg level \<LLOQ \[0.05 IU/mL\]) was defined as the number of days between the date of first study treatment intake and the date of the first occurrence of HBsAg seroclearance. |
| Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Weeks 12, 24, 48, 60, 72, 96 | Percentage of HBeAg-positive partcipants with HBeAg levels \>1 log10 IU/mL were reported. |
| Percentage of Participants With HBV DNA Levels <LLOQ | Baseline, Weeks 12, 24, 48, 60, 72, 96 | Percentage of participants with HBV DNA levels \<LLOQ (20 IU/mL) were reported. |
| Mean Change From Baseline in ALT at EOT (Week 48) in Participants With Elevated ALT at Baseline | Baseline and Week 48 | Mean change from baseline in ALT at EOT (Week 48) in participants with elevated ALT at baseline were reported. |
| Percentage of Participants With ALT Normalization | Baseline, Weeks 12, 24, 48, 60, 72, 96 | Percentage of participants with ALT normalization was reported. A participant with ALT elevation at baseline was considered to achieve ALT normalization if his/her ALT value was \<ULN at any given postbaseline analysis time point. A participant was defined as on treatment failure if he/she never met the criteria for stopping NA treatment during the study. A participant was defined as off-treatment failure if he/she required NA re-treatment after stopping all study interventions. |
| Percentage of Participants With Virologic Breakthrough | Baseline (Day 1) up to Week 48 | Virologic breakthrough was defined as having a confirmed on-treatment HBV DNA increase by \>1 log10 from nadir (that is, lowest value during treatment) or a confirmed HBV DNA level \>200 IU/mL in participants who had on-treatment HBV DNA level below the LLOQ (20 IU/mL). On-treatment was defined as the time period in which the participant received any of the study intervention. |
| Percentage of Participants With Undetectable HBV DNA Levels After Re-start of NA Treatment During Follow-up | Week 48 up to Week 96 | Percentage of participants with undetectable HBV DNA levels after re-start of NA treatment during follow-up was reported. |
| Percentage of Participants With HBsAg Seroclearance 48 Weeks After Completion of All Study Intervention at Week 48 | Week 96 | Percentage of participants with HBsAg seroclearance 48 weeks after completion of all study intervention at Week 48 were reported. HBsAg Seroclearance was defined as HBsAg \<LLOQ (0.05 IU/mL). A responder was defined as a participant who achieved HBsAg seroclearance at Week 96 if the participant completed 48 weeks of treatment, met the criteria for stopping NA treatment at Week 48, did not require NA re-treatment between Week 48 and Week 96, and had HBsAg seroclearance at Week 96. Multiple Imputation using a longitudinal multiple regression model was applied to impute missing data. |
Countries
Belgium, Brazil, Canada, China, Czechia, France, Germany, Hong Kong, Italy, Japan, Malaysia, Poland, Russia, South Korea, Spain, Thailand, Turkey (Türkiye), United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Participants Received Participants with chronic hepatitis B (CHB) received JNJ-73763989 100 milligrams (mg) as subcutaneous (SC) injection once every 4 weeks along with JNJ-56136379 250 mg as oral tablet once daily and Nucleos(t)ide Analog (NA) (either entecavir \[ETV\] monohydrate 0.5 mg, tenofovir disoproxil fumarate \[TDF\] 300 mg, or tenofovir alafenamide \[TAF\] 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is alanine aminotransferase (ALT) less than (\<) 3\*upper limit of normal (ULN), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ), hepatitis B e antigen (HBeAg) negative, hepatitis B surface antigen (HBsAg) less than (\<) 10 international unit per milliliter (IU/mL) entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48). | 95 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA Participants with CHB received JNJ-73763989 200 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48). | 96 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA Participants with CHB received JNJ-73763989 100 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double-blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48). | 93 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA Participants with CHB received JNJ-73763989 40 mg as SC injection once every 4 weeks along with placebo matching to JNJ-56136379 tablet orally once daily and NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48). | 93 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and a fixed dose of JNJ-56136379 250 mg oral tablet once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48). | 48 |
| Arm 6: Placebo + Placebo + NA Participants with CHB received placebo matching to JNJ-73763989 as SC injection once every 4 weeks and placebo matching to JNJ-56136379 tablet orally once daily along with NA (either ETV 0.5 mg, TDF 300 mg, or TAF 25 mg) tablet orally once daily up to 48 weeks during double blind phase. Participants who met NA treatment completion criteria at Week 48 that is ALT \<3\*ULN, HBV DNA \< LLOQ, HBeAg negative, HBsAg \<10 IU/mL entered follow up phase 1: participants who did not meet NA treatment completion criteria or did not stop NA, follow up phase 2: participants who Met NA treatment completion criteria at Week 44 and stopped NA at Week 48, follow up phase 3: participants who met NA treatment completion criteria after Week 44 and stopped NA during follow-up and were monitored closely for 48 weeks. Participants who did not meet above criteria at Week 48 continued NA treatment during 48-week follow-up phase. Participants who completed NA treatment during the follow-up phase entered the extended follow up phase up to 48 weeks (extended follow up Week 1 to extended follow up Week 48). | 45 |
| Total | 470 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 2 | 1 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Randomized and not treated | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 4 | 1 | 7 | 2 | 0 |
Baseline characteristics
| Characteristic | Arm 1: JNJ-73763989 (100 mg) + JNJ-56136379 (250 mg) + NA Participants Received | Arm 2: JNJ-73763989 200 mg + Placebo + NA | Arm 3: JNJ-73763989 100 mg + Placebo + NA | Arm 4: JNJ-73763989 40 mg + Placebo + NA | Arm 5: Placebo + JNJ-56136379 250 mg + NA | Arm 6: Placebo + Placebo + NA | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 42.8 years STANDARD_DEVIATION 10.72 | 42.9 years STANDARD_DEVIATION 10.9 | 43 years STANDARD_DEVIATION 11.3 | 42.2 years STANDARD_DEVIATION 10.92 | 43.9 years STANDARD_DEVIATION 9.8 | 43.8 years STANDARD_DEVIATION 9.99 | 43.0 years STANDARD_DEVIATION 10.71 |
| Age, Customized 85 years and over | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Adolescents (12-17 years) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Adults (18-64 years) | 94 Participants | 95 Participants | 89 Participants | 93 Participants | 46 Participants | 45 Participants | 462 Participants |
| Age, Customized Children (2-11 years) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized From 65 to 84 years | 1 Participants | 1 Participants | 4 Participants | 0 Participants | 2 Participants | 0 Participants | 8 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 35 Participants | 39 Participants | 39 Participants | 42 Participants | 20 Participants | 15 Participants | 190 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 7 Participants | 5 Participants | 9 Participants | 2 Participants | 1 Participants | 30 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown or not reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 54 Participants | 50 Participants | 48 Participants | 39 Participants | 25 Participants | 28 Participants | 244 Participants |
| Region of Enrollment BELGIUM | 4 Participants | 4 Participants | 3 Participants | 5 Participants | 1 Participants | 2 Participants | 19 Participants |
| Region of Enrollment BRAZIL | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants |
| Region of Enrollment CANADA | 3 Participants | 4 Participants | 6 Participants | 4 Participants | 2 Participants | 1 Participants | 20 Participants |
| Region of Enrollment CHINA | 1 Participants | 0 Participants | 4 Participants | 1 Participants | 0 Participants | 0 Participants | 6 Participants |
| Region of Enrollment CZECH REPUBLIC | 9 Participants | 8 Participants | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 27 Participants |
| Region of Enrollment FRANCE | 4 Participants | 7 Participants | 3 Participants | 4 Participants | 4 Participants | 0 Participants | 22 Participants |
| Region of Enrollment GERMANY | 6 Participants | 5 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 16 Participants |
| Region of Enrollment Hong Kong, S.A.R., China | 3 Participants | 2 Participants | 4 Participants | 0 Participants | 0 Participants | 2 Participants | 11 Participants |
| Region of Enrollment ITALY | 6 Participants | 7 Participants | 4 Participants | 5 Participants | 3 Participants | 5 Participants | 30 Participants |
| Region of Enrollment JAPAN | 10 Participants | 12 Participants | 13 Participants | 18 Participants | 6 Participants | 2 Participants | 61 Participants |
| Region of Enrollment MALAYSIA | 2 Participants | 5 Participants | 2 Participants | 3 Participants | 3 Participants | 3 Participants | 18 Participants |
| Region of Enrollment POLAND | 8 Participants | 8 Participants | 8 Participants | 6 Participants | 2 Participants | 5 Participants | 37 Participants |
| Region of Enrollment RUSSIAN FEDERATION | 12 Participants | 8 Participants | 13 Participants | 13 Participants | 11 Participants | 5 Participants | 62 Participants |
| Region of Enrollment SOUTH KOREA | 2 Participants | 2 Participants | 0 Participants | 3 Participants | 1 Participants | 2 Participants | 10 Participants |
| Region of Enrollment SPAIN | 5 Participants | 1 Participants | 5 Participants | 8 Participants | 0 Participants | 3 Participants | 22 Participants |
| Region of Enrollment THAILAND | 6 Participants | 5 Participants | 5 Participants | 4 Participants | 2 Participants | 1 Participants | 23 Participants |
| Region of Enrollment TURKEY | 11 Participants | 10 Participants | 12 Participants | 6 Participants | 3 Participants | 7 Participants | 49 Participants |
| Region of Enrollment UNITED KINGDOM | 1 Participants | 3 Participants | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 12 Participants |
| Region of Enrollment UNITED STATES | 1 Participants | 3 Participants | 6 Participants | 5 Participants | 3 Participants | 3 Participants | 21 Participants |
| Sex: Female, Male Female | 24 Participants | 35 Participants | 38 Participants | 32 Participants | 11 Participants | 20 Participants | 160 Participants |
| Sex: Female, Male Male | 71 Participants | 61 Participants | 55 Participants | 61 Participants | 37 Participants | 25 Participants | 310 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk | EG027 affected / at risk | EG028 affected / at risk | EG029 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 95 | 0 / 96 | 0 / 93 | 0 / 93 | 0 / 48 | 0 / 45 | 0 / 81 | 0 / 70 | 0 / 71 | 0 / 85 | 0 / 47 | 0 / 44 | 0 / 8 | 0 / 17 | 0 / 15 | 0 / 5 | 0 / 0 | 0 / 1 | 0 / 3 | 0 / 8 | 0 / 5 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 3 | 0 / 7 | 0 / 5 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 66 / 95 | 59 / 96 | 59 / 93 | 60 / 93 | 41 / 48 | 30 / 45 | 28 / 81 | 28 / 70 | 35 / 71 | 32 / 85 | 26 / 47 | 14 / 44 | 3 / 8 | 5 / 17 | 9 / 15 | 3 / 5 | 0 / 0 | 0 / 1 | 1 / 3 | 3 / 8 | 1 / 5 | 0 / 0 | 0 / 0 | 0 / 0 | 2 / 3 | 5 / 7 | 5 / 5 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 2 / 95 | 3 / 96 | 2 / 93 | 1 / 93 | 2 / 48 | 0 / 45 | 1 / 81 | 5 / 70 | 3 / 71 | 1 / 85 | 1 / 47 | 0 / 44 | 1 / 8 | 0 / 17 | 0 / 15 | 0 / 5 | 0 / 0 | 0 / 1 | 1 / 3 | 0 / 8 | 0 / 5 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 3 | 1 / 7 | 2 / 5 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Percentage of Participants Meeting the Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at Week 48
Percentage of participants meeting the NA treatment completion criteria at Week 48 were reported. A participant was defined as a responder in meeting the NA treatment completion criteria at Week 48, if the following criteria were met based on the clinical laboratory tests performed at Week 44: participants had alanine transaminase (ALT) less than (\<) 3\*upper limit of normal range (ULN); had hepatitis B virus deoxyribonucleic acid (HBV DNA) \< lower limit of quantification (LLOQ); was hepatitis B e antigen (HBeAg)-negative; had hepatitis B surface antigen (HBsAg) \<10 international units per milliliter (IU/mL). Multiple Imputation using a longitudinal multiple regression model was applied to impute missing data.
Time frame: Week 48
Population: Modified Intent-to-Treat (mITT) set was defined as all participants who were randomized in the study and received at least one dose of study treatment excluding those participants impacted by the COVID-19 pandemic defined as those participants who, because of COVID-19 or similar pandemic-related reasons, withdrew prematurely from the study prior to Week 44, or had no efficacy assessment for the primary outcome measure.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants Meeting the Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at Week 48 | 9.4 Percentage of participants | 90% Confidence Interval 4.36 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants Meeting the Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at Week 48 | 19.1 Percentage of participants | 90% Confidence Interval 12.76 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants Meeting the Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at Week 48 | 16.3 Percentage of participants | 90% Confidence Interval 10.33 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants Meeting the Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at Week 48 | 5.5 Percentage of participants | 90% Confidence Interval 2.19 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants Meeting the Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at Week 48 | 0.0 Percentage of participants | 90% Confidence Interval 0 |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants Meeting the Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at Week 48 | 2.2 Percentage of participants | 90% Confidence Interval 0.11 |
p-value: =0.84890% CI: [-5.97, 1.38]Mantel Haenszel
p-value: =0.02790% CI: [1.07, 13.68]Mantel Haenszel
p-value: =0.91790% CI: [4.16, 14.07]Mantel Haenszel
p-value: =0.91790% CI: [-14.67, 1.25]Mantel Haenszel
Secondary
Change From Baseline in HBeAg Levels
Change from baseline in HBeAg levels was reported.
Time frame: Baseline, Weeks 12, 24, 48, 60, 72, 96
Population: mITT analysis set: all HbeAg + participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'n' (number analyzed) represents participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBeAg Levels | Baseline | 1.22 log10 IU/mL | Standard Deviation 1.494 |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBeAg Levels | Week 60 | -1.40 log10 IU/mL | Standard Deviation 1.253 |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBeAg Levels | Week 12 | -0.82 log10 IU/mL | Standard Deviation 0.746 |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBeAg Levels | Week 96 | -1.55 log10 IU/mL | Standard Deviation 1.334 |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBeAg Levels | Week 24 | -1.00 log10 IU/mL | Standard Deviation 0.88 |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBeAg Levels | Week 72 | -1.50 log10 IU/mL | Standard Deviation 1.276 |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBeAg Levels | Week 48 | -1.43 log10 IU/mL | Standard Deviation 1.194 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Week 12 | -0.90 log10 IU/mL | Standard Deviation 0.629 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Week 48 | -1.50 log10 IU/mL | Standard Deviation 1.142 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Week 24 | -1.17 log10 IU/mL | Standard Deviation 0.832 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Week 60 | -1.61 log10 IU/mL | Standard Deviation 1.168 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Baseline | 1.60 log10 IU/mL | Standard Deviation 1.449 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Week 96 | -1.58 log10 IU/mL | Standard Deviation 1.325 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Week 72 | -1.67 log10 IU/mL | Standard Deviation 1.303 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Week 24 | -1.12 log10 IU/mL | Standard Deviation 0.636 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Week 12 | -0.95 log10 IU/mL | Standard Deviation 0.502 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Baseline | 1.68 log10 IU/mL | Standard Deviation 1.54 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Week 60 | -1.32 log10 IU/mL | Standard Deviation 0.763 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Week 72 | -1.44 log10 IU/mL | Standard Deviation 1 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Week 48 | -1.53 log10 IU/mL | Standard Deviation 0.999 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Week 96 | -1.43 log10 IU/mL | Standard Deviation 1.092 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Week 48 | -0.78 log10 IU/mL | Standard Deviation 0.55 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Baseline | 1.26 log10 IU/mL | Standard Deviation 1.318 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Week 12 | -0.44 log10 IU/mL | Standard Deviation 0.273 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Week 24 | -0.54 log10 IU/mL | Standard Deviation 0.372 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Week 60 | -0.83 log10 IU/mL | Standard Deviation 0.6 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Week 72 | -0.80 log10 IU/mL | Standard Deviation 0.687 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBeAg Levels | Week 96 | -0.84 log10 IU/mL | Standard Deviation 0.71 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBeAg Levels | Week 24 | -0.77 log10 IU/mL | Standard Deviation 0.817 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBeAg Levels | Week 12 | -0.60 log10 IU/mL | Standard Deviation 0.652 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBeAg Levels | Week 96 | -1.21 log10 IU/mL | Standard Deviation 1.104 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBeAg Levels | Baseline | 0.81 log10 IU/mL | Standard Deviation 1.261 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBeAg Levels | Week 72 | -0.95 log10 IU/mL | Standard Deviation 0.891 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBeAg Levels | Week 48 | -0.84 log10 IU/mL | Standard Deviation 0.876 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBeAg Levels | Week 60 | -0.87 log10 IU/mL | Standard Deviation 0.874 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBeAg Levels | Week 96 | -1.07 log10 IU/mL | Standard Deviation 1.357 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBeAg Levels | Week 60 | -1.03 log10 IU/mL | Standard Deviation 1.384 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBeAg Levels | Week 24 | -0.59 log10 IU/mL | Standard Deviation 0.782 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBeAg Levels | Week 12 | -0.32 log10 IU/mL | Standard Deviation 0.425 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBeAg Levels | Week 72 | -0.97 log10 IU/mL | Standard Deviation 1.361 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBeAg Levels | Baseline | 1.03 log10 IU/mL | Standard Deviation 1.435 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBeAg Levels | Week 48 | -0.96 log10 IU/mL | Standard Deviation 1.325 |
Secondary
Change From Baseline in HBsAg Levels
Change from baseline in HBsAg levels was reported.
Time frame: Baseline, Weeks 12, 24, 48, 60, 72, 96
Population: mITT analysis set included all participants who were randomized in the study and received at least one dose of study treatment excluding those participants impacted by the pandemic defined as those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, 'n' (number analyzed) represents number of participants evaluable for the specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBsAg Levels | Baseline | 3.66 Log10 international units per milliliter | Standard Deviation 0.691 |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBsAg Levels | Week 60 | -1.59 Log10 international units per milliliter | Standard Deviation 0.613 |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBsAg Levels | Week 12 | -0.96 Log10 international units per milliliter | Standard Deviation 0.533 |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBsAg Levels | Week 96 | -1.04 Log10 international units per milliliter | Standard Deviation 0.634 |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBsAg Levels | Week 24 | -1.52 Log10 international units per milliliter | Standard Deviation 0.582 |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBsAg Levels | Week 72 | -1.38 Log10 international units per milliliter | Standard Deviation 0.63 |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBsAg Levels | Week 48 | -1.76 Log10 international units per milliliter | Standard Deviation 0.643 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Week 12 | -1.51 Log10 international units per milliliter | Standard Deviation 0.79 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Week 48 | -2.58 Log10 international units per milliliter | Standard Deviation 0.996 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Week 24 | -2.22 Log10 international units per milliliter | Standard Deviation 0.768 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Week 60 | -2.21 Log10 international units per milliliter | Standard Deviation 0.975 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Baseline | 3.83 Log10 international units per milliliter | Standard Deviation 0.721 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Week 96 | -1.39 Log10 international units per milliliter | Standard Deviation 0.895 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Week 72 | -1.85 Log10 international units per milliliter | Standard Deviation 0.927 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Week 24 | -1.84 Log10 international units per milliliter | Standard Deviation 0.612 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Week 12 | -1.24 Log10 international units per milliliter | Standard Deviation 0.646 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Baseline | 3.70 Log10 international units per milliliter | Standard Deviation 0.778 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Week 60 | -1.75 Log10 international units per milliliter | Standard Deviation 0.699 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Week 72 | -1.50 Log10 international units per milliliter | Standard Deviation 0.783 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Week 48 | -2.09 Log10 international units per milliliter | Standard Deviation 0.665 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Week 96 | -1.15 Log10 international units per milliliter | Standard Deviation 0.744 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Week 48 | -1.50 Log10 international units per milliliter | Standard Deviation 0.47 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Baseline | 3.81 Log10 international units per milliliter | Standard Deviation 0.678 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Week 12 | -0.82 Log10 international units per milliliter | Standard Deviation 0.361 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Week 24 | -1.26 Log10 international units per milliliter | Standard Deviation 0.43 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Week 60 | -1.22 Log10 international units per milliliter | Standard Deviation 0.456 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Week 72 | -1.01 Log10 international units per milliliter | Standard Deviation 0.487 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBsAg Levels | Week 96 | -0.74 Log10 international units per milliliter | Standard Deviation 0.497 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBsAg Levels | Week 24 | -0.05 Log10 international units per milliliter | Standard Deviation 0.356 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBsAg Levels | Week 12 | -0.01 Log10 international units per milliliter | Standard Deviation 0.286 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBsAg Levels | Week 96 | -0.14 Log10 international units per milliliter | Standard Deviation 0.36 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBsAg Levels | Baseline | 3.63 Log10 international units per milliliter | Standard Deviation 0.681 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBsAg Levels | Week 72 | -0.15 Log10 international units per milliliter | Standard Deviation 0.366 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBsAg Levels | Week 48 | -0.07 Log10 international units per milliliter | Standard Deviation 0.354 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBsAg Levels | Week 60 | -0.12 Log10 international units per milliliter | Standard Deviation 0.367 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBsAg Levels | Week 96 | -0.25 Log10 international units per milliliter | Standard Deviation 1.031 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBsAg Levels | Week 60 | -0.21 Log10 international units per milliliter | Standard Deviation 0.747 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBsAg Levels | Week 24 | -0.12 Log10 international units per milliliter | Standard Deviation 0.35 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBsAg Levels | Week 12 | -0.07 Log10 international units per milliliter | Standard Deviation 0.244 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBsAg Levels | Week 72 | -0.26 Log10 international units per milliliter | Standard Deviation 1.032 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBsAg Levels | Baseline | 3.83 Log10 international units per milliliter | Standard Deviation 0.714 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBsAg Levels | Week 48 | -0.22 Log10 international units per milliliter | Standard Deviation 0.854 |
Secondary
Change From Baseline in HBV DNA Levels
Change from baseline in HBV DNA levels were reported.
Time frame: Baseline, Weeks 12, 24, 48, 60, 72, 96
Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBV DNA Levels | Baseline | 5.97 log10 IU/mL | Standard Deviation 1.989 |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBV DNA Levels | Week 60 | -4.85 log10 IU/mL | Standard Deviation 1.91 |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBV DNA Levels | Week 12 | -4.13 log10 IU/mL | Standard Deviation 1.267 |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBV DNA Levels | Week 96 | -4.96 log10 IU/mL | Standard Deviation 2.01 |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBV DNA Levels | Week 24 | -4.59 log10 IU/mL | Standard Deviation 1.532 |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBV DNA Levels | Week 72 | -4.97 log10 IU/mL | Standard Deviation 1.912 |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Change From Baseline in HBV DNA Levels | Week 48 | -4.85 log10 IU/mL | Standard Deviation 1.896 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 12 | -3.90 log10 IU/mL | Standard Deviation 1.221 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 48 | -5.28 log10 IU/mL | Standard Deviation 1.663 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 24 | -5.03 log10 IU/mL | Standard Deviation 1.441 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 60 | -5.39 log10 IU/mL | Standard Deviation 1.673 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Baseline | 6.64 log10 IU/mL | Standard Deviation 1.972 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 96 | -5.45 log10 IU/mL | Standard Deviation 1.948 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 72 | -5.40 log10 IU/mL | Standard Deviation 1.849 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 24 | -4.68 log10 IU/mL | Standard Deviation 1.199 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 12 | -3.83 log10 IU/mL | Standard Deviation 1.079 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Baseline | 6.34 log10 IU/mL | Standard Deviation 1.778 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 60 | -5.27 log10 IU/mL | Standard Deviation 1.759 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 72 | -5.25 log10 IU/mL | Standard Deviation 1.727 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 48 | -5.18 log10 IU/mL | Standard Deviation 1.669 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 96 | -5.18 log10 IU/mL | Standard Deviation 2.004 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 48 | -4.86 log10 IU/mL | Standard Deviation 1.605 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Baseline | 6.10 log10 IU/mL | Standard Deviation 1.916 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 12 | -3.72 log10 IU/mL | Standard Deviation 1.008 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 24 | -4.53 log10 IU/mL | Standard Deviation 1.273 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 60 | -4.95 log10 IU/mL | Standard Deviation 1.602 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 72 | -5.04 log10 IU/mL | Standard Deviation 1.606 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 96 | -5.06 log10 IU/mL | Standard Deviation 1.693 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBV DNA Levels | Week 24 | -5.08 log10 IU/mL | Standard Deviation 1.566 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBV DNA Levels | Week 12 | -4.28 log10 IU/mL | Standard Deviation 1.052 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBV DNA Levels | Week 96 | -5.63 log10 IU/mL | Standard Deviation 1.827 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBV DNA Levels | Baseline | 6.48 log10 IU/mL | Standard Deviation 2.008 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBV DNA Levels | Week 72 | -5.49 log10 IU/mL | Standard Deviation 1.845 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBV DNA Levels | Week 48 | -5.71 log10 IU/mL | Standard Deviation 1.578 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Change From Baseline in HBV DNA Levels | Week 60 | -5.40 log10 IU/mL | Standard Deviation 1.808 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 96 | -4.95 log10 IU/mL | Standard Deviation 1.963 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 60 | -4.67 log10 IU/mL | Standard Deviation 2.028 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 24 | -4.34 log10 IU/mL | Standard Deviation 1.457 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 12 | -3.64 log10 IU/mL | Standard Deviation 1.365 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 72 | -4.81 log10 IU/mL | Standard Deviation 1.903 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBV DNA Levels | Baseline | 6.39 log10 IU/mL | Standard Deviation 1.922 |
| Arm 6: Placebo + Placebo + NA | Change From Baseline in HBV DNA Levels | Week 48 | -4.68 log10 IU/mL | Standard Deviation 1.97 |
Secondary
Double-blind Phase: Percentage of Participants With Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important.
Time frame: Baseline up to Week 48
Population: Safety analysis set included all participants who received at least one dose of any of the study treatments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Double-blind Phase: Percentage of Participants With Serious Adverse Events (SAEs) | 2.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Double-blind Phase: Percentage of Participants With Serious Adverse Events (SAEs) | 3.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Double-blind Phase: Percentage of Participants With Serious Adverse Events (SAEs) | 2.2 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Double-blind Phase: Percentage of Participants With Serious Adverse Events (SAEs) | 1.1 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Double-blind Phase: Percentage of Participants With Serious Adverse Events (SAEs) | 4.2 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Double-blind Phase: Percentage of Participants With Serious Adverse Events (SAEs) | 0 Percentage of participants |
Secondary
Double-blind Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment.
Time frame: Baseline up to Week 48
Population: Safety analysis set included all participants who received at least one dose of any of the study treatments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Double-blind Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | 71.6 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Double-blind Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | 64.6 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Double-blind Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | 71.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Double-blind Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | 74.2 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Double-blind Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | 85.4 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Double-blind Phase: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | 66.7 Percentage of participants |
Secondary
Extended Follow-up Phase: Percentage of Participants With SAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important.
Time frame: Extended Follow up Week 1 to extended follow up Week 48
Population: Safety analysis set included all participants who received at least one dose of any of the study treatments. '0' in the number of participants analyzed field signifies that none of the participant from the follow up phase entered the extended follow up phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Extended Follow-up Phase: Percentage of Participants With SAEs | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Extended Follow-up Phase: Percentage of Participants With SAEs | 14.3 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Extended Follow-up Phase: Percentage of Participants With SAEs | 40.0 Percentage of participants |
Secondary
Extended Follow-up Phase: Percentage of Participants With TEAEs
An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment.
Time frame: Extended Follow up Week 1 to extended follow up Week 48
Population: Safety analysis set included all participants who received at least one dose of any of the study treatments. '0' in the number of participants analyzed field signifies that none of the participant from the follow up phase entered the extended follow up phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Extended Follow-up Phase: Percentage of Participants With TEAEs | 66.7 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Extended Follow-up Phase: Percentage of Participants With TEAEs | 71.4 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Extended Follow-up Phase: Percentage of Participants With TEAEs | 100.0 Percentage of participants |
Secondary
Follow-up Phase 1: Percentage of Participants With SAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important.
Time frame: From Week 48 up to Week 96
Population: Safety analysis set included all participants who received at least one dose of any of the study treatments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Follow-up Phase 1: Percentage of Participants With SAEs | 1.2 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Follow-up Phase 1: Percentage of Participants With SAEs | 7.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Follow-up Phase 1: Percentage of Participants With SAEs | 4.2 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Follow-up Phase 1: Percentage of Participants With SAEs | 1.2 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Follow-up Phase 1: Percentage of Participants With SAEs | 2.1 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Follow-up Phase 1: Percentage of Participants With SAEs | 0 Percentage of participants |
Secondary
Follow-up Phase 1: Percentage of Participants With TEAEs
An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment.
Time frame: From Week 48 up to Week 96
Population: Safety analysis set included all participants who received at least one dose of any of the study treatments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Follow-up Phase 1: Percentage of Participants With TEAEs | 48.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Follow-up Phase 1: Percentage of Participants With TEAEs | 45.7 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Follow-up Phase 1: Percentage of Participants With TEAEs | 56.3 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Follow-up Phase 1: Percentage of Participants With TEAEs | 44.7 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Follow-up Phase 1: Percentage of Participants With TEAEs | 55.3 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Follow-up Phase 1: Percentage of Participants With TEAEs | 31.8 Percentage of participants |
Secondary
Follow-up Phase 2: Percentage of Participants With SAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important.
Time frame: From Week 48 up to Week 96
Population: Safety analysis set included all participants who received at least one dose of any of the study treatments. '0' in the number of participants analyzed field signifies that none of the participant from the double-blind phase entered the respective follow up phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Follow-up Phase 2: Percentage of Participants With SAEs | 12.5 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Follow-up Phase 2: Percentage of Participants With SAEs | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Follow-up Phase 2: Percentage of Participants With SAEs | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Follow-up Phase 2: Percentage of Participants With SAEs | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Follow-up Phase 2: Percentage of Participants With SAEs | 0 Percentage of participants |
Secondary
Follow-up Phase 2: Percentage of Participants With TEAEs
An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment.
Time frame: From Week 48 up to Week 96
Population: Safety analysis set included all participants who received at least one dose of any of the study treatments. '0' in the number of participants analyzed field signifies that none of the participant from the double-blind phase entered the respective follow up phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Follow-up Phase 2: Percentage of Participants With TEAEs | 37.5 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Follow-up Phase 2: Percentage of Participants With TEAEs | 29.4 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Follow-up Phase 2: Percentage of Participants With TEAEs | 60.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Follow-up Phase 2: Percentage of Participants With TEAEs | 60.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Follow-up Phase 2: Percentage of Participants With TEAEs | 0 Percentage of participants |
Secondary
Follow-up Phase 3: Percentage of Participants With SAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, and was medically important.
Time frame: From Week 48 up to Week 96
Population: Safety analysis set included all participants who received at least one dose of any of the study treatments. '0' in the number of participants analyzed field signifies that none of the participant from the double-blind phase entered the respective follow up phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Follow-up Phase 3: Percentage of Participants With SAEs | 33.3 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Follow-up Phase 3: Percentage of Participants With SAEs | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Follow-up Phase 3: Percentage of Participants With SAEs | 0 Percentage of participants |
Secondary
Follow-up Phase 3: Percentage of Participants With TEAEs
An AE was any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs were defined as AEs with onset or worsening on or after date of first dose of study treatment.
Time frame: From Week 48 up to Week 96
Population: Safety analysis set included all participants who received at least one dose of any of the study treatments. '0' in the number of participants analyzed field signifies that none of the participant from the double-blind phase entered the respective follow up phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Follow-up Phase 3: Percentage of Participants With TEAEs | 33.3 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Follow-up Phase 3: Percentage of Participants With TEAEs | 37.5 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Follow-up Phase 3: Percentage of Participants With TEAEs | 20.0 Percentage of participants |
Secondary
Mean Change From Baseline in ALT at EOT (Week 48) in Participants With Elevated ALT at Baseline
Mean change from baseline in ALT at EOT (Week 48) in participants with elevated ALT at baseline were reported.
Time frame: Baseline and Week 48
Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'N' (number of participants analyzed) signifies participants with ALT elevation at baseline who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Mean Change From Baseline in ALT at EOT (Week 48) in Participants With Elevated ALT at Baseline | -72.77 Units per liter (U/L) | Standard Deviation 106.851 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Mean Change From Baseline in ALT at EOT (Week 48) in Participants With Elevated ALT at Baseline | -65.47 Units per liter (U/L) | Standard Deviation 110.213 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Mean Change From Baseline in ALT at EOT (Week 48) in Participants With Elevated ALT at Baseline | -37.51 Units per liter (U/L) | Standard Deviation 63.468 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Mean Change From Baseline in ALT at EOT (Week 48) in Participants With Elevated ALT at Baseline | -42.53 Units per liter (U/L) | Standard Deviation 41.767 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Mean Change From Baseline in ALT at EOT (Week 48) in Participants With Elevated ALT at Baseline | -17.68 Units per liter (U/L) | Standard Deviation 272.44 |
| Arm 6: Placebo + Placebo + NA | Mean Change From Baseline in ALT at EOT (Week 48) in Participants With Elevated ALT at Baseline | -49.28 Units per liter (U/L) | Standard Deviation 85.374 |
Secondary
Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker
Number of participants with (sustained) reduction considering multiple markers were reported. HBV DNA results \<LLOQ were reported as: (a) target detected, that is, traces of HBV DNA were detected/found but were too low to be quantified, or (b) target not detected, that is, no traces of HBV DNA were detected/found. LLOQ value for HBV DNA was 20 IU/mL.
Time frame: Weeks 12, 24, 36 and 48
Population: mITT population. Here, 'N' (number of participants analyzed) signifies number of participants with non-missing data for both blood markers at specified time point after stopping all study treatments (including NA), who also met NA treatment completion criteria and at least 24 week off-treatment data available; and 'n' (number analysed) represents number of participants evaluable at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 12: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 6 Participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 36: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 12: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 24: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 24: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 4 Participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 36: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 3 Participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 48: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 48: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 6 Participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 24: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 1 Participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 48: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 7 Participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 48: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 1 Participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 36: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 8 Participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 36: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 2 Participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 12: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 20 Participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 12: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 1 Participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 24: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 13 Participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 12: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 12: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 7 Participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 24: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 48: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 5 Participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 24: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 6 Participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 36: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 36: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 7 Participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 48: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 24: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 24: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 1 Participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 48: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 1 Participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 36: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 12: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 2 Participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 36: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 2 Participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 12: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 48: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 36: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 12: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 12: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 1 Participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 24: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 36: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 1 Participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 48: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 24: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 1 Participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 48: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 1 Participants |
| Arm 6: Placebo + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 24: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 1 Participants |
| Arm 6: Placebo + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 36: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 6: Placebo + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 24: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 6: Placebo + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 36: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 1 Participants |
| Arm 6: Placebo + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 12: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 6: Placebo + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 48: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 6: Placebo + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 48: HBsAg < LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
| Arm 6: Placebo + Placebo + NA | Number of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Marker | Week 12: HBsAg >= LLOQ and HBV DNA < LLOQ for target detected and not detected | 0 Participants |
Secondary
Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL
Percentage of HBeAg-positive partcipants with HBeAg levels \>1 log10 IU/mL were reported.
Time frame: Weeks 12, 24, 48, 60, 72, 96
Population: mITT population. Here, 'N' (number of participants analyzed) signifies HBeAg + participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 60 | 52.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 48 | 50.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 24 | 44.4 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 96 | 53.8 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 72 | 56.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 12 | 33.3 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 24 | 48.3 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 60 | 63.3 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 12 | 33.3 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 72 | 59.3 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 48 | 53.6 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 96 | 59.3 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 12 | 39.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 24 | 60.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 48 | 66.7 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 72 | 65.2 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 60 | 62.5 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 96 | 58.3 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 24 | 10.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 96 | 42.3 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 12 | 3.4 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 48 | 25.9 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 60 | 37.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 72 | 35.7 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 48 | 35.7 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 24 | 30.8 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 12 | 23.1 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 96 | 42.9 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 72 | 40.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 60 | 40.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 96 | 30.8 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 24 | 23.1 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 48 | 30.8 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 60 | 33.3 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 72 | 30.8 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels >1 log10 IU/mL | Week 12 | 10.0 Percentage of participants |
Secondary
Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ
Percentage of HBeAg-positive participants with HBeAg levels \<LLOQ were reported.
Time frame: Weeks 12, 24, 48, 60, 72, 96
Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 72 | 8.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 24 | 7.4 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 96 | 15.4 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 12 | 7.4 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 48 | 19.2 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 60 | 12.0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 72 | 11.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 60 | 11.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 12 | 3.7 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 48 | 7.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 24 | 3.4 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 96 | 14.8 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 24 | 16.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 48 | 20.8 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 72 | 21.7 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 12 | 17.4 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 60 | 16.7 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 96 | 20.8 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 12 | 6.9 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 24 | 6.7 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 48 | 11.1 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 60 | 7.4 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 72 | 10.7 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 96 | 11.5 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 24 | 7.7 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 96 | 21.4 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 12 | 7.7 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 72 | 6.7 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 60 | 6.7 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 48 | 7.1 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 60 | 16.7 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 24 | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 72 | 15.4 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 12 | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 96 | 15.4 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of HBeAg-positive Participants With HBeAg Levels <LLOQ | Week 48 | 15.4 Percentage of participants |
Secondary
Percentage of Participants Meeting the NA Treatment Completion Criteria During Follow-up
Percentage of participants meeting the NA treatment completion criteria during follow-up were reported. A participant was defined as a responder in meeting the NA treatment completion criteria at Week 48, if the following criteria were met based on the clinical laboratory tests performed at Week 44: participants had alanine transaminase (ALT) less than (\<) 3\*upper limit of normal range (ULN); had hepatitis B virus deoxyribonucleic acid (HBV DNA) \< lower limit of quantification (LLOQ); was hepatitis B e antigen (HBeAg)-negative; had hepatitis B surface antigen (HBsAg) \<10 international units per milliliter (IU/mL). A responder was defined as a participant who stopped NA at Week 48 and met the NA treatment completion criteria at any time during the follow-up phase, regardless of the treatment duration.
Time frame: Week 48 up to Week 96
Population: mITT analysis set included all participants who were randomised in the study and received at least one dose of study treatment excluding those participants impacted by the pandemic defined as those subjects who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants Meeting the NA Treatment Completion Criteria During Follow-up | 11.7 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants Meeting the NA Treatment Completion Criteria During Follow-up | 27.7 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants Meeting the NA Treatment Completion Criteria During Follow-up | 16.3 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants Meeting the NA Treatment Completion Criteria During Follow-up | 4.4 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants Meeting the NA Treatment Completion Criteria During Follow-up | 0.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants Meeting the NA Treatment Completion Criteria During Follow-up | 2.2 Percentage of participants |
Secondary
Percentage of Participants Who Required NA Re-treatment During Follow-up
Percentage of participants who required NA re-treatment during follow-up were reported. Responder was defined as a participant who met the criteria for NA re-treatment at any time during follow-up, for those participants who met the NA treatment completion criteria at any time during the study and actually stopped NA treatment. NA re-treatment criteria: (1) Re-start NA treatment immediately with signs of decreasing liver function based on laboratory findings (eg, International Normalized Ratio \[INR\], direct bilirubin) or clinical assessment (eg, ascites, hepatic encephalopathy). (2) Immediately with an HBV DNA value of \>100,000 IU/mL (irrespective of confirmation and/or ALT increase). (3) With confirmed post-treatment HBeAg seroreversion (HBeAg positive after it was negative at NA completion) (4) With confirmed\* post-treatment increases in HBV DNA \>2,000 IU/mL and ALT \>5x ULN (5) With confirmed\* post-treatment increases in HBV DNA \>20,000 IU/mL.
Time frame: Week 48 up to Week 96
Population: mITT analysis set included all participants who were randomised in the study and received at least one dose of study treatment excluding those participant impacted by the pandemic defined as those participant who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants Who Required NA Re-treatment During Follow-up | 1.1 Percentage of participants | 90% Confidence Interval 0.05 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants Who Required NA Re-treatment During Follow-up | 1.1 Percentage of participants | 90% Confidence Interval 0.05 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants Who Required NA Re-treatment During Follow-up | 2.2 Percentage of participants | 90% Confidence Interval 0.39 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants Who Required NA Re-treatment During Follow-up | 0.0 Percentage of participants | 90% Confidence Interval 0 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants Who Required NA Re-treatment During Follow-up | 0.0 Percentage of participants | 90% Confidence Interval 0 |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants Who Required NA Re-treatment During Follow-up | 0.0 Percentage of participants | 90% Confidence Interval 0 |
Secondary
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry)
Percentage of participants with abnormalities in clinical laboratory tests (Chemistry: abnormally high and serum alpha fetoprotein, serum chloride, Serum gamma glutamyl tranferase \[GGT\], Serum high density cholesterol \[HDL\] Cholesterol, Indirect Bilirubin, Lactate Dehydrogenase, Serum Protein, Urea Nitrogen) were reported. Abnormality was determined at the investigator's discretion. Participants with abnormally low or high values were reported.
Time frame: Double blind (DB) phase: Baseline up to Week 48, Follow up (FU) phase: Week 48 up to Week 96
Population: Safety analysis set included all participants who received at least one dose of any of study treatments. Here, 'n' (number analyzed) represents number of participants evaluable at specified categories and N (number of participants analyzed) represents number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Indirect Bilirubin AH | 7.5 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Indirect Bilirubin AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum HDL Cholesterol AH | 50.5 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Urea Nitrogen AH | 6.5 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum HDL Cholesterol AH | 23.4 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum HDL Cholesterol AL | 18.1 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum AlphaFetoprotein AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Urea Nitrogen AL | 6.50 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum AlphaFetoprotein AH | 1.1 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Urea Nitrogen AH | 6.4 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Protein AH | 4.3 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Protein AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Chloride AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Protein AH | 2.2 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Chloride AH | 1.1 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Alpha Fetoprotein AH | 1.1 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Protein AL | 5.4 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Lactate Dehydrogenase AH | 6.5 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum GGT AL | 1.1 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Lactate Dehydrogenase AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum GGT AH | 10.8 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Alpha Fetoprotein AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Lactate Dehydrogenase AH( | 9.7 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Lactate Dehydrogenase AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum GGT AL | 1.1 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Indirect Bilirubin AH | 6.5 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum GGT AH | 4.3 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Urea Nitrogen AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Indirect Bilirubin AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum HDL Cholesterol AL | 6.5 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Indirect Bilirubin AH | 1.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum HDL Cholesterol AL | 18.8 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Urea Nitrogen AH | 4.2 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Indirect Bilirubin AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Chloride AH | 2.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum HDL Cholesterol AH | 12.8 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum GGT AH | 2.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum HDL Cholesterol AH | 15.6 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Lactate Dehydrogenase AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Lactate Dehydrogenase AH | 7.4 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum HDL Cholesterol AL | 20.2 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Indirect Bilirubin AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Indirect Bilirubin AH | 3.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum AlphaFetoprotein AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Urea Nitrogen AH | 4.3 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Urea Nitrogen AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum GGT AL | 3.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Protein AH | 1.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Alpha Fetoprotein AH | 3.3 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum AlphaFetoprotein AH | 2.4 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Lactate Dehydrogenase AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum GGT AL | 3.2 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Protein AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Lactate Dehydrogenase AH( | 11.7 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Alpha Fetoprotein AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Chloride AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Urea Nitrogen AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Protein AH | 3.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum GGT AH | 3.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Protein AL | 3.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum GGT AH | 3.2 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Alpha Fetoprotein AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Alpha Fetoprotein AH | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum AlphaFetoprotein AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum AlphaFetoprotein AH | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Chloride AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Chloride AH | 1.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum GGT AL | 5.4 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum GGT AL | 3.3 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum GGT AH | 6.7 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum HDL Cholesterol AL | 24.7 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum HDL Cholesterol AH | 11.8 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum HDL Cholesterol AL | 15.6 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum HDL Cholesterol AH | 10.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Indirect Bilirubin AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Indirect Bilirubin AH | 4.3 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Indirect Bilirubin AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Indirect Bilirubin AH | 2.2 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Lactate Dehydrogenase AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Lactate Dehydrogenase AH( | 3.2 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Lactate Dehydrogenase AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Lactate Dehydrogenase AH | 7.8 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Protein AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Protein AH | 4.3 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Protein AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Protein AH | 2.2 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Urea Nitrogen AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Urea Nitrogen AH | 3.2 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Urea Nitrogen AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Urea Nitrogen AH | 2.2 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Urea Nitrogen AH | 5.4 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum GGT AL | 8.6 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum HDL Cholesterol AL | 28.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Lactate Dehydrogenase AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Indirect Bilirubin AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum AlphaFetoprotein AH | 1.2 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Protein AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum GGT AL | 9.1 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Urea Nitrogen AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Lactate Dehydrogenase AH | 9.1 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum HDL Cholesterol AH | 8.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Protein AH | 3.2 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Chloride AH | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Chloride AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Indirect Bilirubin AH | 8.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Protein AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum GGT AH | 3.4 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum HDL Cholesterol AH | 6.5 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum HDL Cholesterol AL | 28.4 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Urea Nitrogen AH | 1.1 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Alpha Fetoprotein AH | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Lactate Dehydrogenase AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Indirect Bilirubin AH | 6.5 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Urea Nitrogen AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum GGT AH | 2.2 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum AlphaFetoprotein AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Protein AH | 2.3 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Lactate Dehydrogenase AH( | 8.7 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Indirect Bilirubin AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Alpha Fetoprotein AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Alpha Fetoprotein AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum GGT AH | 4.3 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Indirect Bilirubin AH | 8.3 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Urea Nitrogen AH | 6.3 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Indirect Bilirubin AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum GGT AL | 8.7 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Indirect Bilirubin AH | 6.5 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum GGT AH | 6.3 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Lactate Dehydrogenase AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Lactate Dehydrogenase AH( | 14.6 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum GGT AL | 2.1 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Urea Nitrogen AH | 8.7 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Lactate Dehydrogenase AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Chloride AH | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Lactate Dehydrogenase AH | 13.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Urea Nitrogen AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Protein AL | 2.1 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Chloride AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Protein AH | 7 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum AlphaFetoprotein AH | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Protein AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Protein AH | 2.2 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum AlphaFetoprotein AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Urea Nitrogen AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum HDL Cholesterol AH | 41.7 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum HDL Cholesterol AL | 19.6 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Alpha Fetoprotein AH | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum HDL Cholesterol AH | 19.6 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum HDL Cholesterol AL | 8.3 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Indirect Bilirubin AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Lactate Dehydrogenase AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum AlphaFetoprotein AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Lactate Dehydrogenase AH( | 4.4 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Alpha Fetoprotein AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Urea Nitrogen AH | 6.7 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Protein AH | 2.2 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Indirect Bilirubin AH | 2.2 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum GGT AL | 8.9 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Urea Nitrogen AH | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Lactate Dehydrogenase AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum HDL Cholesterol AH | 2.2 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Urea Nitrogen AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum HDL Cholesterol AH | 8.9 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Indirect Bilirubin AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Alpha Fetoprotein AH | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum GGT AH | 4.4 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Indirect Bilirubin AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Protein AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum HDL Cholesterol AL | 17.8 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Chloride AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Urea Nitrogen AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Lactate Dehydrogenase AH | 6.7 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Indirect Bilirubin AH | 2.2 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum Protein AH | 6.7 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum AlphaFetoprotein AH | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | DB:Serum HDL Cholesterol AL | 37.8 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum GGT AH | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Chloride AH | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum GGT AL | 4.4 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Chemistry) | F-U:Serum Protein AL | 0 Percentage of participants |
Secondary
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology)
Percentage of participants with abnormalities in clinical laboratory tests (hematology: Abnormally low \[AL\] and Abnormally high \[AH\] basophils, eosinophils, erthrocytes mean corpuscular hemoglobin concentration, erthrocytes mean corpuscular heamoglobin, erthrocytes mean corpuscular volume, erthrocytes, hematocrit, lymphocytes atypical, metamyelocytes, monocytes, myelocytes, neutrophils, segmented, reticulocytes) were reported. Abnormality was determined at the investigator's discretion. Here, M.C: Mean corpuscular. Participants with abnormally low or high values were reported.
Time frame: Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96
Population: Safety analysis set included all participants who received at least one dose of any of study treatments. Here, 'n' (number analyzed) represents number of participants evaluable at specified categories. Here 'n=0' signifies no participants were available for analysis at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C Volume AH | 16.3 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C Volume AL | 4.3 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C HGB Conc. AH | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Monocytes AH | 1.1 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Volume AH | 29.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Volume AL | 3.2 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U::Ery. M.C Hemoglobin AH | 4.3 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U::Ery. M.C Hemoglobin AL | 7.5 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C HGB Conc. AL | 13.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Basophils AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Basophils AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Hemoglobin AH | 7.5 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Hemoglobin AL | 3.2 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C HGB Conc. AH | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Neutrophils,Segmented AH | 3.2 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Neutrophils, Segmented AL | 36.6 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Monocytes AL | 10.8 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Metamyelocytes AH | 100.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Metamyelocytes AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:LymphocyteAtypical/Leukocyte AH | 100.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Reticulocytes AL | 34.1 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Myelocytes AH | 100.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:LymphocyteAtypical/Leukocyte AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Eosinophils AH | 3.2 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocyte Atypical/Leukocyte AH | 80.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocyte Atypical/Leukocyte AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Reticulocytes AH | 4.4 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Myelocytes AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Lymphocytes Atypical AH | 100.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Lymphocytes Atypical AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocytes Atypical AH | 80.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocytes Atypical AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Reticulocytes AL | 27.2 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Eosinophils AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U: Hematocrit AH | 1.1 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Hematocrit AL | 6.5 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Eosinophils AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Basophils AH | 1.1 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Reticulocytes AH | 3.3 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Neutrophils,Segmented AL | 30.1 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Hematocrit AH | 1.1 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Hematocrit AL | 7.5 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Erythrocytes AH | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Eosinophils AH | 1.1 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Neutrophils, Segmented AH | 5.4 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Erythrocytes AL | 18.3 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Erythrocytes AH | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Erythrocytes AL | 20.4 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Monocytes AH | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C HGB Conc. AL | 10.8 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Monocytes AL | 4.3 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Basophils AH | 2.2 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Lymphocytes Atypical AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Neutrophils, Segmented AH | 4.3 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Neutrophils,Segmented AL | 23.9 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Eosinophils AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Neutrophils,Segmented AH | 4.3 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Reticulocytes AL | 27.2 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Reticulocytes AH | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Reticulocytes AL | 32.6 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Reticulocytes AH | 4.3 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Eosinophils AH | 1.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Basophils AH | 2.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C HGB Conc. AL | 13.8 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C HGB Conc. AH | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C HGB Conc. AL | 17.4 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C HGB Conc. AH | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Hemoglobin AL | 4.3 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Basophils AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Hemoglobin AH | 1.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U::Ery. M.C Hemoglobin AL | 8.7 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Basophils AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U::Ery. M.C Hemoglobin AH | 1.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Volume AL | 4.3 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Volume AH | 19.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C Volume AL | 6.5 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C Volume AH | 12.0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Erythrocytes AL | 14.9 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Basophils AH | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Erythrocytes AH | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Erythrocytes AL | 13.0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Erythrocytes AH | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Hematocrit AL | 10.6 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Hematocrit AH | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Hematocrit AL | 13.0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Eosinophils AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U: Hematocrit AH | 1.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocytes Atypical AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocytes Atypical AH | 100.0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Lymphocytes Atypical AH | 100.0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocyte Atypical/Leukocyte AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocyte Atypical/Leukocyte AH | 100.0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:LymphocyteAtypical/Leukocyte AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:LymphocyteAtypical/Leukocyte AH | 100.0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Monocytes AL | 12.8 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Eosinophils AH | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Monocytes AH | 2.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Monocytes AL | 7.6 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Monocytes AH | 1.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Neutrophils, Segmented AL | 24.5 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Reticulocytes AH | 4.4 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Volume AH | 15.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Hematocrit AH | 1.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Basophils AH | 1.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:LymphocyteAtypical/Leukocyte AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Reticulocytes AL | 26.4 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C HGB Conc. AL | 26.9 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocyte Atypical/Leukocyte AH | 100.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Hematocrit AL | 10.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C HGB Conc. AL | 24.4 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocyte Atypical/Leukocyte AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Volume AL | 7.5 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Reticulocytes AL | 24.4 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Neutrophils,Segmented AL | 18.9 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U: Hematocrit AH | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Erythrocytes AL | 24.7 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Lymphocytes Atypical AH | 100.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Eosinophils AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Reticulocytes AH | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Neutrophils, Segmented AL | 23.7 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocytes Atypical AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Basophils AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Lymphocytes Atypical AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Hemoglobin AH | 1.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocytes Atypical AH | 100.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Monocytes AH | 1.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U::Ery. M.C Hemoglobin AH | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Eosinophils AH | 1.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Erythrocytes AH | 3.2 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U::Ery. M.C Hemoglobin AL | 6.7 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Neutrophils,Segmented AH | 2.2 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Basophils AH | 1.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Eosinophils AH | 1.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Neutrophils, Segmented AH | 6.5 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Erythrocytes AL | 21.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C Volume AL | 7.8 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Hemoglobin AL | 7.5 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C HGB Conc. AH | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C HGB Conc. AH | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Monocytes AL | 5.4 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Erythrocytes AH | 1.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Basophils AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:LymphocyteAtypical/Leukocyte AH | 100.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Myelocytes AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Myelocytes AH | 100.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Monocytes AL | 7.8 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Hematocrit AL | 14.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Monocytes AH | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Eosinophils AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C Volume AH | 13.3 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Hemoglobin AH | 1.1 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Basophils AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Volume AH | 16.3 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C Volume AL | 6.9 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C HGB Conc. AL | 14.1 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C Volume AH | 13.8 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Monocytes AH | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Erythrocytes AL | 15.2 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Eosinophils AH | 1.1 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Erythrocytes AH | 3.3 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Neutrophils,Segmented AL | 26.4 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Erythrocytes AL | 19.5 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Basophils AH | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Neutrophils, Segmented AL | 25.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Erythrocytes AH | 3.4 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Reticulocytes AH | 1.2 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Hematocrit AL | 8.7 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Basophils AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Monocytes AL | 1.1 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Hematocrit AH | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Reticulocytes AL | 20.9 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Hematocrit AL | 11.5 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Eosinophils AH | 3.3 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U: Hematocrit AH | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocytes Atypical AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Eosinophils AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocytes Atypical AH | 100.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Reticulocytes AH | 2.2 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Monocytes AH | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Eosinophils AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocyte Atypical/Leukocyte AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocyte Atypical/Leukocyte AH | 100.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Reticulocytes AL | 24.7 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Basophils AH | 2.2 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C HGB Conc. AH | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Neutrophils,Segmented AH | 2.3 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Hemoglobin AL | 6.5 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C HGB Conc. AL | 18.4 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Neutrophils, Segmented AH | 6.5 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Volume AL | 6.5 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U::Ery. M.C Hemoglobin AL | 8.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Monocytes AL | 5.4 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U::Ery. M.C Hemoglobin AH | 1.1 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C HGB Conc. AH | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Reticulocytes AL | 41.3 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Eosinophils AH | 14.6 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Monocytes AL | 4.3 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C HGB Conc. AL | 16.7 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocyte Atypical/Leukocyte AH | 100.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Volume AH | 29.2 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Reticulocytes AL | 30.4 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Neutrophils, Segmented AH | 4.2 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Hematocrit AH | 2.1 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:LymphocyteAtypical/Leukocyte AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Hematocrit AL | 10.4 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Basophils AH | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Erythrocytes AH | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:LymphocyteAtypical/Leukocyte AH | 100.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U::Ery. M.C Hemoglobin AL | 2.2 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C HGB Conc. AL | 13.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Neutrophils,Segmented AH | 4.3 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Reticulocytes AH | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Volume AL | 6.3 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C HGB Conc. AH | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Basophils AH | 2.1 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Erythrocytes AL | 27.1 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C HGB Conc. AH | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Erythrocytes AL | 21.7 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Monocytes AL | 4.2 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Hemoglobin AL | 6.3 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Erythrocytes AH | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Basophils AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Neutrophils,Segmented AL | 17.4 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Monocytes AH | 6.3 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Reticulocytes AH | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U::Ery. M.C Hemoglobin AH | 2.2 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocytes Atypical AH | 100.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Eosinophils AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Hemoglobin AH | 6.3 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Neutrophils, Segmented AL | 35.4 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocytes Atypical AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Lymphocytes Atypical AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Eosinophils AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Eosinophils AH | 2.2 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U: Hematocrit AH | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Lymphocytes Atypical AH | 100.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C Volume AH | 19.6 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Monocytes AH | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Hematocrit AL | 13.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C Volume AL | 2.2 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocyte Atypical/Leukocyte AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Basophils AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Reticulocytes AH | 2.3 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Basophils AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Basophils AH | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Basophils AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Basophils AH | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Eosinophils AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Eosinophils AH | 2.2 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Eosinophils AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Eosinophils AH | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C HGB Conc. AH | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C HGB Conc. AL | 22.7 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C HGB Conc. AH | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Hemoglobin AL | 11.1 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Hemoglobin AH | 2.2 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U::Ery. M.C Hemoglobin AL | 6.8 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U::Ery. M.C Hemoglobin AH | 2.3 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Volume AL | 8.9 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C Volume AH | 13.3 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C Volume AL | 4.5 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Ery. M.C Volume AH | 9.1 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Erythrocytes AL | 22.2 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Erythrocytes AH | 2.2 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Erythrocytes AL | 13.6 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Erythrocytes AH | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Hematocrit AL | 13.3 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Hematocrit AH | 2.2 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Hematocrit AL | 11.4 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U: Hematocrit AH | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocytes Atypical AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocytes Atypical AH | 100.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocyte Atypical/Leukocyte AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Lymphocyte Atypical/Leukocyte AH | 100.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Monocytes AL | 8.9 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Monocytes AH | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Monocytes AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Monocytes AH | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Neutrophils, Segmented AL | 33.3 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Neutrophils, Segmented AH | 4.4 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Neutrophils,Segmented AL | 20.5 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Neutrophils,Segmented AH | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Reticulocytes AL | 37.8 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Reticulocytes AH | 2.2 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | F-U:Reticulocytes AL | 13.6 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Hematology) | DB:Ery. M.C HGB Conc. AL | 22.2 Percentage of participants |
Secondary
Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis)
Percentage of participants with abnormalities in clinical laboratory tests(Urinalysis: abnormally high and low urine granular casts, urine hyaline casts, Urine Leukocytes,Urine Specific Gravity,Urine Squamous Epithelial cell, Urine T.E Cells, Urine Transitinoal erythrocyte count \[E.C\],Urine Tubular erthrocyte count ) were reported. Abnormality was determined at the investigator's discretion. Participants with abnormally low or high values were reported.
Time frame: Double blind (DB) phase: Baseline up to Week 48, Follow up (FU) phase: Week 48 up to Week 96
Population: Safety analysis set included all participants who received at least one dose of any of study treatments. Here, 'n' (number analyzed) represents number of participants evaluable at specified categories and N (number of participants analyzed) represents number of participants evaluable for this outcome measure. Here 'n=0' signifies no participants were available for analysis at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Squamous Epithelial cell AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Specific Gravity AH | 1.6 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Hyaline Casts AH | 100.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Specific Gravity AH | 5.9 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Specific Gravity AL | 5.9 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Hyaline Casts AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Hyaline Casts AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Hyaline Casts AH | 100.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Leukocytes AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Leukocytes AH | 8.5 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Squamous Epithelial cellAH | 100.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Leukocytes AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Granular Casts AH | 100.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Leukocytes AH | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Granular Casts AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Specific Gravity AL | 1.6 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Leukocytes AH | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Specific Gravity AH | 11.5 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Leukocytes AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Squamous Epithelial cell AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Specific Gravity AH | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Leukocytes AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Leukocytes AH | 6.3 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Specific Gravity AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Specific Gravity AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Hyaline Casts AH | 60.0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Hyaline Casts AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Squamous Epithelial cellAH | 66.7 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Transitinoal E.C AH | 100.0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine T.E Cells AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine T.E Cells AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Leukocytes AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Squamous Epithelial cellAH | 75.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Leukocytes AH | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Leukocytes AH | 9.5 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Hyaline Casts AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Specific Gravity AH | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Specific Gravity AL | 3.8 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Specific Gravity AH | 1.9 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Leukocytes AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Specific Gravity AL | 5.6 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Hyaline Casts AH | 100.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Transitinoal E.C AH | 100.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Squamous Epithelial cell AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Tubular E.C AH | 100.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Granular Casts AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Granular Casts AH | 100.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Hyaline Casts AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Hyaline Casts AH | 100.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Leukocytes AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Leukocytes AH | 2.6 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Leukocytes AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Leukocytes AH | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Specific Gravity AL | 3.7 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Specific Gravity AH | 5.6 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Specific Gravity AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Specific Gravity AH | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Squamous Epithelial cell AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Squamous Epithelial cellAH | 50.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine T.E Cells AL | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Transitinoal E.C AH | 100.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Tubular E.C AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Specific Gravity AH | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Leukocytes AH | 25.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Leukocytes AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Hyaline Casts AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Squamous Epithelial cell AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Leukocytes AH | 9.5 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Transitinoal E.C AH | 100.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Squamous Epithelial cellAH | 50.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Leukocytes AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine T.E Cells AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Hyaline Casts AH | 100.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | F-U:Urine Specific Gravity AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Specific Gravity AH | 3.4 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Specific Gravity AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Transitinoal E.C AH | 100.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Squamous Epithelial cell AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Leukocytes AH | 9.1 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Specific Gravity AH | 24.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Leukocytes AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine T.E Cells AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Hyaline Casts AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Squamous Epithelial cellAH | 50.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Specific Gravity AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Clinical Laboratory Tests (Urinalysis) | DB:Urine Hyaline Casts AH | 100.0 Percentage of participants |
Secondary
Percentage of Participants With Abnormalities in Electrocardiogram (ECG)
Percentage of participants with abnormalities in ECG parameters (heart rate, PR interval, QRS duration, and QTcF interval) were reported. Abnormality criteria: Heart rate abnormally low (AL): \<45 beats per minute (bpm); PR interval AH:\>220 msec; QRS duration AH:\>120 msec; QTcF borderline prolonged (BP) QT: 450 msec to \<=480 msec. Participants with abnormally low or high values were reported.
Time frame: Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96
Population: Safety analysis set included all participants who received at least one dose of any of the study treatments. Here, 'N' (number of participant analysed) signifies number of participant who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participant evaluable for specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: PR interval AH | 1.1 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: Heart Rate AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: Heart Rate AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: PR interval AH | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: QRS duration AH | 2.2 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: QRS duration AH | 2.2 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: QTcF interval BP-QT | 2.2 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: QTcF interval BP-QT | 1.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: PR interval AH | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: QTcF interval BP-QT | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: Heart Rate AL | 2.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: QTcF interval BP-QT | 2.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: QRS duration AH | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: PR interval AH | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: Heart Rate AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: QRS duration AH | 1.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: Heart Rate AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: PR interval AH | 3.3 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: PR interval AH | 1.2 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: QTcF interval BP-QT | 2.4 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: QRS duration AH | 1.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: QRS duration AH | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: QTcF interval BP-QT | 3.3 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: Heart Rate AL | 1.1 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: QTcF interval BP-QT | 1.1 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: QRS duration AH | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: QRS duration AH | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: Heart Rate AL | 3.3 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: PR interval AH | 1.1 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: PR interval AH | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: QTcF interval BP-QT | 1.2 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: Heart Rate AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: QTcF interval BP-QT | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: Heart Rate AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: QRS duration AH | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: QRS duration AH | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: QTcF interval BP-QT | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: Heart Rate AL | 2.2 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: PR interval AH | 4.3 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: PR interval AH | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: QTcF interval BP-QT | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: QRS duration AH | 2.2 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: PR interval AH | 2.2 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: PR interval AH | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: QRS duration AH | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | FU Phase: Heart Rate AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: QTcF interval BP-QT | 2.2 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Electrocardiogram (ECG) | DB Phase: Heart Rate AL | 0 Percentage of participants |
Secondary
Percentage of Participants With Abnormalities in Vital Signs
Percentage of participants with abnormalities in vital signs parameters (pulse rate, diastolic and systolic blood pressure) were reported. Abnormality criteria: Pulse rate AL:\<=45 bpm; Systolic blood pressure (SBP) AL: \<=90 millimeters of mercury (mmHg), mild:\>140 mmHg to \<160 mmHg; moderate:\>=160 mmHg to \<180 mmHg; Diastolic blood pressure (DBP): AL: \<=150 mmHg; mild:\>90 mmHg to \<100 mmHg; moderate: \>=100 mmHg to \<110 mmHg; severe:\>=110 mmHg. Abnormality was determined at the investigator's discretion. Participants with abnormally low or high values were reported.
Time frame: Double blind (DB) phase: Baseline (Day 1) up to Week 48, Follow up (FU) phase: Week 48 up to Week 96
Population: Safety analysis set included all participants who received at least one dose of any of the study treatments. Here, 'N' (number of subject analysed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represented number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP moderate | 4.3 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | DB:Pulse rate AL | 1.1 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: SBP moderate | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | FU:Pulse rate AH | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: SBP mild | 12.8 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP severe | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | DB:Pulse rate AH | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: DBP moderate | 1.1 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: DBP mild | 10.16 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP AL | 4.3 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: SBP AL | 3.2 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: SBP moderate | 4.3 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | FU:Pulse rate AL | 1.1 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: DBP AL | 1.1 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: SBP AL | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP mild | 20.4 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: SBP mild | 23.7 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP mild | 18.8 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: SBP mild | 12.8 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP moderate | 4.2 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: DBP moderate | 2.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP severe | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: SBP moderate | 3.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: SBP moderate | 2.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU:Pulse rate AL | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: SBP AL | 2.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU:Pulse rate AH | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: SBP mild | 18.8 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: DBP mild | 10.16 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP AL | 1.0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: SBP AL | 6.3 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: DBP AL | 1.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB:Pulse rate AL | 4.2 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB:Pulse rate AH | 2.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP mild | 12.9 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB:Pulse rate AH | 1.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: SBP mild | 12.9 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: SBP moderate | 4.3 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU:Pulse rate AL | 1.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU:Pulse rate AH | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP AL | 4.3 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: SBP mild | 11.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: SBP AL | 2.2 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB:Pulse rate AL | 2.2 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP moderate | 3.2 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP severe | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: DBP AL | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: SBP moderate | 2.2 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: SBP AL | 1.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: DBP mild | 4.4 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: DBP moderate | 4.4 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP AL | 4.3 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: SBP AL | 6.5 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: DBP AL | 1.1 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: DBP moderate | 1.1 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: SBP moderate | 2.1 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: SBP mild | 10.2 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB:Pulse rate AH | 2.2 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: SBP mild | 22.6 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: DBP mild | 12.5 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU:Pulse rate AH | 1.1 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU:Pulse rate AL | 2.3 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB:Pulse rate AL | 2.2 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: SBP moderate | 2.2 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP severe | 1.1 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP moderate | 3.2 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: SBP AL | 4.5 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP mild | 14.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | FU:Pulse rate AH | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | DB:Pulse rate AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | DB:Pulse rate AH | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | FU:Pulse rate AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP mild | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP moderate | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP severe | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: DBP AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: DBP mild | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: DBP moderate | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: SBP AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: SBP mild | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: SBP moderate | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: SBP AL | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: SBP mild | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: SBP moderate | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: DBP mild | 8.9 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: DBP AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP severe | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: DBP moderate | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: SBP AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP moderate | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP mild | 6.7 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: DBP AL | 2.2 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU:Pulse rate AH | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: SBP moderate | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU: SBP mild | 4.4 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | FU:Pulse rate AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB:Pulse rate AH | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: SBP mild | 17.8 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB:Pulse rate AL | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: SBP moderate | 2.2 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Abnormalities in Vital Signs | DB: SBP AL | 4.4 Percentage of participants |
Secondary
Percentage of Participants With ALT Normalization
Percentage of participants with ALT normalization was reported. A participant with ALT elevation at baseline was considered to achieve ALT normalization if his/her ALT value was \<ULN at any given postbaseline analysis time point. A participant was defined as on treatment failure if he/she never met the criteria for stopping NA treatment during the study. A participant was defined as off-treatment failure if he/she required NA re-treatment after stopping all study interventions.
Time frame: Baseline, Weeks 12, 24, 48, 60, 72, 96
Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With ALT Normalization | Week 12 On-treatment | 54.3 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With ALT Normalization | Week 72 On-treatment | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With ALT Normalization | Week 24 On-treatment | 61.8 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With ALT Normalization | Week 72 Off-treatment | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With ALT Normalization | Week 60 Off-treatment | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With ALT Normalization | Week 96 On-treatment | 21.2 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With ALT Normalization | Week 60 On-treatment | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With ALT Normalization | Baseline | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With ALT Normalization | Week 48 On-treatment | 60.6 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With ALT Normalization | Week 96 Off-treatment | 21.2 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 96 On-treatment | 11.5 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 60 Off-treatment | 3.6 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 12 On-treatment | 41.9 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 96 Off-treatment | 11.5 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 24 On-treatment | 43.3 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 48 On-treatment | 46.7 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 60 On-treatment | 3.6 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Baseline | 0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 72 On-treatment | 3.6 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 72 Off-treatment | 3.6 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 96 Off-treatment | 35.3 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 48 On-treatment | 65.7 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 60 Off-treatment | 12.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Baseline | 0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 60 On-treatment | 12.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 96 On-treatment | 35.3 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 72 Off-treatment | 12.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 12 On-treatment | 58.3 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 72 On-treatment | 12.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 24 On-treatment | 69.4 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 96 On-treatment | 10.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 60 On-treatment | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 72 On-treatment | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 24 On-treatment | 78.8 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 48 On-treatment | 83.9 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 60 Off-treatment | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 72 Off-treatment | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Baseline | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 12 On-treatment | 64.5 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With ALT Normalization | Week 96 Off-treatment | 10.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With ALT Normalization | Week 60 On-treatment | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With ALT Normalization | Week 72 Off-treatment | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With ALT Normalization | Baseline | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With ALT Normalization | Week 12 On-treatment | 56.3 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With ALT Normalization | Week 48 On-treatment | 87.5 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With ALT Normalization | Week 24 On-treatment | 76.5 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With ALT Normalization | Week 72 On-treatment | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With ALT Normalization | Week 96 On-treatment | 16.7 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With ALT Normalization | Week 60 Off-treatment | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With ALT Normalization | Week 96 Off-treatment | 16.7 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With ALT Normalization | Week 96 On-treatment | 11.1 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With ALT Normalization | Week 72 On-treatment | 5.6 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With ALT Normalization | Week 60 On-treatment | 5.6 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With ALT Normalization | Week 48 On-treatment | 58.8 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With ALT Normalization | Week 24 On-treatment | 55.6 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With ALT Normalization | Week 12 On-treatment | 47.1 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With ALT Normalization | Baseline | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With ALT Normalization | Week 72 Off-treatment | 5.6 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With ALT Normalization | Week 96 Off-treatment | 11.1 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With ALT Normalization | Week 60 Off-treatment | 5.6 Percentage of participants |
Secondary
Percentage of Participants With Flares
Percentage of participants with flares (virologic, biochemical, and clinical) were reported. Virologic flare: confirmed HBV DNA \>peak threshold ( 20,000 IU/mL 2,000 IU/mL and 200 IU/mL); biochemical Flare: confirmed ALT and/or AST increase of 3\*ULN and 3\*nadir; clinical flare: confirmed HBV DNA \>peak threshold and confirmed ALT and/or AST increase of 3\*ULN and 3\*nadir. Virologic and clinical flare was assessed only for those participants who were off-treatment and had HBV DNA\<LLOQ at the last observed time point on all study treatments and biochemical flares was identified on treatment and off treatment, respectively. Each virologic flare was categorized based on the confirmed (i.e., two consecutive values) peak HBV DNA above any of the three thresholds within the start and end date of that flare as follows: 20,000 IU/mL 2,000 IU/mL and 200 IU/mL. A participant was defined as off-treatment failure if he/she required NA re-treatment after stopping all study interventions.
Time frame: Follow-up phase (Week 48 up to Week 96)
Population: mITT analysis set included all participants who were randomised in the study and received at least one dose of study treatment excluding those participants impacted by the pandemic defined as those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44. Here, 'n' (number analysed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Flares | Clinical HBVDNA>200:Off NA | 0.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Flares | Virologic HBVDNA>2000:Off NA | 3.3 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Flares | Clinical HBVDNA>2000:Off NA | 0.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Flares | Virologic HBVDNA>20000:Off NA | 3.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Flares | Biochemical: Off NA | 0.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Flares | Clinical HBVDNA>20000:Off NA | 0.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Flares | Biochemical: On NA | 0.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Flares | Virologic HBVDNA>200:Off NA | 13.3 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Flares | Virologic HBVDNA>200:Off NA | 24.3 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Flares | Virologic HBVDNA>2000:Off NA | 2.7 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Flares | Biochemical: On NA | 0.0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Flares | Clinical HBVDNA>20000:Off NA | 2.7 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Flares | Biochemical: Off NA | 2.5 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Flares | Virologic HBVDNA>20000:Off NA | 2.7 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Flares | Clinical HBVDNA>2000:Off NA | 0.0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Flares | Clinical HBVDNA>200:Off NA | 0.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Flares | Virologic HBVDNA>200:Off NA | 21.6 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Flares | Clinical HBVDNA>200:Off NA | 0.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Flares | Clinical HBVDNA>2000:Off NA | 0.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Flares | Biochemical: Off NA | 0.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Flares | Clinical HBVDNA>20000:Off NA | 0.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Flares | Virologic HBVDNA>2000:Off NA | 8.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Flares | Biochemical: On NA | 0.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Flares | Virologic HBVDNA>20000:Off NA | 5.4 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Flares | Biochemical: On NA | 0.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Flares | Biochemical: Off NA | 0.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Flares | Clinical HBVDNA>20000:Off NA | 0.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Flares | Clinical HBVDNA>200:Off NA | 0.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Flares | Clinical HBVDNA>2000:Off NA | 0.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Flares | Virologic HBVDNA>200:Off NA | 14.3 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Flares | Virologic HBVDNA>20000:Off NA | 0.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Flares | Virologic HBVDNA>2000:Off NA | 7.1 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Flares | Biochemical: Off NA | 0.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Flares | Biochemical: On NA | 2.1 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Flares | Clinical HBVDNA>200:Off NA | 0.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Flares | Virologic HBVDNA>200:Off NA | 0.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Flares | Virologic HBVDNA>2000:Off NA | 0.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Flares | Virologic HBVDNA>20000:Off NA | 0.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Flares | Clinical HBVDNA>2000:Off NA | 0.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Flares | Clinical HBVDNA>20000:Off NA | 0.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Flares | Clinical HBVDNA>20000:Off NA | 0.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Flares | Clinical HBVDNA>2000:Off NA | 0.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Flares | Virologic HBVDNA>2000:Off NA | 10.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Flares | Virologic HBVDNA>200:Off NA | 0.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Flares | Biochemical: Off NA | 0.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Flares | Biochemical: On NA | 0.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Flares | Clinical HBVDNA>200:Off NA | 0.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Flares | Virologic HBVDNA>20000:Off NA | 0.0 Percentage of participants |
Secondary
Percentage of Participants With HBeAg Seroconversion
HBeAg seroconversion was defined as achieving HBeAg seroclearance (HBeAg \[quantitative\] \<LLOQ) together with an appearance of anti-HBe antibodies (baseline anti-HBe antibodies \[qualitative\] with a negative result and a post-baseline assessment with positive result.
Time frame: Weeks 48, 60, 72, and 96
Population: mITT population. Here, 'N' (number of participants analyzed) signifies HbeAg positive participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBeAg Seroconversion | Week 48 | 4.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBeAg Seroconversion | Week 60 | 4.3 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBeAg Seroconversion | Week 72 | 4.2 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBeAg Seroconversion | Week 96 | 8.0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBeAg Seroconversion | Week 72 | 3.7 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBeAg Seroconversion | Week 60 | 7.4 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBeAg Seroconversion | Week 48 | 3.6 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBeAg Seroconversion | Week 96 | 14.8 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBeAg Seroconversion | Week 96 | 13.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBeAg Seroconversion | Week 72 | 9.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBeAg Seroconversion | Week 60 | 4.5 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBeAg Seroconversion | Week 48 | 8.7 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBeAg Seroconversion | Week 48 | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBeAg Seroconversion | Week 96 | 4.2 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBeAg Seroconversion | Week 60 | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBeAg Seroconversion | Week 72 | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBeAg Seroconversion | Week 72 | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBeAg Seroconversion | Week 96 | 7.7 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBeAg Seroconversion | Week 60 | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBeAg Seroconversion | Week 48 | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBeAg Seroconversion | Week 60 | 20.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBeAg Seroconversion | Week 72 | 18.2 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBeAg Seroconversion | Week 96 | 18.2 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBeAg Seroconversion | Week 48 | 18.2 Percentage of participants |
Secondary
Percentage of Participants With HBsAg Levels <100 IU/mL
Percentage of participants with HBsAg levels \<100 IU/mL was reported.
Time frame: Baseline, Weeks 12, 24, 48, 60, 72, 96
Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'n' (number analyzed) represents participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Baseline | 0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 60 | 54.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 12 | 19.6 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 96 | 21.3 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 24 | 42.9 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 72 | 43.5 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 48 | 57.5 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 12 | 33.7 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 48 | 74.7 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 24 | 65.2 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 60 | 61.2 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Baseline | 1.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 96 | 35.4 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 72 | 47.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 24 | 59.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 12 | 30.2 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Baseline | 1.1 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 60 | 56.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 72 | 37.8 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 48 | 69.3 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 96 | 28.2 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 48 | 36.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Baseline | 0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 12 | 15.9 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 24 | 25.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 60 | 22.9 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 72 | 14.3 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 96 | 9.8 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 60 | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 24 | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 96 | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 72 | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 12 | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 48 | 0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Baseline | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 72 | 2.2 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 60 | 2.2 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 24 | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 48 | 2.3 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 12 | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Baseline | 0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Levels <100 IU/mL | Week 96 | 2.2 Percentage of participants |
Secondary
Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline
Percentage of participants with HBsAg levels \>1 log10 IU/mL reduction from baseline was reported.
Time frame: Weeks 12, 24, 48, 60, 72, 96
Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 72 | 71.8 Percentage of partcipants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 24 | 84.6 Percentage of partcipants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 12 | 40.2 Percentage of partcipants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 48 | 93.1 Percentage of partcipants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 96 | 41.6 Percentage of partcipants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 60 | 86.2 Percentage of partcipants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 12 | 72.8 Percentage of partcipants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 72 | 84.4 Percentage of partcipants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 96 | 63.4 Percentage of partcipants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 60 | 94.1 Percentage of partcipants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 48 | 97.8 Percentage of partcipants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 24 | 97.8 Percentage of partcipants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 60 | 90.5 Percentage of partcipants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 48 | 97.7 Percentage of partcipants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 72 | 73.2 Percentage of partcipants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 24 | 93.2 Percentage of partcipants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 12 | 60.5 Percentage of partcipants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 96 | 49.4 Percentage of partcipants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 12 | 27.3 Percentage of partcipants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 24 | 71.6 Percentage of partcipants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 60 | 67.5 Percentage of partcipants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 48 | 82.6 Percentage of partcipants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 72 | 46.6 Percentage of partcipants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 96 | 20.7 Percentage of partcipants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 60 | 4.3 Percentage of partcipants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 12 | 2.2 Percentage of partcipants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 24 | 4.4 Percentage of partcipants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 48 | 4.4 Percentage of partcipants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 72 | 4.3 Percentage of partcipants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 96 | 4.5 Percentage of partcipants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 48 | 4.5 Percentage of partcipants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 24 | 4.5 Percentage of partcipants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 12 | 0 Percentage of partcipants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 60 | 4.4 Percentage of partcipants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 96 | 4.4 Percentage of partcipants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Levels >1 log10 IU/mL Reduction From Baseline | Week 72 | 6.7 Percentage of partcipants |
Secondary
Percentage of Participants With HBsAg Seroclearance 24 Weeks After Completion of All Study Intervention at Week 48
Percentage of participants with HBsAg seroclearance 24 weeks after completion of all study intervention at Week 48 were reported. HBsAg seroclearance was defined as HBsAg (less than \[\<\] lower limit of quantification LLOQ \[0.05 IU/mL\]). Responder was defined as a participant who achieved functional cure at Week 72. A participant was defined as having achieved functional cure at Week 72 if he/she: had met the criteria for stopping NA treatment at Week 48 and stopped treatment; had HBsAg seroclearance at Week 72 (that is, 24 weeks after stopping all study interventions); did not require NA re-treatment between Weeks 48 and 72. Multiple Imputation using a longitudinal multiple regression model was applied to impute missing data.
Time frame: Week 72
Population: mITT set was defined as all participants who were randomized in the study and received at least one dose of study treatment excluding those participants impacted by the COVID-19 pandemic defined as those participants who, because of COVID-19 or similar pandemic-related reasons, withdrew prematurely from the study prior to Week 44, or had no efficacy assessment for the primary outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroclearance 24 Weeks After Completion of All Study Intervention at Week 48 | 0.0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Seroclearance 24 Weeks After Completion of All Study Intervention at Week 48 | 0.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Seroclearance 24 Weeks After Completion of All Study Intervention at Week 48 | 0.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Seroclearance 24 Weeks After Completion of All Study Intervention at Week 48 | 0.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroclearance 24 Weeks After Completion of All Study Intervention at Week 48 | 0.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Seroclearance 24 Weeks After Completion of All Study Intervention at Week 48 | 2.2 Percentage of participants |
Secondary
Percentage of Participants With HBsAg Seroclearance 48 Weeks After Completion of All Study Intervention at Week 48
Percentage of participants with HBsAg seroclearance 48 weeks after completion of all study intervention at Week 48 were reported. HBsAg Seroclearance was defined as HBsAg \<LLOQ (0.05 IU/mL). A responder was defined as a participant who achieved HBsAg seroclearance at Week 96 if the participant completed 48 weeks of treatment, met the criteria for stopping NA treatment at Week 48, did not require NA re-treatment between Week 48 and Week 96, and had HBsAg seroclearance at Week 96. Multiple Imputation using a longitudinal multiple regression model was applied to impute missing data.
Time frame: Week 96
Population: mITT analysis set included all participants who were randomized in the study and received at least one dose of study treatment excluding those participants impacted by the pandemic defined as those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from the study prior to Week 44.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroclearance 48 Weeks After Completion of All Study Intervention at Week 48 | 0.0 Percentage of participants | 90% Confidence Interval 0 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Seroclearance 48 Weeks After Completion of All Study Intervention at Week 48 | 1.1 Percentage of participants | 90% Confidence Interval 0.05 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Seroclearance 48 Weeks After Completion of All Study Intervention at Week 48 | 0.0 Percentage of participants | 90% Confidence Interval 0 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Seroclearance 48 Weeks After Completion of All Study Intervention at Week 48 | 0.0 Percentage of participants | 90% Confidence Interval 0 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroclearance 48 Weeks After Completion of All Study Intervention at Week 48 | 0.0 Percentage of participants | 90% Confidence Interval 0 |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Seroclearance 48 Weeks After Completion of All Study Intervention at Week 48 | 2.2 Percentage of participants | 90% Confidence Interval 0.11 |
Secondary
Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96
Percentage of participants with HBsAg seroclearance after completion of NA treatment at Weeks 60, 84, and 96 were reported. Seroclearance of HBsAg was defined as HBsAg level \<LLOQ (0.05 IU/mL). For Week 60: a responder was defined as a participant who achieved HBsAg seroclearance 12 weeks off treatment if the subject achieved HBsAg seroclearance 12 weeks after stopping; for Week 84:A responder was defined as a participant who achieved HBsAg seroclearance 36 weeks off-treatment if the participant achieved HBsAg seroclearance 36 weeks after stopping all study treatments; for Week 96:A responder was defined as a participant who achieved HBsAg seroclearance at Week 96 if the participant completed 48 weeks of treatment, met the criteria for stopping NA treatment at Week 48, did not require NA re-treatment between Week 48 and Week 96, and had HBsAg seroclearance at Week 96.
Time frame: Weeks 60, 84, and 96
Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'n' (number analyzed) represents participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96 | Week 96 | 0.0 Percentage of of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96 | Week 60 | 0.0 Percentage of of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96 | Week 84 | 0.0 Percentage of of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96 | Week 60 | 9.1 Percentage of of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96 | Week 96 | 1.1 Percentage of of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96 | Week 84 | 9.1 Percentage of of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96 | Week 96 | 0.0 Percentage of of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96 | Week 60 | 0.0 Percentage of of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96 | Week 84 | 0.0 Percentage of of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96 | Week 84 | 0.0 Percentage of of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96 | Week 60 | 0.0 Percentage of of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96 | Week 96 | 0.0 Percentage of of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96 | Week 96 | 0.0 Percentage of of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96 | Week 84 | 100.0 Percentage of of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96 | Week 60 | 0.0 Percentage of of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Seroclearance After Completion of NA Treatment at Weeks 60, 84, and 96 | Week 96 | 2.2 Percentage of of participants |
Secondary
Percentage of Participants With HBsAg Seroconversion
HBsAg seroconversion was defined as achieving HBsAg seroclearance (HBsAg \[quantitative\] \<LLOQ \[0.05 IU/mL\]) together with an appearance of anti-HBs antibodies (baseline anti-HBs antibodies \[quantitative\] \<LLOQ and a post-baseline assessment greater than or equal to \[\>=\] LLOQ).
Time frame: Weeks 48, 60, 72, and 96
Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) represents participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroconversion | Week 72 | 0.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroconversion | Week 96 | 0.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroconversion | Week 60 | 0.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroconversion | Week 48 | 0.0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Seroconversion | Week 96 | 1.2 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Seroconversion | Week 48 | 1.1 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Seroconversion | Week 60 | 0.0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBsAg Seroconversion | Week 72 | 0.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Seroconversion | Week 48 | 0.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Seroconversion | Week 60 | 0.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Seroconversion | Week 96 | 0.0 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBsAg Seroconversion | Week 72 | 1.3 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Seroconversion | Week 60 | 0.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Seroconversion | Week 48 | 0.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Seroconversion | Week 96 | 0.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBsAg Seroconversion | Week 72 | 0.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroconversion | Week 48 | 0.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroconversion | Week 60 | 0.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroconversion | Week 96 | 0.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroconversion | Week 72 | 0.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Seroconversion | Week 96 | 0.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Seroconversion | Week 48 | 0.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Seroconversion | Week 60 | 0.0 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBsAg Seroconversion | Week 72 | 2.4 Percentage of participants |
Secondary
Percentage of Participants With HBV DNA Levels <LLOQ
Percentage of participants with HBV DNA levels \<LLOQ (20 IU/mL) were reported.
Time frame: Baseline, Weeks 12, 24, 48, 60, 72, 96
Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'n' (number analyzed) represents participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 24 | 84.6 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 48 | 92.0 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 96 | 94.4 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Baseline | 64.4 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 72 | 89.5 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 12 | 78.3 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 60 | 88.6 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 48 | 85.7 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 72 | 81.2 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 12 | 71.7 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 96 | 75.6 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 60 | 85.9 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Baseline | 60.4 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 24 | 80.4 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Baseline | 63.7 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 12 | 76.7 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 24 | 81.8 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 48 | 86.4 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 60 | 79.5 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 72 | 81.9 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 96 | 80.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 72 | 86.9 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Baseline | 60.9 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 12 | 70.5 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 24 | 83.0 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 96 | 87.5 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 60 | 85.9 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 48 | 90.8 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 96 | 95.5 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 12 | 73.3 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 60 | 93.5 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 24 | 80.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 48 | 95.6 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 72 | 95.7 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Baseline | 60.6 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 12 | 75.6 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 48 | 93.3 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 60 | 93.3 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Baseline | 63.8 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 72 | 91.1 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 24 | 77.3 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBV DNA Levels <LLOQ | Week 96 | 93.3 Percentage of participants |
Secondary
Percentage of Participants With HBV DNA <LLOQ 24 and 48 Weeks After Completion of All Study Intervention at Week 48
Percentage of participants with HBV DNA \<LLOQ at 24 and 48 weeks after completion of all study intervention at Week 48 were reported. A responder was defined as a participant who achieved HBV DNA \<LLOQ 24 and 48 weeks after stopping all study treatments at any time during the study and without restarting NA treatment thereafter.
Time frame: Weeks 72 and 96
Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'n' (number analyzed) represents participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBV DNA <LLOQ 24 and 48 Weeks After Completion of All Study Intervention at Week 48 | Week 72 | 5.3 Percentage of participants |
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With HBV DNA <LLOQ 24 and 48 Weeks After Completion of All Study Intervention at Week 48 | Week 96 | 6.4 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBV DNA <LLOQ 24 and 48 Weeks After Completion of All Study Intervention at Week 48 | Week 72 | 16.0 Percentage of participants |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With HBV DNA <LLOQ 24 and 48 Weeks After Completion of All Study Intervention at Week 48 | Week 96 | 9.6 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBV DNA <LLOQ 24 and 48 Weeks After Completion of All Study Intervention at Week 48 | Week 72 | 7.6 Percentage of participants |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With HBV DNA <LLOQ 24 and 48 Weeks After Completion of All Study Intervention at Week 48 | Week 96 | 5.4 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBV DNA <LLOQ 24 and 48 Weeks After Completion of All Study Intervention at Week 48 | Week 72 | 1.1 Percentage of participants |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With HBV DNA <LLOQ 24 and 48 Weeks After Completion of All Study Intervention at Week 48 | Week 96 | 1.1 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBV DNA <LLOQ 24 and 48 Weeks After Completion of All Study Intervention at Week 48 | Week 72 | 0.0 Percentage of participants |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With HBV DNA <LLOQ 24 and 48 Weeks After Completion of All Study Intervention at Week 48 | Week 96 | 2.1 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBV DNA <LLOQ 24 and 48 Weeks After Completion of All Study Intervention at Week 48 | Week 72 | 4.4 Percentage of participants |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With HBV DNA <LLOQ 24 and 48 Weeks After Completion of All Study Intervention at Week 48 | Week 96 | 0.0 Percentage of participants |
Secondary
Percentage of Participants With Undetectable HBV DNA Levels After Re-start of NA Treatment During Follow-up
Percentage of participants with undetectable HBV DNA levels after re-start of NA treatment during follow-up was reported.
Time frame: Week 48 up to Week 96
Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Undetectable HBV DNA Levels After Re-start of NA Treatment During Follow-up | 1.1 Percentage of participants | 90% Confidence Interval 0.05 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Undetectable HBV DNA Levels After Re-start of NA Treatment During Follow-up | 1.1 Percentage of participants | 90% Confidence Interval 0.05 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Undetectable HBV DNA Levels After Re-start of NA Treatment During Follow-up | 1.1 Percentage of participants | 90% Confidence Interval 0.06 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Undetectable HBV DNA Levels After Re-start of NA Treatment During Follow-up | 0.0 Percentage of participants | 90% Confidence Interval 0 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Undetectable HBV DNA Levels After Re-start of NA Treatment During Follow-up | 0.0 Percentage of participants | 90% Confidence Interval 0 |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Undetectable HBV DNA Levels After Re-start of NA Treatment During Follow-up | 0.0 Percentage of participants | 90% Confidence Interval 0 |
Secondary
Percentage of Participants With Virologic Breakthrough
Virologic breakthrough was defined as having a confirmed on-treatment HBV DNA increase by \>1 log10 from nadir (that is, lowest value during treatment) or a confirmed HBV DNA level \>200 IU/mL in participants who had on-treatment HBV DNA level below the LLOQ (20 IU/mL). On-treatment was defined as the time period in which the participant received any of the study intervention.
Time frame: Baseline (Day 1) up to Week 48
Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Percentage of Participants With Virologic Breakthrough | 2.1 Percentage of participants | 90% Confidence Interval 0.38 |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Percentage of Participants With Virologic Breakthrough | 2.1 Percentage of participants | 90% Confidence Interval 0.38 |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Percentage of Participants With Virologic Breakthrough | 2.2 Percentage of participants | 90% Confidence Interval 0.39 |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Percentage of Participants With Virologic Breakthrough | 2.2 Percentage of participants | 90% Confidence Interval 0.39 |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Percentage of Participants With Virologic Breakthrough | 0.0 Percentage of participants | 90% Confidence Interval 0 |
| Arm 6: Placebo + Placebo + NA | Percentage of Participants With Virologic Breakthrough | 2.2 Percentage of participants | 90% Confidence Interval 0.11 |
Secondary
Time to Achieve HBeAg Seroclearance
Time to HBeAg seroclearance (defined as HBeAg level \<LLOQ \[0.11 IU/mL\]) was defined as the number of days between the date of first study treatment intake and the date of the first occurrence of HBeAg seroclearance.
Time frame: Baseline (Day 1) up to Week 96
Population: mITT analysis set: all participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic: those participants who, because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. Here, 'Here, 'N' (number of participants analyzed) signifies HBeAg positive participants who achieved seroclearance and were available for the analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm 1: JNJ-73763989 100 mg + JNJ-56136379 250 mg + NA | Time to Achieve HBeAg Seroclearance | NA Weeks |
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Time to Achieve HBeAg Seroclearance | NA Weeks |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Time to Achieve HBeAg Seroclearance | NA Weeks |
| Arm 4: JNJ-73763989 40 mg + Placebo + NA | Time to Achieve HBeAg Seroclearance | NA Weeks |
| Arm 5: Placebo + JNJ-56136379 250 mg + NA | Time to Achieve HBeAg Seroclearance | NA Weeks |
| Arm 6: Placebo + Placebo + NA | Time to Achieve HBeAg Seroclearance | NA Weeks |
Secondary
Time to Achieve HBsAg Seroclearance
Time to HBsAg seroclearance (defined as HBsAg level \<LLOQ \[0.05 IU/mL\]) was defined as the number of days between the date of first study treatment intake and the date of the first occurrence of HBsAg seroclearance.
Time frame: Baseline (Day 1) up to Week 96
Population: mITT set: participants who were randomized in study and received at least one dose of study treatment excluding those participants impacted by pandemic because of COVID-19 or similar pandemics related reasons, withdrew prematurely from study prior to Week 44. N (number of participants analyzed): participants who achieved seroclearance and were available for the analysis and '0' in the number of participants analyzed field signifies none of the participant achieved seroclearance.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm 2: JNJ-73763989 200 mg + Placebo + NA | Time to Achieve HBsAg Seroclearance | NA Weeks |
| Arm 3: JNJ-73763989 100 mg + Placebo + NA | Time to Achieve HBsAg Seroclearance | NA Weeks |
| Arm 6: Placebo + Placebo + NA | Time to Achieve HBsAg Seroclearance | NA Weeks |