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JNJ-73763989

Phase 2

Hepatitis B | Small molecule | Infectious Disease |Johnson & Johnson|Last Updated: Jul 22, 2026

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

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Clinical trial landscape

JNJ-73763989 · 12 trials · 6 indications

Phase 2 7Phase 1 5
NCT05275023An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B ParticipantsHepatitis B, Chronic
COMPLETED37 Analytics
NCT04585789A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus InfectionHepatitis B
COMPLETED24 Analytics
NCT04667104A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus InfectionHepatitis B, Chronic
COMPLETED48 Analytics
NCT04535544A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D VirusHepatitis D, Chronic
COMPLETED52 Analytics
NCT04439539A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) InfectionHepatitis B, Chronic
COMPLETED54 Analytics
NCT04129554A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus InfectionHepatitis B, Chronic
COMPLETED130 Analytics
NCT03982186A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus InfectionHepatitis B, Chronic
COMPLETED471 Analytics
PHASE2COMPLETED
An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants
Hepatitis B, ChronicUnlock trial analytics
PHASE2COMPLETED
A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection
Hepatitis BUnlock trial analytics
PHASE2COMPLETED
A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection
Hepatitis B, ChronicUnlock trial analytics
PHASE2COMPLETED
A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
Hepatitis D, ChronicUnlock trial analytics
PHASE2COMPLETED
A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection
Hepatitis B, ChronicUnlock trial analytics
PHASE2COMPLETED
A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection
Hepatitis B, ChronicUnlock trial analytics
PHASE2COMPLETED
A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection
Hepatitis B, ChronicUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Who Achieved Hepatitis B Surface Antigen (HBsAg) Seroclearance at Follow-up (FU) Week 24
At FU Week 24

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

Panel 1 and 2: Absolute Change From Baseline in the Percentage of Hepatitis B Surface Antigen (HBsAg) Hepatocytes at Week 40
Baseline, Week 40

Absolute change from baseline to on-treatment liver biopsy timepoint (Week 40) in terms of the percentage of HBsAg-positive hepatocytes (at Week 40) were reported.

Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 12
At Week 12 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989)

Liver concentrations of JNJ-73763989 (JNJ-73763976, JNJ-73763924 - Molecules of JNJ-73763989 and JNJ-87719164 \[M65; deaminated metabolite of JNJ-73763976\]) at Week 12 were reported.

Panel 3: Liver Concentrations of JNJ-73763989 (JNJ-73763976, and JNJ-73763924 and JNJ-87719164 [M65; Deaminated Metabolite of JNJ-73763976]) at Week 40
At Week 40 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989)

Liver concentrations of JNJ-73763989 (JNJ-73763976, and JNJ-73763924 and JNJ-87719164 \[M65; deaminated metabolite of JNJ-73763976\]) at Week 40 were reported.

Panel 3: Plasma Concentration of JNJ-73763989 (JNJ-73763976, and JNJ-73763924) at Week 12
At Week 12 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989)

Plasma concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924-molecules of JNJ-73763989) at Week 12 were reported.

Panel 3: Plasma Concentrations of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) at Week 40
At Week 40 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989)

Plasma concentrations of JNJ-73763989 (JNJ-73763976 and JNJ-73763924-molecules of JNJ-73763989) at Week 40 were reported.

Panel 3: Correlation of Liver Concentration to Plasma Concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and Liver Concentration of JNJ-87719164 (M65: Deaminated Metabolite of JNJ-73763976) to Liver Concentration JNJ-73763976 at Week 12
Week 12 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989)

Correlation of liver concentration to plasma concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and liver concentration of JNJ-87719164 (M65: Deaminated metabolite of JNJ-73763976) to liver concentration JNJ-73763976 at Week 12 were reported.

Panel 3: Correlation of Liver to Plasma Concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and Liver Concentration of JNJ-87719164 (M65: Deaminated Metabolite of JNJ-73763976) to Liver Concentration JNJ-73763976 at Week 40
Week 40 (at the time of liver biopsy: 24 hours post dose of JNJ-73763989)

Correlation of liver concentration to plasma concentration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) and liver concentration of JNJ-87719164 (M65: Deaminated metabolite of JNJ-73763976) to liver concentration JNJ-73763976 at Week 40 were reported.

Percentage of Participants With a Reduction of at Least 2 log10 International Unit/Millilitres (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels From Baseline to Week 24
From Baseline (Day 1) to Week 24

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

Double-blind:Part 1: Percentage of Participants With HDV Ribonucleic Acid (RNA) >=2 log10 IU/mL Decline From Baseline or HDV RNA Target Not Detected (TND) in Combination With Normal Alanine Aminotransferase (ALT) at Week 48 (Multiple Imputation Approach)
Week 48

Percentage of participants with hepatitis D virus (HDV) RNA greater than or equal to (\>=) 2 log10 international units per milliliter (IU/mL) decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT less than (\<) upper limit of normal (ULN) with ULN = 34 units per liter (U/L) for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.

Double-blind: Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT at Week 48 (Multiple Imputation Approach)
Week 48

Percentage of participants with HDV RNA \>=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported. TND was defined as no traces of HBV RNA were detected/found. Normal ALT was defined as ALT \<ULN with ULN = 34 U/L for female and 43 U/L for male. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1. The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.

Percentage of Participants With Functional Cure: Hepatitis B Surface Antigen (HBsAg) Seroclearance at 24 Weeks After Stopping All Study Interventions at the End of Consolidation Phase (CP) and Without Restarting Nucleos(t)Ide Analog (NA) Treatment
At follow-up (FU) phase Week 24

Percentage of participants with functional cure (defined as percentage of participants with HBsAg seroclearance at 24 weeks after stopping all study interventions at the end of consolidation phase and without restarting NA treatment) were reported. Seroclearance HBsAg was defined as a (quantitative) HBsAg level \<lower limit of quantification (LLOQ; \<0.05 international units per milliliter \[IU/mL\]).

Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 72 Without Restarting NA Treatment
Week 72

Percentage of participants with HBsAg seroclearance at Week 72 (24 weeks after completion of all study interventions at Week 48) without restarting NA treatment was reported. Seroclearance at Week 72 of the treatment defined as a confirmed loss of HBsAg at Week 72. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result.

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.

Percentage of Participants with a Reduction of at Least 2 log10 International Units per Milliliter (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels from Baseline to Week 36
Baseline to Week 36 (end of study intervention)

Percentage of participants with a reduction of at least 2 log10 IU/mL in HBsAg levels from baseline to Week 36 will be reported.

Plasma Concentration of JNJ-73763989
Predose, up to 72 hours postdose (up to Day 4)

Plasma samples will be analyzed to determine concentrations of JNJ-73763989 (as the 2 triggers JNJ-73763976 and JNJ-73763924) using a validated and qualified method.

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Up to 4 Weeks

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Urine Concentration of JNJ-73763989
Predose up to 48 hours postdose (up to Day 3)

Urine samples will be analyzed to determine concentrations of JNJ-73763989 (as the 2 triggers JNJ-73763976 and JNJ-73763924).

Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989
Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose

Cmax is the maximum observed plasma analyte concentration.

Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989
Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose

Tmax is defined as actual sampling time to reach maximum observed plasma analyte concentration.

Last Measurable Observed Plasma Concentration (Clast) of JNJ-73763989
Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose

Clast is last measurable observed plasma analyte concentration.

Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC[0-last]) of JNJ-73763989
Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose

AUC(0-last) is area under the plasma concentration-time curve from time zero to the time of the last measurable (non-below quantification limit \[non-BQL\]) concentration, calculated by linear-linear trapezoidal summation.

Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Up to 30 days after last study drug administration (Up to 7 weeks)

AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Secondary Endpoints

Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) of Special Interest
IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Number of Participants With TEAEs by Severity
IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
Number of Participants With Immune Related TEAEs
IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1: JNJ-73763989 + PD-1 Inhibitor + Nucleos(t)ide analog (NA)EXPERIMENTALParticipants will receive JNJ-73763989 subcutaneous (SC) injections and single dose of programmed cell death protein receptor-1 (PD-1) inhibitor as intravenous (IV) infusion. Participants will also receive background treatment with NA (either tenofovir disoproxil, tenofovir alafenamide \[TAF\] or entecavir \[ETV\]).
Arm 2: JNJ-73763989 + PD-1 Inhibitor + NAEXPERIMENTALParticipants will receive JNJ-73763989 SC injections and multiple doses of PD-1 inhibitor as IV infusion. Participants will also receive background treatment with NA (either tenofovir disoproxil, TAF or ETV).
Panel 1: JNJ-73763989+ NAEXPERIMENTALOngoing and new participants will receive JNJ-73763989 subcutaneous (SC) injection once every 4 weeks (last injection at Week 44) and nucleos(t)ide analog (NA) treatment (either entecavir \[ETV\], tenofovir disoproxil or tenofovir alafenamide \[TAF\] tablets) once daily up to 48 weeks. Participants may receive optional treatment with pegylated interferon alpha-2a (PegIFN-alpha-2a) after the Week 40 for a duration of either 12 or 24 weeks at the investigator's discretion. As per amendment-5, JNJ-56136379 is no longer included as part of the study intervention and all participants are counted as single arm in each panel.
Panel 2: JNJ-73763989+ NAEXPERIMENTALOngoing and new participants will receive JNJ-73763989 SC injection once every 4 weeks (last injection at Week 44) and NA treatment (ETV, tenofovir disoproxil or TAF tablets) once daily up to 48 weeks. Participants may receive optional treatment with PegIFN-alpha-2a after the Week 40 for a duration of either 12 or 24 weeks at the investigator's discretion. As per amendment-5, JNJ-56136379 is no longer included as part of the study intervention and all participants are counted as single arm in each panel.
Treatment Period (TP) 1 (JNJ-73763989 + Nucleos(t)ide Analog)+ TP 2 (TP 1+PegIFN-alpha2a)EXPERIMENTALParticipants will receive combination treatment with JNJ-73763989+ nucleos(t)ide analog (NA) for 12 weeks during Treatment Period 1 and the participants who meet the eligibility criteria for PegIFN-alpha2a at Week 12 will receive combination treatment with JNJ-73763989 + NA plus PegIFN-α2a for 12 weeks during Treatment Period 2.
Immediate Active Treatment arm: JNJ-73763989 + NAEXPERIMENTALParticipants will receive JNJ-73763989 subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\], tenofovir disoproxil, or tenofovir alafenamide \[TAF\]) once daily for 144 Weeks in Part 1 and for at least 96 weeks in Part 2.
Deferred Active Treatment arm: Placebo+NA+JNJ-73763989+NAPLACEBO_COMPARATORParticipants will receive matching placebo to JNJ-73763989 SC injection Q4W along with NA (ETV, tenofovir disoproxil, or TAF) once daily for 52 Weeks followed by JNJ-73763989 SC injection Q4W along with NA once daily for 96 weeks in Part 1 and for at least 48 weeks in Part 2.
Cohort 1: Participants Enrolled Prior to Protocol Amendment 5 is in EffectEXPERIMENTALDuring the Induction phase, participants will receive JNJ-73763989 subcutaneously along with JNJ-56136379 tablet orally with NA (either tenofovir disoproxil or tenofovir alafenamide tablets orally) treatment. At the start of consolidation phase, participants will be randomized to receive PegIFN-alpha-2a subcutaneously in addition to JNJ-73763989 and JNJ-56136379 with NA in arm 1 and arm 2 (without PegIFN-alpha-2a). According to predefined criteria NA treatment may be continued during the follow up (FU) phase.
Cohort 2: Participants Enrolled After Protocol Amendment 5 is in EffectEXPERIMENTALFollowing implementation of protocol amendment- 5 and 6, all participants will receive JNJ-73763989 subcutaneously along with NA (tenofovir disoproxil tablets orally) for 36 weeks (induction phase). In the consolidation phase, participants will receive PegIFN-alpha-2a subcutaneously in addition to JNJ-73763989 and NA for 12 weeks. According to predefined criteria NA treatment may be continued during the follow up (FU) phase. JNJ-56136379 (JNJ-6379) was discontinued as per amendment 6 of the study.
JNJ-73763989+ JNJ-56136379+ NAEXPERIMENTALParticipants will receive fixed dose of JNJ-73763989 subcutaneous injection once every 4 weeks along with fixed dose of JNJ-56136379 tablet once daily and nucleos(t)ide analog (NA) treatment (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\], or tenofovir alafenamide \[TAF\]) once daily up to 48 weeks.
Placebo for JNJ-73763989+ Placebo for JNJ-56136379+ NAPLACEBO_COMPARATORParticipants will receive matching placebo for JNJ-73763989 subcutaneous injection once every 4 weeks with matching placebo for JNJ-56136379 once daily and NA treatment (either ETV, TDF or TAF) once daily up to 48 weeks.
Arm 1: JNJ-73763989 (medium dose) + JNJ-56136379 + NAEXPERIMENTALParticipants will receive medium dose of JNJ-73763989 along with JNJ-56136379 and nucleos(t)ide analog (NA) treatment (either entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\], or tenofovir alafenamide \[TAF\]) up to 48 weeks.
Arm 2: JNJ-73763989 (high dose) + Placebo + NAEXPERIMENTALParticipants will receive high dose of JNJ-73763989 along with placebo for JNJ-56136379 and NA (either ETV, TDF, or TAF) up to 48 weeks.
Arm 3: JNJ-73763989 (medium dose) + Placebo + NAEXPERIMENTALParticipants will receive medium dose of JNJ-73763989 along with placebo for JNJ-56136379 and NA (either ETV, TDF, or TAF) up to 48 weeks.
Arm 4: JNJ-73763989 (low dose) + Placebo + NAEXPERIMENTALParticipants will receive low dose of JNJ-73763989 along with placebo for JNJ-56136379 and NA (either ETV, TDF, or TAF) up to 48 weeks.
Arm 5: Placebo + JNJ-56136379 + NAEXPERIMENTALParticipants will receive placebo for JNJ-73763989 and a fixed dose of JNJ-56136379 along with NA (either ETV, TDF, or TAF) up to 48 weeks.
Arm 6 (Control): Placebo + Placebo + NAPLACEBO_COMPARATORParticipants will receive placebo for JNJ-73763989 and placebo for JNJ-56136379 along with NA (either ETV, TDF, or TAF) up to 48 weeks.
JNJ-73763989 plus JNJ-64300535 plus Nucleos(t)ide Analogs (NAs)EXPERIMENTALParticipants will receive JNJ-73763989 subcutaneous (SC) injection once every 4 weeks (q4w), NA (either Entecavir monohydrate \[ETV\], Tenofovir disoproxil or Tenofovir alafemide \[TAF\]) oral tablets once daily (qd) and JNJ-64300535 intramuscular (IM) injection q4w. From day 187, participants will receive treatment with NA oral tablets qd up to Week 36.
Group 1: JNJ-73763989EXPERIMENTALParticipants with moderate renal impairment will receive a single subcutaneous (SC) injection of JNJ-73763989 on Day 1.
Group 2: JNJ-73763989EXPERIMENTALParticipants with severe renal impairment or end-stage renal disease (ESRD) will receive a single SC injection of JNJ-73763989 on Day 1.
Group 3: JNJ-73763989EXPERIMENTALParticipants with normal renal function will receive a single SC injection of JNJ-73763989 on Day 1.
Panel A: JNJ-73763989EXPERIMENTALParticipants will receive single subcutaneous (SC) injection of low dose of JNJ-73763989 on Day 1.
Panel B: J NJ-73763989EXPERIMENTALParticipants will receive single SC injection of high dose of JNJ-73763989 on Day 1.
Part A: Group 1EXPERIMENTALParticipants with liver cirrhosis with moderate hepatic impairment will receive single subcutaneous (SC) injection of JNJ-73763989 on Day 1 under fasted condition.
Part A: Group 2EXPERIMENTALParticipants with normal liver function with no liver cirrhosis will receive single SC injection of JNJ-73763989 on Day 1 under fasted condition.
Part B: Group 3 (optional)EXPERIMENTALParticipants with liver cirrhosis with mild hepatic impairment will receive single SC injection of JNJ-73763989 on Day 1 under fasted condition.
Part B: Group 4 (optional)EXPERIMENTALParticipants with liver cirrhosis with severe hepatic impairment will receive SC injection of JNJ-73763989 on Day 1 under fasted condition.
Panel A: JNJ-73763989 or PlaceboEXPERIMENTALParticipants will receive JNJ-73763989 (Dose Level 1) or matching placebo as single subcutaneous injection.
Panel B: JNJ-73763989 or PlaceboEXPERIMENTALParticipants will receive JNJ-73763989 (Dose Level 2) or matching placebo as single subcutaneous injection.
Panel C: JNJ-73763989 or PlaceboEXPERIMENTALParticipants will receive JNJ-73763989 (Dose Level 3) or matching placebo as single subcutaneous injection.

Interventions

NameTypeDescription
JNJ-73763989DRUGJNJ-73763989 will be administered subcutaneously.
PD-1 inhibitorDRUGPD-1 inhibitor will be administered as IV infusion.
Tenofovir DisoproxilDRUGTenofovir disoproxil film-coated tablets will be administered orally.
Tenofovir AlafenamideDRUGTAF film-coated tablets will be administered orally.
EntecavirDRUGETV film-coated tablets will be administered orally.
JNJ-56136379DRUGJNJ-56136379 tablets will be administered orally once daily up to 48 weeks.
Entecavir (ETV)DRUGETV tablet will be administered orally once daily up to 48 weeks as NA treatment.
Tenofovir alafenamide (TAF)DRUGTAF will be administered orally once daily up to 48 weeks as NA treatment.
PegIFN-alpha-2a (Optional)DRUGPegIFN-alpha-2a injection will be administered subcutaneously once weekly after Week 40 for either 12 or 24 weeks.
Entecavir (ETV) monohydrateDRUGETV monohydrate film-coated tablet will be administered orally once daily.
PegIFN-alpha2aDRUGPegIFN-alpha2a injection will be administered subcutaneously once weekly.
PlaceboDRUGMatching placebo to JNJ-73763989 will be administered as a SC injection.
PegIFN-alpha-2aDRUGPegIFN-alpha-2a injection will be administered subcutaneously.
Placebo for JNJ-73763989DRUGMatching placebo for JNJ-73763989 will be administered as subcutaneous injection up to 48 weeks.
Placebo for JNJ-56136379DRUGMatching placebo for JNJ-56136379 tablets will be administered orally up to 48 weeks.
Tenofovir disoproxil fumarate (TDF)DRUGTDF will be administered orally once daily up to 48 weeks as NA treatment.
Nucleos(t)ide Analog (NA)DRUGNA treatment that is either of ETV, TDF or TAF tablets will be administered orally.
JNJ-64300535BIOLOGICALJNJ-64300535 deoxyribonucleic acid (DNA) vaccine injection will be administered intramuscularly.
ETV monohydrateDRUGETV monohydrate film-coated tablets will be administered orally.
TAFDRUGTAF film-coated tablets will be administered orally.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * Participants must have chronic hepatitis B virus (HBV) infection * Participants must have fibroscan liver stiffness measurement less than or equal to (\<=) 9.0 kilopascal (kPa) or a liver biopsy result classified as metavir F0-F2 Exclusion Criteria: * Participants with evide...

Countries:CanadaCzechiaFranceItalySpainTaiwanTurkey (Türkiye)United KingdomUnited StatesBelgiumGermanyNew ZealandPolandJapanAustraliaBrazilChinaRussiaSwedenHong KongMalaysiaSouth KoreaThailand
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Recent Changes (Last 90 Days)

MEDIUMAug 22, 2026NCT04535544TRIAL_REMOVED: changed
MEDIUMAug 22, 2026NCT04535544TRIAL_REMOVED: changed
MEDIUMAug 22, 2026NCT04535544TRIAL_REMOVED: changed
MEDIUMAug 22, 2026NCT04535544TRIAL_REMOVED: changed

Frequently asked questions about JNJ-73763989

What is JNJ-73763989 used for?

JNJ-73763989 is an investigational small molecule being studied for chronic hepatitis B, chronic hepatitis D, and related conditions. Clinical trials have evaluated it in participants with hepatitis B and hepatitis D, including those co-infected with both viruses, as well as in healthy volunteers and people with renal or hepatic impairment.

Who makes JNJ-73763989?

JNJ-73763989 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company has sponsored multiple clinical trials of this investigational drug across various countries.

What phase is JNJ-73763989 in?

JNJ-73763989 has been studied in Phase 1 and Phase 2 clinical trials. All six trials listed are completed, with no active trials currently enrolling. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is JNJ-73763989 in?

JNJ-73763989 has been studied in six completed trials, including NCT04535544 for hepatitis B and D co-infection, NCT04585789 for chronic hepatitis B, NCT05123599 for virologically suppressed hepatitis B, and NCT05275023 combining it with a PD-1 inhibitor. These trials enrolled a total of 764 participants.

How does JNJ-73763989 work?

JNJ-73763989 is a small molecule therapeutic being investigated for viral hepatitis. The specific molecular target has not been disclosed in the available information, so its precise mechanism of action is not detailed here.

Is JNJ-73763989 the same as JNJ-64300535?

No, JNJ-73763989 and JNJ-64300535 are distinct investigational agents. They have been studied together in combination with nucleos(t)ide analogs in a clinical trial for chronic hepatitis B, but they are separate drugs with different names and properties.