Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05275023 | 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 | PHASE2 | COMPLETED | 37 | — | — | Jun 30, 2022 | May 31, 2024 | Apr 25, 2025 | 26 | Canada, Czechia +6 |
| NCT04667104 | 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 | PHASE2 | COMPLETED | 48 | — | — | Feb 1, 2021 | Apr 17, 2023 | Jul 3, 2024 | 11 | Japan, New Zealand +2 |
| NCT04439539 | 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 | PHASE2 | COMPLETED | 54 | — | — | Sep 14, 2020 | Feb 13, 2024 | Jun 24, 2025 | 47 | United States, Canada +8 |
| NCT04129554 | 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 | PHASE2 | COMPLETED | 130 | — | — | Nov 6, 2019 | Jun 9, 2022 | Feb 4, 2025 | 41 | Belgium, France +5 |
| NCT03982186 | A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection | PHASE2 | COMPLETED | 471 | — | — | Aug 1, 2019 | Apr 26, 2022 | Feb 4, 2025 | 108 | United States, Belgium +17 |
| NCT05123599 | A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection | PHASE1 | COMPLETED | 24 | — | — | Dec 6, 2021 | Jun 26, 2024 | May 26, 2025 | 13 | Belgium, France +6 |
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 \[IU/mL\]).
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.
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 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 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 IU/mL in HBsAg levels from baseline to Week 36 will be reported.
| Arm | Type | Description |
|---|---|---|
| Arm 1: JNJ-73763989 + PD-1 Inhibitor + Nucleos(t)ide analog (NA) | EXPERIMENTAL | Participants 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 + NA | EXPERIMENTAL | Participants 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). |
| Treatment Period (TP) 1 (JNJ-73763989 + Nucleos(t)ide Analog)+ TP 2 (TP 1+PegIFN-alpha2a) | EXPERIMENTAL | Participants 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. |
| Cohort 1: Participants Enrolled Prior to Protocol Amendment 5 is in Effect | EXPERIMENTAL | During 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 Effect | EXPERIMENTAL | Following 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+ NA | EXPERIMENTAL | Participants 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+ NA | PLACEBO_COMPARATOR | Participants 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 + NA | EXPERIMENTAL | Participants 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 + NA | EXPERIMENTAL | Participants 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 + NA | EXPERIMENTAL | Participants 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 + NA | EXPERIMENTAL | Participants 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 + NA | EXPERIMENTAL | Participants 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 + NA | PLACEBO_COMPARATOR | Participants 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) | EXPERIMENTAL | Participants 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. |
| Name | Type | Description |
|---|---|---|
| JNJ-73763989 | DRUG | JNJ-73763989 will be administered subcutaneously. |
| PD-1 inhibitor | DRUG | PD-1 inhibitor will be administered as IV infusion. |
| Tenofovir Disoproxil | DRUG | Tenofovir disoproxil film-coated tablets will be administered orally. |
| Tenofovir Alafenamide | DRUG | TAF film-coated tablets will be administered orally. |
| Entecavir | DRUG | ETV film-coated tablets will be administered orally. |
| Tenofovir alafenamide (TAF) | DRUG | TAF film-coated tablet will be administered orally once daily. |
| Entecavir (ETV) monohydrate | DRUG | ETV monohydrate film-coated tablet will be administered orally once daily. |
| PegIFN-alpha2a | DRUG | PegIFN-alpha2a injection will be administered subcutaneously once weekly. |
| PegIFN-alpha-2a | DRUG | PegIFN-alpha-2a injection will be administered subcutaneously. |
| JNJ-56136379 | DRUG | JNJ-56136379 will be administered orally. |
| Placebo for JNJ-73763989 | DRUG | Matching placebo for JNJ-73763989 will be administered as subcutaneous injection up to 48 weeks. |
| Placebo for JNJ-56136379 | DRUG | Matching placebo for JNJ-56136379 tablets will be administered orally up to 48 weeks. |
| Tenofovir disoproxil fumarate (TDF) | DRUG | TDF will be administered orally once daily up to 48 weeks as NA treatment. |
| Nucleos(t)ide Analog (NA) | DRUG | NA treatment that is either of ETV, TDF or TAF tablets will be administered orally. |
| JNJ-64300535 | BIOLOGICAL | JNJ-64300535 deoxyribonucleic acid (DNA) vaccine injection will be administered intramuscularly. |
| ETV monohydrate | DRUG | ETV monohydrate film-coated tablets will be administered orally. |
| TAF | DRUG | TAF film-coated tablets will be administered orally. |
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...