Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as JNJ-6379
JNJ-56136379 · 3 trials · 4 indications
Change from baseline in HBsAg levels in currently not treated population at Week 24 based on Hepatitis B e Antigen (HBeAg) status was reported. Currently not treated population defined as participants who didn't receive any hepatitis B virus (HBV) treatment 6 months prior to baseline.
Change from baseline in HBsAg levels in virologically suppressed population at Week 24 based on HBeAg status was reported. Virologically suppressed population defined as participants who were on entecavir (ETV) or tenofovir disoproxil fumarate (TDF) for at least 12 months prior to screening and had HBV deoxyribonucleic acid (DNA) \<60 IU/mL. This outcome measure was planned to be analyzed for specified arms only.
Plasma concentration of oral dose of JNJ-56136379 will be assessed.
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Physical examinations (including body weight measurement and skin examination) will be performed.
Physical examinations (including body weight measurement and skin examination) will be performed.
Vital signs (Supine Blood Pressure \[SBP\], Diastolic Blood Pressure \[DBP\] pulse rate: supine and standing) will be performed.
Vital signs (SBP, DBP pulse rate: supine and standing) will be performed.
The laboratory abnormalities will be determined according to the criteria specified in the World Health Organization (WHO) Toxicity Grading Scale and in accordance with the normal ranges of the clinical laboratory.
The laboratory abnormalities will be determined according to the criteria specified in the World Health Organization (WHO) Toxicity Grading Scale and in accordance with the normal ranges of the clinical laboratory.
Cmax is the Maximum observed plasma concentration.
Cmax is the Maximum observed plasma concentration.
Cmax is the Maximum observed plasma concentration.
AUClast is the area under the curve from time 0 to the time of the last measurable Concentration.
AUClast is the area under the curve from time 0 to the time of the last measurable Concentration.
AUC infinity is the area under the curve from time 0 to infinity.
AUC infinity is the area under the curve from time 0 to infinity.
| Arm | Type | Description |
|---|---|---|
| Part A: Arm 1 (JNJ-56136379 or NA) (open label) | EXPERIMENTAL | Participants with hepatitis B virus (HBV) currently not being treated and receiving JNJ-56136379 tablet (at a lower dose) orally for 24 weeks, will stop further dosing with JNJ-56136379 and start treatment with nucleos(t)ide analog (NA) (entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\]), and enter the 24 week post treatment follow-up phase. |
| Part A: Arm 2 (Placebo+NA [ETV] or [TDF]) | PLACEBO_COMPARATOR | Participants with HBV currently not being treated will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part A: Arm 3 (JNJ-56136379 + NA [ETV or TDF]) | EXPERIMENTAL | Participants with HBV currently not being treated will receive JNJ-56136379 along with NA (ETV or TDF) tablet orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part A: Arm 4 (Placebo + NA [ETV or TDF]) | PLACEBO_COMPARATOR | Virologically suppressed participants will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part A: Arm 5 (JNJ-56136379 + NA [ETV or TDF]) | EXPERIMENTAL | Virologically suppressed participants will receive JNJ-56136379 along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part B: Arm 6 (JNJ-56136379 + NA [ETV or TDF]) (open label) | EXPERIMENTAL | Participants with HBV currently not being treated will receive JNJ-56136379 tablet at a high dose, orally for 24 weeks. The eligible participants may enter the extension phase and will receive JNJ-56136379 along with NA (ETV or TDF) from Week 24 to Week 48. |
| Part B: Arm 7 (placebo + NA [ETV or TDF]) | PLACEBO_COMPARATOR | Participants with HBV currently not being treated will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part B: Arm 8 (JNJ-56136379 + NA [ETV or TDF]) | EXPERIMENTAL | Participants with HBV currently not being treated will receive JNJ-56136379 tablet at a high dose along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part B: Arm 9 (placebo + NA [ETV or TDF]) | PLACEBO_COMPARATOR | Virologically suppressed participants will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part B: Arm 10 (JNJ-56136379 + NA [ETV or TDF]) | EXPERIMENTAL | Virologically suppressed participants will receive JNJ-56136379 tablet at a high dose along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part A: Group 1 | EXPERIMENTAL | Participants with liver cirrhosis with moderate hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition. |
| Part A: Group 2 | EXPERIMENTAL | Participants with normal liver function with no liver cirrhosis will receive a single oral dose of JNJ-56136379 in fed condition. |
| Part B: Group 3 (optional) | EXPERIMENTAL | Participants with liver cirrhosis with mild hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition. |
| Part B: Group 4 (optional) | EXPERIMENTAL | Participants with liver cirrhosis with severe hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition. |
| Part 1: Single Dose Escalation | EXPERIMENTAL | The single dose escalation phase of the study will consist of 6 dosing sessions (Sessions I to VI) evaluated in 2 panels (Panels 1 and 2). The dose of JNJ-56136379 will be consecutively escalated over 5 levels, alternating between the 2 panels. Panel 1 will receive 3 single doses (SD1, SD3 and SD3fed) in Sessions I, III and V, respectively. Panel 2 will receive 3 single doses (SD2, SD4 and SD5) in Sessions II, IV and VI, respectively. There will be a washout period of at least 14 days between consecutive JNJ-56136379/placebo dosing in each individual participant. |
| Part 1: Multiple dose session | EXPERIMENTAL | After completion of the fifth single dose session another panel of healthy participant (panel 3) receive multiple doses of JNJ-56136379 at one dose level (MDx) or placebo for 12 or 19 consecutive days (Session VII) in fed or fasted conditions. |
| Part 2: Multiple dose escalation | EXPERIMENTAL | Multiple dose levels will be given in Panel 4 in Session VIII (European sites), Sessions IX and X (European and/or Asian sites) Session XI (Asian sites) for 28 consecutive days in fed conditions. Optional Sessions A-B-C (Panel 4) used for further dose evaluations at European and/or Asian sites. Per session, participants will receive JNJ 56136379 or placebo. Dose progression to the next multiple dose level may be adapted based on the emerging safety and PK outcome of the previous dosing levels. |
| Name | Type | Description |
|---|---|---|
| JNJ-56136379 | DRUG | Participants will receive JNJ-56136379 tablet orally. |
| Placebo | DRUG | Participants will receive matching placebo tablet orally. |
| NA (ETV or TDF) | DRUG | Participants will receive NA (ETV or TDF) tablet orally as per approved label. |
Inclusion Criteria: * Participants must have a body mass index (weight in kilogram (kg) divided by the square of height in meters) of 18.0 to 35.0 kilogram / square meter (kg/m\^2), extremes included * Participants must have chronic hepatitis B virus infection (CHB) infection documented by: Serum h...
Top 6 of 8 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Gilead Sciences, Inc. | GILD | 3 | PHASE3 | Viread, Tenofovir alafenamide |
| Vir Biotechnology, Inc. | VIR | 6 | PHASE3 | Tobevibart, Elebsiran |
| Bausch Health Companies Inc. | BHC | 1 | PHASE3 | Larsucosterol |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Daplusiran/Tomligisiran, Bepirovirsen |
| Aligos Therapeutics, Inc. | ALGS | 1 | PHASE2 | ALG-000184 |
| Precision BioSciences, Inc. | DTIL | 2 | PHASE1 | PBGENE-HBV |
JNJ-56136379 is an investigational small molecule developed by Johnson & Johnson for chronic hepatitis B and related liver conditions. It has been studied in clinical trials involving participants with chronic hepatitis B virus infection and in volunteers with hepatic impairment. It is not described as an approved medicine and remains in clinical development.
JNJ-56136379 has been studied for chronic hepatitis B virus infection and for hepatic impairment. Trials enrolled adults with chronic hepatitis B as well as healthy participants, including a study evaluating how hepatic impairment affects the drug. The program covers hepatitis B and chronic hepatitis within the gastrointestinal therapeutic area.
Johnson & Johnson develops JNJ-56136379. The company trades on the New York Stock Exchange under the ticker JNJ. The compound is an investigational small molecule in the company's hepatitis B pipeline, studied across multiple countries including the United States, Belgium, Canada, China, France, Germany, Japan and others.
JNJ-56136379 is in clinical development, with Phase 1 and Phase 2 trials completed. A Phase 2 study evaluated efficacy, safety and pharmacokinetics in participants with chronic hepatitis B virus infection, and Phase 1 studies assessed safety, tolerability and pharmacokinetics in healthy participants and those with hepatic impairment.
Completed trials include NCT03361956, a Phase 2 efficacy, safety and pharmacokinetics study in chronic hepatitis B with 232 participants, NCT02662712, a Phase 1 safety and pharmacokinetics study in healthy participants and chronic hepatitis B patients, and NCT04208399, a Phase 1 study of hepatic impairment effects conducted in Germany with 16 participants.