Phase 2
Completed N=130
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, Chronic
Source: ClinicalTrials.gov NCT04129554 ↗
Enrolled (actual)
130
Serious AEs
5.4%
Results posted
Jul 2024
Primary outcomePrimary: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 72 Without Restarting NA Treatment — 0.0; 0.0 Percentage of participants
Summary
The purpose of this study is to evaluate the efficacy of 48-week study intervention with JNJ-73763989+JNJ-56136379+nucleos(t)ide analog (NA) regimen compared to NA alone assessed by HBsAg levels. This study is part of HepB Wings Platform Trial (PLATFORMPAHPB2001).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 72 Without Restarting NA Treatment |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) |
85.9; 80.0 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) |
3.5; 8.9 | — |
| SECONDARY Percentage of Participants With HBsAg Seroclearance at Week 48 |
0; 0 | — |
| SECONDARY Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Less Than (<) Lower Limit of Quantification (LLOQ) at Week 48 |
97.3; 100 | — |
| SECONDARY Percentage of Participants With HBsAg Seroclearance at Week 96 (48 Weeks After Stopping All Study Interventions at Week 48 Without Restarting NA Treatment) |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance |
23.9; 3.6; 64.8; 64.3 | — |
| SECONDARY Percentage of Participants With HBsAg Seroconversion at Week 96 |
0; 0 | — |
| SECONDARY Change From Baseline in HBsAg Values at Weeks 48, 72, and 96 |
-1.89; -0.06; -1.76; -0.25; -1.46; -0.49 | — |
| SECONDARY Change From Baseline in HBV DNA Values at Weeks 48, 72, and 96 |
— | — |
| SECONDARY Time to Achieve First HBsAg Seroclearance |
NA; NA | — |
| SECONDARY Percentage of Participants With Reduction of More Than (>) 1 log10 IU/mL in HBsAg Levels From Baseline |
81.5; 12.5 | — |
| SECONDARY Percentage of Participants With HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96 |
71.1; 2.4; 67.1; 10.3; 46.9; 15.0 | — |
| SECONDARY Percentage of Participants With HBV DNA Levels Less Than (<) LLOQ From Baseline up to Week 96 (End of Study) |
23.9; 3.6 | — |
| SECONDARY Percentage of Participants With Flares |
38.7; 25.0; 24.0; 30.0; 8.0; 10.0 | — |
| SECONDARY Percentage of Participants With Virologic Breakthrough |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants Requiring NA Re-Treatment During Follow-up |
9.1; 26.8 | — |
| SECONDARY Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline Characteristics |
0.2860; 0.1746; 0.2381; 0.4324; -0.9970; -0.5923 | — |
| SECONDARY Observed Plasma Concentration at Predose (C[Predose]) of JNJ-73763976 (Molecule of JNJ-73763989) |
NA | — |
| SECONDARY Maximum Observed Analyte Concentration (Cmax) of JNJ-73763976 (Molecule of JNJ-73763989) |
1111 | — |
| SECONDARY Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763976 (Molecule of JNJ-73763989) |
6.00 | — |
| SECONDARY Observed Plasma Concentration at 24 Hour Postdose (C[24h]) of JNJ-73763976 (Molecule of JNJ-73763989) |
275 | — |
| SECONDARY Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-73763976 (Molecule of JNJ-73763989) |
17833 | — |
| SECONDARY Maximum Observed Analyte Concentration (Cmax) of JNJ-73763976 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (Cmax[Dose Normalized]) |
8.34 | — |
| SECONDARY Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours of JNJ-73763976 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (AUC[0-24h], Dose Normalized) |
134 | — |
| SECONDARY Observed Plasma Concentration at Predose (C[Predose]) of JNJ-73763924 (Molecule of JNJ-73763989) |
NA | — |
| SECONDARY Maximum Observed Analyte Concentration (Cmax) of JNJ-73763924 (Molecule of JNJ-73763989) |
222 | — |
| SECONDARY Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763924 (Molecule of JNJ-73763989) |
5.07 | — |
| SECONDARY Observed Plasma Concentration at 24 Hour Postdose (C[24h]) of JNJ-73763924 (Molecule of JNJ-73763989) |
35.0 | — |
| SECONDARY Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hour (AUC[0-24h]) of JNJ-73763924 (Molecule of JNJ-73763989) |
3386 | — |
| SECONDARY Maximum Observed Analyte Concentration (Cmax) of JNJ-73763924 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (Cmax[Dose Normalized]) |
3.33 | — |
| SECONDARY Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours of JNJ-73763924 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (AUC[0-24h], Dose Normalized) |
50.8 | — |
| SECONDARY Observed Plasma Concentration at Predose (C[Predose]) of JNJ-56136379 |
10812 | — |
| SECONDARY Maximum Observed Analyte Concentration (Cmax) of JNJ-56136379 |
14754 | — |
| SECONDARY Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-56136379 |
4.00 | — |
| SECONDARY Observed or Predicted Concentration at the End of a Dosing Interval (Ctau) of JNJ-56136379 |
12763 | — |
| SECONDARY Area Under the Analyte Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCtau) of JNJ-56136379 |
282458 | — |
Eligibility Criteria
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 e (antigen) (HBeAg)-negative on stable nucleotide analogue (NA) treatment for at least 24 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 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
- History or signs of cirrhosis or portal hypertension (nodules, no smooth liver contour, no normal portal vein, spleen size ≥12 cm) or 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
- Known allergies, hypersensitivity, or intolerance to JNJ-73763989 and JNJ-56136379 or their excipients or to 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
Data sourced from ClinicalTrials.gov (NCT04129554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.