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

A Phase 1b, Open-label, Single-arm, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Treatment With JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, HBeAg-negative Participants With Chronic Hepatitis B Virus Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of the study intervention based on hepatitis B surface antigen (HBsAg) levels.

Detailed description

JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic hepatitis B virus (HBV) infection via a ribonucleic acid interference (RNAi) mechanism. JNJ-64300535 is a DNA vaccine encoding the core protein and the Polymerase (Pol) protein of HBV. The therapeutic vaccine aims at inducing T-cell-specific immunity against HBV antigens in participants with chronic hepatitis B (CHB). Selected nucleos(t)ide analogs (NAs) used in this study are approved treatments of chronic HBV infection. This study is designed to assess efficacy, safety, and tolerability of a 24-week (Day 1 to Week 24) combination treatment with JNJ-73763989 + NA + JNJ-64300535. The study consists of a Screening phase (4 weeks), Treatment period with JNJ-73763989, NA and JNJ-64300535 (187 days), and a follow-up period (FU Week 1 till FO Week 48). Safety will be assessed by adverse events (AEs), clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations. The total duration of the study is up to 88 weeks (including 4 weeks of screening).

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	JNJ-73763989	JNJ-73763989 injection will be administered subcutaneously.
BIOLOGICAL	JNJ-64300535	JNJ-64300535 deoxyribonucleic acid (DNA) vaccine injection will be administered intramuscularly.
DRUG	ETV monohydrate	ETV monohydrate film-coated tablets will be administered orally.
DRUG	Tenofovir disoproxil	Tenofovir disoproxil film-coated tablets will be administered orally.
DRUG	TAF	TAF film-coated tablets will be administered orally.

Timeline

• Start date: 2021-12-06
• Primary completion: 2023-07-31
• Completion: 2024-06-26
• First posted: 2021-11-17
• Last updated: 2025-05-26

Locations

13 sites across 8 countries: Belgium, France, Italy, New Zealand, Poland, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study