A Phase 2 Open-label Trial to Evaluate Safety, Efficacy, Tolerability, and Pharmacodynamics of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs, and a PD-1 Inhibitor in Chronic Hepatitis B Patients (OCTOPUS-1)
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- STATUS
- Recruiting
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- End date
- May 29, 2024
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- participants needed
- 44
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- sponsor
- Janssen Research & Development, LLC
Summary
The purpose of this study is to evaluate efficacy of the study intervention, based on hepatitis B surface antigen (HBsAg) levels at follow-up (FU) Week 24.
Description
JNJ-73763989 (JNJ-3989) is a small interfering ribonucleic acid (siRNA) targeting all hepatitis B virus (HBV) messenger ribonucleic acid (mRNAs). The programmed cell death protein receptor-1 (PD-1) inhibitor aims at preventing the interaction of PD-1 with its ligands. The purpose of this study to determine whether at least one of the combination regimens of JNJ-3989 + PD-1 inhibitor + Nucleos(t)ide analog (NA) is more efficacious than JNJ-3989 + NA treatment. This study will be conducted in 3 periods: screening period, treatment period and follow-up (FU) period. Safety assessments will include adverse events (AEs), serious AEs, clinical safety laboratory tests, electrocardiograms (ECGs), vital signs, and physical examinations. Total duration of individual participation will be up to 78 weeks (including screening period).
Details
| Condition | Hepatitis B, Chronic |
|---|---|
| Treatment | Entecavir, Tenofovir disoproxil, Tenofovir alafenamide, PD-1 Inhibitor, JNJ-73763989 |
| Clinical Study Identifier | NCT05275023 |
| Sponsor | Janssen Research & Development, LLC |
| Last Modified on | 18 October 2022 |
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