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

Phase 2 Completed 37 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2022-06-30
Primary completion: 2023-12-12
Completion: 2024-05-31

Outcome

Missed primary endpoint

paper None achieved the primary endpoint of hepatitis B surface antigen seroclearance at 24-week follow-up PMID 42320551 ↗

Publications

Asselah T, Fung SK, Akhan S, Chuang WL, Buti M, Brunetto M, Agarwal K, Diba C, Jezorwski J, Berger V, T'jollyn H, Tsou WI, Kakuda TN, Lonjon-Domanec I, Nalpas C, Guinard-Azadian C, Verbinnen T, Lathouwers E, De Creus A, Lenz O, Biermer M. No Impact of Low-Dose Nivolumab Addition to JNJ-73763989 on Hepatitis B Surface Antigen Declines in Chronic Hepatitis B: The OCTOPUS-1 Study. Clin Gastroenterol Hepatol. 2026 Jun 19:S1542-3565(26)00471-4. doi: 10.1016/j.cgh.2026.06.018. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	JNJ-73763989	Small interfering RNA (siRNA)	200 mg	Subcutaneous
Subject	Nivolumab	Monoclonal antibody	0.3 mg/kg	Intravenous
Background	Entecavir	Small molecule	—	Oral
Background	Tenofovir disoproxil fumarate	Small molecule	—	Oral
Background	tenofovir alafenamide	Small molecule	—	Oral