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

NCT05275023 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: CR10916173763989PAHPB20082021-005132-33
• Study Type: interventional
• Target: 37
• Locations: 8 countries
• Sites: 26

Brief 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.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved Hepatitis B Surface Antigen (HBsAg) Seroclearance at Follow-up (FU) Week 24

  Percentage of participants who achieved HBsAg seroclearance at FU Week 24 were reported. Seroclearance of HBsAg was defined as a (quantitative) HBsAg level less than (\<) lower limit of quantification (LLOQ) (0.05 international unit per milliliters \[IU/mL\]).

  At FU Week 24

Secondary Outcomes (19)

• Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) of Special Interest

  IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

• Number of Participants With TEAEs by Severity

  IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

• Number of Participants With Immune Related TEAEs

  IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

• Number of Participants With Abnormalities in Vital Signs

  IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

• Number of Participants With Abnormalities in 12-lead Electrocardiogram (ECGs)

  IP: Week 0 up to Week 24; FU Phase: FU Week 1 up to FU Week 48

Study Arms (2)

Arm 1: JNJ-73763989 + PD-1 Inhibitor + Nucleos(t)ide analog (NA)

EXPERIMENTAL

Participants will receive JNJ-73763989 subcutaneous (SC) injections and single dose of programmed cell death protein receptor-1 (PD-1) inhibitor as intravenous (IV) infusion. Participants will also receive background treatment with NA (either tenofovir disoproxil, tenofovir alafenamide \[TAF\] or entecavir \[ETV\]).

Drug: JNJ-73763989; Drug: PD-1 inhibitor; Drug: Tenofovir Disoproxil; Drug: Tenofovir Alafenamide; Drug: Entecavir

Arm 2: JNJ-73763989 + PD-1 Inhibitor + NA

EXPERIMENTAL

Participants will receive JNJ-73763989 SC injections and multiple doses of PD-1 inhibitor as IV infusion. Participants will also receive background treatment with NA (either tenofovir disoproxil, TAF or ETV).

Drug: JNJ-73763989; Drug: PD-1 inhibitor; Drug: Tenofovir Disoproxil; Drug: Tenofovir Alafenamide; Drug: Entecavir

Interventions

JNJ-73763989 DRUG

JNJ-73763989 will be administered subcutaneously.

Also known as: JNJ-3989

Arm 1: JNJ-73763989 + PD-1 Inhibitor + Nucleos(t)ide analog (NA); Arm 2: JNJ-73763989 + PD-1 Inhibitor + NA

PD-1 inhibitor DRUG

PD-1 inhibitor will be administered as IV infusion.

Arm 1: JNJ-73763989 + PD-1 Inhibitor + Nucleos(t)ide analog (NA); Arm 2: JNJ-73763989 + PD-1 Inhibitor + NA

Tenofovir Disoproxil DRUG

Tenofovir disoproxil film-coated tablets will be administered orally.

Arm 1: JNJ-73763989 + PD-1 Inhibitor + Nucleos(t)ide analog (NA); Arm 2: JNJ-73763989 + PD-1 Inhibitor + NA

Tenofovir Alafenamide DRUG

TAF film-coated tablets will be administered orally.

Arm 1: JNJ-73763989 + PD-1 Inhibitor + Nucleos(t)ide analog (NA); Arm 2: JNJ-73763989 + PD-1 Inhibitor + NA

Entecavir DRUG

ETV film-coated tablets will be administered orally.

Arm 1: JNJ-73763989 + PD-1 Inhibitor + Nucleos(t)ide analog (NA); Arm 2: JNJ-73763989 + PD-1 Inhibitor + NA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must have chronic hepatitis B virus (HBV) infection
• Participants must have fibroscan liver stiffness measurement less than or equal to (\<=) 9.0 kilopascal (kPa) or a liver biopsy result classified as metavir F0-F2

You may not qualify if:

• Participants with evidence of hepatitis A virus infection (hepatitis A antibody immunoglobulin IgM), hepatitis C virus (HCV) infection (HCV antibody), hepatitis D virus (HDV) infection (HDV antibody), hepatitis E virus (HEV) infection (hepatitis E antibody IgM), or human immunodeficiency virus type 1 (HIV-1) or human immunodeficiency virus type 2 (HIV-2) infection (laboratory confirmed) at screening
• History or evidence of clinical signs or symptoms of hepatic decompensation, including but not limited to portal hypertension, ascites, hepatic encephalopathy, esophageal varices
• Participants with history or signs of cirrhosis or portal hypertension or signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities
• Participants with personal/familial history/indicative of immune-mediated disease risk

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (26)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

IKEM

Prague, 140 21, Czechia

Location

Hopital Beaujon

Clichy, 92110, France

Location

Hopital Saint Joseph

Marseille, 13008, France

Location

Chu Rennes Hopital Pontchaillou

Rennes, 35000, France

Location

CHRU Nancy Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano

Milan, 20122, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56124, Italy

Location

Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma

Rome, 00161, Italy

Location

Hosp Univ Vall D Hebron

Barcelona, 8035, Spain

Location

Hosp. Univ. Pta. de Hierro Majadahonda

Madrid, 28222, Spain

Location

Hosp. Montecelo

Pontevedra, 36071, Spain

Location

Hosp. Gral. Univ. Valencia

Valencia, 46014, Spain

Location

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

E-DA Hospital

Kaohsiung City, 824, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

Hacettepe University Medical Faculty

Ankara, 06230, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

Ege University Medical Faculty

Izmir, 35040, Turkey (Türkiye)

Location

Kocaeli University Medical Faculty

Kocaeli, 41001, Turkey (Türkiye)

Location

Karadeniz Teknik University Medical Faculty

Trabzon, 61080, Turkey (Türkiye)

Location

Glasgow Royal Infirmary

Glasgow, G31 2ER, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Imperial College London and Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Immune Checkpoint Inhibitors; Tenofovir; tenofovir alafenamide; entecavir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Per protocol amendment 2 (28 Mar 2023), due to difficulties in recruitment, further participants enrollment was stopped. Hence, pharmacokinetic assessments were not performed due to change in planned analysis.

Results Point of Contact

• Title: Executive Medical Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 11, 2022
• Study Start: June 30, 2022
• Primary Completion: December 12, 2023
• Study Completion: May 31, 2024
• Last Updated: April 25, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

TW (4); TU (5); CA (1); IT (3); CZ (2); FR (4); ES (4); GB (3)