A Clinical Study to evaluate the effects of a Combination of JNJ-73763989, Nucleos(t)ide Analogs, and a PD-1 inhibitor in Chronic Hepatitis B Patients.

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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005132-33-FR

Enrollment

Registered

2022-02-09

Start date

2022-04-11

Completion date

Unknown

Last updated

2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B Virus Infection MedDRA version: 20.1 Level: PT Classification code 10008910 Term: Chronic hepatitis B System Organ Class: 10021881 - Infections and infestations

Interventions

Product Code: JNJ-73763989 Pharmaceutical Form: Solution for injection INN or Proposed INN: Not yet assigned Current Sponsor code: JNJ-73763989 Other descriptive name: JNJ-73763989 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A01. Adult male or female participants =18 (or the legal age of consent in the jurisdiction in which the study is taking place) to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: A01. Participants with evidence of hepatitis A virus infection, HCV infection, hepatitis D virus infection, hepatitis E virus infection, or HIV-1 or HIV-2 infection at screening. A02. Participants with evidence of hepatic decompensation at any time point prior to or at the time of screening. M03. History or evidence of clinical signs or symptoms of hepatic decompensation. M04. Participants with evidence of liver disease of non-HBV etiology. A05. Participants with history or signs of cirrhosis or portal hypertension or signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities. Please refer to the study protocol for a full list of exclusion criteria.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate efficacy of the study intervention, based on HBsAg levels at FU Week 24.;Secondary Objective: 1. To characterize the safety and tolerability of the study intervention. 2. To evaluate efficacy in terms of changes in HBsAg levels from baseline over time during the study intervention and follow-up periods. 3. To evaluate efficacy in terms of HBsAg seroclearance/seroconversion during the study intervention and follow-up periods. 4. To evaluate the efficacy as measured by blood markers during the study intervention and follow-up period. 5. To evaluate the frequency of virologic breakthrough throughout the study. 6. To evaluate the pharmacokinetics of JNJ-3989 and optionally of NA and/or nivolumab.;Primary end point(s): Proportion of participants who achieve HBsAg seroclearance at FU Week 24.;Timepoint(s) of evaluation of this end point: Week 24.	—

Measure

Time frame

Main Objective: To evaluate efficacy of the study intervention, based on HBsAg levels at FU Week 24.;Secondary Objective: 1. To characterize the safety and tolerability of the study intervention. 2. To evaluate efficacy in terms of changes in HBsAg levels from baseline over time during the study intervention and follow-up periods. 3. To evaluate efficacy in terms of HBsAg seroclearance/seroconversion during the study intervention and follow-up periods. 4. To evaluate the efficacy as measured by blood markers during the study intervention and follow-up period. 5. To evaluate the frequency of virologic breakthrough throughout the study. 6. To evaluate the pharmacokinetics of JNJ-3989 and optionally of NA and/or nivolumab.;Primary end point(s): Proportion of participants who achieve HBsAg seroclearance at FU Week 24.;Timepoint(s) of evaluation of this end point: Week 24.

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Secondary

Measure	Time frame
Secondary end point(s): 1a. Proportion of participants who experienced AEs of interest. 1b. Safety profile of JNJ-3989 with nivolumab throughout the study. 2a. Change from baseline in HBsAg levels during the study intervention and follow-up periods. 2b. Proportion of participants with HBsAg levels below/above different cut-offs over time. 3a. Proportion of participants with HBsAg seroclearance/seroconversion during the study intervention and follow-up periods. 3b. Time to achieve HBsAg seroclearance/seroconversion. 4a. Change from baseline in HBV DNA levels during the study intervention and follow-up periods. 4b. Proportion of participants with HBV DNA and HBeAg levels below/above different cut-offs over time. 5. Proportion of participants with virological breakthrough throughout the study. 6a. PK parameters of JNJ-3989. 6b. Optionally, PK parameters of NA and/or nivolumab.;Timepoint(s) of evaluation of this end point: Throughout the duration of the study.	—

Measure

Time frame

Secondary end point(s): 1a. Proportion of participants who experienced AEs of interest. 1b. Safety profile of JNJ-3989 with nivolumab throughout the study. 2a. Change from baseline in HBsAg levels during the study intervention and follow-up periods. 2b. Proportion of participants with HBsAg levels below/above different cut-offs over time. 3a. Proportion of participants with HBsAg seroclearance/seroconversion during the study intervention and follow-up periods. 3b. Time to achieve HBsAg seroclearance/seroconversion. 4a. Change from baseline in HBV DNA levels during the study intervention and follow-up periods. 4b. Proportion of participants with HBV DNA and HBeAg levels below/above different cut-offs over time. 5. Proportion of participants with virological breakthrough throughout the study. 6a. PK parameters of JNJ-3989. 6b. Optionally, PK parameters of NA and/or nivolumab.;Timepoint(s) of evaluation of this end point: Throughout the duration of the study.

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Countries

Canada, Czechia, France, Italy, Malaysia, Russian Federation, Spain, Taiwan, Turkey, United Kingdom

Contacts

Public ContactClinical Registry Group

Janssen-Cilag International N.V.

ClinicalTrialsEU@its.jnj.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026