A Study of Cetrelimab in Participants With Chronic Hepatitis B Virus Infection

NCT ID: NCT05242445

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-19
• Study Completion Date: 2023-05-09

Brief Summary

The purpose of the study is to characterize the pharmacokinetic (PK) profile of cetrelimab administered subcutaneous (SC) and optionally intravenous (IV) in chronic hepatitis B (CHB) participants.

Detailed Description

Hepatitis B virus (HBV) is a small deoxyribonucleic acid (DNA) virus that infects the liver and can cause either acute (less than 6 months) or chronic (more than 6 months) infection. Persistence of HBV infection requires antigen-specific immune tolerance that prevents clearance of infected cells. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin (Ig) G4 kappa monoclonal antibody (mAb) that binds to programmed cell death receptor-1 (PD-1) with high affinity and specificity. PD-(L)1 inhibitors could possibly reverse the immune dysfunction from HBV. The study will be conducted in 3 phases: a screening phase (6 weeks), a single dose intervention phase (1 day), and a 24-week follow-up phase. The duration of individual participation will be up to 30 weeks. Key safety assessments include monitoring of Adverse Events (AEs), physical examination, vital signs, Electrocardiogram (ECGs), Injection site reaction (ISRs), Infusion-related reaction (IRRs), and clinical laboratory tests.

Conditions

Hepatitis B, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1: Cetrelimab or Placebo (Dose 1)

Participants will receive cetrelimab Dose 1 or placebo via subcutaneous (SC) injection on Day 1.

Group Type: EXPERIMENTAL

Cetrelimab

Intervention Type: DRUG

Cetrelimab (Dose 1 and Dose 2) will be administered via SC injection or as an IV infusion.

Placebo

Intervention Type: DRUG

Placebo will be administered via SC injection or as an IV infusion.

Cohort 2 (Optional): Cetrelimab or Placebo (Dose 2)

Participants will receive cetrelimab Dose 2 or placebo administered via an Intravenous (IV) infusion on Day 1 based on the data review of previous cohort(s) (safety and tolerability data through at least 6 weeks postdose as well as pharmacokinetic (PK) and receptor occupancy (RO) data through at least day 4 postdose).

Group Type: EXPERIMENTAL

Cetrelimab

Intervention Type: DRUG

Cetrelimab (Dose 1 and Dose 2) will be administered via SC injection or as an IV infusion.

Placebo

Intervention Type: DRUG

Placebo will be administered via SC injection or as an IV infusion.

Cohort 3 (Optional): Cetrelimab or Placebo

Participant will receive cetrelimab or placebo via SC injection based on the data review of previous cohort(s) (safety and tolerability data through at least 6 weeks postdose as well as PK and RO data through at least day 4 postdose).

Group Type: EXPERIMENTAL

Cetrelimab

Intervention Type: DRUG

Cetrelimab (Dose 1 and Dose 2) will be administered via SC injection or as an IV infusion.

Placebo

Intervention Type: DRUG

Placebo will be administered via SC injection or as an IV infusion.

Cohort 4 (Optional): Cetrelimab or Placebo

Participant will receive cetrelimab or placebo via SC injection based on the data review of previous cohorts (safety and tolerability data through at least 6 weeks postdose as well as PK and RO data through at least day 4 postdose).

Group Type: EXPERIMENTAL

Cetrelimab

Intervention Type: DRUG

Cetrelimab (Dose 1 and Dose 2) will be administered via SC injection or as an IV infusion.

Placebo

Intervention Type: DRUG

Placebo will be administered via SC injection or as an IV infusion.

Interventions

Cetrelimab

Cetrelimab (Dose 1 and Dose 2) will be administered via SC injection or as an IV infusion.

Intervention Type: DRUG

Placebo

Placebo will be administered via SC injection or as an IV infusion.

Intervention Type: DRUG

Other Intervention Names

JNJ-63723283

Eligibility Criteria

Inclusion Criteria

• Must have chronic hepatitis B virus (HBV) infection documented
• Participants should be virologically suppressed, Hepatitis Be antigen (HBeAg) status (positive or negative) be on stable Nucleotide analog (NA) treatment for at least 6 months
• Must have: a) A liver biopsy result classified as Metavir F0-F2 within 2 years prior to screening; b) If a liver biopsy result is not available: Fibroscan liver stiffness measurement less than or equal to (<=) to 9.0 kilopascals (kPa) within 6 months prior to screening or at the time of screening
• Must be medically stable
• Must have a body mass index (weight in kilogram [kg] divided by the square of height in meters) between 18.0 and 30.0 kilograms per meter square (kg/m^2), extremes included

Exclusion Criteria

• 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 evidence of liver disease of non-HBV etiology.
• Participants with history or signs of cirrhosis or portal hypertension (nodules, no smooth liver contour, no normal portal vein, spleen size greater than or equal to [>=] 12 centimeters) or signs of hepatocellular carcinoma (HCC) on an abdominal ultrasound performed within 6 months prior to screening or at the time of screening
• History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research and Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research and Development LLC

Locations

SGS Belgium NV

Edegem, , Belgium

Az Sint-Maarten

Mechelen, , Belgium

Hopital Beaujon

Clichy, , France

APHP - Hopital Henri Mondor

Créteil, , France

CHU Grenoble

Grenoble, , France

Hopital Saint-Antoine

Paris, , France

Universitaetsklinikum Essen

Essen, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p.

Gdansk, , Poland

ID Clinic

Mysłowice, , Poland

Hosp. Univ. Marques de Valdecilla

Santander, , Spain

Hosp. Virgen Del Rocio

Seville, , Spain

Hosp. Gral. Univ. Valencia

Valencia, , Spain

Countries

Belgium; France; Germany; Poland; Spain

Other Identifiers

2021-004857-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

63723283HPB1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR109158

Identifier Type: -

Identifier Source: org_study_id