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

NCT05242445 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR1091582021-004857-2163723283HPB1001
• Study Type: interventional
• Target: 11
• Locations: 5 countries
• Sites: 13

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.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (4)

• Maximum Observed Serum Concentration (Cmax) of Cetrelimab

  Cmax is defined as maximum observed serum concentration of cetrelimab.

  Up to 24 weeks

• Area Under the Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of Cetrelimab

  AUC(0-last) is defined as area under the concentration-time curve from time 0 to the time of the last measurable concentration (non-below quantification limit \[non-BQL\]) of cetrelimab as calculated by linear-linear trapezoidal summation.

  Up to 24 weeks

• Apparent Terminal Elimination Half-life (t1/2) of Cetrelimab

  t1/2 is defined as apparent terminal elimination half-life of cetrelimab.

  Up to 24 weeks

• Total Systemic Clearance of Cetrelimab

  Total systemic clearance is a quantitative measure of the rate at which cetrelimab is removed from the body.

  Up to 24 weeks

Secondary Outcomes (5)

• Change from Baseline in HBsAg and HBeAg Levels Over Time

  Baseline up to 30 weeks

• Change from Baseline in Hepatitis B Virus Deoxyribonucleic acid (HBV DNA) Levels Over Time

  Baseline up to 30 weeks

• Number of Participants with Adverse Events (AEs)

  Up to 30 weeks

• Cohorts 1,3 and 4: Number of Participants with Injection Site Reaction (ISR)

  Up to 30 weeks

• Number of Participants with Abnormalities in Clinical Laboratory Tests

  Up to 30 weeks

Study Arms (4)

Cohort 1: Cetrelimab or Placebo (Dose 1)

EXPERIMENTAL

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

Drug: Cetrelimab; Drug: Placebo

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

EXPERIMENTAL

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).

Drug: Cetrelimab; Drug: Placebo

Cohort 3 (Optional): Cetrelimab or Placebo

EXPERIMENTAL

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).

Drug: Cetrelimab; Drug: Placebo

Cohort 4 (Optional): Cetrelimab or Placebo

EXPERIMENTAL

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).

Drug: Cetrelimab; Drug: Placebo

Interventions

Cetrelimab DRUG

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

Also known as: JNJ-63723283

Cohort 1: Cetrelimab or Placebo (Dose 1); Cohort 2 (Optional): Cetrelimab or Placebo (Dose 2); Cohort 3 (Optional): Cetrelimab or Placebo; Cohort 4 (Optional): Cetrelimab or Placebo

Placebo DRUG

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

Cohort 1: Cetrelimab or Placebo (Dose 1); Cohort 2 (Optional): Cetrelimab or Placebo (Dose 2); Cohort 3 (Optional): Cetrelimab or Placebo; Cohort 4 (Optional): Cetrelimab or Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (13)

SGS Belgium NV

Edegem, 2650, Belgium

Location

Az Sint-Maarten

Mechelen, 2800, Belgium

Location

Hopital Beaujon

Clichy, 92110, France

Location

APHP - Hopital Henri Mondor

Créteil, 94010, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

Hopital Saint-Antoine

Paris, 75571, France

Location

Universitaetsklinikum Essen

Essen, 45147, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p.

Gdansk, 80405, Poland

Location

ID Clinic

Mysłowice, 41-400, Poland

Location

Hosp. Univ. Marques de Valdecilla

Santander, 39008, Spain

Location

Hosp. Virgen Del Rocio

Seville, 41013, Spain

Location

Hosp. Gral. Univ. Valencia

Valencia, 46014, Spain

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

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

Study Officials

• Janssen Research and Development, LLC Clinical Trial

  Janssen Research and Development LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 16, 2022
• Study Start: April 19, 2022
• Primary Completion: May 9, 2023
• Study Completion: May 9, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

DE (2); ES (3); FR (4); PL (2); BE (2)