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

Primary Purpose

Hepatitis B, Chronic

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Cetrelimab
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hepatitis B, Chronic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • SGS Belgium NV
  • Az Sint-Maarten
  • Hopital Beaujon
  • APHP - Hopital Henri Mondor
  • CHU Grenoble
  • Hopital Saint-Antoine
  • Universitaetsklinikum Essen
  • Medizinische Hochschule Hannover
  • PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p.
  • ID Clinic
  • Hosp. Univ. Marques de Valdecilla
  • Hosp. Virgen Del Rocio
  • Hosp. Gral. Univ. Valencia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

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

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).

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).

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).

Outcomes

Primary Outcome Measures

Maximum Observed Serum Concentration (Cmax) of Cetrelimab
Cmax is defined as maximum observed serum concentration of cetrelimab.
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.
Apparent Terminal Elimination Half-life (t1/2) of Cetrelimab
t1/2 is defined as apparent terminal elimination half-life of cetrelimab.
Total Systemic Clearance of Cetrelimab
Total systemic clearance is a quantitative measure of the rate at which cetrelimab is removed from the body.

Secondary Outcome Measures

Change from Baseline in HBsAg and HBeAg Levels Over Time
Change from baseline in Hepatitis B surface antigen (HBsAg), Hepatitis Be antigen (HBeAg) levels over time will be reported.
Change from Baseline in Hepatitis B Virus Deoxyribonucleic acid (HBV DNA) Levels Over Time
Change from baseline in HBV DNA levels over time will be reported.
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Cohorts 1,3 and 4: Number of Participants with Injection Site Reaction (ISR)
Number of Participants with ISR will be reported. An ISR is any adverse reaction at a subcutaneous (SC) study intervention injection-site.
Number of Participants with Abnormalities in Clinical Laboratory Tests
Number of participants with abnormalities in clinical laboratory tests (including hematology, serum chemistry and urinalysis) will be reported.

Full Information

First Posted
February 15, 2022
Last Updated
July 21, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05242445
Brief Title
A Study of Cetrelimab in Participants With Chronic Hepatitis B Virus Infection
Official Title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Single Doses of Cetrelimab (JNJ 63723283), an Anti-PD-1 Monoclonal Antibody, in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 19, 2022 (Actual)
Primary Completion Date
May 9, 2023 (Actual)
Study Completion Date
May 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: Cetrelimab or Placebo (Dose 1)
Arm Type
Experimental
Arm Description
Participants will receive cetrelimab Dose 1 or placebo via subcutaneous (SC) injection on Day 1.
Arm Title
Cohort 2 (Optional): Cetrelimab or Placebo (Dose 2)
Arm Type
Experimental
Arm Description
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).
Arm Title
Cohort 3 (Optional): Cetrelimab or Placebo
Arm Type
Experimental
Arm Description
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).
Arm Title
Cohort 4 (Optional): Cetrelimab or Placebo
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Cetrelimab
Other Intervention Name(s)
JNJ-63723283
Intervention Description
Cetrelimab (Dose 1 and Dose 2) will be administered via SC injection or as an IV infusion.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered via SC injection or as an IV infusion.
Primary Outcome Measure Information:
Title
Maximum Observed Serum Concentration (Cmax) of Cetrelimab
Description
Cmax is defined as maximum observed serum concentration of cetrelimab.
Time Frame
Up to 24 weeks
Title
Area Under the Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of Cetrelimab
Description
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.
Time Frame
Up to 24 weeks
Title
Apparent Terminal Elimination Half-life (t1/2) of Cetrelimab
Description
t1/2 is defined as apparent terminal elimination half-life of cetrelimab.
Time Frame
Up to 24 weeks
Title
Total Systemic Clearance of Cetrelimab
Description
Total systemic clearance is a quantitative measure of the rate at which cetrelimab is removed from the body.
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in HBsAg and HBeAg Levels Over Time
Description
Change from baseline in Hepatitis B surface antigen (HBsAg), Hepatitis Be antigen (HBeAg) levels over time will be reported.
Time Frame
Baseline up to 30 weeks
Title
Change from Baseline in Hepatitis B Virus Deoxyribonucleic acid (HBV DNA) Levels Over Time
Description
Change from baseline in HBV DNA levels over time will be reported.
Time Frame
Baseline up to 30 weeks
Title
Number of Participants with Adverse Events (AEs)
Description
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time Frame
Up to 30 weeks
Title
Cohorts 1,3 and 4: Number of Participants with Injection Site Reaction (ISR)
Description
Number of Participants with ISR will be reported. An ISR is any adverse reaction at a subcutaneous (SC) study intervention injection-site.
Time Frame
Up to 30 weeks
Title
Number of Participants with Abnormalities in Clinical Laboratory Tests
Description
Number of participants with abnormalities in clinical laboratory tests (including hematology, serum chemistry and urinalysis) will be reported.
Time Frame
Up to 30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research and Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research and Development LLC
Official's Role
Study Director
Facility Information:
Facility Name
SGS Belgium NV
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Az Sint-Maarten
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
APHP - Hopital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU Grenoble
City
Grenoble CEDEX 9
ZIP/Postal Code
38043
Country
France
Facility Name
Hopital Saint-Antoine
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p.
City
Gdansk
ZIP/Postal Code
80405
Country
Poland
Facility Name
ID Clinic
City
Myslowice
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hosp. Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hosp. Gral. Univ. Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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