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Hepatitis B, ChronicPhase 1NCT05242445

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

A Phase 1 study testing Cetrelimab in people with Hepatitis B, Chronic, run by Janssen Research & Development, LLC at 13 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
Cetrelimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
11 participants
Where
13 sitesin 5 countries
Study dates
19 Apr 2022to 9 May 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

13 sites in 5 countries.

13 sites in 5 countries

France4 sites

  • Hopital Beaujon

    Clichy, 92110

  • APHP - Hopital Henri Mondor

    Créteil, 94010

  • CHU Grenoble

    Grenoble, 38043

  • Hopital Saint-Antoine

    Paris, 75571

Other trials in France

Spain3 sites

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Hosp. Virgen Del Rocio

    Seville, 41013

  • Hosp. Gral. Univ. Valencia

    Valencia, 46014

Other trials in Spain

Belgium2 sites

  • SGS Belgium NV

    Edegem, 2650

  • Az Sint-Maarten

    Mechelen, 2800

Other trials in Belgium

Germany2 sites

  • Universitaetsklinikum Essen

    Essen, 45147

  • Medizinische Hochschule Hannover

    Hanover, 30625

Other trials in Germany

Poland2 sites

  • PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p.

    Gdansk, 80405

  • ID Clinic

    Mysłowice, 41-400

Other trials in Poland

About this study

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

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.

Read the 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.

Being tested
Cetrelimab, Placebo
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CetrelimabDrug

    Also called JNJ-63723283

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

  • PlaceboDrug

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

Study groups in NCT05242445
Study groupRoleWhat they receive
Cohort 1: Cetrelimab or Placebo (Dose 1)ExperimentalParticipants will receive cetrelimab Dose 1 or placebo via subcutaneous (SC) injection on Day 1.
Receives: Drug: Cetrelimab; Drug: Placebo
Cohort 2 (Optional): Cetrelimab or Placebo (Dose 2)ExperimentalParticipants 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).
Receives: Drug: Cetrelimab; Drug: Placebo
Cohort 3 (Optional): Cetrelimab or PlaceboExperimentalParticipant 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).
Receives: Drug: Cetrelimab; Drug: Placebo
Cohort 4 (Optional): Cetrelimab or PlaceboExperimentalParticipant 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).
Receives: Drug: Cetrelimab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Serum Concentration (Cmax) of Cetrelimab

    Cmax is defined as maximum observed serum concentration of cetrelimab.

    Measured: Up to 24 weeks

  2. 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.

    Measured: Up to 24 weeks

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

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

    Measured: Up to 24 weeks

  4. Total Systemic Clearance of Cetrelimab

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

    Measured: Up to 24 weeks

Secondary outcomes (5)

  1. 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.

    Measured: Baseline up to 30 weeks

  2. 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.

    Measured: Baseline up to 30 weeks

  3. 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.

    Measured: Up to 30 weeks

  4. 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.

    Measured: Up to 30 weeks

  5. 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.

    Measured: Up to 30 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2022
  2. Study start19 Apr 2022
  3. Primary completion9 May 2023
  4. Study completion9 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05242445
Sponsor's protocol ID
CR109158
Other IDs
2021-004857-21, 63723283HPB1001
Status last verified
Jul 2023
First submitted
15 Feb 2022
Last updated
24 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Asselah T, Kakuda TN, Kulke S, Walenta E, Halter RJ, Ariyawansa J, Verheijden S, Lenz O, Aguilar Z, Lonjon-Domanec I, Biermer M. A Randomized, Double-Blind, Placebo-Controlled Study of the PD-1 Inhibitor Cetrelimab in Chronic Hepatitis B. J Viral Hepat. 2026 Nov;33(11):e70246. doi: 10.1111/jvh.70246.

    PubMed 42934895

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cetrelimab in people with Hepatitis B, Chronic, run by Janssen Research & Development, LLC at 13 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France, Spain, Belgium, Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Serum Concentration (Cmax) of Cetrelimab (time frame: Up to 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05242445, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.

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