A Study of JNJ-67484703 in Participants With Active Rheumatoid Arthritis

May 22, 2025 updated by: Janssen Research & Development, LLC

A Multicenter, Double-blind, Placebo-controlled, Randomized, Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of JNJ-67484703 in Participants With Active Rheumatoid Arthritis

The purpose of this study is to evaluate safety and tolerability of JNJ-67484703 administrations in participants with active rheumatoid arthritis (RA).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

JNJ-67484703 is a humanized immunoglobulin G1 kappa (huIgG1κ) antibody that is being developed as a treatment for systemic autoimmune disorders. The primary hypothesis of this study is that treatment with JNJ-67484703 as compared to placebo will result in a similar tolerability and safety profile, as a measure of participants with abnormalities in vital signs, physical examinations, and laboratory safety tests. This study will be conducted in 3 phases: screening phase (up to 6 weeks), treatment phase (up to 10 weeks), and follow-up phase (up to 14 weeks). The duration of study participation will be approximately 30 weeks. Safety assessment like electrocardiogram (ECG), adverse events will be performed during the study. Efficacy assessment like joint assessments, pain assessments, RA joint pain severity assessment, patient's and physician's global assessment of disease activity, health assessment questionnaires, duration of morning stiffness, functional assessment of chronic illness therapy-fatigue will be performed during the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Georgia
      • Tbilisi, Georgia, 0112
        • ARENSIA Exploratory Medicine
  • Hungary
      • Budapest, Hungary, 1023
        • Budai Irgalmasrendi Korhaz
      • Gyöngyös, Hungary, 3200
        • Clinexpert Kft
      • Kistarcsa, Hungary, 2143
        • CRU Hungary Kft.
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, MD-2025
        • ARENSIA Exploratory Medicine
  • Spain
      • A Coruna, Spain, 15006
        • Hosp Univ A Coruna
      • Madrid, Spain, 28040
        • Hosp. Clinico San Carlos
      • Madrid, Spain, 28041
        • Hosp. Univ. 12 de Octubre
  • Ukraine
      • Kiev, Ukraine, 2000
        • ARENSIA Exploratory Medicine Unit
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group, LLC
    • Illinois
      • Orland Park, Illinois, United States, 60467
        • GCSP/CIS Orland Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Demonstrated an inadequate response to, or loss of response or intolerance to: at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) and/or up to 2 biologic DMARD (bDMARD)/targeted synthetic DMARD (tsDMARD)
  • Have C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligrams per deciliter (mg/dL) at screening
  • Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
  • Have a diagnosis of rheumatoid arthritis (RA) (American College of Rheumatology [ACR]/ European League Against Rheumatism [EULAR] criteria 2010)
  • Body weight within the range of 50.0 kilograms (kg) to 120.0 kg, inclusive, and have a body mass index (BMI) of 19.0 kilograms per meter square (kg/m^2) to 32.0 kg/m^2, inclusive
  • All women must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening

Exclusion Criteria:

  • Known allergies, hypersensitivity, or intolerance to any biologic medication or excipients of JNJ-67484703
  • Has a diagnosed or reported history or current signs or symptoms indicating severe, progressive, or uncontrolled hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
  • Have other known inflammatory diseases that might confound the evaluations of benefit from JNJ-67484703 therapy
  • Have a history of any clinically significant adverse reaction to murine or chimeric proteins, including, but not limited to, allergic reactions
  • Have a history of or currently have felty's syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: JNJ-67484703
Participants will receive multiple doses of JNJ-67484703.
Drug: JNJ-67484703
Participants will receive JNJ-67484703.
Placebo Comparator: Placebo
Participants will receive multiple doses of placebo.
Drug: Placebo
Participants will receive placebo to JNJ-67484703.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to 24 weeks
An adverse event (AEs) 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. TEAEs are AEs with onset during the treatment phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Up to 24 weeks
Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs)
Time Frame: Up to 24 weeks
A serious adverse event based on International Council for Harmonization (ICH) and European Union (EU) guidelines on pharmacovigilance for medicinal products for human use is any untoward medical occurrence that at any dose: a) results in death; b) is life-threatening (the participant was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it were more severe.); c) requires inpatient hospitalization or prolongation of existing hospitalization; d) results in persistent or significant disability/incapacity; e) Is a congenital anomaly/birth defect; f) is a suspected transmission of any infectious agent via a medicinal product.
Up to 24 weeks
Percentage of Participants with TEAEs by System Organ Class (SOC) with a Frequency Threshold of 5 Percent (%) or More
Time Frame: Up to 24 weeks
Percentage of participants with TEAEs by SOC with a frequency threshold of 5% or more by study intervention will be reported. TEAEs are AEs with onset during the treatment phase or that are a consequence of a pre-existing condition that has worsened since baseline.
Up to 24 weeks
Percentage of Participants with Abnormalities in Vital Signs
Time Frame: Up to 24 weeks
Percentage of participants with abnormalities in vital signs (temperature [oral or tympanic], pulse/heart rate, respiratory rate and blood pressure [systolic and diastolic]) will be reported.
Up to 24 weeks
Percentage of Participants with Abnormalities in Physical Examination
Time Frame: Up to 24 weeks
Percentage of participants with abnormalities in physical examination will be reported.
Up to 24 weeks
Percentage of Participants with Abnormalities in Laboratory Parameters
Time Frame: Up to 24 weeks
Percentage of participants with abnormalities in laboratory parameters (hematology, serum chemistry, and urinalysis) will be reported.
Up to 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum Concentration of JNJ-67484703 Over Time
Time Frame: Up to 24 weeks
Serum concentration of JNJ-67484703 over time will be reported using a validated, specific, and sensitive method.
Up to 24 weeks
Percentage of Participants with Antibodies to JNJ-67484703 in Participants Receiving Active Study Intervention
Time Frame: Up to 24 weeks
Percentage of participants with antibodies to JNJ-67484703 in participants receiving active study intervention will be reported.
Up to 24 weeks
Change from Baseline in Disease Activity Index Score 28 using C-reactive Protein (DAS28-CRP) at Week 12
Time Frame: Baseline, Week 12
DAS28-CRP is a derived score combining tender joints (28 joints), swollen joints (28 joints), CRP, and patient's global assessment of disease activity (GH). The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP)1, MCP2, MCP3, MCP4, MCP5, proximal interphalangeal (PIP)1, PIP2, PIP3, PIP4, PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. Scores below 3.2 indicate best disease control and scores above 5.1 indicate worse disease control.
Baseline, Week 12
Percentage of Participants Achieving American College of Rheumatology (ACR)20, ACR50, and ACR70 Response
Time Frame: Up to 24 weeks
ACR responses are presented as numerical measurement of improvement in multiple disease assessment criteria. For example, ACR20 response is defined as percent improvement of 20 or higher from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), combined with a percent improvement of 20 or higher from baseline in 3 of the following 5 assessments: patient's assessment of pain by visual analog scale (VAS), patient's global assessment of disease activity by VAS, physician's global assessment of disease activity by VAS, patient's assessment of physical function measured by health assessment questionnaire-disability index (HAQ-DI, a 20-question instrument assessing 8 functional areas), and CRP. ACR50 and ACR70 are similarly defined except percent improvement threshold from baseline is 50 and 70, respectively.
Up to 24 weeks
Percentage of Participants Achieving DAS28-CRP Remission (less than [<] 2.6) at Week 12
Time Frame: Week 12
Percentage of participants achieving DAS28-CRP remission < 2.6 at Week 12 will be reported.
Week 12
Percentage of Participants Achieving DAS28-CRP Low Disease Activity (<=3.2) at Week 12
Time Frame: Week 12
Percentage of participants achieving DAS28-CRP low disease activity (defined as DAS28-CRP less than or equal to [<=] 3.2) at week 12 will be reported.
Week 12
Change in Number of T-lymphocyte Populations in Blood
Time Frame: Up to 24 weeks
Change in number of T-lymphocytes in blood will be reported. T-lymphocyte populations in blood will be assessed by flow cytometry.
Up to 24 weeks
Change in Magnitude and Duration of Cell Surface Expression Level of Receptors
Time Frame: Up to 24 weeks
Change in magnitude and duration of cell surface expression level of receptors will be assessed by flow cytometry will be reported.
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR109021
  • 2021-000195-10 (EudraCT Number)
  • 67484703ARA1001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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