JNJ-67484703 for Rheumatoid Arthritis

No longer recruiting at 16 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Must be taking: Dmards

Must not be taking: Biologics

Disqualifiers: Severe hepatic, renal, cardiac, others

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called JNJ-67484703 to determine its safety and tolerability for people with active rheumatoid arthritis (RA), a condition where the immune system attacks the joints, causing pain and swelling. Participants will receive either the new treatment or a placebo, which is a harmless inactive substance resembling the real treatment. The trial seeks individuals who have tried other RA medications without sufficient relief or could not tolerate them. Those with RA who have struggled to find an effective treatment might find this trial suitable. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have had an inadequate response to certain medications, which might imply that some changes to your current treatment could be necessary.

Is there any evidence suggesting that JNJ-67484703 is likely to be safe for humans?

Research shows that JNJ-67484703 has been tested for safety in people with rheumatoid arthritis. Previous studies found this treatment to be generally safe and well-tolerated. Some participants experienced side effects, but these were usually mild and did not require stopping the treatment. The most common side effects were minor reactions. As this treatment remains in early testing stages, more safety information is being collected, but the results so far are promising. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about JNJ-67484703 for rheumatoid arthritis because it offers a novel approach by targeting specific pathways involved in inflammation that current treatments may not address. Unlike traditional options like methotrexate or TNF inhibitors, JNJ-67484703 is designed to precisely inhibit certain proteins responsible for immune system overactivity, potentially leading to more effective symptom control. This targeted action may also reduce the risk of broad immune suppression, which is a common side effect with existing therapies.

What evidence suggests that JNJ-67484703 might be an effective treatment for rheumatoid arthritis?

Research shows that JNJ-67484703, which participants in this trial may receive, can reduce rheumatoid arthritis (RA) symptoms over 12 weeks compared to a placebo. It targets and reduces a specific type of immune cell, helping to lower the harmful inflammation seen in RA. Earlier studies linked it to a decrease in inflammation markers in the joints. These early results suggest it could effectively manage RA symptoms, offering hope for further development and testing. ^{1 2 3 5 6}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Exclusion Criteria

You have had or currently have a medical condition called Felty's syndrome.

Known allergies, hypersensitivity, or intolerance to any biologic medication or excipients of JNJ-67484703

Have a history of any clinically significant adverse reaction to murine or chimeric proteins, including, but not limited to, allergic reactions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 6 weeks

Treatment

Participants receive multiple doses of JNJ-67484703 or placebo for rheumatoid arthritis

Up to 10 weeks

Regular visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 14 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-67484703

How Is the Trial Designed?

Group I: JNJ-67484703 Experimental Treatment 1 Intervention

Participants will receive multiple doses of JNJ-67484703.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive multiple doses of placebo.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41146691/

Safety, tolerability, and efficacy of the PD ... JNJ-67484703 reduced symptoms of RA over 12 weeks compared with placebo. The results from this study support additional larger clinical studies ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496725015158

POS0094 PHARMACODYNAMIC ACTIVITY OF JNJ- ... In RA, but not SjD or UC, 3 mg/kg JNJ-67484703 was associated with a reduction in PD1hi Tfh/Tph in target tissue and other parameters of tissue inflammation, ...

3. jnjmedicalconnect.com jnjmedicalconnect.com/media/attestation/congresses/immunology/2025/eular/safety-tolerability-and-activity-of-jnj67484703-in-participants-with-active-rheumatoid-arthritis-res.pdf

Safety, Tolerability, and Activity of JNJ-67484703 in ... JNJ-67484703 is a humanized IgG1k antibody that agonizes and depletes PD-1+ T cells, potentially reducing aberrant inflammatory responses in autoimmune ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04985812

NCT04985812 | A Study of JNJ-67484703 in Participants ... The purpose of this study is to evaluate safety and tolerability of JNJ-67484703 administrations in participants with active rheumatoid arthritis (RA).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12553887/

Safety, tolerability, and efficacy of the ... Infections occurred in 20.0% of participants in each JNJ-67484703 treatment group and in 21.4% of participants in the placebo group. Urinary tract infections ( ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496725020102

POS0597 SAFETY, TOLERABILITY, AND ACTIVITY OF ... The primary objective to characterize the safety and tolerability of JNJ-67484703 was assessed by number of treatment-emergent adverse events (TEAEs) and other ...