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

Recruiting at 14 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

44 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

This trial is testing JNJ-67484703, a specially designed antibody, in people with active rheumatoid arthritis. The treatment aims to help the immune system stop attacking its own tissues, which can reduce inflammation and symptoms.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

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

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

Treatment Details

Interventions

• JNJ-67484703

Participant Groups

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+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires