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

NCT ID: NCT04985812

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-18
• Study Completion Date: 2023-05-18

Brief Summary

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

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

JNJ-67484703

Participants will receive multiple doses of JNJ-67484703.

Group Type: EXPERIMENTAL

JNJ-67484703

Intervention Type: DRUG

Participants will receive JNJ-67484703.

Placebo

Participants will receive multiple doses of placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will receive placebo to JNJ-67484703.

Interventions

JNJ-67484703

Participants will receive JNJ-67484703.

Intervention Type: DRUG

Placebo

Participants will receive placebo to JNJ-67484703.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Pinnacle Research Group, LLC

Anniston, Alabama, United States

GCSP/CIS Orland Park

Orland Park, Illinois, United States

Arensia Exploratory Medicine

Tbilisi, , Georgia

Budai Irgalmasrendi Korhaz

Budapest, , Hungary

Clinexpert Kft

Gyöngyös, , Hungary

CRU Hungary Kft.

Kistarcsa, , Hungary

Arensia Exploratory Medicine

Chisinau, , Moldova

Hosp Univ A Coruna

A Coruña, , Spain

Hosp. Clinico San Carlos

Madrid, , Spain

Hosp. Univ. 12 de Octubre

Madrid, , Spain

ARENSIA Exploratory Medicine Unit

Kiev, , Ukraine

Countries

United States; Georgia; Hungary; Moldova; Spain; Ukraine

References

Ling ITC, Marciniak SJ, Clarke SH, Lakshminarayanan V, Loza MJ, Liva SG, Wang T, Orillion A, Tikhonov I, Noss EH. Safety, tolerability, and efficacy of the PD-1 agonist antibody JNJ-67484703 in adults with active rheumatoid arthritis: results of a multicenter, double-blind, placebo-controlled, randomized, multiple-dose phase Ib study. Ther Adv Musculoskelet Dis. 2025 Oct 21;17:1759720X251385857. doi: 10.1177/1759720X251385857. eCollection 2025.

Reference Type: DERIVED

PMID: 41146691 (View on PubMed)

Other Identifiers

2021-000195-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

67484703ARA1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR109021

Identifier Type: -

Identifier Source: org_study_id