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

NCT04985812 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR1090212021-000195-1067484703ARA1001
• Study Type: interventional
• Target: 44
• Locations: 6 countries
• Sites: 11

Brief Summary

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)

  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)

  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

  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

  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

  Percentage of participants with abnormalities in physical examination will be reported.

  Up to 24 weeks

• Percentage of Participants with Abnormalities in Laboratory Parameters

  Percentage of participants with abnormalities in laboratory parameters (hematology, serum chemistry, and urinalysis) will be reported.

  Up to 24 weeks

Secondary Outcomes (8)

• Serum Concentration of JNJ-67484703 Over Time

  Up to 24 weeks

• Percentage of Participants with Antibodies to JNJ-67484703 in Participants Receiving Active Study Intervention

  Up to 24 weeks

• Change from Baseline in Disease Activity Index Score 28 using C-reactive Protein (DAS28-CRP) at Week 12

  Baseline, Week 12

• Percentage of Participants Achieving American College of Rheumatology (ACR)20, ACR50, and ACR70 Response

  Up to 24 weeks

• Percentage of Participants Achieving DAS28-CRP Remission (less than [<] 2.6) at Week 12

  Week 12

Study Arms (2)

JNJ-67484703

EXPERIMENTAL

Participants will receive multiple doses of JNJ-67484703.

Drug: JNJ-67484703

Placebo

PLACEBO COMPARATOR

Participants will receive multiple doses of placebo.

Drug: Placebo

Interventions

JNJ-67484703 DRUG

Participants will receive JNJ-67484703.

JNJ-67484703

Placebo DRUG

Participants will receive placebo to JNJ-67484703.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (11)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

GCSP/CIS Orland Park

Orland Park, Illinois, 60467, United States

Location

Arensia Exploratory Medicine

Tbilisi, 0112, Georgia

Location

Budai Irgalmasrendi Korhaz

Budapest, 1023, Hungary

Location

Clinexpert Kft

Gyöngyös, 3200, Hungary

Location

CRU Hungary Kft.

Kistarcsa, 2143, Hungary

Location

Arensia Exploratory Medicine

Chisinau, MD-2025, Moldova

Location

Hosp Univ A Coruna

A Coruña, 15006, Spain

Location

Hosp. Clinico San Carlos

Madrid, 28040, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

ARENSIA Exploratory Medicine Unit

Kiev, 2000, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 41146691 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: August 2, 2021
• Study Start: October 18, 2021
• Primary Completion: May 18, 2023
• Study Completion: May 18, 2023
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

ES (3); US (2); HU (3); MO (1); GE (1); UA (1)