NCT04985812

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	JNJ-67484703	Participants will receive JNJ-67484703.
DRUG	Placebo	Participants will receive placebo to JNJ-67484703.

Timeline

• Start date: 2021-10-18
• Primary completion: 2023-05-18
• Completion: 2023-05-18
• First posted: 2021-08-02
• Last updated: 2025-05-23

Locations

11 sites across 6 countries: United States, Georgia, Hungary, Moldova, Spain, Ukraine

Regulatory

• FDA-regulated drug study