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

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Janssen

Status and phase

Completed
Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Drug: Placebo
Drug: JNJ-67484703

Study type

Interventional

Funder types

Industry

Identifiers

NCT04985812
67484703ARA1001 (Other Identifier)
CR109021
2021-000195-10 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment

44 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

44 participants in 2 patient groups, including a placebo group

JNJ-67484703
Experimental group
Description:
Participants will receive multiple doses of JNJ-67484703.
Treatment:
Drug: JNJ-67484703
Placebo
Placebo Comparator group
Description:
Participants will receive multiple doses of placebo.
Treatment:
Drug: Placebo

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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