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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 10
- 主要终点
- Percentage of Participants with Abnormalities in Vital Signs
研究概览
简要总结
The purpose of this study is to evaluate safety and tolerability of JNJ-67484703 administrations in participants with active rheumatoid arthritis (RA).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
JNJ-67484703
Participants will receive multiple doses of JNJ-67484703.
干预措施: JNJ-67484703 (Drug)
Placebo
Participants will receive multiple doses of placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants with Abnormalities in Vital Signs
时间窗: Up to 24 weeks
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.
Percentage of Participants with Abnormalities in Physical Examination
时间窗: Up to 24 weeks
Percentage of participants with abnormalities in physical examination will be reported.
Percentage of Participants with Abnormalities in Laboratory Parameters
时间窗: Up to 24 weeks
Percentage of participants with abnormalities in laboratory parameters (hematology, serum chemistry, and urinalysis) will be reported.
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 24 weeks
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.
Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs)
时间窗: Up to 24 weeks
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.
Percentage of Participants with TEAEs by System Organ Class (SOC) with a Frequency Threshold of 5 Percent (%) or More
时间窗: Up to 24 weeks
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.
次要结局
- Percentage of Participants Achieving DAS28-CRP Remission (less than [<] 2.6) at Week 12(Week 12)
- Percentage of Participants with Antibodies to JNJ-67484703 in Participants Receiving Active Study Intervention(Up to 24 weeks)
- Change in Number of T-lymphocyte Populations in Blood(Up to 24 weeks)
- Serum Concentration of JNJ-67484703 Over Time(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 DAS28-CRP Low Disease Activity (<=3.2) at Week 12(Week 12)
- Percentage of Participants Achieving American College of Rheumatology (ACR)20, ACR50, and ACR70 Response(Up to 24 weeks)
- Change in Magnitude and Duration of Cell Surface Expression Level of Receptors(Up to 24 weeks)