A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) by Severity and Serious Adverse Events (SAEs) Through Week 16
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of JNJ-56022473 following multiple subcutaneous (SC) study agent administrations in subjects with Systemic Lupus Erythematosus (SLE) and to determine whether premedication with corticosteroids is required to improve the tolerability of SC JNJ-56022473.
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
- Double (Participant, Investigator)
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
- •Subject must have a body weight in the range of 40 to 100 kilogram (kg), inclusive, and have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2), inclusive, at screening
- •Subjects eligible for enrollment in this study must qualify as follows: a) must meet Systemic Lupus International Collaborating Clinics (SLICC) criteria for diagnosis of lupus and b) must have at least one non-serologic clinical activity defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) within 3 months prior to first study agent administration
- •Have a positive gene signature score during screening, prior to first administration of study agent
- •Subjects using allowed pre-existing lupus treatments, if stable for at least 6 weeks prior to the first dose of study medication:
- •oral corticosteroids equivalent to an average dose up to or equal to (<=) 10 milligram (mg) of prednisone/day
- •use of antimalarials (such as chloroquine or hydroxychloroguine) for at least 8 weeks
- •maximum of 1 non-corticosteroid immunosuppressive drug
排除标准
- •Subject with history or suspected occurrence of drug-induced systemic lupus erythematosus (SLE)
- •Subject has unstable lupus nephritis and/ or has active Central nervous system (CNS) lupus or history of severe CNS lupus, including but not limited to seizures, psychosis, transverse myelitis, CNS vasculitis and optic neuritis
- •Major surgery prior to, and, if planned, during and shortly after the study is not eligible
- •Subject has or has had an acute illness, including a common cold, within 2 weeks prior to the study agent administration or has had a major illness or hospitalization within 4 months prior to the screening visit
- •Any other inflammatory diseases that might confound the evaluations of efficacy are excluded
研究组 & 干预措施
Part A: JNJ-56022473 or Placebo (4:1)
Subjects will receive 3 subcutaneous (SC) administrations of the same dose level of JNJ-56022473 Dose 1, Dose 2, or Dose 3 or placebo every 2 weeks (in the ratio of 4:1 [4 active: 1 placebo]).
干预措施: JNJ-56022473 (Drug)
Part A: JNJ-56022473 or Placebo (4:1)
Subjects will receive 3 subcutaneous (SC) administrations of the same dose level of JNJ-56022473 Dose 1, Dose 2, or Dose 3 or placebo every 2 weeks (in the ratio of 4:1 [4 active: 1 placebo]).
干预措施: Placebo (Drug)
Part B: JNJ-56022473 or Placebo (5:1)
Subjects will receive 3 SC administrations of the same dose level of JNJ-56022473 or placebo every 2 weeks (in the ratio of 5:1 [5 active: 1 placebo]). The dose level(s) will be based upon an interim analysis (IA) of the Part A data.
干预措施: JNJ-56022473 (Drug)
Part B: JNJ-56022473 or Placebo (5:1)
Subjects will receive 3 SC administrations of the same dose level of JNJ-56022473 or placebo every 2 weeks (in the ratio of 5:1 [5 active: 1 placebo]). The dose level(s) will be based upon an interim analysis (IA) of the Part A data.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) by Severity and Serious Adverse Events (SAEs) Through Week 16
时间窗: Up to 16 weeks
Percentage of Subjects With Grade 1, Grade 2, and Grade 3 Systemic Administration-Related Reactions (SARR) After Drug Administration
时间窗: Up to 16 weeks
次要结局
- Serum Concentration of JNJ-56022473(Up to 16 weeks)
- Number of Subjects With Presence of Anti-JNJ-56022473 Antibodies(Up to 16 weeks)
- Gene Expression Measured in Whole Blood by Quantitative Polymerase Chain Reaction (qPCR)(Up to 38 weeks)
- Counts of Target Cells(Up to 38 weeks)