A Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of AMG 557 in Systemic Lupus Erythematosus (SLE) Subjects With Active Lupus Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory tests, ECGs, and the incidence of binding and neutralizing antibodies to AMG 557.
研究概览
简要总结
This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus arthritis.
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
- Quadruple (Participant, Care Provider, 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
- •Diagnosis of SLE for at least 6 months as defined by the most recent American College of Rheumatology criteria
- •Presence of lupus related inflammatory arthritis with at least four tender and four swollen joints; and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) ≥ 6 at screening;
- •Other inclusion criteria may apply.
排除标准
- •Presence or history of vasculitis, and presence or history of active lupus nephritis requiring therapy within the last 3 years
- •Any disorder (including psychiatric), condition, clinically significant disease, disease activity related to SLE
- •Positive for HIV antibodies, hepatitis B surface antigen or anti-HBc, or hepatitis C antibodies
- •Known residential exposure to an individual with tuberculosis or positive Quantiferon test or PPD test at screening
- •Men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study
- •Other exclusion criteria may apply
研究组 & 干预措施
AMG 557
All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155.
干预措施: AMG 557 (Drug)
AMG 557 Matching Placebo
All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155.
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory tests, ECGs, and the incidence of binding and neutralizing antibodies to AMG 557.
时间窗: 330 days, including a 21-day screening period
Lupus Arthritis Response Rate
时间窗: Day 169
Defined by: 1) achieving at least a 50% decrease in the combined tender and swollen joint count compared to baseline at Day 169; 2) achieving one letter improvement in the Musculoskeletal System BILAG at Day 169 compared to baseline; 3) reduction in and maintenance of prednisone (or its equivalent) dose to ≤ 50% of baseline corticosteroid dose (Day 1 predose) or ≤ 7.5 mg/day, whichever is lower, from Day 85 to Day 169 in subjects not treated with immunosuppressants at baseline, or reduction in and maintenance of prednisone (or its equivalent) dose to ≤ 7.5 mg/day from Day 85 to Day 169 and discontinuation of immunosuppressants by Day 29 in subjects treated with immunosuppressants at baseline
次要结局
- Proportion of subjects achieving a) one letter improvement; and b) 'C' or better score in the Musculoskeletal system from BILAG index at Day 169 compared to baseline, by treatment group.(Day 169)
- Percentage change in the tender and swollen joint counts at Day 169 relative to baseline.(Day 169)
- Proportion of subjects achieving reduction in and maintenance of prednisone (or its(Days 85-169)
- Subject Global Assessment of Disease Activity (SGADA).(330 days, including a 21-day screening period)
- Serum PK profile of AMG 557 after multiple dose administrations.(330 days, including a 21-day screening period)
- Proportion of subjects who discontinued immunosuppressants by Day 29 in subjects(Day 29)
- Cumulative dose of prednisone (or its equivalent) from Day 85 to Day 169.(Day 85 to Day 169)
- Proportion of subjects achieving reduction in and maintenance ≤ 7.5 mg/day of prednisone (or equivalent) from Day 85- Day 169 and discontinuation of immunosuppressants by Day 29 in subjects treated with immunosuppressants at baseline.(Days 85-169)
- Physician Global Assessment of Disease Activity (PGADA).(330 days, including a 21-day screening period)