NCT01031836已完成2 期
A Phase II, Multicenter, Open-Label, Dose-Escalation Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Japanese Patients Who Have Systemic Lupus Erythematosus (SLE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants in Each Category of Adverse Events (AE) in Stage II
研究概览
简要总结
The purpose of the study is to evaluate the safety and tolerability of MEDI-545 in Japanese adult SLE patients. This will be done by collecting the data from 3 cohorts of IV doses and 1 cohort of SC doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have previously met ≥4 of the 11 revised ACR criteria
- •Have positive antinuclear antibody test (ANA) at ≥1:80 serum dilute in the past or at screening
- •Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG index at screening, or have a SELENA-SLEDAI score ≥6
排除标准
- •Have received prednisone >20 mg/day (or an equivalent dose of another oral corticosteroid) within 14 days before Visit 2 (Day 1)
- •Have received the following medications within 28 days before Visit 2 (Day 1):
- •Systemic cyclophosphamide at any dose
- •Cyclosporine at any dose
- •Tacrolimus at any dose
- •Thalidomide at any dose
- •Mycophenolate mofetil >2 g/day
- •Methotrexate >15 mg/week
- •Azathioprine >2 mg/kg/day
- •Women who have a positive pregnancy test (serum hCG) at Visit 1
研究组 & 干预措施
MEDI-545 1.0 mg/kg
Experimental
Cohort 1
干预措施: MEDI-545 (Drug)
MEDI-545 3.0 mg/kg
Experimental
Cohort 2
干预措施: MEDI-545 (Drug)
MEDI-545 10.0 mg/kg
Experimental
Cohort 3
干预措施: MEDI-545 (Drug)
MEDI-545 100 mg
Experimental
Cohort 4
干预措施: MEDI-545 (Drug)
MEDI-545 600 mg
Experimental
Cohort 5
干预措施: MEDI-545 600 (Drug)
MEDI-545 1,200 mg
Experimental
Cohort 6
干预措施: MEDI-545 (Drug)
结局指标
主要结局
Number of Participants in Each Category of Adverse Events (AE) in Stage II
时间窗: Stage II (1 year to 3.5 years after first dose)
Number of Participants With Each Category of Adverse Events in Stage I
时间窗: Stage I (up to 1 year)
次要结局
- Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I(After first dose in Stage I (0 upto 28 days))
- AUC0-14 of MEDI-545 After First Dose in Stage I(After first dose in Stage I)
- Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I(Stage I)
- Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I(After first dose in Stage I)
- Change From Baseline in 21-gene Signature Fold Change in Stage I(Stage I)
研究者
研究点 (1)
Loading locations...
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