NCT01559090已完成2 期
A Phase 2, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Intravenous Dose of MEDI-546, a Human Monoclonal Antibody Directed Against Type I Interferon Receptor (IFNAR), in Japanese Subjects With Active 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
- 17
- 试验地点
- 1
- 主要终点
- Overall Summary of Adverse Events
研究概览
简要总结
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.
详细描述
A phase 2, multicenter, open-label, dose-escalation study to evaluate the safety and tolerability of intravenous dose of MEDI-546, a human monoclonal antibody directed against type I interferon receptor (IFNAR), in Japanese subjects with active systemic lupus erythematosus (SLE)
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE.
- •Weight greater than or equal to 40.0 kg.
- •Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing treatment or observation for ≥ 24 weeks prior to screening.
- •Currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives.
- •Active moderate to severe SLE disease based on SLE disease activity score.
排除标准
- •Active severe or unstable neuropsychiatric SLE.
- •Active severe SLE-driven renal disease or unstable renal disease.
- •Clinically significant active infection including ongoing and chronic infections.
- •Known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus infection or splenectomy that predisposes the subject to infection.
- •Confirmed positive tests for hepatitis B or positive test for hepatitis C.
研究组 & 干预措施
1
Experimental
MEDI-546 100 mg IV
干预措施: MEDI-546 (Drug)
2
Experimental
MEDI-546 300 mg IV
干预措施: MEDI-546 (Drug)
3
Experimental
MEDI-546 1000 mg IV
干预措施: MEDI-546 (Drug)
结局指标
主要结局
Overall Summary of Adverse Events
时间窗: Stage I (up to 48 weeks)
次要结局
- Pharmacokinetic Parameters of MEDI-546 After Single Dose: Cmax(Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29)
- Pharmacokinetic Parameters of MEDI-546 After Single Dose: AUClast(Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29)
- Anti-drug Antibody (ADA)(Stage I (up to Week 48))
研究者
研究点 (1)
Loading locations...
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