NCT01018238撤回1 期
A Multiple Dose, Randomised, Double-blind, Placebo-controlled, Multiple Site Study of Anti-C5a Receptor Antibody (NNC 0151-0000-0000) in Subjects With Systemic Lupus Erythematosus (SLE)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Observed adverse events
研究概览
简要总结
This trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and signs of bioactivity of increasing repeated doses of NNC 151-0000-0000 in subjects with Systemic Lupus Erythematosus (SLE).
详细描述
The trial was terminated before any patients were exposed to the trial drug based on new findings indicating that dose escalation with multiple doses should be performed in a different trial population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Diagnosis of systemic lupus erythematosus (SLE)
- •Disease duration: 6 months or longer
- •Stable, mild to moderately active systemic lupus erythematosus (SLE)
- •Receiving stable maintenance therapy
排除标准
- •Significant Lupus Nephritis
- •Active central nervous system (CNS) disease
- •Significant arterial or venous thrombosis (blood clots) within 12 months prior to trial start
- •Body weight of 260 lbs/120 kg or more
- •History of alcohol or substance abuse
- •History of cancer
- •Infections
- •Viral infections: HIV, Hepatitis B or C, Epstein-Barr Virus (EBV), Cytomegalovirus (CMV), Varicella-Zoster Virus (VZV), or Herpes Simplex Virus (HSV-1 or HSV-2)
- •Tuberculosis
- •Severe systemic bacterial, viral or fungal infections within the past 12 months prior to trial start
- •Immunosuppressive and immune modulating therapy
研究组 & 干预措施
Placebo arm
Placebo Comparator
干预措施: placebo (Drug)
Cohort 1
Experimental
干预措施: NNC 0151-0000-0000 (Drug)
Cohort 2
Experimental
干预措施: NNC 0151-0000-0000 (Drug)
Cohort 3
Experimental
干预措施: NNC 0151-0000-0000 (Drug)
Cohort 4
Experimental
干预措施: NNC 0151-0000-0000 (Drug)
结局指标
主要结局
Observed adverse events
时间窗: From day -28 to day 113
次要结局
- Number of adverse Events (including injection site reactions)(Every visit through study completion (Day 113))
- Pharmacokinetics: terminal half-life, trough values, serum concentrations(Day 1 through Day 113)
- Pharmacodynamics: levels of serum, plasma, and urine markers, auto-antibodies(Day 1 through Day 113)
- Clinical disease endpoints: Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), British Isles Lupus Assessment Group (BILAG), and Quality of Life by use of SF-36 (QOL)(Day 1 through Day 113)
研究者
研究点 (1)
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