NCT01955603已完成1 期
A Randomised, Placebo-controlled, Double-blind Within Cohort, Dose Escalation, Multiple-dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered Subcutaneously to Subjects With Moderate to Severe Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0215-0384 administered to subjects with moderate to severe rheumatoid arthritis (RA) concomitantly treated with methotrexate (MTX).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age between 18 and 75 years (both years inclusive), for Russia only: Age between 18-65 years (both years inclusive)
- •Moderate to severe RA, confirmed by a Disease Activity Score based on 28 joints and C-reactive protein (DAS28 (CRP)) equal to or above 4.5 and a minimum of five tender and five swollen joints based on a 28 joint count (a joint can score as both tender and swollen)
- •MTX (10-25 mg/week both inclusive) for at least 16 weeks, with an unchanged dose for at least 6 weeks prior to screening and until randomisation
- •Females who are not of child-bearing potential must have been post-menopausal for at least 1 year confirmed by follicle-stimulating hormone (FSH) equal to or above 26.7 U/L or be surgically sterile
排除标准
- •Past or current inflammatory joint disease other than RA (e.g. gout [crystal proven], psoriatic arthritis, juvenile idiopathic arthritis, reactive arthritis or Lyme disease
- •Any active or ongoing chronic infectious disease (e.g. chronic osteomyelitis, chronic pyelonephritis) within 4 weeks prior to randomisation
- •Clinically significant cardiac or cardiovascular disease
- •Past or current malignancy
- •Evaluation of tuberculosis screening indicative of latent or active tuberculosis (TB)
研究组 & 干预措施
Dose level 1
Experimental
干预措施: NNC0215-0384 (Drug)
Dose level 1
Experimental
干预措施: placebo (Drug)
Dose level 2
Experimental
干预措施: NNC0215-0384 (Drug)
Dose level 2
Experimental
干预措施: placebo (Drug)
Dose level 3
Experimental
干预措施: NNC0215-0384 (Drug)
Dose level 3
Experimental
干预措施: placebo (Drug)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: From first dosing until 19 weeks after first dosing
次要结局
- Concentration of NNC0215-0384 in serum(3 days after first and last dose)
- Incidence and characterisation of antibodies directed against NNC0215-0384 and, if present, their in vitro neutralising activity(From first dosing until 19 weeks after first dosing)
- Duration of full and duration of detectable levels of C5a receptor (C5aR) occupancy by NNC0215-0384 on neutrophils from baseline(From week 0 until 19 weeks after first dosing)
- Change in health assessment questionnaire - disability index (HAQ-DI) from baseline(Week 0, week 7 first dosing)
研究者
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