A Phase 2, Multicenter, Double-Blind Within Cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of Multiple Doses of CAT-354 (Tralokinumab) in Japanese Patients With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 37
- 试验地点
- 5
- 主要终点
- Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events
研究概览
简要总结
The purpose of the study is to evaluate the safety and tolerability of multiple-doses of tralokinumab in Japanese patients with Idiopathic Pulmonary Fibrosis.
详细描述
This is a phase II, multicenter, blinded within cohort, dose-escalation study to evaluate the safety and tolerability of two ascending doses of tralokinumab in Japanese patients aged ≥ 50 years with mild to moderate Idiopathic Pulmonary Fibrosis.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures
- •Confirmed IPF diagnosis for ≤ 5 years prior to Visit 1 (screening). Confirmation of diagnosis of IPF
- •Mild to moderate IPF to include all of the following at Visit 1
- •FVC ≥ 50% and ≤ 90% predicted normal
- •Partial pressure of oxygen in arterial blood (PaO2) of ≥ 55 mmHg on room air, or oxygen saturation by pulse oximetry (SpO2) of ≥ 90% on room air at rest
- •Hemoglobin-corrected diffusion capacity for carbon monoxide (DLCO) ≥ 30% and ≤ 90% predicted normal
排除标准
- •History of clinically significant environmental exposure (eg, domestic and occupational) to a known cause of pulmonary fibrosis
- •Diagnosis of connective tissue disease or drug toxicity as the likely cause of the interstitial disease
- •A suspected IPF exacerbation not fully resolved and treatment completed ≤ 14 days prior to Visit 1
- •A suspected IPF exacerbation during the screening period
- •A FEV1/FVC ratio < 0.70 at the time of Visit 1 (postbronchodilator)
- •The extent of emphysema on the HRCT is greater than the extent of fibrosis
结局指标
主要结局
Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events
时间窗: From baseline to Week 48 (treatment-emergent only)
Adverse events and serious adverse events using the Safety Population. Other variables used for the safety assessments include electrocardiogram, vital signs, and routine laboratory assessments. These variables as well as their changes from baseline will be summarized descriptively.
次要结局
- Serum Tralokinumab Concentration Data(From baseline to Week 48 (Week 0 [post-dose, within +5 minutes after end of infusion], Week 4 [pre-dose], Week 12 [pre-dose]. Week 28, Week 40, Week 48))
- Immunogenecity(From baseline to Week 48)