NCT01629667终止2 期
A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults With Idiopathic Pulmonary Fibrosis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 409
- 试验地点
- 45
- 主要终点
- Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52
研究概览
简要总结
To study the safety and effectiveness of multiple-doses of tralokinumab on pulmonary function in adults with mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a chronic, progressive, irreversible, and usually fatal lung disease of unknown cause.
详细描述
The primary objective of this study is to determine the effect of multiple doses of tralokinumab on pulmonary function in adults with mild to moderate IPF
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
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IPF diagnosis for <= 5 years prior to Visit 1 (screening). Confirmation of diagnosis of IPF in accordance is required for subject inclusion 2) Confirmed diagnosis of IPF by clinical characteristics, HRCT and surgical lung biopsy (if required) 3)Mild to moderate IPF to include all of the following at screening:
- •FVC >= 50% predicted normal
- •Partial pressure of oxygen in arterial blood (PaO2) of >= 55 mmHg on room air or 50 mmHg at high altitude (> 1500 meters), or oxygen saturation by pulse oximetry (SpO2) of >= 90%on room air at rest
- •Hemoglobin-corrected diffusion capacity for carbon monoxide (DLCO) >= 30% predicted normal 4) Be able to walk >= 100 meters unassisted
排除标准
- •A FEV1/FVC ratio less than 0.70 at the time of screening (postbronchodilator)
- •The extent of emphysema on the HRCT is greater than the extent of fibrosis.
- •Currently listed for lung transplantation
- •Use of the following medications:
- •Immunosuppressive medications (eg, methotrexate, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid) within 3 months prior to Visit 1 (screening). Oral prednisone <= 15 mg/day (or equivalent oral corticosteroid) is allowed for chronic use if subject was on a stable dose at least 30 days prior to Visit 1 (screening)
- •Pirfenidone within 4 weeks prior to Visit 1 (screening)
- •N-acetylcysteine within 4 weeks prior to Visit 1 (screening)
- •Live attenuated vaccines within 4 weeks prior to Visit 1 (screening)
结局指标
主要结局
Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52
时间窗: Baseline and Week 52
Forced vital capacity (FVC) is a standard pulmonary function test used to monitor disease progression in IPF. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) \* 100%.
次要结局
- Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events(From the start of study treatment through Week 88)
- Percentage of Participants With Disease Progression(Week 52 and 72)
- Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72(Baseline, Week 52 and 72)
- Change From Baseline in Lung Volumes Through Week 72(Baseline, Week 52 and 72)
- Percentage of Participants With Adjudicated Hospitalization(Week 52 and 72)
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72(Baseline, Week 52 and 72)
- Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72(Baseline, Week 52 and 72)
- Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events(From the start of study treatment through Week 88)
- Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72(Baseline, Week 52 and 72)
- Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68(Baseline and Week 68)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)(From the start of study treatment through Week 88)
- Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events(From the start of study treatment through Week 88)
- Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations(Week 52 and 72)
- Percentage of Participants With Adjudicated Mortality(Week 52 and 72)
- Change From Baseline in Percent-predicted FEV1 Through Week 72(Baseline, Week 52 and 72)
- Number of Participants With Clinical Global Impression of Severity Scores(Week 72)
- Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 72(Baseline and Week 72)
- Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF)(Week 72)
- Number of Participants With Clinical Global Impression of Change Scores(Week 72)
- Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score at Week 72(Baseline and Week 72)
- Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72(Baseline, Week 52 and 72)
- Change From Baseline in European Quality of Life-5-Dimension 3 Level Version (EQ-5D-3L) (Including Visual Analog Scale [VAS]) at Week 72(Baseline and Week 72)
- Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF)(Week 72)
- Mean Serum Concentration of Tralokinumab(Predose, 0 hour, and 2 hour postdose on Week 0; predose on Week 4, 48, 72, 82 and 88)
- Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab(From the start of study treatment through Week 88)
研究者
研究点 (45)
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