A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Mucus Plugging and Other Lung Imaging Parameters in Patients With Chronic Obstructive Pulmonary Disease.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 218
- 试验地点
- 90
- 主要终点
- Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring)
研究概览
简要总结
LPS18583 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study with 2 treatment groups. The purpose of this study is to assess the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling including mucus plugging and its association with improvement on lung function, exacerbations, and quality of life improvement in participants aged 40 years of age up to 85 years of age (inclusive).
Study details include:
The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The number of visits will be 9.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD) who meet the following criteria at screening:
- •Current or former smokers with a smoking history of ≥10 pack-years
- •Moderate-to-severe COPD (post-BD FEV1/FVC ratio <0.70 and post-BD FEV1 % predicted >30% and ≤70%)
- •Medical Research Council Dyspnea Scale grade ≥2 or COPD assessment test (CAT) score ≥10
- •Global Initiative for Chronic Obstructive Lung Disease (GOLD) category E , Frequent or severe exacerbations
- •Background triple therapy (ICS + LABA + LAMA) for 3 months before randomization with a stable dose of medication for ≥1 month before Visit 1; dual therapy (LABA + LAMA) allowed if ICS is contraindicated
- •Evidence of Type 2 inflammation: Participants with blood eosinophils ≥300 cells/μL at screening or with blood eosinophils ≥150 cells/μL at Visit 1 (screening) and with a history of blood eosinophils ≥300 cells/μL within the past year during stable state (non-exacerbation).
- •Mucus score cutoff of ≥3
排除标准
- •A current diagnosis of asthma according to the Global Initiative for Asthma diagnostic (GINA) guidelines, or documented history of asthma
- •Significant pulmonary disease other than COPD (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts
- •Treatment with oxygen >4.0 L/min for ≥8 hours/day Respiratory tract infection within 4 weeks before screening, or during the screening period
- •Diagnosis of α-1 anti-trypsin deficiency
- •Any biologic therapy (including experimental treatments and dupilumab)
- •Participants on treatment with mucolytics unless on stable therapy for >6 months
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Placebo
Subcutaneous injection as per protocol
干预措施: Placebo (Drug)
Dupilumab
Subcutaneous injection as per protocol
干预措施: Dupilumab (Drug)
结局指标
主要结局
Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring)
时间窗: Baseline to Week 24
The score is calculated by counting the number of bronchopulmonary segments which on CT scans contain at least one mucus plugs. The score ranges from 0 up to a maximum score of 18 corresponding to the 18 bronchopulmonary segments present in most people. In this system, a mucus plug is defined as a complete occlusion of the airway imaged at Total Lung Capacity (TLC). Higher scores indicate worse outcome.
次要结局
- Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC by HRCT(Baseline to Week 24)
- Change from baseline to Week 24 in mucus volume for global lung by High-resolution Computed Tomography (HRCT)(Baseline to Week 24)
- Change from baseline to Week 24 in airway resistance from R5 to R20 measured by Forced Oscillation Technique (FOT)(Baseline to Week 24)
- Change from baseline to Week 24 in Reactance area (AX) measured by FOT(Baseline to Week 24)
- Incidence of Treatment-Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) including potentially clinically significant abnormalities(Baseline to Week 36)