A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
Investigating Airway Inflammation in Chronic Obstructive Pulmonary Disease (COPD) Patients with Investigational Medication
Study Overview
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.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Chronic Obstructive Pulmonary Disease
-
Age: 40 years - 85 years
-
Gender: All
Inclusion Criteria:
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
Exclusion Criteria:
- 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 purpose of this study is to investigate airway inflammation in individuals with Chronic Obstructive Pulmonary Disease (COPD). This study will compare the effects of an investigational medication and a placebo on airway inflammation, resistance, and remodeling, which includes mucus plugging. It will also examine how these factors relate to lung function, exacerbations, and quality of life in participants aged 40 to 85 years.
Participants will be randomly assigned to receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study involves taking the medication subcutaneously, meaning it is injected under the skin. Participants will undergo various assessments to measure airway inflammation, lung function, and quality of life.
- Who can participate: Participants aged 40 to 85 years with a diagnosis of COPD can join. Eligibility includes being a current or former smoker with a history of at least 10 pack-years, moderate-to-severe COPD, and evidence of Type 2 inflammation, while on a stable dose of COPD medication.
- Study details: Participants will take the investigational medication or placebo through subcutaneous injections. They will undergo tests to assess airway inflammation, lung function, and quality of life. The placebo used is an inactive substance that resembles the investigational medication but contains no active ingredients.
- Study timelines and visits: The study will last up to 40 weeks. The study requires 9 visits.