A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT07053423
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 218
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dupilumab Dupilumab Subcutaneous injection as per protocol Placebo Placebo Subcutaneous injection as per protocol
- Primary Outcome Measures
Name Time Method Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring) 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.
- Secondary Outcome Measures
Name Time Method 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