NIPH Clinical Trials Search

A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged >=40 to <=85 Years With Chronic Obstructive Pulmonary Disease.

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Chronic Obstructive Pulmonary Disease
Date of first enrollment	13/03/2026
Target sample size	218
Countries of recruitment	Argentina,Japan,Brazil,Japan,Denmark,Japan,France,Japan,Hungary,Japan,Italy,Japan,Netherlands,Japan,Poland,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,United Kingdom,Japan,United States,Japan
Study type	Interventional
Intervention(s)	Drug: Dupilumab (SAR231893, Dupixent) - Pharmaceutical form:Solution for injection, Route of administration:SC injection Drug: Placebo - Pharmaceutical form:Solution for injection, Route of administration:SC injection Study arm Experimental: Dupilumab - Subcutaneous injection as per protocol Placebo Comparator: Placebo - Subcutaneous injection as per protocol

Outcome(s)

Primary Outcome

1. Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring) [Time Frame: 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

1. Change from baseline to Week 24 in mucus volume for global lung by High-resolution Computed Tomography (HRCT) [Time Frame: Baseline to Week 24] 2. Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC by HRCT [Time Frame: Baseline to Week 24] 3. Change from baseline to Week 24 in airway resistance from R5 to R20 measured by Forced Oscillation Technique (FOT) [Time Frame: Baseline to Week 24] 4. Change from baseline to Week 24 in Reactance area (AX) measured by FOT [Time Frame: Baseline to Week 24] 5. Incidence of Treatment-Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) including potentially clinically significant abnormalities [Time Frame: Baseline to Week 36]

Key inclusion & exclusion criteria

Age minimum	>= 40age old
Age maximum	<= 85age old
Gender	Both
Include 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 (inhaled corticosteroids [ICS] + long acting beta-agonist [LABA] + long acting muscarinic antagonist [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/micro L at screening or with blood eosinophils >=150 cells/micro L at Visit 1 (screening) and with a history of blood eosinophils >=300 cells/micro L within the past year during stable state (non-exacerbation). - Mucus score cutoff of >=3
Exclude 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 alpha-1 anti-trypsin deficiency - Any biologic therapy (including experimental treatments and dupilumab) - Participants on treatment with mucolytics unless on stable therapy for >6 months