A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease. (AEOLUS)

Sanofi

Status and phase: Enrolling; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Dupilumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07053423

U1111-1314-5262 (Registry Identifier)

2025-521268-37 (Registry Identifier)

LPS18583

Details and patient eligibility

About

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.

Enrollment: 218 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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218 participants in 2 patient groups, including a placebo group

Dupilumab

Experimental group

Description:

Subcutaneous injection as per protocol

Treatment:

Drug: Dupilumab

Placebo

Placebo Comparator group

Description:

Subcutaneous injection as per protocol

Treatment:

Drug: Placebo