A study to investigate airway inflammation with dupilumab subcutaneously in participants aged ≥40 to ≤85 years with chronic obstructive pulmonary disease.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi-Aventis Recherche & Developpement

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

25 Nov 2025 → ongoing

Decision date (initial)

2025-10-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi-Aventis Recherche & Developpement

External identifiers

EU CT number

2025-521268-37-00

WHO UTN

U1111-1314-5262

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

To evaluate the effect of dupilumab compared to placebo at Week 24 on mucus plugging derived from HRCT scans

Secondary objectives 2

1. To evaluate the effect of dupilumab compared to placebo at Week 24 on mucus volume, airway wall thickness, and airway resistance derived from HRCT scans and forced oscillation technique
2. To evaluate safety of dupilumab

Conditions and MedDRA coding

Respiratory tract diseases

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Current or former smokers with a smoking history of ≥10 pack-years
2. Moderate-to-severe COPD (post-BD FEV1/FVC ratio <0.70 and post- BD FEV1 % predicted >30% and ≤70%)
3. Medical Research Council Dyspnea Scale grade ≥2 or COPD assessment test (CAT) score ≥10
4. Global Initiative for Chronic Obstructive Lung Disease (GOLD) category E, Frequent or severe exacerbations
5. 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
6. 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).
7. Mucus score cutoff of ≥3

Exclusion criteria 7

1. A current diagnosis of asthma according to the Global Initiative for Asthma diagnostic (GINA) guidelines, or documented history of asthma
2. 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
3. Treatment with oxygen >4.0 L/min for ≥8 hours/day
4. Respiratory tract infection within 4 weeks before screening, or during the screening period
5. Diagnosis of α-1 anti-trypsin deficiency
6. Any biologic therapy (including experimental treatments and dupilumab)
7. Participants on treatment with mucolytics unless on stable therapy for >6 months

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 5

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Recherche & Developpement

Sponsor organisation

Sanofi-Aventis Recherche & Developpement

Address

82 Avenue Raspail

City

Gentilly

Postcode

94250

Country

France

Scientific contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Third parties 9

Locations

10 EU/EEA countries · 40 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 60 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications