Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of SAR440340 (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

Study participation for each patient will be up to a total of 46 weeks to 76 weeks including
up to 10 days to 4 weeks of screening, 24 to 52 week treatment period on investigational
medical product (IMP), and 20 weeks of post IMP treatment period.

Inclusion criteria :

- Participants with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) for at
least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD]
definition.

- Participants with moderate-to-severe COPD (post-bronchodilator Forced Expiratory
Volume in 1 Second [FEV1]/forced vital capacity [FVC] <70% and post-bronchodilator
FEV1 % predicted <80%, but ≥30%).

- Participants with COPD Assessment Test (CAT) score ≥10 at Screening

- Participants with reported history of signs and symptoms of chronic bronchitis
(chronic productive cough for 3 months in the year up to screening in a patient in
whom other causes of chronic cough [e.g., gastroesophageal reflux, chronic
rhinosinusitis, bronchiectasis] have been excluded).

- Participants with a documented history (eg. medical record verification) of ≥2
moderate exacerbations or ≥1 severe exacerbation within the year prior to screening. A
moderate exacerbation is defined as an acute exacerbation of COPD (AECOPD) requiring
systemic corticosteroids (oral, intravenous, or intramuscular) and/or treatment with
antibiotics (however, use of antibiotics alone does not qualify as a "moderate
exacerbation" unless documentation is available that use of antibiotics was necessary
for treatment of worsening symptoms of COPD). A severe exacerbation is defined as an
AECOPD that required a hospitalization.

- Participants with Standard of Care background therapy, for 3 months and at a stable
dose for at least 1 month, including either:

- Double therapy: Long acting beta agonist (LABA) + Long acting muscarinic agonist
(LAMA) or inhaled corticosteroid (ICS) + LABA or ICS + LAMA.

or

- Triple therapy: LABA + LAMA +ICS.

- Current or former smokers with a smoking history of ≥10 packs/year.

Exclusion criteria:

- Concomitant severe diseases or diseases for which the use of Inhaled Corticosteroids
(ICS) (e.g., active pulmonary tuberculosis, etc.) or Long Acting Beta Agonists (LABA)
are contraindicated (e.g., diagnosis of a history of significant cardiovascular
diseases, insulin-dependent diabetes mellitus, hyperthyroidism, thyrotoxicosis,
pheochromocytoma, hypokalemia).

- Use of injectable glucocorticosteroids or oral systemic glucocorticosteroids within
previous 1 month or more than 4 courses of IV glucocorticosteroids within the previous
6 months

- Participants with Bronchial thermoplasty procedure (up to 3 years prior to Visit 1)

- A current diagnosis of asthma according to the Global Initiative for Asthma (GINA)
guidelines.

- Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis,
interstitial lung disease, pulmonary hypertension, bronchiectasis, eosinophilic
granulomatosis with polyangiitis, significant sleep apnea on Bilevel Positive Airway
Pressure, etc) or another diagnosed pulmonary or systemic disease associated with
elevated peripheral eosinophil counts.

- Diagnosis of α-1 anti-trypsin deficiency.

- Advanced COPD with need for chronic (>15 hours/day) oxygen support.

- Participant with a moderate or severe Acute Exacerbation of COPD event within previous
4 weeks

- A participant who has experienced an upper or lower respiratory tract infection within
previous 4 weeks

- Prior history of or planned pneumonectomy or lung volume reduction surgery.

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.