Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Patients

The total duration of the study (per patient) is approximately 36 weeks, including 4 weeks
screening, 12 weeks treatment, and 20 weeks post-treatment.

Inclusion criteria :

- Adult patients with a physician diagnosis of asthma for at least 12 months based on
the Global Initiative for Asthma (GINA) 2017 Guidelines.

- Patients with existing treatment with medium to high dose ICS (≥250 mcg of fluticasone
propionate twice a day (BID) or equipotent ICS daily dosage to a maximum of 2000
mcg/day of fluticasone propionate or clinically comparable) in combination with a LABA
as second controller for at least 3 months with a stable dose ≥1 month prior to Visit
1.

- Patients with prebronchodilator forced expiratory volume (FEV1) >40% of predicted
normal at Visit 1/Screening. Pre-bronchodilator FEV1 ≥50% but ≤85% of predicted normal
at Visit 2/Baseline.

- Patients with reversibility of at least 12% and 200 mL in FEV1 after administration of
2 to 4 puffs (200-400 mcg) of albuterol/salbutamol or levalbuterol/levosalbutamol
during screening or documented history of a reversibility test that meets this
criteria within 12 months prior to Visit 1 or documented positive response to
methacholine challenge (a decrease in FEV by 20% [PC20] of <8mg/mL) within 12 months
prior to Visit 1/Screening is considered acceptable to meet this inclusion criterion.

- Patients must have experienced, within 1 year prior to Visit 1, any of the following
events at least once:

- Treatment with a systemic steroid (oral or parenteral) for worsening asthma;

- Hospitalization or emergency medical care visit for worsening asthma.

- Signed written informed consent.

Exclusion criteria:

- Patients <18 years or >70 years of age (i.e., have reached the age of 71 at the
screening visit).

- Patients with body mass index (BMI) <16.

- Chronic lung disease (for example, chronic obstructive pulmonary disease [COPD], or
idiopathic pulmonary fibrosis [IPF]), which may impair lung function.

- History of life threatening asthma (i.e., severe exacerbation that requires
intubation).

- Co-morbid disease that might interfere with the evaluation of investigational
medicinal product (IMP).

- Patients with any of the following events within the 4 weeks prior to their Screening
Visit 1:

- Treatment with 1 or more systemic (oral and/or parenteral) steroid bursts for
worsening asthma;

- Hospitalization or emergency medical care visit for worsening asthma.

- Asthma Control Questionnaire 5-question version (ACQ-5) score <1.25 or >3.0 at
V2/randomization. During the screening period, an ACQ-5 of up to ≤4 is acceptable.

- Anti-immunoglobulin E (IgE) therapy (e.g., omalizumab [Xolair®]) within 130 days prior
to Visit 1 or any other biologic therapy (including anti-IL5 mAb) or systemic
immunosuppressant (e.g., methotrexate) to treat inflammatory disease or autoimmune
disease (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary
cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc.) and other diseases,
within 2 months or 5 half-lives prior to Visit 1, whichever is longer.

- Patients with a history of a systemic hypersensitivity reaction to a biologic drug.

- Patients on or initiation of bronchial thermoplasty within 2 years prior to Visit 1 or
plan to begin therapy during the screening period or the randomized treatment period.

- Current smoker or cessation of smoking within the 6 months prior to Visit 1.

- Previous smoker with a smoking history >10 pack-years.

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