Clinical trial NCT03387852 (phase 2, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: sar440340, dupilumab, fluticasone or fluticasone/salmeterol combination, placebo for sar440340, placebo for dupilumab
SMILES: CCO, [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion criteria :

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

          -  Participants with existing treatment with medium to high dose ICS (greater than or
             equal to [≥] 250 microgram (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.

          -  Participants with pre-bronchodilator FEV1 greater than (>) 40 percentage (%) of
             predicted normal at Visit 1/Screening. Pre-bronchodilator FEV1 ≥50% but less than or
             equal to (≤) 85% of predicted normal at Visit 2/Baseline.

          -  Participants with reversibility of at least 12% and 200 milliliters (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 less than [<] 8
             milligram per milliliter [mg/mL]) within 12 months prior to Visit 1/Screening is
             considered acceptable to meet this inclusion criterion.

          -  Participants had 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:

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

          -  Participants 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).

          -  Participants 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 was acceptable.

          -  Anti-immunoglobulin E (IgE) therapy (e.g., omalizumab [Xolair®]) within 130 days prior
             to Visit 1 or any other biologic therapy (including anti interleukin-5 [anti-IL5]
             monoclonal antibodies [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.

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

          -  Participants 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
        participant's potential participation in a clinical trial.