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Physician diagnosis of asthma based on the Global Initiative for Asthma (GINA) 2020 Guidelines for 12 months treated with medium to high dose inhaled corticosteroid (ICS) and a second controller (ie, long-acting beta agonist, leukotriene receptor antagonist). A third controller is allowed but not mandatory. The dose regimen should be stable for at least 1 month before the study and during the screening period |
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History of at least one asthma exacerbation within 1 year prior to screening. Exacerbation is defined as deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids (oral or injectable) |
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Eosinophils 150 cells/L and fractional exhaled nitric oxide (FeNO) 25 ppb during screening, prior to randomization |
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Asthma control questionnaire (ACQ)-5 2.5 at screening Visit 1 and Visit 2, prior to randomization |
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Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) 80% of predicted normal during screening, prior to randomization |
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Exhibit bronchodilator reversibility (12% and 200 mL improvement in FEV1 post short-acting beta agonist administration) during screening period, prior to randomization, unless reversibility test meeting the inclusion criteria was done within 6 months prior to screening Visit 1 |
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Weekly average nocturnal awakenings due to asthma symptoms in the week prior to screening Visit 1 is 1 |
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Current smoker
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Former smoker for 10 years with a smoking history of >10 pack-years
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Asthma exacerbation during screening, prior to randomization
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History or clinical evidence of chronic obstructive pulmonary disease (COPD) including Asthma-COPD Overlap Syndrome (ACOS) or any other significant lung disease (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome)
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History of or current evidence of clinically significant non-respiratory diseases that in the opinion of the investigator may interfere with the aims of the study or put the participant at undue risk
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Active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated TB will be excluded unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing would be performed on a country by country basis, according to local guidelines if required by Regulatory Authorities or ethics boards
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Diagnosed active endoparasitic infection; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment have ruled out active infection before randomization
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History of human immunodeficiency (HIV) infection or positive HIV test at screening Visit 1
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Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before screening
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Known or suspected immunodeficiency including history of invasive opportunistic infections, despite infection resolution
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Current evidence of clinically significant oncological disease
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History of systemic hypersensitivity or anaphylaxis to any biologic therapy
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Severe uncontrolled depression
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Sleep disturbances not related to asthma, including sleep apnea, hypersomnia, or insomnia secondary to chronic pain, atopic dermatitis (AD), COPD or other conditions
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Participant who works night shift (ie, any work between 8 pm and 6 am)
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Erratic sleep habits, as determined by the Investigator
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Restless leg syndrome or periodic limb movement disorder
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Chronic treatment with oral corticosteroid (OCS) for more than 2 weeks before screening Visit 1
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Participant taking sedative, anxiolytic, or hypnotic treatments, including melatonin, within 3 months before randomization
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Participant taking systemic sedative antihistamines (excluding newer generations of antihistamines) or theophylline
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Current treatment with antidepressants, lipophilic beta blockers, clonidine, opioids, or other medications known to interfere with sleep and may confound the study assessments, as determined by the Investigator
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Treatment with live (attenuated) vaccine within 4 weeks before screening Visit 1
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The above information is not intended to contain all considerations relevant
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to a patient's potential participation in a clinical trial
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