SAR440340

All AEs (serious or nonserious) will be collected from the signing of the ICF until end of study (EOS) visit

The Nasal Polyp Score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Nasal polyp is graded based on polyp size from 0 to 4 with higher scores indicating larger polyps. The sum of right and left nostril scores ranges from 0 (no polyps) to 8 (large polyps).

The Nasal Congestion Score (NCS) is scored using a 0-3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms. Outcome value is defined as the preceding 28-day average of morning scores recorded in eDiary.

All AEs (serious or nonserious) will be collected from the signing of the informed consent form (ICF) until the end of study visit

Change from baseline in sinus inflammation as assessed by Computerized Tomography (CT) scan of the sinuses in the itepekimab-- compared to placebo-- treated study participants on the background of intranasal corticosteroid (INCS).

PEs were recorded by Investigator. Moderate PEs were defined as acute worsening of respiratory symptoms (\>=3 symptoms for \>=48 hours) requiring antibiotic treatment. Severe PEs were moderate PEs resulting in intravenous antibiotic treatment, hospitalization, observation \>24 hours in emergency department/urgent care, or death. Events separated by \<14 days were considered as single events. All PE events were adjudicated by an independent committee. For both moderate and severe events to be counted as 2 separate events, they were separated by at least 14 days between any course of antibiotics and/or systemic corticosteroids or 14 days between discharge and new admission in case of hospitalization (severe events only). Annualized rate: number of events divided by total observation duration and was estimated based on negative binomial regression.

Moderate exacerbations events were recorded by the investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. Severe exacerbations events were defined as AECOPD requiring hospitalization, emergency medical care visit or resulting in death. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.

An LOAC event during the 12-week treatment period was a deterioration of asthma defined as any of the following: a) 30 percent (%) or greater reduction from baseline in morning peak expiratory flow (PEF) on 2 consecutive days; b) greater than or equal to (\>=) 6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; c) increase in inhaled corticosteroid (ICS) \>=4 times the last prescribed ICS dose (or \>=50% of the prescribed ICS dose at Baseline if background therapy withdrawal completed); d) required use of systemic (oral and/or parenteral) steroid treatment; e) required hospitalization or emergency room visit.