A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps

Inclusion Criteria:

• A minimum bilateral nasal polyp score of 5 out of a maximum score of 8 for both nostrils (with at least a score of 2 for each nostril) despite use of intranasal corticosteroid treatment for at least 2 months prior to screening

Ongoing symptoms for at least 2 months prior to screening, including:

• Nasal congestion, blockage, or obstruction with moderate or severe symptom severityat screening (Score 2 or 3 on NC Score) and a weekly average severity score of atleast 1 (range 0 to 3) at randomization (NC Score: 0=no symptoms, 1=mild, 2=moderate, and 3=severe).

• At least 1 of the following 2 symptoms: (1) partial loss of smell (hyposmia) ortotal loss of smell (anosmia); (2) anterior and/or posterior rhinorrhea.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

• Patient who has received any therapies such as for example systemic corticosteroids,anti-IgE therapy, monoclonal antibody and some others in the specified timeframe(s)prior to the screening visit

• Patients who have undergone any nasal/sinus surgery within 6 months before screeningor for whom NPS cannot be determined accurately on endoscopy due to anatomic changesto the nasal cavity from past nasal/sinus surgery

• Patients with conditions/concomitant diseases making them non evaluable for theprimary efficacy endpoint

• Signs or a CT scan suggestive of Allergic fungal rhinosinusitis

• Active/chronic helminthic infection

• History of human immunodeficiency virus (HIV) infection or positive HIV screen (Anti-HIV- and HIV-2 antibodies) at screening visit

• Patients with positive or indeterminate hepatitis B surface antigen (HBsAg),hepatitis B core antibody (HBcAb), or hepatitis C antibody at screening visit NOTE:The above information is not intended to contain all considerations relevant to apatient's potential participation in a clinical trial