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

80 patients around the world

Available in Argentina, United States

Sanofi

80Patients around the world

This study is for people with

Rhinosinusitis

Chronic Rhinosinusitis

To 70 Years

All Gender

: 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.
Nasal congestion, blockage, or obstruction with moderate or severe symptom severity at screening (Score 2 or 3 on NC Score) and a weekly average severity score of at least 1 (range 0 to 3) at randomization.
At least 1 of the following 2 symptoms: partial loss of smell (hyposmia) or total loss of smell (anosmia); anterior and/or posterior rhinorrhea.

: 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 screening or for whom NPS cannot be determined accurately on endoscopy due to anatomic changes to the nasal cavity from past nasal/sinus surgery.
Patients with conditions/concomitant diseases making them non evaluable for the primary 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.

SponsorSanofi

Conditions

Chronic Rhinosinusitis

Requirements

To 70 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06454240