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

Launched by SANOFI · Jun 6, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called lunsekimig to see how effective it is for adults who have chronic rhinosinusitis with nasal polyps (CRSwNP) and are not getting enough relief from their current nasal spray treatments. The study will include adults aged 18 to 70 years who have significant nasal polyps and ongoing symptoms like nasal congestion and loss of smell, despite using nasal corticosteroids for at least two months. Participants will be randomly assigned to receive either lunsekimig or a placebo (a treatment that doesn’t contain the active drug) for about 24 weeks, followed by a 12-week follow-up period.

The trial will last up to 40 weeks for each participant, starting with a 4-week screening phase. During the study, participants will receive regular assessments to monitor their symptoms and lung function, whether or not they have asthma. It’s important to note that certain individuals, such as those who have had recent surgery on their nose or sinuses, or those with specific infections or diseases, will not be eligible to participate. This study aims to find out if lunsekimig can provide better control of symptoms for people suffering from CRSwNP.

Gender

ALL

Eligibility criteria

• 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 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 (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) or total 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 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 NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial