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

Investigational Medication for Chronic Rhinosinusitis with Nasal Polyps

Not Recruiting
18 years - 70 years
All
Phase 2
79 participants needed

Study Overview

This is a parallel, Phase 2, 2-arm, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study for treatment of CRSwNP.

The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants (aged 18 to 70 years, inclusive) with CRSwNP who are inadequately controlled on intranasal corticosteroid treatment. Participants with and without co-morbid asthma will be included in the study, and lung function will be assessed in both groups.

The study duration will be up to approximately 40 weeks per participant, including 4 weeks of screening run-in period, 24 weeks of intervention period, and 12 weeks of follow-up.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Rhinosinusitis With Nasal Polyps
  • Age: 18 years - 70 years
  • Gender: All

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

This study investigates the effectiveness and safety of an investigational medication compared to a placebo for treating adults with chronic rhinosinusitis with nasal polyps (CRSwNP). The study includes adults aged 18 to 70 who have not had success with standard nasal steroid treatments.

Participants in the study will be randomly assigned to receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will involve subcutaneous injections and will assess lung function in participants, including those with asthma. The study will evaluate the medication's effectiveness by observing changes in nasal polyp size and related symptoms.

  • Who can participate: Adults aged 18 to 70 years with chronic rhinosinusitis with nasal polyps, who have had ongoing symptoms despite using nasal corticosteroids for at least 2 months, may participate. Key eligibility includes a specific nasal polyp score and symptoms such as nasal congestion or loss of smell.
  • Study details: Participants will receive subcutaneous injections of either the investigational medication or a placebo. The study will monitor changes in nasal polyp size, symptom severity, and lung function, especially for those with asthma.
  • Study timelines: The study will last up to approximately 40 weeks per participant.
Updated on 25 Sep 2025. Study ID: NCT06454240