A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps
Study on Nose and Sinus Growths Treatment
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
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Age: 18 years - 70 years
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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 treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). The study focuses on evaluating the safety, effectiveness, and tolerability of an investigational medication used alongside current treatments for adults with CRSwNP.
- Who can participate: Adults aged 18 to 70 years with chronic rhinosinusitis and nasal polyps who have ongoing symptoms despite using nasal steroids may be eligible.
- Study details: Participants will receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
- Study timelines: The study will last 40 weeks.
