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