Phase 3 Chronic Rhinosinusitis Trial, Not Yet Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You must be 18 years of age or older.
• You must have been diagnosed with chronic sinusitis with nasal polyps for at least 1 year.
• You must have had either previous surgery on your sinuses or nose for nasal polyps, OR your sinusitis symptoms got worse and needed steroid tablets or liquid in the past year.
• A nasal examination (using a small camera) must show a certain level of polyp growth in both nostrils, meeting a minimum score set by the trial.
• You must have had a stuffy or blocked nose at a moderate or severe level for at least 12 weeks before your first visit, plus either a loss of smell or runny nose (front or back of the nose).
• You must not currently be using, and must not have used, nasal steroid sprays for at least one month before joining.
• If you are a woman who could become pregnant, you must not be pregnant or breastfeeding, and you must agree to use a highly effective form of contraception during the study and for at least 20 weeks after your last dose.

Who may not be able to join:

• You have a significant medical condition affecting your kidneys, liver, heart, brain, blood, eyes, stomach, nerves, or other major organ that could affect the study (confirm with trial site).
• You are currently smoking tobacco or vaping, or you stopped smoking or vaping less than 6 months ago.
• You have had a serious allergic reaction to a type of medication called a monoclonal antibody (a laboratory-made protein used to treat certain conditions).
• You have certain conditions that would make it impossible to properly measure whether the treatment is working (confirm with trial site).
• You have any tumour, whether cancerous or non-cancerous, inside your nasal cavity.
• You have severe, uncontrolled asthma with two or more serious flare-ups requiring steroid tablets, or one hospital stay requiring steroid tablets, in the past year.
• You have used nasal steroid sprays, certain nasal devices or stents, or specific nasal spray systems within one month before the study screening period.
• You have had any sinus or nasal surgery, including removal of polyps, within the 6 months before your first visit.
• You have taken steroid tablets or liquid within one month before your first visit or during the screening period.
• You have a known allergy to the study drug (itepekimab) or any of its ingredients, or any other allergy that the doctor feels would make it unsafe for you to participate.

Important: Always verify eligibility with the trial site directly before applying.