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 are able to understand what the study involves and are willing to sign a consent form agreeing to take part
• You are between 18 and 75 years old (any gender)
• You have been diagnosed with nasal polyps in both nostrils, meeting specific Chinese medical guidelines for this condition
• You have had nasal congestion plus at least one other symptom (such as reduced/lost sense of smell or a runny nose) continuously for 12 weeks or more before the study screening
• Your nasal polyps score at least 4 points total (and at least 2 points in each nostril) on a standard medical scale, both at screening and at the start of the study
• You report moderate to severe nasal congestion or loss of smell based on a standard scoring scale, both at screening and at the start of the study
• A CT scan of your sinuses shows a significant level of sinus involvement based on a standard scoring system
• Your nasal polyps or blood tests show signs of a specific type of inflammation (called "type 2 inflammation"), confirmed through tissue or blood samples
• If you have asthma, it must be stable and any inhaled steroid treatment must have been at a consistent dose for at least 4 weeks before screening, and must not exceed a certain daily amount

Who may not be able to join:

• You have previously had any sinus or nasal surgery, including procedures to straighten the nasal passage, reduce nasal tissue, or remove polyps
• You have a medical reason why you cannot safely receive general anaesthesia
• You have a medical reason why you cannot receive the study drug (stapokibart)
• You have previously been treated with any similar type of biologic medicine that targets the same part of the immune system (anti-IL-4Rα biologics)
• You have had a nasal infection, upper respiratory tract infection, or acute asthma attack recently, or you have certain other nasal or sinus conditions such as fungal sinusitis or nasal tumours (confirm with trial site)
• You have certain serious ongoing conditions that could affect the study results, such as cystic fibrosis or specific rare inflammatory diseases (confirm with trial site)
• You have another serious or poorly controlled long-term illness, such as active infections, heart disease, diabetes, autoimmune disease, HIV, hepatitis B or C, tuberculosis, or cancer
• Your liver or kidney function tests show results significantly outside the normal range
• You have a known or suspected problem with your immune system, or have a history of certain serious infections even if they have cleared up (confirm with trial site)
• You are pregnant, planning to become pregnant during the study, or are currently breastfeeding
• You are of childbearing age and are not willing to use an approved method of contraception during the study
• You have a history of alcohol or drug misuse
• The trial doctors have another medical or personal reason they feel makes participation unsuitable for you

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