Phase 3 Chronic Rhinosinusitis Trial, 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:

• People who are 18 years of age or older at the time of signing the consent form
• People who have been diagnosed by a doctor with chronic rhinosinusitis with nasal polyps (a long-term sinus condition with growths in the nose) for at least 12 months before the first visit
• People whose nasal polyps are scored at a certain severity level (total score of 4 or more, with at least 2 in each nostril) as assessed by a central reviewer at screening
• People who have had a nasal congestion score of 2 or more on average in the 2 weeks before the second visit
• People who have had ongoing nasal polyp symptoms for more than 8 weeks before screening, such as a runny nose, reduced or lost sense of smell, and/or poor sleep
• People who score 30 or above on a standardised quality-of-life questionnaire related to nasal and sinus symptoms (SNOT-22) at screening
• People who are on standard treatment for their condition, which must include a nasal corticosteroid spray, and have been on a stable dose for at least 30 days before the first visit
• People who either: have had their nasal polyps treated with steroid tablets or an injectable steroid for at least 3 consecutive days within the past 12 months (but not within the last 3 months before the first visit), OR have a history of nasal polyp surgery — or have medical reasons why they cannot have surgery or steroids
• People with a JESREC score of 11 or higher (a measure used by doctors to assess a specific type of sinus inflammation — confirm details with the trial site)
• People who weigh at least 40 kg at the first visit
• Men and women are both eligible to participate
• Women who are able to become pregnant must be willing to use an approved method of contraception from the time of signing the consent form throughout the study and for 16 weeks after the last dose of the study drug (confirm acceptable methods with the trial site)
• Women who cannot become pregnant are defined as those who have had certain permanent sterilisation procedures, or who are postmenopausal (no menstrual period for 12 months without another medical cause), with specific age-related criteria applying (confirm with trial site)
• People who have signed and dated the consent form before any study-related procedures begin

Who may not be able to join:

• People who have been diagnosed with allergic fungal rhinosinusitis or central compartment atopic disease (specific types of nasal/sinus conditions)
• People with significant lung disease other than asthma (such as active lung infection, pulmonary fibrosis, cystic fibrosis, or similar conditions) that could affect the interpretation of study results
• People with an unstable medical condition — such as heart, liver, kidney, nerve, blood, hormonal, or psychiatric conditions — that in the doctor's opinion could affect safety, study results, or the person's ability to complete the study
• People who have had sinus surgery within 6 months before screening, or who have had past sinus surgery that altered the nasal wall in a way that makes it impossible to measure nasal polyp size
• People with certain nasal or sinus conditions that would make it impossible to properly assess the study's main outcomes, such as specific types of nasal polyps (antrochoanal polyps), a severely deviated nasal septum blocking at least one nostril, or active sinus/nasal infections, asthma flare-ups, or upper respiratory infections at or within 2 weeks of screening — or certain rare conditions such as Churg-Strauss syndrome, Young's syndrome, or Kartagener's syndrome
• People with a history of most cancers, unless curative treatment was completed at least 5 years before the first visit; people with a history of certain skin cancers or cervical cancer in situ may be eligible if curative treatment was completed at least 12 months before the first visit
• People who have had uncontrolled nosebleeds within 2 months before the first visit
• People who have been diagnosed with a parasitic worm infection within 6 months before the first visit that has not been successfully treated
• People with asthma who are current smokers, use vaping or e-cigarette products, or have a smoking history of more than 10 packs per year; former smokers or former vaping/e-cigarette users with less than 10 packs per year history must have stopped for at least 6 months before the first visit
• People with a history of ongoing alcohol or drug misuse in the 12 months before the first visit
• People who have had tuberculosis requiring treatment in the 12 months before the first visit, or who have evidence of active or latent tuberculosis that has not been properly treated
• People who have had major surgery within 8 weeks before the first visit, or who have planned nasal polyp surgery or any planned surgery requiring general anaesthesia or a hospital stay of more than 1 day during the study
• People with a known immune deficiency condition, a positive HIV test at the first visit, or who are taking HIV antiviral medications
• People who have had an infection requiring antibiotic treatment within 14 days before the first visit (note: a screening extension may be possible in some cases — confirm with trial site)
• People who have received any biological medicine (marketed or experimental) within 4 months or 5 half-lives before the first visit, whichever is longer, or any non-biological experimental medicine within 30 days or 5 half-lives before the first visit, whichever is longer
• People who have used immune-suppressing or immune-modifying medications (such as methotrexate or cyclosporine) within approximately 12 weeks or 5 half-lives before the first visit, whichever is longer (steroid tablets used for asthma are an exception)
• People who have received immunoglobulin or blood products within 30 days before the first visit
• People who have received a live vaccine within 30 days before the first visit or who would need one during the study
• People with a known allergy or sensitivity to the study drug (tezepelumab) or any of its ingredients, or a history of drug allergy that the doctor considers a reason not to participate
• People with a history of a severe allergic reaction (anaphylaxis) or a specific type of immune reaction (Type III hypersensitivity) following any biological medicine
• People who regularly use nasal or oral decongestant medicines from the first visit onward (except when used for a medical procedure)
• People who have used corticosteroid-releasing nasal stents within 6 months before the first visit or who would need them during the study
• People who have undergone aspirin desensitisation treatment within 6 months before enrolment
• People who are currently enrolled in another clinical trial involving a treatment or intervention
• People with significant abnormal results on physical examination, blood tests, or other assessments at the first visit that the doctor considers a reason not to participate
• People with signs of active liver disease, including jaundice or certain elevated liver enzyme levels at the first visit
• People with a positive test for hepatitis B surface antigen or hepatitis C antibodies, or a known history of hepatitis B or C (people vaccinated against hepatitis B without a history of the infection may still be eligible)
• People with a JESREC score below 11
• People involved in planning or running this study, or people who are employed by or are relatives of employees of the study site or the study sponsor
• People who, in the doctor's judgement, are unlikely to follow study procedures and requirements
• Women who are pregnant, breastfeeding, or lactating; pregnancy testing will be required for women who could become pregnant, and anyone whose menstrual or sexual history suggests the possibility of early pregnancy would be excluded

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