A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Trial Parameters
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Brief Summary
The main objective of this study is to evaluate treatment outcomes of tezepelumab among participants with physician-determined surgery-eligible CRSwNP, with or without asthma. Study details include: 1. The study duration will be up to 40 weeks. 2. The treatment duration will be up to 24 weeks. 3. The visit frequency will be once every 4 weeks (Q4W).
Eligibility Criteria
Inclusion Criteria: * Participants must be 18 years of age or older, at the time of signing the informed consent. * Participants with physician-diagnosed CRSwNP for at least 12 months prior to Visit 1 who have all of the following: * Severity consistent with the need for surgery as defined by total NPS ≥ 4 (at least 2 for each nostril) at screening, as determined by the central reader * Mean NCS ≥ 2 in the 2 weeks prior to Visit 2 * Ongoing documented NP symptoms for \> 8 weeks prior to screening such as rhinorrhoea, reduction or loss of smell and/or poor quality/loss of sleep * SNOT-22 total score ≥ 30 as assessed at screening. Note: approximately 50 participants with a NPS = 4 at screening will receive treatment with tezepelumab. * Any standard of care for treatment of CRSwNP, which must include treatment with intranasal corticosteroids, provided the participant is stable on that treatment for at least 30 days prior to Visit 1. Investigators should also assure that participants are c