A Study to Investigate NPS and Symptoms in Chinese Adult Participants With CRSwNP Initiating Treatment With Tezepelumab
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
This is a multicentre, open-label, single-arm, Phase 3b study to assess nasal polyps score and symptoms in Chinese adult participants with chronic rhinosinusitis with nasal polyposis initiating treatment with tezepelumab.
Eligibility criteria
Qualifiers
Age
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
Disqualifiers
Participants with documented allergic fungal rhinosinusitis and/or central compartment atopic disease.
Any clinically important pulmonary disease other than asthma (eg, active lung infection, bronchiectasis, pulmonary fibrosis, cystic fibrosis, primary ciliary dyskinesia, allergic bronchopulmonary mycosis, hypereosinophilic syndromes, etc) that could confound interpretation of clinical CRSwNP endpoints results.
Affect the safety of the participant throughout the study
Influence the findings of the study or the interpretation
Trial design
Treatments tested in this trial
- Tezepelumab
Treatment groups
230 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov