A Multicentre, Single-Arm, Phase 3b Study to Assess Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab (ESSENCE)
AstraZeneca
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).
Description
This is a multicentre, open-label, single-arm, phase IIIb study is to describe changes from baseline in (1) participant-reported nasal congestion as evaluated by the nasal congestion score (NCS) and (2) participant-reported sino-nasal symptoms as evaluated by sino-nasal outcome test, 22 item (SNOT-22) following initiation of tezepelumab treatment. Approximately 60 sites in 10 countries will enrol adult patients with physician determined surgery eligible CRSwNP. The study is divided into 3 periods as described below: * Screening Period (from Week -4 until Week 0, up to 4 Weeks) * Treatment p…
Eligibility
- Age range
- 18–130 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Combination ProductTezepelumab
IMP. Subcutaneous injection. Unit dose strengths 210 mg.
Locations (45)
- Research SiteNewport Beach, California
- Research SiteChicago, Illinois
- Research SiteChestnut Hill, Massachusetts
- Research SiteColumbia, Missouri
- Research SitePlovdiv
- Research SiteSofia