Real-World Study of Tezepelumab in Adults With Chronic Rhinosinusitis and Nasal Polyps
Follows adults with nasal polyps who recently started tezepelumab in routine care.
Plain-language title generated from the registry record
Registry title: ReAl-woRld Evaluation of tEzepelumab for Chronic rhinoSinusitis With Nasal Polyps in Russia
Key facts
- Where
- Kazan', Kemerovo, Krasnoyarsk, Lermontov, Moscow, Rostov-on-Don, Ryazan, Saint-Petesburg, Ulyanovsk, and Yekaterinburg, RussiaSee the 10 sites
Where in Russia
- Kazan'Kazan', RussiaTaking people
- KemerovoKemerovo, RussiaTaking people
- KrasnoyarskKrasnoyarsk, RussiaTaking people
- LermontovLermontov, RussiaTaking people
- MoscowMoscow, RussiaTaking people
- Rostov-on-DonRostov-on-Don, RussiaTaking people
- RyazanRyazan, RussiaTaking people
- Saint-PetesburgSaint-Petesburg, RussiaTaking people
- UlyanovskUlyanovsk, RussiaTaking people
- YekaterinburgYekaterinburg, RussiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07399665
- Record updated
- 16 September 2026
- Original description
ARES is a multi-centre, retrospective-prospective, non-comparative and non-interventional (observational) cohort study involving primary and secondary data collection within real-world settings of participants who have initiated tezepelumab (no more than 4 weeks before inclusion) for treatment of CRSwNP (with or without comorbid asthma).Read full original descriptionShow less
Open-label Single-arm, Non-interventional, Multi-centre Study for Evaluation of Clinical and Patient Reported Outcomes in Adult Patients With CRSwNP on Tezepelumab
ARES is a multi-centre, retrospective-prospective, non-comparative and non-interventional (observational) cohort study involving primary and secondary data collection within real-world settings of participants who have initiated tezepelumab (no more than 4 weeks before inclusion) for treatment of CRSwNP (with or without comorbid asthma).
Inclusion: Male or female participants aged 18 years or older at the time of signing the ICF; Diagnosis of CRSwNP established for at least 52 weeks prior to tezepelumab initiation; Availability of participants' medical records for at least 52 weeks prior to tezepelumab initiation, including history of sCS use / nasal polyps surgery (or information about contraindications / intolerance to); Prescribed and initiated treatment with tezepelumab according to SmPC and local market reimbursement criteria. A period between treatment initiation and enrolment should be no more than 4 weeks; The severity of CRSwNP consistent with need for surgery as defined by total NPS ≥ 5 (at least 2 for each nostril) at the enrollment; Nasal Blockage score as part of SNOT-22 (NBS-SNOT-22) ≥ 3 at the enrollment; SNOT-22 total score ≥ 30 at enrollment or up to 12 weeks before enrollment; Currently receive care from specialist physicians (e.g., otolaryngologist) at the Investigator's or sub-Investigator's site; Provision of signed and dated written informed consent; Participants are able to read, understand and complete the questionnaires required by the protocol.
Exclusion: Administration of concurrent biologic drug for CRSwNP / asthma since the index date, except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment). Enrolment of patients who were switched from other biologic(s) to tezepelumab is allowed, and an acceptable timeframe since the last prior biologic drug is ≥ 60 days. The number of participants with prior biologic treatment (switching to tezepelumab) should be targeted at 20% or less; Any contraindication to tezepelumab as per the approved product SmPC in Russia or in the opinion of the Investigator; Participation in an observational study that might, in the Investigator's opinion, influence the assessment for the current study, or participation in an interventional clinical trial in the last 3 months; Pregnancy or lactation period.