Taking people in RussiaNo phase
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.
Key facts
- Who runs it
- AstraZeneca
- Where
- Kazan', Kemerovo, Krasnoyarsk, Lermontov, Moscow, Rostov-on-Don, Ryazan, Saint-Petesburg, Ulyanovsk, and Yekaterinburg, RussiaSee the 10 sites
- Trial code
- Registry title
- ReAl-woRld Evaluation of tEzepelumab for Chronic rhinoSinusitis With Nasal Polyps in Russia
- Status
- Recruiting
- People taking part
- 110 people, planned
- Started
- 25 Dec 2025
- Expected to end
- 31 Mar 2028
- Type of study
- Observational
- Record updated
- 16 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic rhinosinusitis with nasal polyps who started tezepelumab no more than 4 weeks before joining. It follows them in normal care.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- Chronic rhinosinusitis with nasal polyps diagnosed at least 52 weeks before starting tezepelumab. The disease must be severe enough to need surgery: total nasal polyp score of at least 5 (at least 2 in each nostril). Nasal blockage score of at least 3. SNOT-22 total score of at least 30 at enrolment or up to 12 weeks before.
- Earlier treatment
- Must have started tezepelumab no more than 4 weeks before joining. Medical records must cover at least 52 weeks before tezepelumab, including any oral steroid use or nasal polyp surgery. Switching from another biologic drug is allowed if the last dose was at least 60 days ago. The trial aims for 20% or less of people who switched.
Main reasons for not taking part
- Any reason in the approved tezepelumab product information (SmPC) that bars its use
- Taking another biologic drug for nasal polyps or asthma since starting tezepelumab, except stable allergen immunotherapy
- Joining another observational study that might affect this one
- Joining an interventional clinical trial in the last 3 months
- Pregnancy or breastfeeding
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Russia
- Kazan'Hospital not named in the registryTaking people
- KemerovoHospital not named in the registryTaking people
- KrasnoyarskHospital not named in the registryTaking people
- LermontovHospital not named in the registryTaking people
- MoscowHospital not named in the registryTaking people
- Rostov-on-DonHospital not named in the registryTaking people
- RyazanHospital not named in the registryTaking people
- Saint-PetesburgHospital not named in the registryTaking people
- UlyanovskHospital not named in the registryTaking people
- YekaterinburgHospital not named in the registryTaking people
About the trial
What the trial wants to find out
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).
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Open-label Single-arm, Non-interventional, Multi-centre Study for Evaluation of Clinical and Patient Reported Outcomes in Adult Patients With CRSwNP on Tezepelumab
- Plain-language title
- Real-World Study of Tezepelumab in Adults With Chronic Rhinosinusitis and Nasal PolypsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 16 September 2026