NCT07399665Recruiting
ReAl-woRld Evaluation of tEzepelumab for Chronic rhinoSinusitis With Nasal Polyps in Russia
Open-label Single-arm, Non-interventional, Multi-centre Study for Evaluation of Clinical and Patient Reported Outcomes in Adult Patients With CRSwNP on Tezepelumab
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 110 (estimated)
- First submitted
- 24 Nov 2025
- Start date
- 25 Dec 2025
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- AstraZeneca
- Diseases
- Asthma
- NCT number
- NCT07399665
What you commit to
- Study type: Observational
- Planned participants: 110
- From 25 Dec 2025 to the primary completion date, 31 Mar 2028
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Kazan' | Russia | Recruiting |
| - Coordinator of this site? Confirm its status | Kemerovo | Russia | Recruiting |
| - Coordinator of this site? Confirm its status | Krasnoyarsk | Russia | Recruiting |
| - Coordinator of this site? Confirm its status | Lermontov | Russia | Recruiting |
| - Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
| - Coordinator of this site? Confirm its status | Rostov-on-Don | Russia | Recruiting |
| - Coordinator of this site? Confirm its status | Ryazan | Russia | Recruiting |
| - Coordinator of this site? Confirm its status | Saint-Petesburg | Russia | Recruiting |
| - Coordinator of this site? Confirm its status | Ulyanovsk | Russia | Recruiting |
| - Coordinator of this site? Confirm its status | Yekaterinburg | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.