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Real-world use 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

Observational AstraZeneca · NCT07399665

This study will see how tezepelumab works in adults in Russia who have chronic rhinosinusitis with nasal polyps, with or without asthma.

Quick facts

Study typeObservational
Enrollment110 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionstezepelumab, immunotherapy
Locations9 sites (Kazan' and 8 other locations)
Trial IDNCT07399665 on ClinicalTrials.gov

What this trial studies

ARES is a multi-centre, retrospective-prospective, non-interventional cohort collecting primary and secondary real-world data on adults who recently started tezepelumab for CRSwNP. Participants must have initiated tezepelumab no more than four weeks before enrollment and have at least 52 weeks of prior medical records. About 110 adults will be enrolled across approximately 10 sites in the Russian Federation to document effectiveness, symptom scores, prior systemic corticosteroid use, and surgical history. Data collection will follow routine clinical practice rather than assigning treatments or procedures.

Who should consider this trial

Good fit: Adults (≥18 years) in Russia with a diagnosis of CRSwNP for at least 52 weeks who have started tezepelumab within the prior 4 weeks, have high symptom burden (NPS ≥5 and SNOT-22 ≥30), and are under specialist care are ideal candidates.

Not a fit: Patients who do not have nasal polyps, have mild CRSwNP, have not started tezepelumab, are under 18, or receive care outside participating Russian sites are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could show whether tezepelumab improves symptoms and reduces the need for additional steroids or surgery in routine care for CRSwNP patients.

How similar studies have performed: Other biologic therapies have shown benefit in CRSwNP, and tezepelumab has been studied in controlled trials, but real-world evidence on its use for CRSwNP is still limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male or female participants aged 18 years or older at the time of signing the ICF.
2. Diagnosis of CRSwNP established for at least 52 weeks prior to tezepelumab initiation.
3. 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).
4. 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.
5. The severity of CRSwNP consistent with need for surgery as defined by total NPS ≥ 5 (at least 2 for each nostril) at the enrollment.
6. Nasal Blockage score as part of SNOT-22 (NBS-SNOT-22) ≥ 3 at the enrollment.
7. SNOT-22 total score ≥ 30 at enrollment or up to 12 weeks before enrollment.
8. Currently receive care from specialist physicians (e.g., otolaryngologist) at the Investigator's or sub-Investigator's site.
9. Provision of signed and dated written informed consent.
10. Participants are able to read, understand and complete the questionnaires required by the protocol.

Exclusion Criteria:

1. Any contraindication to tezepelumab as per the approved product SmPC in Russia or in the opinion of the Investigator.
2. 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.
3. 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.
4. Pregnancy or lactation period.

Where this trial is running

Kazan' and 8 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Rhinosinusitis With Nasal PolypsAsthmaTezepelumabCRSwNP
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.