RecruitingNCT07399665

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

Sponsor

AstraZeneca

Enrollment

110 participants

Start Date

Dec 25, 2025

Study Type

OBSERVATIONAL

Conditions

Asthma Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Summary

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria10

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 Criteria4

Any contraindication to tezepelumab as per the approved product SmPC in Russia or in the opinion of the Investigator.
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.
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.