ReAl-woRld Evaluation of tEzepelumab for Chronic rhinoSinusitis With Nasal Polyps in Russia (ARES)

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).

Study Overview

• Status: Recruiting
• Conditions: Asthma; Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Detailed 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) to capture real-world data on the effectiveness and use patterns of tezepelumab outside the controlled conditions of a randomized clinical trial.

The study will be conducted in real-world setting at approximately 10 sites in the Russian Federation. A total of 110 eligible adult participants (aged ≥18 years) of both sexes who will be treated with tezepelumab as prescribed by their treating physicians will be enrolled.

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Russia
  • Kazan', Russia
    • Recruiting
    • Research Site
  • Kemerovo, Russia
    • Not yet recruiting
    • Research Site
  • Krasnoyarsk, Russia
    • Recruiting
    • Research Site
  • Moscow, Russia
    • Not yet recruiting
    • Research Site
  • Moscow, Russia
    • Recruiting
    • Research Site
  • Rostov-on-Don, Russia
    • Recruiting
    • Research Site
  • Ryazan, Russia
    • Recruiting
    • Research Site
  • Saint-Petesburg, Russia
    • Recruiting
    • Research Site
  • Saint-Petesburg, Russia
    • Not yet recruiting
    • Research Site
  • Ulyanovsk, Russia
    • Recruiting
    • Research Site
  • Yekaterinburg, Russia
    • Recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants of both sexes aged 18 years and older with severe nasal polyposis (NPS ≥ 5) and the need for surgery, severe nasal congestion (Nasal Blockage ≥ 3 as part of SNOT-22), significant decrease in quality of life (SNOT-22 ≥ 30) despite the use of intranasal CS, who have indications for the prescription of biological therapy, who have commenced treatment with Tezepelumab as determined by their routine clinical care, will be enrolled in the otolaryngology setting of clinical institutions in Russia. Eligible patients will be enrolled consecutively at each site to minimize selection bias at each site. The study will target to enroll no more than 20% participants switching from a prior biologic drug to Tezepelumab and no more than 60% participants with comorbid asthma.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Change in endoscopic status of CRSwNP based on NPS	Change in NPS score from baseline	time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
2. Change in a nasal congestion status based on Nasal Blockage score as part of SNOT-22 (NBS-SNOT-22)	Change in Nasal blockage score as part of SNOT-22 (NBS-SNOT-22) from baseline	time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
3. Change in endoscopic status of CRSwNP based on NPS	Proportion of patients with at least a 1-point improvement in NPS score from baseline	time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
4. Change in a nasal congestion status based on Nasal Blockage score as part of SNOT-22 (NBS-SNOT-22)	Proportion of patients with at least a 1-point improvement in Nasal blockage score as part of SNOT-22 (NBS-SNOT-22) from baseline	time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Change in SNOT-22 total score from baseline	To describe the participant-reported evaluation of the symptoms of CRSwNP using the Sinonasal Outcome Test-22 (SNOT-22) at baseline* and up to 52 weeks following tezepelumab initiation.	time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
2. Proportion of participants with clinically meaningful change (reduction in SNOT-22 score by ≥ 8.9) from baseline	To describe the participant-reported evaluation of the symptoms of CRSwNP using the Sinonasal Outcome Test-22 (SNOT-22) at baseline* and up to 52 weeks following tezepelumab initiation.	To describe the participant-reported evaluation of the symptoms of CRSwNP using the Sinonasal Outcome Test-22 (SNOT-22) at baseline* and up to 52 weeks following tezepelumab initiation.
3. Change in loss of smell (as a part of SNOT-22) from baseline	To describe a smell status based on loss of smell score as part of SNOT-22 at baseline* and up to 52 weeks following tezepelumab initiation.	time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
4. Proportion of patients with at least a 1-point change in loss of smell (as a part of SNOT-22) from baseline	To describe a smell status based on loss of smell score as part of SNOT-22 at baseline* and up to 52 weeks following tezepelumab initiation.	time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
5. Change in Lund-Mackay score from baseline	To describe status of nasal cavity and paranasal sinuses using CT and Lund-Mackay score at baseline* and up to 52 weeks following tezepelumab initiation.	time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
6. Change in ACQ-5 score from baseline	To describe asthma control questionnaire (ACQ-5) among participants with ongoing diagnosis of asthma	time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
7. Proportion of participants with ACQ-5 response (reduction of ≥ 0.5 in score from baseline)	To describe asthma control questionnaire (ACQ-5) among participants with ongoing diagnosis of asthma	time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
8. Number (proportion) of participants with CRSwNP-related healthcare resource utilisation (by each type)	To describe CRSwNP-related healthcare resource utilisation (HCRU)	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
9. Annualised rates of CRSwNP-related hospitalisation, emergency calls (or emergency department visits), and unscheduled out-patient visits to a physician	To describe CRSwNP-related healthcare resource utilisation (HCRU)	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
10. Annualised rates of CRSwNP-related scheduled physician visits or healthcare calls for CRSwNP	To describe CRSwNP-related healthcare resource utilisation (HCRU).	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
11. Median overall duration (days) of CRSwNP-related hospitalisations	To describe CRSwNP-related healthcare resource utilisation (HCRU)	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
12. Number (proportion) of participants with asthma-related healthcare resource utilisation (by each type)	To describe asthma-related HCRU among participants with ongoing diagnosis of asthma	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
13. Annualised rates of asthma-related hospitalisation, emergency calls (or emergency department visits), and unscheduled out-patient visits to a physician	To describe asthma-related HCRU among participants with ongoing diagnosis of asthma	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
14. Annualised rates of asthma-related scheduled physician visits or healthcare calls for asthma	To describe asthma-related HCRU among participants with ongoing diagnosis of asthma	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
15. • Median overall duration (days) of asthma-related hospitalisations	To describe asthma-related HCRU among participants with ongoing diagnosis of asthma	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
16. Annualised rate of CRSwNP exacerbations	To describe CRSwNP exacerbations.	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
17. Change in annualised rate of CRSwNP exacerbations from the baseline period to the follow-up period after tezepelumab initiation	To describe CRSwNP exacerbations.	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
18. Proportion of participants with 0, 1, 2, ≥3 CRSwNP exacerbations	To describe CRSwNP exacerbations.	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
19. Cumulative days of CRSwNP exacerbations (calculated in participants who had CRSwNP exacerbations at baseline)	To describe CRSwNP exacerbations.	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
20. Annualised rate of severe* asthma exacerbations	To describe severe asthma exacerbations among participants with ongoing diagnosis of asthma.	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
21. Change in annualised rate of severe* asthma exacerbations from the baseline period to the follow-up period after tezepelumab initiation	To describe severe asthma exacerbations among participants with ongoing diagnosis of asthma.	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
22. Proportion of participants with 0, 1, 2, ≥3 severe* asthma exacerbations	To describe severe asthma exacerbations among participants with ongoing diagnosis of asthma.	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
23. Cumulative days of severe* asthma exacerbations (calculated in participants who had asthma exacerbations at baseline)	To describe severe asthma exacerbations among participants with ongoing diagnosis of asthma.	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
24. Median duration (days) of treatment with tezepelumab (to be calculated in all enrolled participants)	To describe tezepelumab treatment features, including duration of therapy, in the 52 weeks following initiation of treatment.	time points to measure: Week 52/End of Study
25. Proportion of participants with tezepelumab discontinuation overall and by reason	To describe tezepelumab treatment features, including duration of therapy, discontinuation, and reasons for discontinuation in the 52 weeks following initiation of treatment.	time points to measure: Week 52/End of Study
26. • Median time (days) to tezepelumab discontinuation (to be calculated in participants who discontinued tezepelumab earlier than Week 52 by any reason)	To describe tezepelumab treatment features, including duration of therapy, discontinuation, and reasons for discontinuation in the 52 weeks following initiation of treatment.	time points to measure: Week 52/End of Study
27. Proportion of participants discontinued tezepelumab and switched to other biologic drug for CRSwNP / asthma treatment and reason(s)	To describe duration of Tezepelumab therapy in the 52 weeks following initiation of treatment.	time points to measure: Week 52/End of Study
28. Change in blood eosinophils level (cells/μL) from baseline	To describe biomarkers profile of participants and its dynamics from baseline* and up to 52 weeks following tezepelumab initiation.	time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
29. Change in total IgE level (IU/mL) from baseline	To describe biomarkers profile of participants and its dynamics from baseline* and up to 52 weeks following tezepelumab initiation.	time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
30. Mean duration (days) of treatment with tezepelumab (to be calculated in all enrolled participants)	To describe tezepelumab treatment features, including duration of therapy in the 52 weeks following initiation of treatment.	time points to measure: Week 52/End of Study
31. Proportion of participants discontinued tezepelumab and switched to other biologic drug for CRSwNP / asthma treatment and reason(s)	To describe reasons for discontinuation in the 52 weeks following initiation of treatment.	time points to measure: Week 52/End of Study

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Proportion of participants with medications for CRSwNP treatment by drug class	To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
2. Proportion of patients with InCS use	To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
3. Mean daily dose of sCS (to be calculated in participants who used sCS)	To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
4. Proportion of patients with oral antibiotics use due to CRSwNP or its exacerbation	To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
5. Proportion of patients with any sCS use due to CRSwNP or its exacerbation ('systemic' means oral, parenteral CS)	To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
6. Proportion of patients with 0, 1 and ≥2 courses of sCS due to CRSwNP or its exacerbation	To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
7. Median number of sCS courses due to CRSwNP or its exacerbation	To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
8. • Proportion of patients with any other biologic therapy use due to CRSwNP and/or severe asthma	To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation
9. Medication possession ratio (MPR) - total days' supply of a medication in a particular time period, divided by the number of days in the time period	To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.	time points to measure: Week 52/End of Study
10. Proportion of participants with CRSwNP-related surgical interventions by type of surgery	To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.	time points to measure: from the date of CRSwNP diagnosis and up to 52 weeks following tezepelumab initiation
11. Median time since the most recent nasal polyp surgery, calculated at the date of tezepelumab initiation.	To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.	The date of tezepelumab initiation
12. Proportion of patients with 0, 1, 2, 3, 4 and ≥5 CRSwNP-related surgical interventions	To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.	time points to measure: from the date of CRSwNP diagnosis and up to 52 weeks following tezepelumab initiation
13. Median number of CRSwNP-related surgical interventions	To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.	time points to measure: from the date of CRSwNP diagnosis and up to 52 weeks following tezepelumab initiation
14. Proportion of patients with indications for CRSwNP-related surgery	To describe the need for sCS use and/or nasal polyp surgery during the tezepelumab treatment period (52 weeks).	time points to measure: from the index date and up to 52 weeks following tezepelumab initiation
15. Proportion of patients with the need of sCS therapy	To describe the need for sCS use and/or nasal polyp surgery during the tezepelumab treatment period (52 weeks).	time points to measure: from the index date and up to 52 weeks following tezepelumab initiation
16. Median time to first sCS use and/or nasal polyp surgery during the treatment period	To describe the need for sCS use and/or nasal polyp surgery during the tezepelumab treatment period (52 weeks).	time points to measure: from the index date and up to 52 weeks following tezepelumab initiation
17. Patients' adherence to treatment, which will be calculated at the date of the corresponding visit as (actual number of injections received / planned number of injections prescribed by physician * 100%)	To describe participants' adherence to treatment up to 52 weeks following tezepelumab initiation.	time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
18. Proportion of participants with each category of PGI-S scale	To describe patient-reported impression of disease severity (PGI-S) scale	time points to measure: baseline
19. • Proportion of participants with each category of PGI-C scale	To describe patient-reported impression of treatment using Patient Global Impression of Change (PGI-C) scale throughout the 52-week treatment period.	time points to measure: Weeks 4, 24 and 52 following tezepelumab initiation
20. Proportion of participants with CRSwNP-related surgical interventions by volume of surgery	To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.	time points to measure: from the date of CRSwNP diagnosis and up to 52 weeks following tezepelumab initiation

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: CRSwNP; Tezepelumab
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: D5242R00010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No