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NCT Number: NCT07399665

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

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).

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Kazan', Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 1. Change in endoscopic status of CRSwNP based on NPS

    Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation

    Change in NPS score from baseline

  2. 2. Change in a nasal congestion status based on Nasal Blockage score as part of SNOT-22 (NBS-SNOT-22)

    Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation

    Change in Nasal blockage score as part of SNOT-22 (NBS-SNOT-22) from baseline

  3. 3. Change in endoscopic status of CRSwNP based on NPS

    Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation

    Proportion of patients with at least a 1-point improvement in NPS score from baseline

  4. 4. Change in a nasal congestion status based on Nasal Blockage score as part of SNOT-22 (NBS-SNOT-22)

    Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation

    Proportion of patients with at least a 1-point improvement in Nasal blockage score as part of SNOT-22 (NBS-SNOT-22) from baseline

Secondary outcomes

  1. 1. Change in SNOT-22 total score from baseline

    Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 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.

  2. 2. Proportion of participants with clinically meaningful change (reduction in SNOT-22 score by ≥ 8.9) from baseline

    Time frame: 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. 3. Change in loss of smell (as a part of SNOT-22) from baseline

    Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation

    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.

  4. 4. Proportion of patients with at least a 1-point change in loss of smell (as a part of SNOT-22) from baseline

    Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation

    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.

  5. 5. Change in Lund-Mackay score from baseline

    Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation

    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.

  6. 6. Change in ACQ-5 score from baseline

    Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation

    To describe asthma control questionnaire (ACQ-5) among participants with ongoing diagnosis of asthma

  7. 7. Proportion of participants with ACQ-5 response (reduction of ≥ 0.5 in score from baseline)

    Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation

    To describe asthma control questionnaire (ACQ-5) among participants with ongoing diagnosis of asthma

  8. 8. Number (proportion) of participants with CRSwNP-related healthcare resource utilisation (by each type)

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe CRSwNP-related healthcare resource utilisation (HCRU)

  9. 9. Annualised rates of CRSwNP-related hospitalisation, emergency calls (or emergency department visits), and unscheduled out-patient visits to a physician

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe CRSwNP-related healthcare resource utilisation (HCRU)

  10. 10. Annualised rates of CRSwNP-related scheduled physician visits or healthcare calls for CRSwNP

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe CRSwNP-related healthcare resource utilisation (HCRU).

  11. 11. Median overall duration (days) of CRSwNP-related hospitalisations

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe CRSwNP-related healthcare resource utilisation (HCRU)

  12. 12. Number (proportion) of participants with asthma-related healthcare resource utilisation (by each type)

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe asthma-related HCRU among participants with ongoing diagnosis of asthma

  13. 13. Annualised rates of asthma-related hospitalisation, emergency calls (or emergency department visits), and unscheduled out-patient visits to a physician

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe asthma-related HCRU among participants with ongoing diagnosis of asthma

  14. 14. Annualised rates of asthma-related scheduled physician visits or healthcare calls for asthma

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe asthma-related HCRU among participants with ongoing diagnosis of asthma

  15. 15. • Median overall duration (days) of asthma-related hospitalisations

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe asthma-related HCRU among participants with ongoing diagnosis of asthma

  16. 16. Annualised rate of CRSwNP exacerbations

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe CRSwNP exacerbations.

  17. 17. Change in annualised rate of CRSwNP exacerbations from the baseline period to the follow-up period after tezepelumab initiation

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe CRSwNP exacerbations.

  18. 18. Proportion of participants with 0, 1, 2, ≥3 CRSwNP exacerbations

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe CRSwNP exacerbations.

  19. 19. Cumulative days of CRSwNP exacerbations (calculated in participants who had CRSwNP exacerbations at baseline)

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe CRSwNP exacerbations.

  20. 20. Annualised rate of severe* asthma exacerbations

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe severe asthma exacerbations among participants with ongoing diagnosis of asthma.

  21. 21. Change in annualised rate of severe* asthma exacerbations from the baseline period to the follow-up period after tezepelumab initiation

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe severe asthma exacerbations among participants with ongoing diagnosis of asthma.

  22. 22. Proportion of participants with 0, 1, 2, ≥3 severe* asthma exacerbations

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe severe asthma exacerbations among participants with ongoing diagnosis of asthma.

  23. 23. Cumulative days of severe* asthma exacerbations (calculated in participants who had asthma exacerbations at baseline)

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe severe asthma exacerbations among participants with ongoing diagnosis of asthma.

  24. 24. Median duration (days) of treatment with tezepelumab (to be calculated in all enrolled participants)

    Time frame: time points to measure: Week 52/End of Study

    To describe tezepelumab treatment features, including duration of therapy, in the 52 weeks following initiation of treatment.

  25. 25. Proportion of participants with tezepelumab discontinuation overall and by reason

    Time frame: time points to measure: Week 52/End of Study

    To describe tezepelumab treatment features, including duration of therapy, discontinuation, and reasons for discontinuation in the 52 weeks following initiation of treatment.

  26. 26. • Median time (days) to tezepelumab discontinuation (to be calculated in participants who discontinued tezepelumab earlier than Week 52 by any reason)

    Time frame: time points to measure: Week 52/End of Study

    To describe tezepelumab treatment features, including duration of therapy, discontinuation, and reasons for discontinuation in the 52 weeks following initiation of treatment.

  27. 27. Proportion of participants discontinued tezepelumab and switched to other biologic drug for CRSwNP / asthma treatment and reason(s)

    Time frame: time points to measure: Week 52/End of Study

    To describe duration of Tezepelumab therapy in the 52 weeks following initiation of treatment.

  28. 28. Change in blood eosinophils level (cells/μL) from baseline

    Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation

    To describe biomarkers profile of participants and its dynamics from baseline* and up to 52 weeks following tezepelumab initiation.

  29. 29. Change in total IgE level (IU/mL) from baseline

    Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation

    To describe biomarkers profile of participants and its dynamics from baseline* and up to 52 weeks following tezepelumab initiation.

  30. 30. Mean duration (days) of treatment with tezepelumab (to be calculated in all enrolled participants)

    Time frame: time points to measure: Week 52/End of Study

    To describe tezepelumab treatment features, including duration of therapy in the 52 weeks following initiation of treatment.

  31. 31. Proportion of participants discontinued tezepelumab and switched to other biologic drug for CRSwNP / asthma treatment and reason(s)

    Time frame: time points to measure: Week 52/End of Study

    To describe reasons for discontinuation in the 52 weeks following initiation of treatment.

Other outcomes

  1. 1. Proportion of participants with medications for CRSwNP treatment by drug class

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.

  2. 2. Proportion of patients with InCS use

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.

  3. 3. Mean daily dose of sCS (to be calculated in participants who used sCS)

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.

  4. 4. Proportion of patients with oral antibiotics use due to CRSwNP or its exacerbation

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.

  5. 5. Proportion of patients with any sCS use due to CRSwNP or its exacerbation ('systemic' means oral, parenteral CS)

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.

  6. 6. Proportion of patients with 0, 1 and ≥2 courses of sCS due to CRSwNP or its exacerbation

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.

  7. 7. Median number of sCS courses due to CRSwNP or its exacerbation

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.

  8. 8. • Proportion of patients with any other biologic therapy use due to CRSwNP and/or severe asthma

    Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation

    To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.

  9. 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

    Time frame: time points to measure: Week 52/End of Study

    To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.

  10. 10. Proportion of participants with CRSwNP-related surgical interventions by type of surgery

    Time frame: time points to measure: from the date of CRSwNP diagnosis and up to 52 weeks following tezepelumab initiation

    To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.

  11. 11. Median time since the most recent nasal polyp surgery, calculated at the date of tezepelumab initiation.

    Time frame: The date of tezepelumab initiation

    To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.

  12. 12. Proportion of patients with 0, 1, 2, 3, 4 and ≥5 CRSwNP-related surgical interventions

    Time frame: time points to measure: from the date of CRSwNP diagnosis and up to 52 weeks following tezepelumab initiation

    To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.

  13. 13. Median number of CRSwNP-related surgical interventions

    Time frame: time points to measure: from the date of CRSwNP diagnosis and up to 52 weeks following tezepelumab initiation

    To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.

  14. 14. Proportion of patients with indications for CRSwNP-related surgery

    Time frame: time points to measure: from the index date and up to 52 weeks following tezepelumab initiation

    To describe the need for sCS use and/or nasal polyp surgery during the tezepelumab treatment period (52 weeks).

  15. 15. Proportion of patients with the need of sCS therapy

    Time frame: time points to measure: from the index date and up to 52 weeks following tezepelumab initiation

    To describe the need for sCS use and/or nasal polyp surgery during the tezepelumab treatment period (52 weeks).

  16. 16. Median time to first sCS use and/or nasal polyp surgery during the treatment period

    Time frame: time points to measure: from the index date and up to 52 weeks following tezepelumab initiation

    To describe the need for sCS use and/or nasal polyp surgery during the tezepelumab treatment period (52 weeks).

  17. 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%)

    Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation

    To describe participants' adherence to treatment up to 52 weeks following tezepelumab initiation.

  18. 18. Proportion of participants with each category of PGI-S scale

    Time frame: time points to measure: baseline

    To describe patient-reported impression of disease severity (PGI-S) scale

  19. 19. • Proportion of participants with each category of PGI-C scale

    Time frame: time points to measure: Weeks 4, 24 and 52 following tezepelumab initiation

    To describe patient-reported impression of treatment using Patient Global Impression of Change (PGI-C) scale throughout the 52-week treatment period.

  20. 20. Proportion of participants with CRSwNP-related surgical interventions by volume of surgery

    Time frame: time points to measure: from the date of CRSwNP diagnosis and up to 52 weeks following tezepelumab initiation

    To describe use of CRSwNP treatment (including surgery) at baseline* and up to 52 weeks following tezepelumab initiation.

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: ARES

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 10, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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