Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)ARESNCT07399665
ReAl-woRld Evaluation of tEzepelumab for Chronic rhinoSinusitis With Nasal Polyps in Russia
An observational study of Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) and Asthma, run by AstraZeneca at 10 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), Asthma
- How many people
- 110 participants
- Where
- 10 sitesRussia
- Study dates
- 25 Dec 2025to 31 Mar 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
10 sites in 1 country
Russia10 sites, 10 recruiting
- Recruiting
Research Site
Kazan'
- Recruiting
Research Site
Kemerovo
- Recruiting
Research Site
Krasnoyarsk
- Recruiting
Research Site
Lermontov
- Recruiting
Research Site
Moscow
- Recruiting
Research Site
Rostov-on-Don
- Recruiting
Research Site
Ryazan
- Recruiting
Research Site
Saint-Petesburg
- Recruiting
Research Site
Ulyanovsk
- Recruiting
Research Site
Yekaterinburg
About this study
Official 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
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).
Read the 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.
- Keywords
- Tezepelumab, CRSwNP
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Change in endoscopic status of CRSwNP based on NPS
Change in NPS score from baseline
Measured: 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
Measured: 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
Measured: 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
Measured: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
Secondary outcomes (31)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: time points to measure: Week 52/End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start25 Dec 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399665
- Sponsor's protocol ID
- D5242R00010
- Acronym
- ARES
- Status last verified
- Sep 2026
- First submitted
- 24 Nov 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.