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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07399665

Acronym

ARES

Enrollment

110

Registered

2026-02-10

Start date

2025-12-25

Completion date

2028-03-31

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Keywords

Tezepelumab, CRSwNP

Brief summary

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Measure	Time frame	Description
1. Change in SNOT-22 total score from baseline	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. 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	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. Proportion of patients with at least a 1-point change in loss of smell (as a part of SNOT-22) from baseline	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. Change in Lund-Mackay score from baseline	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. Change in ACQ-5 score from baseline	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. Proportion of participants with ACQ-5 response (reduction of ≥ 0.5 in score from baseline)	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. Number (proportion) of participants with CRSwNP-related healthcare resource utilisation (by each type)	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. Annualised rates of CRSwNP-related hospitalisation, emergency calls (or emergency department visits), and unscheduled out-patient visits to a physician	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. Annualised rates of CRSwNP-related scheduled physician visits or healthcare calls for CRSwNP	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. Median overall duration (days) of CRSwNP-related hospitalisations	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. Number (proportion) of participants with asthma-related healthcare resource utilisation (by each type)	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. Annualised rates of asthma-related hospitalisation, emergency calls (or emergency department visits), and unscheduled out-patient visits to a physician	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. Annualised rates of asthma-related scheduled physician visits or healthcare calls for asthma	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. • Median overall duration (days) of asthma-related hospitalisations	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. Annualised rate of CRSwNP exacerbations	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation	To describe CRSwNP exacerbations.
17. Change in annualised rate of CRSwNP exacerbations from the baseline period to the follow-up period after tezepelumab initiation	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation	To describe CRSwNP exacerbations.
18. Proportion of participants with 0, 1, 2, ≥3 CRSwNP exacerbations	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation	To describe CRSwNP exacerbations.
19. Cumulative days of CRSwNP exacerbations (calculated in participants who had CRSwNP exacerbations at baseline)	time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation	To describe CRSwNP exacerbations.
20. Annualised rate of severe* asthma exacerbations	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. Change in annualised rate of severe* asthma exacerbations from the baseline period to the follow-up period after tezepelumab initiation	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. Proportion of participants with 0, 1, 2, ≥3 severe* asthma exacerbations	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. Cumulative days of severe* asthma exacerbations (calculated in participants who had asthma exacerbations at baseline)	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. Median duration (days) of treatment with tezepelumab (to be calculated in all enrolled participants)	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. Proportion of participants with tezepelumab discontinuation overall and by reason	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. • Median time (days) to tezepelumab discontinuation (to be calculated in participants who discontinued tezepelumab earlier than Week 52 by any reason)	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. Proportion of participants discontinued tezepelumab and switched to other biologic drug for CRSwNP / asthma treatment and reason(s)	time points to measure: Week 52/End of Study	To describe duration of Tezepelumab therapy in the 52 weeks following initiation of treatment.
28. Change in blood eosinophils level (cells/μL) from baseline	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. Change in total IgE level (IU/mL) from baseline	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. Mean duration (days) of treatment with tezepelumab (to be calculated in all enrolled participants)	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. Proportion of participants discontinued tezepelumab and switched to other biologic drug for CRSwNP / asthma treatment and reason(s)	time points to measure: Week 52/End of Study	To describe reasons for discontinuation in the 52 weeks following initiation of treatment.

Countries

Russia

Contacts

CONTACTAstraZeneca Clinical Study Information Center

information.center@astrazeneca.com1-877-240-9479

Outcome results