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

NCT07399665 | Recruiting

• 1 other identifier: D5242R00010
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 9

Brief 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).

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP); Asthma

Keywords

Tezepelumab; CRSwNP

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (31)

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

  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.

• 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

• 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

• 5. Change in Lund-Mackay score from baseline

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

Other Outcomes (20)

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

  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

  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)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (9)

Research Site

Kazan', Russia

RECRUITING

Research Site

Krasnoyarsk, 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

NOT YET RECRUITING

Research Site

Yekaterinburg, Russia

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: February 10, 2026
• Study Start: December 25, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

RU (9)