Real-world use of tezepelumab for chronic rhinosinusitis with nasal polyps in Russia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ARES is a multi-centre, retrospective-prospective, non-interventional cohort collecting primary and secondary real-world data on adults who recently started tezepelumab for CRSwNP. Participants must have initiated tezepelumab no more than four weeks before enrollment and have at least 52 weeks of prior medical records. About 110 adults will be enrolled across approximately 10 sites in the Russian Federation to document effectiveness, symptom scores, prior systemic corticosteroid use, and surgical history. Data collection will follow routine clinical practice rather than assigning treatments or procedures.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Kazan', Russia Recruiting
• Research Site
  Kemerovo, Russia Recruiting
• Research Site
  Krasnoyarsk, Russia Recruiting
• Research Site
  Lermontov, Russia Recruiting
• Research Site
  Moscow, Russia Recruiting
• Research Site
  Rostov-on-Don, Russia Recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.