ReAl-woRld Evaluation of tEzepelumab for Chronic rhinoSinusitis With Nasal Polyps in Russia (NCT07399665) | Clinical Trial Compass
RecruitingNot Applicable
ReAl-woRld Evaluation of tEzepelumab for Chronic rhinoSinusitis With Nasal Polyps in Russia
Russia110 participantsStarted 2025-12-25
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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.
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.
What they're measuring
1
1. Change in endoscopic status of CRSwNP based on NPS
Timeframe: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
2
2. Change in a nasal congestion status based on Nasal Blockage score as part of SNOT-22 (NBS-SNOT-22)
Timeframe: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
3
3. Change in endoscopic status of CRSwNP based on NPS
Timeframe: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
4
4. Change in a nasal congestion status based on Nasal Blockage score as part of SNOT-22 (NBS-SNOT-22)
Timeframe: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
✕. 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.