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

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

Overview

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).

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.

Primary outcome measures

• 1. Change in endoscopic status of CRSwNP based on NPS [Time frame: 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) [Time frame: 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 [Time frame: 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) [Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation]

Secondary outcome measures (12)

• 1. Change in SNOT-22 total score from baseline [Time frame: 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 [Time frame: 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 frame: 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 frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation]
• 5. Change in Lund-Mackay score from baseline [Time frame: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation]
• 6. Change in ACQ-5 score from baseline [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation]

Eligibility criteria

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.
• Provision of signed and dated written informed consent.
• Participants are able to read, understand and complete the questionnaires required by the protocol.

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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

Russia · 11 centers

• Research Site — Kazan'
• Research Site — Kemerovo
• Research Site — Krasnoyarsk
• Research Site — Moscow
• Research Site — Moscow
• Research Site — Rostov-on-Don
• Research Site — Ryazan
• Research Site — Saint-Petesburg
• … and 3 more centers

Identifiers

NCT: NCT07399665 · D5242R00010

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗