Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Severe Asthma, Chronic Rhinosinusitis With Nasal Polyps(CRSwNP). Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The objectives of this study are to describe the incidence of adverse events and the effectiveness of tezepelumab in patients receiving tezepelumab as indicated for severe asthma or CRSwNP in South Korea.
Detailed description
This is a prospective, single-arm, multicenter, observational study to evaluate the safety and effectiveness of tezepelumab from treatment initiation up to 24 weeks in patients who are prescribed tezepelumab according to its approved indication in South Korea.
The effectiveness assessment will estimate the proportion of patients with improved asthma control or a clinically meaningful improvement in SNOT-22 scores, from treatment initiation up to 24 weeks after the initiation of tezepelumab.
This study design will reflect the actual management of these subjects in routine clinical practice. The treating physician will determine the treatment plan, as well as the frequency of laboratory and clinical assessment, if necessary, based on routine practice.
All patients will be evaluated for safety during tezepelumab use (24 weeks) or within 30 days after the last administration of tezepelumab if the patients discontinued tezepelumab before 24 weeks.
Primary outcome measures
- Incidence proportion of AEs, ADRs, SAEs, SADRs, unexpected AEs/ADRs and unexpected SAEs/SADRs [Time frame: Baseline to Week 24 or 30 days after last dose if discontinued earlier.]
- Characterization of AEs/ADRs (nature, maximum severity, causality to tezepelumab, actions taken, and outcomes) [Time frame: Baseline to Week 24 or 30 days after last dose if discontinued earlier.]
Secondary outcome measures (3)
- Proportion of patients with severe asthma who show improvement in asthma control [Time frame: Baseline to Week 24 or 30 days after last dose if discontinued earlier.]
- Proportion of CRSwNP patients achieving clinically meaningful improvement in SNOT-22 [Time frame: Baseline to Week 24 or 30 days after last dose if discontinued earlier.]
- Incidence rate of AEs, ADRs, SAEs, SADRs,unexpected AEs/ADRs, unexpected SAEs/SADRs [Time frame: Baseline to Week 24 or 30 days after last dose if discontinued earlier.]
Eligibility criteria
Inclusion criteria
- Patients who are treated with at least one dose of tezepelumab according to the indication in the locally approved prescribing information
- Patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
Exclusion criteria
- Other off-label indications according to the locally approved prescribing information
- Current participation in any interventional trial
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
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06998095 · D5180R00020