Clinical trial NCT06998095: Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea
Official title: Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Severe Asthma
Keywords: severe asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-05-31
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study Population:

The study population will consist of adolescent and adult patients with a diagnosis of severe asthma who are receiving tezepelumab according to its approved indication by MFDS. Eligible patients will be enrolled by a continuous registration method.

Brief summary: The objectives of this study are to describe the occurrence of adverse events and the effectiveness of tezepelumab in patients receiving tezepelumab as indicated for severe asthma in South Korea.

Detailed description: Primary objective(s):

* To estimate the incidence proportion of adverse events (AEs), adverse drug reactions (ADR1s), serious adverse events (SAEs), serious adverse drug reaction (SADRs), unexpected2 adverse events, unexpected adverse drug reactions and expected adverse drug reactions, separately among patients receiving tezepelumab for severe asthma in routine clinical practice.
* To describe the nature (type), severity, and causality of adverse events (AEs)/adverse drug reactions (ADRs) and actions taken to address AEs among patients receiving tezepelumab for severe asthma in routine clinical practice.

Secondary objective(s) :

* To estimate the proportion of patients with improved asthma control from baseline to week 24 after tezepelumab initiation or the last known routine visit \[i.e., end of treatment (EoT)\]
* To estimate the incidence rate of adverse events (AEs) , adverse drug reactions (ADRs), serious adverse events (SAEs), serious adverse drug reaction (SADRs), unexpected adverse events, unexpected adverse drug reactions and expected adverse drug reactions per unit time, separately among patients receiving tezepelumab for severe asthma in routine clinical practice.

Exploratory Objective(s):

* To estimate the incidence proportion of AEs by demographic and clinical characteristics
* To estimate the proportion of patients with improved asthma control from baseline to week 24 after tezepelumab initiation or the last known routine visit by demographic and clinical characteristics

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 for severe asthma in South Korea.

The asthma control effectiveness assessment will be an evaluation of change from treatment initiation up to 24 weeks after treatment initiation. 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.

Eligibility criteria: Inclusion Criteria:

1. Patients who are treated with at least one dose of tezepelumab according to the indication in the locally approved prescribing information
2. 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:

1. Other off-label indications according to the locally approved prescribing information
2. Current participation in any interventional trial

Primary outcomes:
measure: Safety (adverse events (AEs), adverse drug reactions (ADRs), serious AEs (SAEs), serious ADRs (SADRs), unexpected AEs/ADRs, unexpected SAEs/SADRs)
timeFrame: up to 24 weeks
Secondary outcomes:
measure: A measure of asthma control at week 24 or at the last known routine visit as assessed by study investigator according to GINA guidelines
timeFrame: up to 24 weeks
measure: Safety (adverse events (AEs), adverse drug reactions (ADRs), serious AEs (SAEs), serious ADRs (SADRs), unexpected AEs/ADRs, unexpected SAEs/SADRs)
timeFrame: up tp 24 weeks
Other outcomes:
Locations:
Study officials:
References: