Severe AsthmaTezepelumabNCT06998095
Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea
An observational study of Severe Asthma and Chronic Rhinosinusitis With Nasal Polyps(CRSwNP), run by AstraZeneca.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Severe Asthma, Chronic Rhinosinusitis With Nasal Polyps(CRSwNP)
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2026to 31 Oct 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study Population: The study population will consist of adolescent and adult patients with a diagnosis of severe asthma or CRSwNP who are receiving tezepelumab according to its approved indication by MFDS. Eligible patients will be enrolled by a continuous registration method.
Who may be able to join
- 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
Who cannot join
- Other off-label indications according to the locally approved prescribing information
- Current participation in any interventional trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
About this study
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.
Read the 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.
- Keywords
- severe asthma, Chronic Rhinosinusitis with Nasal Polyps(CRSwNP)
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence proportion of AEs, ADRs, SAEs, SADRs, unexpected AEs/ADRs and unexpected SAEs/SADRs
Measured: 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)
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 approved indications in routine clinical practice.
Measured: Baseline to Week 24 or 30 days after last dose if discontinued earlier.
Secondary outcomes (3)
Proportion of patients with severe asthma who show improvement in asthma control
A patient whose GINA assessment changed from "Uncontrolled" at baseline to "Partly controlled" or "Well Controlled" at end of study or from "Partly controlled" at baseline to "Well Controlled" at end of study is defined as "Improved".
Measured: Baseline to Week 24 or 30 days after last dose if discontinued earlier.
Proportion of CRSwNP patients achieving clinically meaningful improvement in SNOT-22
Changes from baseline in SNOT-22 total scores, including the minimal clinically important difference(MCID) of 8.9 points, will be assessed to determine clinically meaningful improvement.
Measured: 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
Measured: Baseline to Week 24 or 30 days after last dose if discontinued earlier.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start28 Nov 2026 (estimated)
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998095
- Sponsor's protocol ID
- D5180R00020
- Acronym
- Tezepelumab
- Status last verified
- Apr 2026
- First submitted
- 29 May 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.