Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea

NCT06998095 | Not Yet Recruiting

• 1 other identifier: D5180R00020
• Study Type: observational
• Target: 210
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Severe Asthma

Keywords

severe asthma

Outcome Measures

Primary Outcomes (1)

• Safety (adverse events (AEs), adverse drug reactions (ADRs), serious AEs (SAEs), serious ADRs (SADRs), unexpected AEs/ADRs, unexpected SAEs/SADRs)

  To estimate the incidence proportion 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, 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.

  up to 24 weeks

Secondary Outcomes (2)

• A measure of asthma control at week 24 or at the last known routine visit as assessed by study investigator according to GINA guidelines

  up to 24 weeks

• Safety (adverse events (AEs), adverse drug reactions (ADRs), serious AEs (SAEs), serious ADRs (SADRs), unexpected AEs/ADRs, unexpected SAEs/SADRs)

  up tp 24 weeks

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: May 31, 2025
• Study Start (Estimated): November 28, 2026
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at 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.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.