FASENRA Regulatory Postmarketing Surveillance in Korea (FASENRA rPMS)

As part of a post approval commitment, the MFDS has requested a study to characterize safety in patients who are treated with FASENRA for severe eosinophilic asthma and/or eosinophilic granulomatosis with polyangiitis (EGPA) by physicians in normal clinical practice settings. This study is designed to confirm or assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of FASENRA under conditions of routine daily medical practice in Korea.

Study Overview

• Status: Completed
• Conditions: Asthma, EGPA(Eosinophilic Granulomatosis With Polyangiitis)

Detailed Description

This is a local, prospective, non-interventional, observational study is designed to evaluate safety and effectiveness of FASENRA in real world clinical practice setting in Korea. Adult patients with severe eosinophilic asthma and/or eosinophilic granulomatosis with polyangiitis (EGPA) who are initiating FASENRA for the first time as indicated by the MFDS will be included. At least 45 patients are followed for up 24 weeks and/or 48 weeks.

Patients will be treated as part of routine practice at Korean healthcare centers by accredited physicians. Each investigator will sequentially enroll patients who are initiating FASENRA for the first time and receive at least one dose until the target number of patients per center is reached. The characteristics of the study population and the FASENRA treatment schedule should be consistent with those described in the local product information at the time of enrolment (as the local product information may change). The study will enrol patients until the target number is reached.

All patients will be evaluated for safety during FASENRA use or for 30 days after their last dose of the surveillance drug if patients discontinued FASENRA before 24 weeks. Investigator's follow up of adverse events can be conducted by mail, phone calls, or e-mail for patients who discontinue early. The decision about the duration and discontinuation of treatment is solely at the discretion of the treating investigator with agreement of the patient.

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• South Korea
  • Busan, South Korea
    • Research Site
  • Gangneung-si, South Korea
    • Research Site
  • Seoul, South Korea
    • Research Site
  • Suwon, South Korea
    • Research Site
  • Ulsan, South Korea
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 years and older, Patients with severe asthma with an eosinophilic phenotype eligible for first time treatment with FASENRA according to the indication as indicated in the locally approved prescribing information

Description

Inclusion Criteria:

1. Patients aged 18 years and older
2. Patients with severe asthma with an eosinophilic phenotype eligible for first time treatment with FASENRA according to the indication as indicated in the locally approved prescribing information
3. 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. Hypersensitivity to the active substances or to any of the excipients
2. Current participation in any interventional trial

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage (%) of AEs and SAEs in patients who are treated with FASENRA	24 or 48 weeks
Nature (type) of AEs in patients who are treated with FASENRA	24 or 48 weeks
Incidence of AEs in patients who are treated with FASENRA	24 or 48 weeks
Severity of AEs in patients who are treated with FASENRA	24 or 48 weeks
Nature of unexpected adverse drug reactions in patients who are treated with FASENRA	24 or 48 weeks
Incidence of unexpected adverse drug reactions in patients who are treated with FASENRA	24 or 48 weeks
Severity of unexpected adverse drug reactions in patients who are treated with FASENRA	24 or 48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of exacerbation		24 or 48 weeks
Numbers of hospitalizations or ER visits due to asthma exacerbation		24 or 48 weeks
Overall investigator's assessment on the outcome of the treatment: "Well control", "Partly control", "Uncontrolled"		24 or 48 weeks
Overall investigator's assessment on any of the criteria below	EGPA Remission (defined as BVAS = 0 and prednisolone/prednisone dose ≤ 4 mg/day) ≥ 50% reduction in average daily prednisolone/prednisone dose EGPA relapse free during treatment period	24 or 48 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Pre-bronchodilator FEV1(mL), if available	24 or 48 weeks
Peripheral blood eosinophil count, if available	24 or 48 weeks
FeNO, if available	24 or 48 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• Redacted CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2022
• Primary Completion (Actual): March 6, 2025
• Study Completion (Actual): March 6, 2025

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Autoimmune Diseases; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Skin Diseases, Vascular; Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Granuloma; Systemic Vasculitis; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Asthma; Churg-Strauss Syndrome
• Other Study ID Numbers: D3250R00043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No