Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-25 @ 12:53 PM
Study NCT ID:
NCT06998095
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-11-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-05-29', 'studyFirstSubmitQcDate': '2025-05-29', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': '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.\n\nTo 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.'}], 'secondaryOutcomes': [{'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', 'description': '-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)\\]'}, {'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', 'description': '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.'}]}, 'conditionsModule': {'keywords': ['severe asthma'], 'conditions': ['Severe Asthma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Primary objective(s):\n\n* 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.\n* 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.\n\nSecondary objective(s) :\n\n* 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)\\]\n* 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.\n\nExploratory Objective(s):\n\n* To estimate the incidence proportion of AEs by demographic and clinical characteristics\n* 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\n\nThis 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study Population:\n\nThe 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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who are treated with at least one dose of tezepelumab according to the indication in the locally approved prescribing information\n2. 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\n\nExclusion Criteria:\n\n1. Other off-label indications according to the locally approved prescribing information\n2. Current participation in any interventional trial'}, 'identificationModule': {'nctId': 'NCT06998095', 'acronym': 'Tezepelumab', 'briefTitle': 'Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea', 'orgStudyIdInfo': {'id': 'D5180R00020'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'AstraZeneca Clinical Study Information Center', 'role': 'CONTACT', 'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'timeFrame': '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.\n\nYes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'ipdSharing': 'YES', '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:\n\nhttps://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.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.\n\nSigned Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}