Clinical Trials List
2019-08-01 - 2022-12-31
Phase III
Recruiting3
ICD-10J45.50
Severe persistent asthma, uncomplicated
ICD-9493.10
Intrinsic asthma without mention of status asthmaticus
A Multicentre, Double-blind, Randomized, Parallel Group, Placebo Controlled, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma (Destination)
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Trial Applicant
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Sponsor
AstraZeneca
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Kuan-Yuan Chen Division of Thoracic Medicine
- YEN-HAN TSENG Division of Thoracic Medicine
- Tzu-Tao Chen Division of Thoracic Medicine
- Chien-Hua Tseng Division of Thoracic Medicine
- Ching-Shan Luo Division of Thoracic Medicine
- Wen-Te Liu Division of Thoracic Medicine
- Po-Hao Feng Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ming-Ju Tsai Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chen Chia-Hung Division of General Internal Medicine
- 梁信杰 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Exposure adjusted incidence rates of AEs/SAEs [ Time Frame: Baseline (Week 0 in predecessor study) to Week 104 ]
Exposure adjusted rates defined as the number of events divided by person-time at risk
Secondary Outcome Measures :
Annualized asthma exacerbation rate (AAER) [ Time Frame: Baseline (Week 0 in predecessor study) to Week 104 ]
The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF
Inclution Criteria
Provision of signed and dated written informed consent
Negative urine test for female subjects of childbearing potential prior to administration of IP at visit 1
Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from screening, and must agree to continue using such precautions for 16 weeks after the final dose of IP.
Female or male subjects who have not met investigational product discontinuation criteria and have attended the EOT visit in either study D5180C00007 (NAVIGATOR) or D5180C00009 (SOURCE)
To enter the extended follow-up phase of the study, the following inclusion criteria also apply:
Provision of signed and dated Addendum for Extended Follow-up to informed consent, as well as assent by adolescent subjects where applicable, prior to any mandatory study specific procedures, sampling and analyses before Extended Follow Up.
Must have entered DESTINATION from D5180C00007 study and have completed IP dosing to Week 100, have not met IP Discontinuation criteria and have attended the EOT Visit.
Exclusion Criteria
Any disorder, including, but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable
History of chronic alcohol or drug abuse within 12 months prior to visit 1
Current malignancy or malignancy that developed during a predecessor study
Major surgery or planned surgical procedures requiring general anesthesia or inpatient status for > 1 day during the conduct of the study
Treatment with systemic immunosuppressive/immunomodulating drugs except for OCS used in the treatment of asthma/asthma exacerbations within the last 12 weeks prior to randomization
Concurrent enrolment in another clinical study involving an IP
Any clinically meaningful abnormal finding in physical examination, vital signs, ECG,haematology, clinical chemistry, or urinalysis during the predecessor study
Pregnant, breastfeeding, or lactating
To enter the extended follow-up phase of the study (which extends from week 104 to week 140), the following exclusion criteria also apply:
Discontinuation of IP during the treatment period of DESTINATION.
Entered DESTINATION from D5180C00009 (SOURCE) study.
The Estimated Number of Participants
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Taiwan
6 participants
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Global
975 participants
