Phase 3
Completed N=1,211
Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma
Asthma
Source: ClinicalTrials.gov NCT03706079 ↗
Enrolled (actual)
1,211
Serious AEs
16.2%
Results posted
Feb 2023
Primary outcomePrimary: Exposure Adjusted Incidence Rates of AEs/SAEs — 49.62; 62.66; 47.15; 69.97 Patients with AEs per 100 person-years
◆ Published Evidence
Highly cited
138citations · ~46 / year
Long-term safety and efficacy of tezepelumab in people with severe, uncontrolled asthma (DESTINATION): a randomised, placebo-controlled extension study.
Summary
Subjects who completed either D5180C00007 or D5180C00009 will be offered the opportunity to consent for the Multicentre, Double-blind, Randomized, Placebo Controlled, Parallel Group, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma. The study consists of a treatment phase, followed by a follow-up phase where subjects will not receive IP. The length of the follow up phase is determined by which study the subject had previously completed.
Linked Publications (4)
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Long-term safety and efficacy of tezepelumab in people with severe, uncontrolled asthma (DESTINATION): a randomised, placebo-controlled extension study.
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DESTINATION: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the long-term safety and tolerability of tezepelumab in adults and adolescents with severe, uncontrolled asthma.
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Clinical response and on-treatment clinical remission with tezepelumab in a broad population of patients with severe, uncontrolled asthma: results over 2 years from the NAVIGATOR and DESTINATION studies.
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Biomarkers and clinical outcomes after tezepelumab cessation: Extended follow-up from the 2-year DESTINATION study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exposure Adjusted Incidence Rates of AEs/SAEs |
49.62; 62.66; 47.15; 69.97; 0.76; 0.14 | — |
| PRIMARY Total Time at Risk |
917.0; 699.0; 129.4; 100.0 | — |
| SECONDARY Annualized Asthma Exacerbation Rate (AAER) |
0.82; 1.93; 1.07; 1.76 | — |
Eligibility Criteria
Inclusion 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 clinically important pulmonary disease other than asthma
- 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.
Data sourced from ClinicalTrials.gov (NCT03706079) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.