Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma
DESTINATION
A 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 (DESTINATION)
1 other identifier
interventional
951
17 countries
174
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Jan 2019
Longer than P75 for phase_3 asthma
174 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2018
CompletedFirst Posted
Study publicly available on registry
October 15, 2018
CompletedStudy Start
First participant enrolled
January 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2022
CompletedResults Posted
Study results publicly available
February 9, 2023
CompletedJune 6, 2023
May 1, 2023
2.8 years
October 11, 2018
October 24, 2022
May 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Exposure Adjusted Incidence Rates of AEs/SAEs
Includes adverse events with an onset date between the date of first dose of IP in the predecessor and minimum (date of last dose of IP + 33 days, date of death, date of study withdrawal, day prior to start of another biologic). The analysis is based on the Safety Analysis Set. Exposure adjusted rates are defined as number of subjects with AEs divided by total time at risk across all subjects, multiplied by 100
Baseline (Week 0 in predecessor study) to Week 104. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
Total Time at Risk
Includes time between the date of first dose of IP in the predecessor and minimum (date of last dose of IP + 33 days, date of death, date of study withdrawal, day prior to start of another biologic). The analysis is based on the Safety Analysis Set.
Baseline (Week 0 in predecessor study) to Week 104. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
Secondary Outcomes (1)
Annualized Asthma Exacerbation Rate (AAER)
Baseline (Week 0 in predecessor study) to Week 104. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
Study Arms (2)
Tezepelumab
EXPERIMENTALTezepelumab subcutaneous injection
Placebo
PLACEBO COMPARATORPlacebo: Placebo subcutaneous injection
Interventions
Eligibility Criteria
You may qualify if:
- 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)
- 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.
You may not qualify if:
- 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
- Discontinuation of IP during the treatment period of DESTINATION.
- Entered DESTINATION from D5180C00009 (SOURCE) study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Amgencollaborator
Study Sites (180)
Research Site
Dothan, Alabama, 36303, United States
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Gilbert, Arizona, 85234, United States
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Bakersfield, California, 93301, United States
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Huntington Beach, California, 92647, United States
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Long Beach, California, 90808, United States
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Los Angeles, California, 90025, United States
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Newport Beach, California, 92663, United States
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Northridge, California, 91324, United States
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Palm Desert, California, 92260, United States
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Rolling Hills Estates, California, 90274, United States
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Walnut Creek, California, 94598, United States
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Westminster, California, 92683, United States
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New Haven, Connecticut, 06519, United States
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Kissimmee, Florida, 34744, United States
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Kissimmee, Florida, 34746, United States
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Port Charlotte, Florida, 33952, United States
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Sarasota, Florida, 34239, United States
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Tampa, Florida, 33607, United States
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Winter Park, Florida, 32789-4681, United States
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Boise, Idaho, 83706, United States
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Zachary, Louisiana, 70791, United States
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White Marsh, Maryland, 21162, United States
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Boston, Massachusetts, 02115, United States
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Ann Arbor, Michigan, 48109, United States
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St Louis, Missouri, 63141, United States
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Lincoln, Nebraska, 68510, United States
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Las Vegas, Nevada, 89119, United States
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Northfield, New Jersey, 08225, United States
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Brooklyn, New York, 11235, United States
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The Bronx, New York, 10459, United States
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The Bronx, New York, 10461, United States
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Charlotte, North Carolina, 28207, United States
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Durham, North Carolina, 27705, United States
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Winston-Salem, North Carolina, 27104, United States
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Cincinnati, Ohio, 45229, United States
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Cincinnati, Ohio, 45236, United States
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Edmond, Oklahoma, 73034, United States
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Oklahoma City, Oklahoma, 73120, United States
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Medford, Oregon, 97504, United States
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Philadelphia, Pennsylvania, 19140, United States
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Anderson, South Carolina, 29621, United States
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Columbia, South Carolina, 29204, United States
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Greenville, South Carolina, 29607, United States
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Amarillo, Texas, 79109, United States
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Boerne, Texas, 78006, United States
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McKinney, Texas, 75069, United States
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McKinney, Texas, 75071, United States
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Plano, Texas, 75093, United States
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San Antonio, Texas, 78251, United States
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Manassas, Virginia, 20110, United States
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Cudahy, Wisconsin, 53110, United States
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Madison, Wisconsin, 53792, United States
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Buenos Aires, 1027, Argentina
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Buenos Aires, C1414AIF, Argentina
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CABA, C1425BEN, Argentina
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Ciudad de Buenos Aires, 1425, Argentina
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Córdoba, X5003DCE, Argentina
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Mendoza, 5500, Argentina
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Nueve de Julio, B6500EZL, Argentina
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Quilmes, B1878FNR, Argentina
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San Fernando, B1646EBJ, Argentina
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San Miguel de Tucumán, T4000IAQ, Argentina
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Kent Town, 5067, Australia
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Melbourne, 3004, Australia
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New Lambton, 2310, Australia
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Spearwood, 6163, Australia
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Westmead, 2145, Australia
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Woolloongabba, 4102, Australia
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Vienna, 1090, Austria
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Vienna, 1130, Austria
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Blumenau, 89030-101, Brazil
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Botucatu, 18618-970, Brazil
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Curitiba, 80060-900, Brazil
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Porto Alegre, 9002-060, Brazil
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Porto Alegre, 90020-090, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Recife, 50070-550, Brazil
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Salvador, 40060-330, Brazil
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Santo André, 09080-110, Brazil
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São Bernardo do Campo, 09750-420, Brazil
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Sorocaba, 18040-425, Brazil
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Calgary, Alberta, T2N 4Z6, Canada
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Sherwood Park, Alberta, T8L 0N2, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Mississauga, Ontario, L5A 3V4, Canada
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Ottawa, Ontario, K1H 1E4, Canada
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Windsor, Ontario, N8X 1T3, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Québec, Quebec, G1G 3Y8, Canada
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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
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Trois-Rivières, Quebec, G8T 7A1, Canada
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Brest, 29609, France
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Le Kremlin-Bicêtre, 94270, France
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Lyon, 69317, France
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Marseille, 13915, France
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Montpellier, 34090, France
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Nantes, 44093, France
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Paris, 75012, France
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Paris, 75018, France
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Pessac, 33604, France
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Strasbourg, 67091, France
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Bamberg, 96049, Germany
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Berlin, 10367, Germany
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Berlin, 10717, Germany
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Berlin, 10969, Germany
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Frankfurt, 60596, Germany
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Frankfurt am Main, 60596, Germany
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Hamburg, 20354, Germany
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Hamburg, 22299, Germany
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Hanover, 30625, Germany
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Hanover, D-30173, Germany
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Koblenz, 56068, Germany
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Landsberg, 86899, Germany
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Leipzig, 04357, Germany
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Lübeck, 23552, Germany
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Mainz, 55131, Germany
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Ashkelon, 7830604, Israel
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Haifa, 34362, Israel
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Jerusalem, 91031, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 49281, Israel
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Rehovot, 7661041, Israel
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Krakow, 31-559, Poland
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Lodz, 90-153, Poland
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Wroclaw, 53-301, Poland
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Izhevsk, 426035, Russia
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Moscow, 115093, Russia
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Moscow, 115522, Russia
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Saint Petersburg, 193231, Russia
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Jeddah, 21423, Saudi Arabia
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Jeddah, 22252, Saudi Arabia
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Bellville, 7530, South Africa
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Cape Town, 7700, South Africa
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Cape Town, 7764, South Africa
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Durban, 4001, South Africa
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Durban, 4091, South Africa
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Durban, 4092, South Africa
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Durban, 4450, South Africa
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eMkhomazi, 4170, South Africa
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Johannesburg, 1724, South Africa
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Johannesburg, 1829, South Africa
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Johannesburg, 2113, South Africa
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Lenasia Ext8, 1820, South Africa
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Meadowdale, Germiston, 1614, South Africa
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Middelburg, 1055, South Africa
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Parow, 7505, South Africa
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Bucheon-si, 420-767, South Korea
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Cheongju-si, 28644, South Korea
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Daegu, 41404, South Korea
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Daegu, 42415, South Korea
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Jeju-do, 63241, South Korea
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Jeonju, 54907, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 02447, South Korea
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Seoul, 03312, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Seoul, 08308, South Korea
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Seoul, 150-713, South Korea
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Seoul, 158-710, South Korea
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Suwon, 16499, South Korea
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Kaohsiung City, 80756, Taiwan
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Taichung, 40447, Taiwan
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Taipei, 235, Taiwan
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Ankara, 06230, Turkey (Türkiye)
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Ankara, 06280, Turkey (Türkiye)
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Bursa, 16059, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Dnipro, 49007, Ukraine
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Ivano-Frankivsk, 76018, Ukraine
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Kharkiv Region, 61075, Ukraine
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Kherson, 73000, Ukraine
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Lutsk, 43000, Ukraine
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Vinnytsia, 21029, Ukraine
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Hanoi, 10000, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
Related Publications (4)
Wechsler ME, Brusselle G, Virchow JC, Bourdin A, Kostikas K, Llanos JP, Roseti SL, Ambrose CS, Hunter G, Jackson DJ, Castro M, Lugogo N, Pavord ID, Martin N, Brightling CE. 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. Eur Respir J. 2024 Dec 5;64(6):2400316. doi: 10.1183/13993003.00316-2024. Print 2024 Dec.
PMID: 39326921DERIVEDBrightling CE, Caminati M, Llanos JP, Caveney S, Kotalik A, Griffiths JM, Lundahl A, Israel E, Pavord ID, Wechsler ME, Porsbjerg C, Corren J, Golabek M, Martin N, Ponnarambil S. Biomarkers and clinical outcomes after tezepelumab cessation: Extended follow-up from the 2-year DESTINATION study. Ann Allergy Asthma Immunol. 2024 Sep;133(3):310-317.e4. doi: 10.1016/j.anai.2024.04.031. Epub 2024 Apr 30.
PMID: 38697286DERIVEDMenzies-Gow A, Wechsler ME, Brightling CE, Korn S, Corren J, Israel E, Chupp G, Bednarczyk A, Ponnarambil S, Caveney S, Almqvist G, Golabek M, Simonsson L, Lawson K, Bowen K, Colice G; DESTINATION study investigators. Long-term safety and efficacy of tezepelumab in people with severe, uncontrolled asthma (DESTINATION): a randomised, placebo-controlled extension study. Lancet Respir Med. 2023 May;11(5):425-438. doi: 10.1016/S2213-2600(22)00492-1. Epub 2023 Jan 23.
PMID: 36702146DERIVEDMenzies-Gow A, Ponnarambil S, Downie J, Bowen K, Hellqvist A, Colice G. 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. Respir Res. 2020 Oct 21;21(1):279. doi: 10.1186/s12931-020-01541-7.
PMID: 33087119DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Head
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Menzies-Gow, MD
Royal Brompton Hospital, United Kingdom
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double-Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2018
First Posted
October 15, 2018
Study Start
January 7, 2019
Primary Completion
October 26, 2021
Study Completion
May 18, 2022
Last Updated
June 6, 2023
Results First Posted
February 9, 2023
Record last verified: 2023-05