Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma
NCT ID: NCT03706079
Last Updated: 2023-06-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
951 participants
INTERVENTIONAL
2019-01-07
2022-05-18
Brief Summary
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Detailed Description
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Following treatment, subjects will enter a follow-up phase, determined by the predecessor study they had previously completed. Subjects will not receive IP during the follow-up phase. For subjects who entered the study from study D5180C00007 and did not meet IP Discontinuation criteria, the follow-up phase will extend from week 104 to Week 140. Subjects who entered the study from study D5180C00009 will have their follow-up phase extend to week 116.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Subjects randomized to placebo arm in the predecessor studies will be re-randomized in a 1:1 ratio to either tezepelumab or placebo.
Given the randomization scheme of subjects in the predecessor studies, this will give an overall subject distribution of 3:1 (tezepelumab:placebo), assuming a similar number of subjects rollover from each arm in the predecessor studies.
TREATMENT
TRIPLE
Study Groups
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Tezepelumab
Tezepelumab subcutaneous injection
Tezepelumab
Tezepelumab subcutaneous injection
Placebo
Placebo: Placebo subcutaneous injection
Placebo
Placebo subcutaneous injection
Interventions
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Tezepelumab
Tezepelumab subcutaneous injection
Placebo
Placebo subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* 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.
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
* Discontinuation of IP during the treatment period of DESTINATION.
* Entered DESTINATION from D5180C00009 (SOURCE) study.
13 Years
81 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew Menzies-Gow, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Brompton Hospital, United Kingdom
Locations
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Dothan, Alabama, United States
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Gilbert, Arizona, United States
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Bakersfield, California, United States
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Huntington Beach, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Northridge, California, United States
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Palm Desert, California, United States
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Rolling Hills Estates, California, United States
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Walnut Creek, California, United States
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Westminster, California, United States
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New Haven, Connecticut, United States
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Kissimmee, Florida, United States
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Kissimmee, Florida, United States
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Port Charlotte, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Boise, Idaho, United States
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Zachary, Louisiana, United States
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White Marsh, Maryland, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Northfield, New Jersey, United States
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Brooklyn, New York, United States
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The Bronx, New York, United States
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The Bronx, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Edmond, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Anderson, South Carolina, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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Amarillo, Texas, United States
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Boerne, Texas, United States
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McKinney, Texas, United States
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McKinney, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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Manassas, Virginia, United States
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Cudahy, Wisconsin, United States
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Madison, Wisconsin, United States
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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CABA, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Córdoba, , Argentina
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Mendoza, , Argentina
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Nueve de Julio, , Argentina
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Quilmes, , Argentina
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San Fernando, , Argentina
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San Miguel de Tucumán, , Argentina
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Kent Town, , Australia
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Melbourne, , Australia
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New Lambton, , Australia
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Spearwood, , Australia
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Westmead, , Australia
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Woolloongabba, , Australia
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Vienna, , Austria
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Vienna, , Austria
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Blumenau, , Brazil
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Botucatu, , Brazil
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Curitiba, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Recife, , Brazil
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Salvador, , Brazil
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Santo André, , Brazil
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São Bernardo do Campo, , Brazil
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Sorocaba, , Brazil
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Calgary, Alberta, Canada
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Sherwood Park, Alberta, Canada
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Ajax, Ontario, Canada
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Mississauga, Ontario, Canada
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Ottawa, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Brest, , France
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Le Kremlin-Bicêtre, , France
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Lyon, , France
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Marseille, , France
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Montpellier, , France
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Nantes, , France
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Paris, , France
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Paris, , France
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Pessac, , France
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Strasbourg, , France
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Bamberg, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Frankfurt, , Germany
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Frankfurt am Main, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Hanover, , Germany
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Koblenz, , Germany
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Landsberg, , Germany
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Leipzig, , Germany
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Lübeck, , Germany
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Mainz, , Germany
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Ashkelon, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Rehovot, , Israel
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Krakow, , Poland
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Lodz, , Poland
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Wroclaw, , Poland
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Izhevsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Jeddah, , Saudi Arabia
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Jeddah, , Saudi Arabia
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Bellville, , South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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Durban, , South Africa
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Durban, , South Africa
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Durban, , South Africa
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Durban, , South Africa
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eMkhomazi, , South Africa
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Johannesburg, , South Africa
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Johannesburg, , South Africa
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Johannesburg, , South Africa
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Lenasia Ext8, , South Africa
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Meadowdale, Germiston, , South Africa
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Middelburg, , South Africa
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Parow, , South Africa
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Bucheon-si, , South Korea
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Cheongju-si, , South Korea
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Daegu, , South Korea
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Daegu, , South Korea
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Jeju-do, , South Korea
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Jeonju, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Bursa, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Dnipro, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv Region, , Ukraine
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Kherson, , Ukraine
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Lutsk, , Ukraine
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Vinnytsia, , Ukraine
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Hanoi, , Vietnam
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Hà Nội, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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References
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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.
Brightling 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.
Menzies-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.
Menzies-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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D5180C00018
Identifier Type: -
Identifier Source: org_study_id
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