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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03706079




Registration number
NCT03706079
Ethics application status
Date submitted
11/10/2018
Date registered
15/10/2018
Date last updated
24/07/2019

Titles & IDs
Public title
Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma
Scientific title
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)
Secondary ID [1] 0 0
D5180C00018
Universal Trial Number (UTN)
Trial acronym
DESTINATION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Tezepelumab
Other interventions - Placebo

Experimental: Tezepelumab - Tezepelumab subcutaneous injection

Placebo Comparator: Placebo - Placebo: Placebo subcutaneous injection


Other interventions: Tezepelumab
Tezepelumab subcutaneous injection

Other interventions: Placebo
Placebo subcutaneous injection

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Exposure adjusted rates of AEs/SAEs - Exposure adjusted rates defined as the number of events divided by person-time at risk
Timepoint [1] 0 0
Baseline (Week 0 in predecessor study) to Week 104
Secondary outcome [1] 0 0
Annualized asthma exacerbation rate (AAER) - The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF
Timepoint [1] 0 0
Baseline (Week 0 in predecessor study) to Week 104

Eligibility
Key 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)
Minimum age
13 Years
Maximum age
81 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Kent Town
Recruitment hospital [2] 0 0
Research Site - Murdoch
Recruitment hospital [3] 0 0
Research Site - Nedlands
Recruitment hospital [4] 0 0
Research Site - New Lambton
Recruitment hospital [5] 0 0
Research Site - Prahran
Recruitment postcode(s) [1] 0 0
5067 - Kent Town
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment postcode(s) [4] 0 0
2310 - New Lambton
Recruitment postcode(s) [5] 0 0
3004 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
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United States of America
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California
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United States of America
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Connecticut
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Florida
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United States of America
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Georgia
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United States of America
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Idaho
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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Michigan
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Missouri
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Nebraska
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Nevada
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Ciudad de Buenos Aires
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Argentina
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Córdoba
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Argentina
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Mendoza
Country [30] 0 0
Argentina
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Nueve de julio
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Argentina
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Quilmes
Country [32] 0 0
Argentina
State/province [32] 0 0
San Fernando
Country [33] 0 0
Argentina
State/province [33] 0 0
San Miguel de Tucuman
Country [34] 0 0
Austria
State/province [34] 0 0
Salzburg
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Austria
State/province [35] 0 0
Wien
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Brazil
State/province [36] 0 0
Santo Andre
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Canada
State/province [37] 0 0
Alberta
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Canada
State/province [38] 0 0
Ontario
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Canada
State/province [39] 0 0
Quebec
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France
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Brest Cedex 2
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France
State/province [41] 0 0
Le Kremlin-Bicêtre
Country [42] 0 0
France
State/province [42] 0 0
Lyon Cedex 4
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France
State/province [43] 0 0
Marseille Cedex 20
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France
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Montpellier
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France
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Nantes
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France
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Paris
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Germany
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Aschaffenburg
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Germany
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Bamberg
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Germany
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Berlin
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Germany
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Frankfurt am Main
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Koblenz
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Germany
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Landsberg
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Germany
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Leipzig
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Germany
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Lübeck
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Germany
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Mainz
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Israel
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Ashkelon
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Rehovot
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Korea, Republic of
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Bucheon-si
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Korea, Republic of
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Daegu
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Korea, Republic of
State/province [66] 0 0
Jeju-do
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Korea, Republic of
State/province [67] 0 0
Jeonju-si
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Seongnam-si
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Korea, Republic of
State/province [69] 0 0
Seoul
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Korea, Republic of
State/province [70] 0 0
Suwon-si
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Poland
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Kraków
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Poland
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Wroclaw
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Poland
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Lódz
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Russian Federation
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Izhevsk
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Russian Federation
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Moscow
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Russian Federation
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St-Petersburg
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South Africa
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Bellville
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South Africa
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Boksburg
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South Africa
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Cape Town
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South Africa
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Durban
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South Africa
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Johannesburg
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South Africa
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Lenasia Ext8
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South Africa
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Middelburg
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South Africa
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Mowbray
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South Africa
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Parow
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South Africa
State/province [86] 0 0
Umkomaas
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Taiwan
State/province [87] 0 0
Kaohsiung
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Taiwan
State/province [88] 0 0
Taichung
Country [89] 0 0
Taiwan
State/province [89] 0 0
Taipei
Country [90] 0 0
Turkey
State/province [90] 0 0
Adana
Country [91] 0 0
Turkey
State/province [91] 0 0
Ankara
Country [92] 0 0
Turkey
State/province [92] 0 0
Bursa
Country [93] 0 0
Turkey
State/province [93] 0 0
Istanbul
Country [94] 0 0
Turkey
State/province [94] 0 0
Manisa
Country [95] 0 0
Ukraine
State/province [95] 0 0
Dnipro
Country [96] 0 0
Ukraine
State/province [96] 0 0
Kharkiv
Country [97] 0 0
Ukraine
State/province [97] 0 0
Lutsk
Country [98] 0 0
Ukraine
State/province [98] 0 0
Vinnytsia
Country [99] 0 0
Vietnam
State/province [99] 0 0
Ha Noi
Country [100] 0 0
Vietnam
State/province [100] 0 0
Hanoi
Country [101] 0 0
Vietnam
State/province [101] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Amgen
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT03706079
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Menzies-Gow, MD
Address 0 0
Royal Brompton Hospital, United Kingdom
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03706079