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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03347279




Registration number
NCT03347279
Ethics application status
Date submitted
9/11/2017
Date registered
20/11/2017
Date last updated
9/06/2020

Titles & IDs
Public title
Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma
Scientific title
A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents With Severe Uncontrolled Asthma (NAVIGATOR)
Secondary ID [1] 0 0
D5180C00007
Universal Trial Number (UTN)
Trial acronym
NAVIGATOR
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 - Experimental: Tezepelumab
Other interventions - Placebo

Experimental: Tezepelumab - Tezepelumab: Tezepelumab subcutaneous injection

Placebo Comparator: Placebo - Placebo: Placebo subcutaneous injection


Other interventions: Experimental: 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
Annualized asthma exacerbation rate (AERR) - The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 52 weeks.
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [1] 0 0
Change from baseline in pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) - Change from baseline in FEV1 as compared to placebo at Week 52. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
Timepoint [1] 0 0
Baseline, Week 52
Secondary outcome [2] 0 0
Change from baseline in Standardized Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(S)+12) total score - Change from baseline in AQLQ(S)+12 as compared to placebo at Week 52. The AQLQ(S)+12 is a questionnaire that measures the health-related quality of life experienced by asthma subjects. The total score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment).
Timepoint [2] 0 0
Baseline, Week 52
Secondary outcome [3] 0 0
Change from baseline in Asthma Control Questionnaire-6 (ACQ-6) Score - Change from baseline in ACQ-6 as compared to placebo at Week 52. The ACQ-6 captures asthma symptoms and short-acting ß2-agonist use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses.
Timepoint [3] 0 0
Baseline, Week 52
Secondary outcome [4] 0 0
Change from baseline in weekly mean daily Asthma Symptom Diary score - Change from baseline in Asthma Symptom Diary score as compared to placebo at Week 52.
The Asthma Symptom Diary comprises of 10 items (5 items in the morning; 5 items in the evening). Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the daily diary. A daily ASD score is the mean of the 10 items. Responses for all 10 items are required to calculate the daily ASD score; otherwise, it is treated as missing. For the 7-day average asthma symptom score, scoring is done with no imputation using the mean of at least 4 of the 7 daily ASD scores as a mean weekly item score. The 7-day average ASD score ranges from 0 to 4.
Timepoint [4] 0 0
Baseline, Week 52
Secondary outcome [5] 0 0
Time to first asthma exacerbation - Time to the first occurrence of asthma exacerbation post randomisation
Timepoint [5] 0 0
Baseline to Week 52
Secondary outcome [6] 0 0
Change from baseline in fractional exhaled nitric oxide FENO (ppb) at clinic - Change from baseline in FeNO at clinic to week 52.
Timepoint [6] 0 0
Baseline, Week 52
Secondary outcome [7] 0 0
Change from baseline in weekly mean rescue medication use - Change from baseline in weekly mean rescue medication use at Week 52. The number of rescue medication inhalations (puffs) and nebulizer treatments taken will be recorded by the subject in the Asthma Symptom Diary twice daily (i.e., in the morning and evening). Each timepoint is calculated as weekly means based on daily diary data.
Timepoint [7] 0 0
Baseline, Week 52
Secondary outcome [8] 0 0
Work Productivity and Activity Impairment (WPAI+CIQ) Questionnaire and Classroom Impairment Questionnaire score - WPAI+CIQ score at Week 52. The WPAI+CIQ consists of questions about how asthma and asthma related issues impact a subject's ability to work, attend classes, and perform regular daily activities.
Timepoint [8] 0 0
Week 52
Secondary outcome [9] 0 0
Serum trough concentrations - Serum trough concentrations at each scheduled visit
Timepoint [9] 0 0
Baseline to Week 52
Secondary outcome [10] 0 0
European Quality of Life - 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) score - EQ-5D at Week 52. The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems, and extreme problems) that reflect increasing levels of difficulty.
Timepoint [10] 0 0
Week 52
Secondary outcome [11] 0 0
Patient Global Impression of Change/Severity (PGI-C, PGI-S) and Clinician Global Impression of Change (CGI-C) - The CGI-C and the PGI-C are used to evaluate the overall response to treatment, and the assessments use a 7-point rating scale ranging from 1 (Very Much Improved) to 7 (Very Much Worse). PGI-S is a single item designed to capture the subject's perception of overall symptom severity using a 6-point categorical response scale (no symptoms to very severe symptoms)
Timepoint [11] 0 0
Week 52
Secondary outcome [12] 0 0
Change from baseline in peripheral blood eosinophils - Change from baseline in blood eosinophil counts at week 52.
Timepoint [12] 0 0
Baseline, Week 52
Secondary outcome [13] 0 0
Change from baseline in total serum IgE - Change from baseline in IgE at week 52.
Timepoint [13] 0 0
Baseline, Week 52
Secondary outcome [14] 0 0
Asthma specific resource utilization (eg, unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) - Number of asthma specific resource utilizations (e.g. unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) over 52 weeks
Timepoint [14] 0 0
Baseline, Week 52
Secondary outcome [15] 0 0
Change from baseline in weekly mean morning and evening peak expiratory flow (PEF) - Change from baseline in weekly mean morning and evening peak expiratory flow (PEF) at Week 52. Home PEF testing will be performed by the subject in the morning upon awakening and in the evening at bedtime using an electronic, hand-held spirometer. Each timepoint is calculated as weekly means.
Timepoint [15] 0 0
Baseline, Week 52
Secondary outcome [16] 0 0
Change from baseline in weekly mean number of night time awakenings - Change from baseline in weekly mean number of night time awakenings at Week 52. Each timepoint is calculated as weekly mean number of awakenings due to asthma based on daily diary data.
Timepoint [16] 0 0
Baseline, Week 52
Secondary outcome [17] 0 0
Immunogenicity anti-drug antibodies - Incidence of anti-drug antibodies over 52 weeks.
Timepoint [17] 0 0
Baseline to Week 52
Secondary outcome [18] 0 0
Proportion of subjects who did not experience an asthma exacerbation - Number and percentage of patients who did not experience an asthma exacerbation post randomization
Timepoint [18] 0 0
Baseline to Week 52
Secondary outcome [19] 0 0
Annualized rate of exacerbations associated with emergency room visit, urgent care visit, or hospitalization - The annualized exacerbation rate is based on exacerbations reported by the investigator that are associated with an emergency room visit, urgent care visit, or a hospitalization
Timepoint [19] 0 0
Baseline to Week 52

Eligibility
Key inclusion criteria
- Age. 12-80

- Documented physician-diagnosed asthma for at least 12 months

- Subjects who have received a physician-prescribed asthma controller medication with
medium or high dose ICS for at least 12 months.

- Documented treatment with a total daily dose of either medium or high dose ICS (= 500
µg fluticasone propionate dry powder formulation equivalent total daily dose) for at
least 3 months.

- At least one additional maintenance asthma controller medication is required according
to standard practice of care and must be documented for at least 3 months.

- Morning pre-BD FEV1 <80% predicted normal (<90% for subjects 12-17 yrs)

- Evidence of asthma as documented by either: Documented historical reversibility of
FEV1 =12% and =200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol)
reversibility of FEV1 =12% and =200 mL during screening.

- Documented history of at least 2 asthma exacerbation events within 12 months.

- ACQ-6 score =1.5 at screening and on day of randomization
Minimum age
12 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pulmonary disease other than asthma.

- History of cancer.

- History of a clinically significant infection.

- Current smokers or subjects with smoking history =10 pack-years and subjects using
vaping products, including electronic cigarettes.

- History of chronic alcohol or drug abuse within 12 months.

- Hepatitis B, C or HIV.

- Pregnant or breastfeeding.

- History of anaphylaxis following any biologic therapy.

- Subject randomized in the current study or previous tezepelumab studies.

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
Active, not 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 - Campbelltown
Recruitment hospital [2] 0 0
Research Site - Kent Town
Recruitment hospital [3] 0 0
Research Site - Murdoch
Recruitment hospital [4] 0 0
Research Site - Nedlands
Recruitment hospital [5] 0 0
Research Site - New Lambton
Recruitment hospital [6] 0 0
Research Site - Prahran
Recruitment hospital [7] 0 0
Research Site - Westmead
Recruitment hospital [8] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
5067 - Kent Town
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
2310 - New Lambton
Recruitment postcode(s) [6] 0 0
3004 - Prahran
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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Sumida-ku
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Takamatsu-shi
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Toshima-ku
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Ube
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Yokkaichi-shi
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Yokohama-shi
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Yoshida-gun
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon-si
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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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Saudi Arabia
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Jeddah
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South Africa
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Bellville
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South Africa
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Boksburg North
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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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Mowbray
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Parow
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South Africa
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Pretoria
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South Africa
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Umkomaas
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South Africa
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Witbank
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Taiwan
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Hsinchu
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Taiwan
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Kaohsiung City
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Taiwan
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Kaohsiung Hsien
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan City
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Taiwan
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Taipei
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Taiwan
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Yilan
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv Region
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United Kingdom
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London
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Vietnam
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Ha Noi
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Vietnam
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Hanoi
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Vietnam
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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
A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to
Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe
Uncontrolled Asthma
Trial website
https://clinicaltrials.gov/show/NCT03347279
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Andrew Menzies-Gow, MD
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Royal Brompton Hospital, United Kingdom
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Contact person for public queries
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Contact person for scientific queries

Summary results
Other publications