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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03347279
Ethics application status
Date submitted
9/11/2017
Date registered
20/11/2017
Date last updated
26/11/2021

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
Treatment: Other - Experimental: Tezepelumab
Other interventions - Placebo

Experimental: Tezepelumab - Tezepelumab: Tezepelumab subcutaneous injection

Placebo comparator: Placebo - Placebo: Placebo subcutaneous injection


Treatment: Other: Experimental: Tezepelumab
Tezepelumab subcutaneous injection

Other interventions: Placebo
Placebo subcutaneous injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma
Timepoint [1] 0 0
From randomisation to Study Week 52.
Primary outcome [2] 0 0
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma in Subjects With Baseline Eosinophils < 300 Cells/uL
Timepoint [2] 0 0
From randomisation to Study Week 52.
Secondary outcome [1] 0 0
Mean Change From Baseline at Week 52 in Pre-dose/Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) (L) (Key Secondary Endpoint)
Timepoint [1] 0 0
From randomisation to Study Week 52
Secondary outcome [2] 0 0
Mean Change From Baseline at Week 52 in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score (Key Secondary Endpoint)
Timepoint [2] 0 0
From randomisation to Study Week 52
Secondary outcome [3] 0 0
Mean Change From Baseline at Week 52 in Asthma Control Questionnaire-6(ACQ-6) (Key Secondary Endpoint)
Timepoint [3] 0 0
From randomisation to Study Week 52
Secondary outcome [4] 0 0
Mean Change From Baseline at Week 52 in Asthma Symptom Diary (Key Secondary Endpoint)
Timepoint [4] 0 0
From randomisation to Study Week 52
Secondary outcome [5] 0 0
Time to First Asthma Exacerbation
Timepoint [5] 0 0
From randomisation to Study Week 52
Secondary outcome [6] 0 0
Mean Change From Baseline at Week 52 in Clinic Fractional Exhaled Nitric Oxide (FeNO) (Ppb)
Timepoint [6] 0 0
From randomisation to Study Week 52
Secondary outcome [7] 0 0
Mean Change From Baseline in Daily Rescue Medication Use (Weekly Means) at Week 52
Timepoint [7] 0 0
From randomisation to Study Week 52
Secondary outcome [8] 0 0
Mean Change From Baseline in Work Productivity Loss Due to Asthma at Week 52
Timepoint [8] 0 0
From randomisation to Study Week 52
Secondary outcome [9] 0 0
Mean Change From Baseline in Class Productivity Loss Due to Asthma at Week 52
Timepoint [9] 0 0
From randomisation to Study Week 52
Secondary outcome [10] 0 0
Activity Impairment at Week 52
Timepoint [10] 0 0
From randomisation to Study Week 52
Secondary outcome [11] 0 0
Pharmacokinetics of Tezepelumab
Timepoint [11] 0 0
Pre-dose samples at Baseline, Week 4, Week 12, Week 24, Week 36, Week 52, Week 64
Secondary outcome [12] 0 0
Mean Change From Baseline at Week 52 in EQ-5D-5L VAS
Timepoint [12] 0 0
At Study Week 52
Secondary outcome [13] 0 0
Clinicians Global Impression of Change at Week 52
Timepoint [13] 0 0
From randomisation to Study Week 52
Secondary outcome [14] 0 0
Patients Global Impression of Change at Week 52
Timepoint [14] 0 0
From randomisation to Study Week 52
Secondary outcome [15] 0 0
Patients Global Impression of Severity at Week 52
Timepoint [15] 0 0
At Study Week 52
Secondary outcome [16] 0 0
Mean Change From Baseline at Week 52 in Blood Eosinophils (Cells/uL)
Timepoint [16] 0 0
From randomisation to Study Week 52
Secondary outcome [17] 0 0
Mean Change From Baseline at Week 52 in Total Serum IgE (IU/mL)
Timepoint [17] 0 0
From randomisation to Study Week 52
Secondary outcome [18] 0 0
Number of Participants With Asthma Specific Healthcare Utilization Over 52 Weeks
Timepoint [18] 0 0
From randomisation to Study Week 52
Secondary outcome [19] 0 0
Mean Change From Baseline in Home Based Morning Peak Expiratory Flow (PEF) at Week 52 (Weekly Means)
Timepoint [19] 0 0
From randomisation to Study Week 52
Secondary outcome [20] 0 0
Mean Change From Baseline in Home Based Evening Peak Expiratory Flow (PEF) at Week 52 (Weekly Means)
Timepoint [20] 0 0
From randomisation to Study Week 52
Secondary outcome [21] 0 0
Mean Change From Baseline in Night Time Awakenings (Weekly Means) at Week 52
Timepoint [21] 0 0
From randomisation to Study Week 52
Secondary outcome [22] 0 0
Immunogenecity of Tezepelumab
Timepoint [22] 0 0
Baseline, and from time of first dose at Week 0 to end of study at Week 64.
Secondary outcome [23] 0 0
Proportion of Subjects Who Had no Asthma Exacerbations
Timepoint [23] 0 0
From randomisation to Study Week 52
Secondary outcome [24] 0 0
Annual Asthma Exacerbation Rate Resulting in Emergency Room Visit or Hospitalisation
Timepoint [24] 0 0
From randomisation to Study Week 52
Secondary outcome [25] 0 0
Proportion of Subjects With at Least One Asthma Exacerbation Associated With Emergency Room Visit or Hospitalisation
Timepoint [25] 0 0
From randomisation to Study Week 52
Secondary outcome [26] 0 0
Proportion of Subjects Who Had no Asthma Exacerbations Associated With Emergency Room or Hospitalisation
Timepoint [26] 0 0
From randomisation to Study 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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/11/2020
Sample size
Target
Accrual to date
Final
1061
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 - Melbourne
Recruitment hospital [4] 0 0
Research Site - Nedlands
Recruitment hospital [5] 0 0
Research Site - New Lambton
Recruitment hospital [6] 0 0
Research Site - Spearwood
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
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
2310 - New Lambton
Recruitment postcode(s) [6] 0 0
6163 - Spearwood
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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Witbank
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London
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Ha Noi
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Hanoi
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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/study/NCT03347279
Trial related presentations / publications
Menzies-Gow A, Corren J, Bourdin A, Chupp G, Israel E, Wechsler ME, Brightling CE, Griffiths JM, Hellqvist A, Bowen K, Kaur P, Almqvist G, Ponnarambil S, Colice G. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021 May 13;384(19):1800-1809. doi: 10.1056/NEJMoa2034975.
Menzies-Gow A, Colice G, Griffiths JM, Almqvist G, Ponnarambil S, Kaur P, Ruberto G, Bowen K, Hellqvist A, Mo M, Garcia Gil E. NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Respir Res. 2020 Oct 13;21(1):266. doi: 10.1186/s12931-020-01526-6.
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/study/NCT03347279