Clinical trial NCT03347279: Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma, Uncontrolled Asthma, Severe Uncontrolled Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2017-11-20
Enrollment: 1061
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized in a 1:1 ratio to either tezepelumab or matching placebo both administered subcutaneously.
Primary purpose: TREATMENT

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

Detailed description: This is a multicentre, randomized, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma on medium to high-dose ICS and at least one additional asthma controller medication with or without OCS. Approximately 1060 subjects will be randomized globally. Subjects will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 12 weeks.

Eligibility criteria: 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

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.

Primary outcomes:
measure: Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma
timeFrame: From randomisation to Study Week 52.
measure: Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma in Subjects With Baseline Eosinophils < 300 Cells/uL
timeFrame: From randomisation to Study Week 52.
Secondary outcomes:
measure: 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)
timeFrame: From randomisation to Study Week 52
measure: 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)
timeFrame: From randomisation to Study Week 52
measure: Mean Change From Baseline at Week 52 in Asthma Control Questionnaire-6(ACQ-6) (Key Secondary Endpoint)
timeFrame: From randomisation to Study Week 52
measure: Mean Change From Baseline at Week 52 in Asthma Symptom Diary (Key Secondary Endpoint)
timeFrame: From randomisation to Study Week 52
measure: Time to First Asthma Exacerbation
timeFrame: From randomisation to Study Week 52
measure: Mean Change From Baseline at Week 52 in Clinic Fractional Exhaled Nitric Oxide (FeNO) (Ppb)
timeFrame: From randomisation to Study Week 52
measure: Mean Change From Baseline in Daily Rescue Medication Use (Weekly Means) at Week 52
timeFrame: From randomisation to Study Week 52
measure: Mean Change From Baseline in Work Productivity Loss Due to Asthma at Week 52
timeFrame: From randomisation to Study Week 52
measure: Mean Change From Baseline in Class Productivity Loss Due to Asthma at Week 52
timeFrame: From randomisation to Study Week 52
measure: Activity Impairment at Week 52
timeFrame: From randomisation to Study Week 52
measure: Pharmacokinetics of Tezepelumab
timeFrame: Pre-dose samples at Baseline, Week 4, Week 12, Week 24, Week 36, Week 52, Week 64
measure: Mean Change From Baseline at Week 52 in EQ-5D-5L VAS
timeFrame: At Study Week 52
measure: Clinicians Global Impression of Change at Week 52
timeFrame: From randomisation to Study Week 52
measure: Patients Global Impression of Change at Week 52
timeFrame: From randomisation to Study Week 52
measure: Patients Global Impression of Severity at Week 52
timeFrame: At Study Week 52
measure: Mean Change From Baseline at Week 52 in Blood Eosinophils (Cells/uL)
timeFrame: From randomisation to Study Week 52
measure: Mean Change From Baseline at Week 52 in Total Serum IgE (IU/mL)
timeFrame: From randomisation to Study Week 52
measure: Number of Participants With Asthma Specific Healthcare Utilization Over 52 Weeks
timeFrame: From randomisation to Study Week 52
measure: Mean Change From Baseline in Home Based Morning Peak Expiratory Flow (PEF) at Week 52 (Weekly Means)
timeFrame: From randomisation to Study Week 52
measure: Mean Change From Baseline in Home Based Evening Peak Expiratory Flow (PEF) at Week 52 (Weekly Means)
timeFrame: From randomisation to Study Week 52
measure: Mean Change From Baseline in Night Time Awakenings (Weekly Means) at Week 52
timeFrame: From randomisation to Study Week 52
measure: Immunogenecity of Tezepelumab
timeFrame: Baseline, and from time of first dose at Week 0 to end of study at Week 64.
measure: Proportion of Subjects Who Had no Asthma Exacerbations
timeFrame: From randomisation to Study Week 52
measure: Annual Asthma Exacerbation Rate Resulting in Emergency Room Visit or Hospitalisation
timeFrame: From randomisation to Study Week 52
measure: Proportion of Subjects With at Least One Asthma Exacerbation Associated With Emergency Room Visit or Hospitalisation
timeFrame: From randomisation to Study Week 52
measure: Proportion of Subjects Who Had no Asthma Exacerbations Associated With Emergency Room or Hospitalisation
timeFrame: From randomisation to Study Week 52
Other outcomes:
measure: Annual Asthma Exacerbation Rate Associated With Hospitalisations
timeFrame: From randomisation to Study Week 52
measure: Annual Asthma Exacerbation Rate Using Adjudicated Data
timeFrame: From randomisation to Study Week 52
measure: Annual Asthma Exacerbation Rate Associated With Emergency Room (ER) Visit or Hospitalisation Using Adjudicated Data
timeFrame: From randomisation to Study Week 52
Locations:
city: Dothan
country: United States
facility: Research Site
state: Alabama
city: Foley
country: United States
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state: Alabama
city: Gilbert
country: United States
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state: Arizona
city: Tucson
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state: Arizona
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state: California
city: Encinitas
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state: California
city: Huntington Beach
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city: Long Beach
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city: Palm Desert
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city: Rolling Hills Estates
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city: Walnut Creek
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state: California
city: Westminster
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city: Kissimmee
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city: Orlando
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country: Australia
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country: Brazil
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city: Calgary
country: Canada
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state: Alberta
city: Sherwood Park
country: Canada
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state: British Columbia
city: Ajax
country: Canada
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state: Ontario
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country: Canada
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city: Mississauga
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city: Ottawa
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city: St Charles Borromee
country: Canada
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city: Trois-Rivières
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state: Quebec
city: Quebec
country: Canada
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city: Brest Cedex
country: France
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city: GRENOBLE Cedex 9
country: France
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city: Le Kremlin Bicêtre
country: France
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country: France
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country: France
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city: MARSEILLE Cedex 20
country: France
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city: Montpellier Cedex 5
country: France
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country: France
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city: PARIS Cedex 12
country: France
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city: Paris Cedex 18
country: France
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city: Paris
country: France
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city: Pessac
country: France
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city: Strasbourg Cedex
country: France
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city: Toulouse CEDEX 09
country: France
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city: Bamberg
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
facility: Research Site
city: Frankfurt am Main
country: Germany
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city: Frankfurt
country: Germany
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city: Hamburg
country: Germany
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country: Germany
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city: Hannover
country: Germany
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country: Germany
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city: Landsberg
country: Germany
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city: Leipzig
country: Germany
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country: Germany
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country: Germany
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country: Germany
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city: Ashkelon
country: Israel
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country: Israel
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country: Israel
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country: Israel
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country: Israel
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country: Japan
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country: Japan
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city: Chuo-ku
country: Japan
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city: Chuo-ku
country: Japan
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country: Japan
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country: Japan
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country: Japan
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city: Fukuoka-shi
country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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country: Russian Federation
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country: Russian Federation
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city: Moscow
country: Russian Federation
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country: Russian Federation
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country: Saudi Arabia
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country: South Africa
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country: South Africa
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country: South Africa
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country: South Africa
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country: South Africa
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country: South Africa
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country: South Africa
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country: South Africa
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country: South Africa
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country: South Africa
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country: South Africa
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country: South Africa
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country: South Africa
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country: Taiwan
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country: Taiwan
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country: Taiwan
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country: Taiwan
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country: Taiwan
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country: Taiwan
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country: Taiwan
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country: Taiwan
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country: Ukraine
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country: Ukraine
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country: United Kingdom
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country: Vietnam
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country: Vietnam
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country: Vietnam
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city: Ho Chi Minh
country: Vietnam
facility: Research Site
Study officials:
affiliation: Royal Brompton Hospital, United Kingdom
name: Andrew Menzies-Gow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.