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AzTrials

AsthmaPhase 3NAVIGATORNCT03347279

Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma

A Phase 3 study testing Experimental: Tezepelumab in people with Asthma, run by AstraZeneca at 289 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 12 to 80 years
Conditions the study is for
Asthma
What is being tested?
Experimental: Tezepelumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,061 participants
Where
289 sitesin 18 countries
Study dates
23 Nov 2017to 12 Nov 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • Pregnant or breastfeeding.
  • History of anaphylaxis following any biologic therapy.
  • Subject randomized in the current study or previous tezepelumab studies.

Trial locations and contacts

289 sites in 18 countries.

289 sites in 18 countries

United States95 sites

  • Research Site

    Allen, Texas, 75013

  • Research Site

    Amarillo, Texas, 79106

  • Research Site

    Anderson, South Carolina, 29621

  • Research Site

    Ann Arbor, Michigan, 48109

  • Research Site

    Bakersfield, California, 93301

  • Research Site

    Boerne, Texas, 78006

  • Research Site

    Boise, Idaho, 83706

  • Research Site

    Boston, Massachusetts, 02115

  • Research Site

    Brooklyn, New York, 11235

  • Research Site

    Celebration, Florida, 34747

  • Research Site

    Charlotte, North Carolina, 28277

  • Research Site

    Cincinnati, Ohio, 45229

  • Research Site

    Cincinnati, Ohio, 45231

  • Research Site

    Columbia, South Carolina, 29204

  • Research Site

    Cudahy, Wisconsin, 53110

  • Research Site

    Dallas, Texas, 75225

  • Research Site

    Dallas, Texas, 75230

  • Research Site

    Denver, Colorado, 80206

  • Research Site

    Dothan, Alabama, 36303

  • Research Site

    Edmond, Oklahoma, 73034

  • Research Site

    Encinitas, California, 92024

  • Research Site

    Fall River, Massachusetts, 02721

  • Research Site

    Fayetteville, Georgia, 30214

  • Research Site

    Flint, Michigan, 48504

  • Research Site

    Foley, Alabama, 36535

  • Research Site

    Fort Mitchell, Kentucky, 41017

  • Research Site

    Gainesville, Georgia, 30501

  • Research Site

    Gastonia, North Carolina, 28054

  • Research Site

    Gilbert, Arizona, 85234

  • Research Site

    Greenville, South Carolina, 29607

  • Research Site

    Huntington Beach, California, 92647

  • Research Site

    Kissimmee, Florida, 34741

  • Research Site

    Kissimmee, Florida, 34744

  • Research Site

    Lake Charles, Louisiana, 70601

  • Research Site

    Lampasas, Texas, 76550

  • Research Site

    Las Vegas, Nevada, 89106

  • Research Site

    Las Vegas, Nevada, 89119

  • Research Site

    Lincoln, Nebraska, 68505

  • Research Site

    Long Beach, California, 90808

  • Research Site

    Los Angeles, California, 90025

  • Research Site

    Louisville, Kentucky, 40215

  • Research Site

    Madison, Wisconsin, 53792

  • Research Site

    Manassas, Virginia, 20110

  • Research Site

    Mayfield Heights, Ohio, 44124

  • Research Site

    McAllen, Texas, 78504

  • Research Site

    Medford, Oregon, 97504

  • Research Site

    Michigan City, Indiana, 46360

  • Research Site

    Mission Viejo, California, 92691

  • Research Site

    New Haven, Connecticut, 06520

  • Research Site

    New York, New York, 10016

  • Research Site

    New York, New York, 10022

  • Research Site

    New York, New York, 10029

  • Research Site

    New York, New York, 10032

  • Research Site

    Newport Beach, California, 92663

  • Research Site

    Northfield, New Jersey, 08225

  • Research Site

    Northridge, California, 91324

  • Research Site

    Novi, Michigan, 48375

  • Research Site

    Oklahoma City, Oklahoma, 73120

  • Research Site

    Orlando, Florida, 32803

  • Research Site

    Orlando, Florida, 32825

  • Research Site

    Palm Desert, California, 92260

  • Research Site

    Panama City, Florida, 32405

  • Research Site

    Pittsburgh, Pennsylvania, 15243

  • Research Site

    Plano, Texas, 75093

  • Research Site

    Port Charlotte, Florida, 33952

  • Research Site

    Port Huron, Michigan, 48060

  • Research Site

    Richmond, Virginia, 23220

  • Research Site

    Richmond, Virginia, 23235

  • Research Site

    Rolling Hills Estates, California, 90274

  • Research Site

    San Antonio, Texas, 78251

  • Research Site

    Sarasota, Florida, 34239

  • Research Site

    Savannah, Georgia, 31406

  • Research Site

    Sebring, Florida, 33870

  • Research Site

    St Louis, Missouri, 63108

  • Research Site

    St Louis, Missouri, 63141

  • Research Site

    St. Petersburg, Florida, 33704

  • Research Site

    St. Petersburg, Florida, 33710

  • Research Site

    St. Petersburg, Florida, 33713

  • Research Site

    Stockbridge, Georgia, 30281

  • Research Site

    Tampa, Florida, 33607

  • Research Site

    The Bronx, New York, 10459

  • Research Site

    The Bronx, New York, 10465

  • Research Site

    Toledo, Ohio, 43608

  • Research Site

    Toms River, New Jersey, 08755

  • Research Site

    Troy, Michigan, 48085

  • Research Site

    Tucson, Arizona, 85724

  • Research Site

    Tulsa, Oklahoma, 74136

  • Research Site

    Valhalla, New York, 10595

  • Research Site

    Walnut Creek, California, 94598

  • Research Site

    Warwick, Rhode Island, 02886

  • Research Site

    Westminster, California, 92683

  • Research Site

    White Marsh, Maryland, 21162

  • Research Site

    Winston-Salem, North Carolina, 27104

  • Research Site

    Winter Park, Florida, 32789

  • Research Site

    Zachary, Louisiana, 70791

Other trials in United States

Japan55 sites

  • Research Site

    Bunkyō City, 113-8431

  • Research Site

    Chūōku, 103-0022

  • Research Site

    Chūōku, 103-0028

  • Research Site

    Chūōku, 104-0031

  • Research Site

    Edogawa-ku, 134-0083

  • Research Site

    Fujieda-shi, 426-8677

  • Research Site

    Fukuoka, 810-0001

  • Research Site

    Fukuoka, 811-1394

  • Research Site

    Fukuoka, 815-8588

  • Research Site

    Habikino-shi, 583-8588

  • Research Site

    Hamamatsu, 431-3192

  • Research Site

    Higashiibaraki-gun, 311-3193

  • Research Site

    Himeji-shi, 672-8064

  • Research Site

    Hitachi-shi, 317-0077

  • Research Site

    Kagoshima, 890-0073

  • Research Site

    Kagoshima, 890-8520

  • Research Site

    Kanazawa, 920-8530

  • Research Site

    Kanazawa, 920-8641

  • Research Site

    Kasuga-shi, 816-0813

  • Research Site

    Kishiwada-shi, 596-8501

  • Research Site

    Kitakyushu, 802-0052

  • Research Site

    Koga-shi, 811-3195

  • Research Site

    Matsusaka-shi, 515-8544

  • Research Site

    Meguro-ku, 152-0021

  • Research Site

    Meguro-ku, 152-8621

  • Research Site

    Minatoku, 105-0003

  • Research Site

    Minatoku, 105-0004

  • Research Site

    Minatoku, 108-0014

  • Research Site

    Mizunami-shi, 509-6134

  • Research Site

    Nagaoka-shi, 940-2085

  • Research Site

    Niigata, 951-8520

  • Research Site

    Ogaki-shi, 503-8502

  • Research Site

    Ohota-ku, 145-0063

  • Research Site

    Omuta-shi, 837-0911

  • Research Site

    Sagamihara-shi, 228-0815

  • Research Site

    Sapporo, 001-0901

  • Research Site

    Sapporo, 064-0804

  • Research Site

    Setagaya-ku, 157-0072

  • Research Site

    Shibuya-ku, 150-0013

  • Research Site

    Shinagawa-ku, 140-8522

  • Research Site

    Shinagawa-ku, 142-8666

  • Research Site

    Shinjuku-ku, 162-8655

  • Research Site

    Shinjuku-ku, 162-8666

  • Research Site

    Sumida-ku, 130-0015

  • Research Site

    tabashi City, 173-0003

  • Research Site

    tabashi City, 173-8610

  • Research Site

    Takamatsu, 761-8073

  • Research Site

    Toshima-ku, 170-0003

  • Research Site

    Toshima-ku, 171-0014

  • Research Site

    Ube, 755-8505

  • Research Site

    Yokkaichi-shi, 510-8567

  • Research Site

    Yokohama, 223-0059

  • Research Site

    Yokohama, 236-0004

  • Research Site

    Yokohama, 236-0024

  • Research Site

    Yoshida-gun, 910-1193

Other trials in Japan

South Africa18 sites

  • Research Site

    Bellville, 7530

  • Research Site

    Boksburg North, 1460

  • Research Site

    Cape Town, 7570

  • Research Site

    Cape Town, 7764

  • Research Site

    Durban, 4001

  • Research Site

    Durban, 4091

  • Research Site

    Durban, 4092

  • Research Site

    Durban, 4450

  • Research Site

    eMkhomazi, 4170

  • Research Site

    Johannesburg, 1724

  • Research Site

    Johannesburg, 1829

  • Research Site

    Johannesburg, 2113

  • Research Site

    Lenasia Ext8, 1820

  • Research Site

    Middelburg, 1055

  • Research Site

    Mowbray, 7700

  • Research Site

    Parow, 7505

  • Research Site

    Pretoria, 0157

  • Research Site

    Witbank, 1035

Other trials in South Africa

South Korea18 sites

  • Research Site

    Bucheon-si, 14584

  • Research Site

    Cheongju-si, 28644

  • Research Site

    Daegu, 41404

  • Research Site

    Daegu, 42415

  • Research Site

    Jeju City, 690-767

  • Research Site

    Jeonju, 54907

  • Research Site

    Seongnam-si, 13620

  • Research Site

    Seoul, 02447

  • Research Site

    Seoul, 03080

  • Research Site

    Seoul, 03312

  • Research Site

    Seoul, 03722

  • Research Site

    Seoul, 05505

  • Research Site

    Seoul, 06351

  • Research Site

    Seoul, 06591

  • Research Site

    Seoul, 07985

  • Research Site

    Seoul, 08308

  • Research Site

    Seoul, 150-713

  • Research Site

    Suwon, 16499

Other trials in South Korea

Brazil14 sites

  • Research Site

    Blumenau, 89030-101

  • Research Site

    Botucatu, 18618-970

  • Research Site

    Curitiba, 80060-900

  • Research Site

    Porto Alegre, 9002-060

  • Research Site

    Porto Alegre, 90035-074

  • Research Site

    Porto Alegre, 90610-000

  • Research Site

    Porto Alegre, 90619-900

  • Research Site

    Porto Alegre, 91350-200

  • Research Site

    Recife, 50070-550

  • Research Site

    Salvador, 41940-455

  • Research Site

    Santo André, 09080-110

  • Research Site

    São Bernardo do Campo, 09750-420

  • Research Site

    Sorocaba, 18040-425

  • Research Site

    Vitória, 29055-450

Other trials in Brazil

France14 sites

  • Research Site

    Brest, 29609

  • Research Site

    Grenoble, 38043

  • Research Site

    Le Kremlin-Bicêtre, 94275

  • Research Site

    Lille, 59037

  • Research Site

    Lyon, 69317

  • Research Site

    Marseille, 13015

  • Research Site

    Montpellier, 34295

  • Research Site

    Nantes, 44093

  • Research Site

    Paris, 75015

  • Research Site

    Paris, 75571

  • Research Site

    Paris, 75877

  • Research Site

    Pessac, 33604

  • Research Site

    Strasbourg, 67091

  • Research Site

    Toulouse, 31059

Other trials in France

Germany14 sites

  • Research Site

    Bamberg, 96049

  • Research Site

    Berlin, 10367

  • Research Site

    Berlin, 10717

  • Research Site

    Frankfurt, 60596

  • Research Site

    Frankfurt am Main, 60596

  • Research Site

    Hamburg, 20354

  • Research Site

    Hamburg, 22299

  • Research Site

    Hanover, 30625

  • Research Site

    Hanover, D-30173

  • Research Site

    Landsberg, 86899

  • Research Site

    Leipzig, 04103

  • Research Site

    Leipzig, 04357

  • Research Site

    Lübeck, 23552

  • Research Site

    Mainz, 55131

Other trials in Germany

Canada12 sites

  • Research Site

    Ajax, Ontario, L1S 2J5

  • Research Site

    Burlington, Ontario, L7N 3V2

  • Research Site

    Calgary, Alberta, T2N 4Z6

  • Research Site

    Mississauga, Ontario, L5A 3V4

  • Research Site

    Montreal, Quebec, H4J 1C5

  • Research Site

    Ottawa, Ontario, K1G 6C6

  • Research Site

    Québec, Quebec, G1G 3Y8

  • Research Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • Research Site

    Sherwood Park, Alberta, T8L 0N2

  • Research Site

    Trois-Rivières, Quebec, G8T 7A1

  • Research Site

    Vancouver, British Columbia, V5Z 1M9

  • Research Site

    Windsor, Ontario, N8X 1T3

Other trials in Canada

Taiwan9 sites

  • Research Site

    Hsinchu, 300

  • Research Site

    Kaohsiung City, 80756

  • Research Site

    Kaohsiung City, 82445

  • Research Site

    Kaohsiung Hsien, TAIWAN

  • Research Site

    Taichung, 40443

  • Research Site

    Tainan, 70403

  • Research Site

    Taipei, 220216

  • Research Site

    Taipei, 235

  • Research Site

    Yilan, 260

Other trials in Taiwan

Argentina8 sites

  • Research Site

    Buenos Aires, C1414AIF

  • Research Site

    CABA, C1056ABJ

  • Research Site

    CABA, C1425BEN

  • Research Site

    Ciudad de Buenos Aires, 1425

  • Research Site

    Córdoba, X5003DCE

  • Research Site

    Mendoza, 5500

  • Research Site

    Nueve de Julio, B6500EZL

  • Research Site

    Quilmes, B1878FNR

Other trials in Argentina

Australia8 sites

  • Research Site

    Campbelltown, 2560

  • Research Site

    Kent Town, 5067

  • Research Site

    Melbourne, 3004

  • Research Site

    Nedlands, 6009

  • Research Site

    New Lambton, 2310

  • Research Site

    Spearwood, 6163

  • Research Site

    Westmead, 2145

  • Research Site

    Woolloongabba, 4102

Other trials in Australia

Israel6 sites

  • Research Site

    Ashkelon, 7830604

  • Research Site

    Haifa, 34362

  • Research Site

    Jerusalem, 91031

  • Research Site

    Jerusalem, 91120

  • Research Site

    Kfar Saba, 49281

  • Research Site

    Rehovot, 7661041

Other trials in Israel

Austria5 sites

  • Research Site

    Klagenfurt, 9020

  • Research Site

    Linz, 4020

  • Research Site

    Salzburg, 5020

  • Research Site

    Vienna, 1090

  • Research Site

    Vienna, 1130

Other trials in Austria

Russia4 sites

  • Research Site

    Izhevsk, 426035

  • Research Site

    Moscow, 115093

  • Research Site

    Moscow, 115522

  • Research Site

    Saint Petersburg, 193231

Other trials in Russia

Vietnam4 sites

  • Research Site

    Hà Nội, 100000

  • Research Site

    Hanoi, 100000

  • Research Site

    Hanoi, 10000

  • Research Site

    Ho Chi Minh City, 70000

Other trials in Vietnam

Saudi Arabia2 sites

  • Research Site

    Jeddah, 21423

  • Research Site

    Jeddah, 22252

Other trials in Saudi Arabia

Ukraine2 sites

  • Research Site

    Ivano-Frankivsk, 76018

  • Research Site

    Kharkiv Region, 61075

Other trials in Ukraine

United Kingdom1 site

  • Research Site

    London, SW3 6NP

Other trials in United Kingdom

About this study

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)

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

Read the 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.

Conditions
Asthma
Being tested
Experimental: Tezepelumab, Placebo
Keywords
Asthma, Uncontrolled Asthma, Severe Uncontrolled Asthma
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: TezepelumabBiological

    Also called Tezepelumab

    Tezepelumab subcutaneous injection

  • PlaceboOther

    Placebo subcutaneous injection

Study groups in NCT03347279
Study groupRoleWhat they receive
TezepelumabExperimentalTezepelumab: Tezepelumab subcutaneous injection
Receives: Biological: Experimental: Tezepelumab
PlaceboPlacebo comparatorPlacebo: Placebo subcutaneous injection
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma

    The annual exacerbation rate is based on unadjudicated exacerbations reported by the investigator in the eCRF. The analysis is based on the primary population (Full Analysis Set)

    Measured: From randomisation to Study Week 52.

  2. Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma in Subjects With Baseline Eosinophils < 300 Cells/uL

    The annual exacerbation rate is based on unadjudicated exacerbations reported by the investigator in the eCRF. This analysis is based on subjects with baseline eosinophils < 300 cells/uL

    Measured: From randomisation to Study Week 52.

Secondary outcomes (26)

  1. 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)

    Mean 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.

    Measured: From randomisation to Study Week 52

  2. 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)

    Mean 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).

    Measured: From randomisation to Study Week 52

  3. Mean Change From Baseline at Week 52 in Asthma Control Questionnaire-6(ACQ-6) (Key Secondary Endpoint)

    Change from baseline in ACQ-6 as compared to placebo at Week 52. The ACQ-6 captures asthma symptoms and short-acting β2-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.

    Measured: From randomisation to Study Week 52

  4. Mean Change From Baseline at Week 52 in Asthma Symptom Diary (Key Secondary Endpoint)

    Mean change from baseline at Week 52 in Asthma Symptom Diary. 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, where 0 indicates no asthma symptoms.

    Measured: From randomisation to Study Week 52

  5. Time to First Asthma Exacerbation

    Time to first occurrence of asthma exacerbation post-randomisation, presented as number of subjects with at least one asthma exacerbation as reported by the investigator in the eCRF.

    Measured: From randomisation to Study Week 52

  6. Mean Change From Baseline at Week 52 in Clinic Fractional Exhaled Nitric Oxide (FeNO) (Ppb)

    Mean change from baseline at Study Week 52 in FeNO (ppb) measured at site

    Measured: From randomisation to Study Week 52

  7. Mean Change From Baseline in Daily Rescue Medication Use (Weekly Means) at Week 52

    Daily rescue medication use is defined as: Number of night inhaler puffs + 2 x [number of night nebulizer times] + number of daytime inhaler puffs + 2 x [number of day nebulizer times]. Weekly means are calculated using at least 4 of 7 days of daily rescue medication use.

    Measured: From randomisation to Study Week 52

  8. Mean Change From Baseline in Work Productivity Loss Due to Asthma at Week 52

    WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked.

    Measured: From randomisation to Study Week 52

  9. Mean Change From Baseline in Class Productivity Loss Due to Asthma at Week 52

    WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Class productivity loss is derived by sum of percentage of missed class hours due to asthma and product of percentage of actual hours in class times degree of asthma affecting productivity while in class. Percentage of missed hours in class due to asthma is calculated by number of hours in class missed due to asthma divided by total number of hours in class missed plus number of hours actually in class.

    Measured: From randomisation to Study Week 52

  10. Activity Impairment at Week 52

    WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Activity impairment is the degree health affected regular activities (other than work or class) rated from 0 to 10, with 0 meaning no effect, divided by 10, and then expressed as a percentage.

    Measured: From randomisation to Study Week 52

  11. Pharmacokinetics of Tezepelumab

    Mean serum trough PK concentrations taken pre-dose at each visit

    Measured: Pre-dose samples at Baseline, Week 4, Week 12, Week 24, Week 36, Week 52, Week 64

  12. Mean Change From Baseline at Week 52 in EQ-5D-5L VAS

    Mean change from baseline at Study Week 52 in EQ-5D-5L VAS. EQ-5D-5L visual analogue scale (VAS) allows subjects to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.

    Measured: At Study Week 52

  13. Clinicians Global Impression of Change at Week 52

    CGIC (Clinical global impression of change) is an overall evaluation of response to treatment, conducted by investigator using 7-point rating scale, ranging from 1 (very much improved), to 7 (very much worse)

    Measured: From randomisation to Study Week 52

  14. Patients Global Impression of Change at Week 52

    PGIC (Patient global impression of change) is an overall evaluation of response to treatment, conducted by the patient using 7-point rating scale, ranging from 1 (very much improved), to 7 (very much worse).

    Measured: From randomisation to Study Week 52

  15. Patients Global Impression of Severity at Week 52

    PGI-S (Patient global impression of severity) is an overall evaluation of patient's perception of overall symptom severity using a 6-point rating scale, ranging from 0 = No symptoms, 1=Very mild symptoms, 2=Mild symptoms, 3=Moderate symptoms, 4=Severe symptoms, 5=Very severe symptoms

    Measured: At Study Week 52

  16. Mean Change From Baseline at Week 52 in Blood Eosinophils (Cells/uL)

    Mean change from baseline at Study Week 52 in blood eosinophils (cells/uL)

    Measured: From randomisation to Study Week 52

  17. Mean Change From Baseline at Week 52 in Total Serum IgE (IU/mL)

    Mean change from baseline at Study Week 52 in total serum IgE (IU/mL)

    Measured: From randomisation to Study Week 52

  18. Number of Participants With Asthma Specific Healthcare Utilization Over 52 Weeks

    Number of participants with asthma specific healthcare utilizations (e.g. unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) over 52 weeks

    Measured: From randomisation to Study Week 52

  19. Mean Change From Baseline in Home Based Morning Peak Expiratory Flow (PEF) at Week 52 (Weekly Means)

    Mean change from baseline in home based morning PEF (L/min) at Study 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. Weekly means are calculated using at least 4 of the 7 days of PEF data.

    Measured: From randomisation to Study Week 52

  20. Mean Change From Baseline in Home Based Evening Peak Expiratory Flow (PEF) at Week 52 (Weekly Means)

    Mean change from baseline in home based evening PEF (L/min) at Study 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. Weekly means are calculated using at least 4 of the 7 days of PEF data.

    Measured: From randomisation to Study Week 52

  21. Mean Change From Baseline in Night Time Awakenings (Weekly Means) at Week 52

    Mean change from baseline in night time awakenings due to asthma at Study Week 52. Night-time awakenings percentage defined as number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data and multiplied by 100%. At least 4 out of 7 days of data is required to calculate a weekly mean.

    Measured: From randomisation to Study Week 52

  22. Immunogenecity of Tezepelumab

    Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post baseline assessments (with >=16 weeks between the first and the last positive) or positive at last post baseline assessment. Transiently positive is defined as having at least one post baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Treatment boosted ADA defined as baseline positive ADA that was boosted to a 4 fold or higher level following treatment. Treatment emergent ADA defined as sum of treatment induced ADA and treatment boosted ADA.

    Measured: Baseline, and from time of first dose at Week 0 to end of study at Week 64.

  23. Proportion of Subjects Who Had no Asthma Exacerbations

    The proportion of subjects who have no exacerbations is presented as the percentage of subjects with no exacerbations. This is defined as subjects who meet both the following criteria: (1) completed the 52 week treatment period and (2) did not report an exacerbation during this period.

    Measured: From randomisation to Study Week 52

  24. Annual Asthma Exacerbation Rate Resulting in Emergency Room Visit or Hospitalisation

    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 (where urgent care visit was captured as an emergency room visit on the eCRF)

    Measured: From randomisation to Study Week 52

  25. Proportion of Subjects With at Least One Asthma Exacerbation Associated With Emergency Room Visit or Hospitalisation

    Proportion of subjects with at least one asthma exacerbation associated with emergency room visit or hospitalisation as recorded by the investigator in the CRF. This is presented as percentage of subjects with at least one asthma exacerbation associated with emergency room visit or hospitalisation.

    Measured: From randomisation to Study Week 52

  26. Proportion of Subjects Who Had no Asthma Exacerbations Associated With Emergency Room or Hospitalisation

    The proportion of subjects with no exacerbations is presented as percentage of subjects who meet both the following criteria: (1) completed the 52 week treatment period and (2) did not report an exacerbation associated with emergency room or hospitalisation during this period.

    Measured: From randomisation to Study Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2017
  2. Study start23 Nov 2017
  3. Primary completion8 Sep 2020
  4. Study completion12 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects will be randomized in a 1:1 ratio to either tezepelumab or matching placebo both administered subcutaneously.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,061 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03347279
Sponsor's protocol ID
D5180C00007
Acronym
NAVIGATOR
Status last verified
Oct 2021
First submitted
9 Nov 2017
Last updated
26 Nov 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Publications

  • Feleszko W, Caminati M, Gern JE, Johnston SL, Marchese C, Clarke D, Ambrose CS, Lindsley AW. Effect of tezepelumab on asthma exacerbations co-occurring with infection-attributed acute respiratory illnesses. Ann Allergy Asthma Immunol. 2026 Jan;136(1):61-65.e1. doi: 10.1016/j.anai.2025.09.015. Epub 2025 Oct 8.

    PubMed 41072729

  • Yang X, Wang L, Huang K, Tang W, Berame EJ, Park HS, Hunter G, Jiang W, Wu CC, Min CW, Domek-Zielinska K, Lal H, Molfino NA, Ponnarambil SS, Zhong N. Efficacy and Safety of Tezepelumab in Adults With Severe, Uncontrolled Asthma in Asia: Results From the Phase 3 DIRECTION Study. J Allergy Clin Immunol Pract. 2025 Nov;13(11):3011-3020.e9. doi: 10.1016/j.jaip.2025.07.046. Epub 2025 Aug 7.

    PubMed 40782846

  • Pavord ID, Brightling CE, Korn S, Martin NL, Ponnarambil SS, Molfino NA, Parnes JR, Ambrose CS. Tezepelumab can Restore Normal Lung Function in Patients with Severe, Uncontrolled Asthma: Pooled Results from the PATHWAY and NAVIGATOR Studies. Pulm Ther. 2025 Jun;11(2):315-325. doi: 10.1007/s41030-025-00294-2. Epub 2025 Apr 26.

    PubMed 40285963

  • Jacobs JS, Han JK, Lee JK, Laidlaw TM, Martin NL, Caveney S, Ambrose CS, Martin N, Spahn JD, Hoyte FCL. Effect of Tezepelumab on Sino-Nasal Outcome Test (SNOT)-22 Domain and Symptom-Specific Scores in Patients with Severe, Uncontrolled Asthma and a History of Chronic Rhinosinusitis with Nasal Polyps. Adv Ther. 2025 Jan;42(1):510-522. doi: 10.1007/s12325-024-03006-5. Epub 2024 Nov 8.

    PubMed 39514041

  • 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.

    PubMed 39326921

  • Carr TF, Moore WC, Kraft M, Brusselle G, Castro M, Chupp GL, Wechsler ME, Hunter G, Lindsley AW, Llanos JP, Burke LK, Chandarana S, Ambrose CS. Efficacy of Tezepelumab in Patients with Severe, Uncontrolled Asthma Across Multiple Clinically Relevant Subgroups in the NAVIGATOR Study. Adv Ther. 2024 Jul;41(7):2978-2990. doi: 10.1007/s12325-024-02889-8. Epub 2024 May 27.

    PubMed 38802635

  • Corren J, Menzies-Gow A, Bimmel J, McGuinness A, Almqvist G, Bowen K, Griffiths JM, Ponnarambil S, Bourdin A, Israel E, Colice G, Brightling CE, Wechsler ME; PATHWAY and NAVIGATOR study investigators. Tezepelumab for the treatment of severe asthma: a plain language summary of the PATHWAY and NAVIGATOR studies. Immunotherapy. 2023 Nov;15(16):1327-1340. doi: 10.2217/imt-2023-0109. Epub 2023 Sep 29.

    PubMed 37772607

  • Menzies-Gow A, Ambrose CS, Colice G, Hunter G, Cook B, Molfino NA, Llanos JP, Israel E. Effect of Tezepelumab on Lung Function in Patients With Severe, Uncontrolled Asthma in the Phase 3 NAVIGATOR Study. Adv Ther. 2023 Nov;40(11):4957-4971. doi: 10.1007/s12325-023-02659-y. Epub 2023 Sep 19.

    PubMed 37723356

  • Pavord ID, Hoyte FCL, Lindsley AW, Ambrose CS, Spahn JD, Roseti SL, Cook B, Griffiths JM, Hellqvist A, Martin N, Llanos JP, Martin N, Colice G, Corren J. Tezepelumab reduces exacerbations across all seasons in patients with severe, uncontrolled asthma (NAVIGATOR). Ann Allergy Asthma Immunol. 2023 Nov;131(5):587-597.e3. doi: 10.1016/j.anai.2023.08.015. Epub 2023 Aug 23.

    PubMed 37619779

  • Menzies-Gow A, Bourdin A, Chupp G, Israel E, Hellqvist A, Hunter G, Roseti SL, Ambrose CS, Llanos JP, Cook B, Corren J, Colice G. Effect of tezepelumab on healthcare utilization in patients with severe, uncontrolled asthma: The NAVIGATOR study. Ann Allergy Asthma Immunol. 2023 Sep;131(3):343-348.e2. doi: 10.1016/j.anai.2023.05.028. Epub 2023 May 30.

    PubMed 37263380

  • Corren J, Menzies-Gow A, Chupp G, Israel E, Korn S, Cook B, Ambrose CS, Hellqvist A, Roseti SL, Molfino NA, Llanos JP, Martin N, Bowen K, Griffiths JM, Parnes JR, Colice G. Efficacy of Tezepelumab in Severe, Uncontrolled Asthma: Pooled Analysis of the PATHWAY and NAVIGATOR Clinical Trials. Am J Respir Crit Care Med. 2023 Jul 1;208(1):13-24. doi: 10.1164/rccm.202210-2005OC.

    PubMed 37015033

  • 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.

    PubMed 36702146

  • Yin Z, Zhou Y, Turnquist HR, Liu Q. Neuro-epithelial-ILC2 crosstalk in barrier tissues. Trends Immunol. 2022 Nov;43(11):901-916. doi: 10.1016/j.it.2022.09.006. Epub 2022 Oct 14.

    PubMed 36253275

  • 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.

    PubMed 33979488

  • 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.

    PubMed 33050934

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Experimental: Tezepelumab in people with Asthma, run by AstraZeneca at 289 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 289 sites in United States, Japan, South Africa, South Korea, Brazil and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma (time frame: From randomisation to Study Week 52.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03347279, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.

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