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

October 29, 2021 updated by: AstraZeneca

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

Study Overview

Status

Completed

Conditions

Asthma

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1061

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1414AIF
    - Research Site
  - Caba, Argentina, C1425BEN
    - Research Site
  - Caba, Argentina, C1056ABJ
    - Research Site
  - Ciudad de Buenos Aires, Argentina, 1425
    - Research Site
  - Córdoba, Argentina, X5003DCE
    - Research Site
  - Mendoza, Argentina, 5500
    - Research Site
  - Nueve de julio, Argentina, B6500EZL
    - Research Site
  - Quilmes, Argentina, B1878FNR
    - Research Site
Australia
- - Campbelltown, Australia, 2560
    - Research Site
  - Kent Town, Australia, 5067
    - Research Site
  - Melbourne, Australia, 3004
    - Research Site
  - Nedlands, Australia, 6009
    - Research Site
  - New Lambton, Australia, 2310
    - Research Site
  - Spearwood, Australia, 6163
    - Research Site
  - Westmead, Australia, 2145
    - Research Site
  - Woolloongabba, Australia, 4102
    - Research Site
Austria
- - Klagenfurt, Austria, 9020
    - Research Site
  - Linz, Austria, 4020
    - Research Site
  - Salzburg, Austria, 5020
    - Research Site
  - Wien, Austria, 1130
    - Research Site
  - Wien, Austria, 1090
    - Research Site
Brazil
- - Blumenau, Brazil, 89030-101
    - Research Site
  - Botucatu, Brazil, 18618-970
    - Research Site
  - Curitiba, Brazil, 80060-900
    - Research Site
  - Porto Alegre, Brazil, 90610-000
    - Research Site
  - Porto Alegre, Brazil, 91350-200
    - Research Site
  - Porto Alegre, Brazil, 9002-060
    - Research Site
  - Porto Alegre, Brazil, 90035-074
    - Research Site
  - Porto Alegre, Brazil, 90619-900
    - Research Site
  - Recife, Brazil, 50070-550
    - Research Site
  - Salvador, Brazil, 41940-455
    - Research Site
  - Santo Andre, Brazil, 09080-110
    - Research Site
  - Sao Bernardo do Campo, Brazil, 09750-420
    - Research Site
  - Sorocaba, Brazil, 18040-425
    - Research Site
  - Vitória, Brazil, 29055-450
    - Research Site
Canada
- - Quebec, Canada, G1G 3Y8
    - Research Site
- Alberta
  - Calgary, Alberta, Canada, T2N 4Z6
    - Research Site
  - Sherwood Park, Alberta, Canada, T8L 0N2
    - Research Site
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 1M9
    - Research Site
- Ontario
  - Ajax, Ontario, Canada, L1S 2J5
    - Research Site
  - Burlington, Ontario, Canada, L7N 3V2
    - Research Site
  - Mississauga, Ontario, Canada, L5A 3V4
    - Research Site
  - Ottawa, Ontario, Canada, K1G 6C6
    - Research Site
  - Windsor, Ontario, Canada, N8X 1T3
    - Research Site
- Quebec
  - Montreal, Quebec, Canada, H4J 1C5
    - Research Site
  - St Charles Borromee, Quebec, Canada, J6E 2B4
    - Research Site
  - Trois-Rivières, Quebec, Canada, G8T 7A1
    - Research Site
France
- - Brest Cedex, France, 29609
    - Research Site
  - GRENOBLE Cedex 9, France, 38043
    - Research Site
  - Le Kremlin Bicêtre, France, 94275
    - Research Site
  - Lille Cedex, France, 59037
    - Research Site
  - Lyon Cedex 04, France, 69317
    - Research Site
  - MARSEILLE Cedex 20, France, 13015
    - Research Site
  - Montpellier Cedex 5, France, 34295
    - Research Site
  - Nantes Cedex 1, France, 44093
    - Research Site
  - PARIS Cedex 12, France, 75571
    - Research Site
  - Paris, France, 75015
    - Research Site
  - Paris Cedex 18, France, 75877
    - Research Site
  - Pessac, France, 33604
    - Research Site
  - Strasbourg Cedex, France, 67091
    - Research Site
  - Toulouse CEDEX 09, France, 31059
    - Research Site
Germany
- - Bamberg, Germany, 96049
    - Research Site
  - Berlin, Germany, 10367
    - Research Site
  - Berlin, Germany, 10717
    - Research Site
  - Frankfurt, Germany, 60596
    - Research Site
  - Frankfurt am Main, Germany, 60596
    - Research Site
  - Hamburg, Germany, 20354
    - Research Site
  - Hamburg, Germany, 22299
    - Research Site
  - Hannover, Germany, 30625
    - Research Site
  - Hannover, Germany, D-30173
    - Research Site
  - Landsberg, Germany, 86899
    - Research Site
  - Leipzig, Germany, 04357
    - Research Site
  - Leipzig, Germany, 04103
    - Research Site
  - Lübeck, Germany, 23552
    - Research Site
  - Mainz, Germany, 55131
    - Research Site
Israel
- - Ashkelon, Israel, 7830604
    - Research Site
  - Haifa, Israel, 34362
    - Research Site
  - Jerusalem, Israel, 91031
    - Research Site
  - Jerusalem, Israel, 91120
    - Research Site
  - Kfar Saba, Israel, 49281
    - Research Site
  - Rehovot, Israel, 7661041
    - Research Site
Japan
- - Bunkyo-ku, Japan, 113-8431
    - Research Site
  - Chuo-ku, Japan, 103-0022
    - Research Site
  - Chuo-ku, Japan, 103-0028
    - Research Site
  - Chuo-ku, Japan, 104-0031
    - Research Site
  - Edogawa-ku, Japan, 134-0083
    - Research Site
  - Fujieda-shi, Japan, 426-8677
    - Research Site
  - Fukuoka-shi, Japan, 810-0001
    - Research Site
  - Fukuoka-shi, Japan, 811-1394
    - Research Site
  - Fukuoka-shi, Japan, 815-8588
    - Research Site
  - Habikino-shi, Japan, 583-8588
    - Research Site
  - Hamamatsu-shi, Japan, 431-3192
    - Research Site
  - Higashiibaraki-gun, Japan, 311-3193
    - Research Site
  - Himeji-shi, Japan, 672-8064
    - Research Site
  - Hitachi-shi, Japan, 317-0077
    - Research Site
  - Itabashi-ku, Japan, 173-0003
    - Research Site
  - Itabashi-ku, Japan, 173-8610
    - Research Site
  - Kagoshima-shi, Japan, 890-0073
    - Research Site
  - Kagoshima-shi, Japan, 890-8520
    - Research Site
  - Kanazawa-shi, Japan, 920-8641
    - Research Site
  - Kanazawa-shi, Japan, 920-8530
    - Research Site
  - Kasuga-shi, Japan, 816-0813
    - Research Site
  - Kishiwada-shi, Japan, 596-8501
    - Research Site
  - Kitakyusyu, Japan, 802-0052
    - Research Site
  - Koga-shi, Japan, 811-3195
    - Research Site
  - Matsusaka-shi, Japan, 515-8544
    - Research Site
  - Meguro-ku, Japan, 152-0021
    - Research Site
  - Meguro-ku, Japan, 152-8621
    - Research Site
  - Minato-ku, Japan, 105-0003
    - Research Site
  - Minato-ku, Japan, 105-0004
    - Research Site
  - Minato-ku, Japan, 108-0014
    - Research Site
  - Mizunami-shi, Japan, 509-6134
    - Research Site
  - Nagaoka-shi, Japan, 940-2085
    - Research Site
  - Niigata-shi, Japan, 951-8520
    - Research Site
  - Ogaki-shi, Japan, 503-8502
    - Research Site
  - Ohota-ku, Japan, 145-0063
    - Research Site
  - Omuta-shi, Japan, 837-0911
    - Research Site
  - Sagamihara-shi, Japan, 228-0815
    - Research Site
  - Sapporo-shi, Japan, 001-0901
    - Research Site
  - Sapporo-shi, Japan, 064-0804
    - Research Site
  - Setagaya-ku, Japan, 157-0072
    - Research Site
  - Shibuya-ku, Japan, 150-0013
    - Research Site
  - Shinagawa-ku, Japan, 140-8522
    - Research Site
  - Shinagawa-ku, Japan, 142-8666
    - Research Site
  - Shinjuku-ku, Japan, 162-8655
    - Research Site
  - Shinjuku-ku, Japan, 162-8666
    - Research Site
  - Sumida-ku, Japan, 130-0015
    - Research Site
  - Takamatsu-shi, Japan, 761-8073
    - Research Site
  - Toshima-ku, Japan, 170-0003
    - Research Site
  - Toshima-ku, Japan, 171-0014
    - Research Site
  - Ube, Japan, 755-8505
    - Research Site
  - Yokkaichi-shi, Japan, 510-8567
    - Research Site
  - Yokohama-shi, Japan, 223-0059
    - Research Site
  - Yokohama-shi, Japan, 236-0004
    - Research Site
  - Yokohama-shi, Japan, 236-0024
    - Research Site
  - Yoshida-gun, Japan, 910-1193
    - Research Site
Korea, Republic of
- - Bucheon-si, Korea, Republic of, 14584
    - Research Site
  - Cheongju-si, Korea, Republic of, 28644
    - Research Site
  - Daegu, Korea, Republic of, 41404
    - Research Site
  - Daegu, Korea, Republic of, 42415
    - Research Site
  - Jeju-si, Korea, Republic of, 690-767
    - Research Site
  - Jeonju-si, Korea, Republic of, 54907
    - Research Site
  - Seongnam-si, Korea, Republic of, 13620
    - Research Site
  - Seoul, Korea, Republic of, 03722
    - Research Site
  - Seoul, Korea, Republic of, 05505
    - Research Site
  - Seoul, Korea, Republic of, 03080
    - Research Site
  - Seoul, Korea, Republic of, 06351
    - Research Site
  - Seoul, Korea, Republic of, 06591
    - Research Site
  - Seoul, Korea, Republic of, 02447
    - Research Site
  - Seoul, Korea, Republic of, 03312
    - Research Site
  - Seoul, Korea, Republic of, 08308
    - Research Site
  - Seoul, Korea, Republic of, 150-713
    - Research Site
  - Seoul, Korea, Republic of, 07985
    - Research Site
  - Suwon-si, Korea, Republic of, 16499
    - Research Site
Russian Federation
- - Izhevsk, Russian Federation, 426035
    - Research Site
  - Moscow, Russian Federation, 115093
    - Research Site
  - Moscow, Russian Federation, 115522
    - Research Site
  - St-Petersburg, Russian Federation, 193231
    - Research Site
Saudi Arabia
- - Jeddah, Saudi Arabia, 21423
    - Research Site
  - Jeddah, Saudi Arabia, 22252
    - Research Site
South Africa
- - Bellville, South Africa, 7530
    - Research Site
  - Boksburg North, South Africa, 1460
    - Research Site
  - Cape Town, South Africa, 7764
    - Research Site
  - Cape Town, South Africa, 7570
    - Research Site
  - Durban, South Africa, 4001
    - Research Site
  - Durban, South Africa, 4091
    - Research Site
  - Durban, South Africa, 4092
    - Research Site
  - Durban, South Africa, 4450
    - Research Site
  - Johannesburg, South Africa, 1724
    - Research Site
  - Johannesburg, South Africa, 2113
    - Research Site
  - Johannesburg, South Africa, 1829
    - Research Site
  - Lenasia Ext8, South Africa, 1820
    - Research Site
  - Middelburg, South Africa, 1055
    - Research Site
  - Mowbray, South Africa, 7700
    - Research Site
  - Parow, South Africa, 7505
    - Research Site
  - Pretoria, South Africa, 0157
    - Research Site
  - Umkomaas, South Africa, 4170
    - Research Site
  - Witbank, South Africa, 1035
    - Research Site
Taiwan
- - Hsinchu, Taiwan, 300
    - Research Site
  - Kaohsiung, Taiwan, 80756
    - Research Site
  - Kaohsiung City, Taiwan, 82445
    - Research Site
  - Kaohsiung Hsien, Taiwan, TAIWAN
    - Research Site
  - Taichung, Taiwan, 40443
    - Research Site
  - Tainan City, Taiwan, 70403
    - Research Site
  - Taipei, Taiwan, 235
    - Research Site
  - Taipei, Taiwan, 220216
    - Research Site
  - Yilan, Taiwan, 260
    - Research Site
Ukraine
- - Ivano-Frankivsk, Ukraine, 76018
    - Research Site
  - Kharkiv Region, Ukraine, 61075
    - Research Site
United Kingdom
- - London, United Kingdom, SW3 6NP
    - Research Site
United States
- Alabama
  - Dothan, Alabama, United States, 36303
    - Research Site
  - Foley, Alabama, United States, 36535
    - Research Site
- Arizona
  - Gilbert, Arizona, United States, 85234
    - Research Site
  - Tucson, Arizona, United States, 85724
    - Research Site
- California
  - Bakersfield, California, United States, 93301
    - Research Site
  - Encinitas, California, United States, 92024
    - Research Site
  - Huntington Beach, California, United States, 92647
    - Research Site
  - Long Beach, California, United States, 90808
    - Research Site
  - Los Angeles, California, United States, 90025
    - Research Site
  - Mission Viejo, California, United States, 92691
    - Research Site
  - Newport Beach, California, United States, 92663
    - Research Site
  - Northridge, California, United States, 91324
    - Research Site
  - Palm Desert, California, United States, 92260
    - Research Site
  - Rolling Hills Estates, California, United States, 90274
    - Research Site
  - Walnut Creek, California, United States, 94598
    - Research Site
  - Westminster, California, United States, 92683
    - Research Site
- Colorado
  - Denver, Colorado, United States, 80206
    - Research Site
- Connecticut
  - New Haven, Connecticut, United States, 06520
    - Research Site
- Florida
  - Celebration, Florida, United States, 34747
    - Research Site
  - Kissimmee, Florida, United States, 34741
    - Research Site
  - Kissimmee, Florida, United States, 34744
    - Research Site
  - Orlando, Florida, United States, 32803
    - Research Site
  - Orlando, Florida, United States, 32825
    - Research Site
  - Panama City, Florida, United States, 32405
    - Research Site
  - Port Charlotte, Florida, United States, 33952
    - Research Site
  - Saint Petersburg, Florida, United States, 33704
    - Research Site
  - Saint Petersburg, Florida, United States, 33710
    - Research Site
  - Saint Petersburg, Florida, United States, 33713
    - Research Site
  - Sarasota, Florida, United States, 34239
    - Research Site
  - Sebring, Florida, United States, 33870
    - Research Site
  - Tampa, Florida, United States, 33607
    - Research Site
  - Winter Park, Florida, United States, 32789
    - Research Site
- Georgia
  - Fayetteville, Georgia, United States, 30214
    - Research Site
  - Gainesville, Georgia, United States, 30501
    - Research Site
  - Savannah, Georgia, United States, 31406
    - Research Site
  - Stockbridge, Georgia, United States, 30281
    - Research Site
- Idaho
  - Boise, Idaho, United States, 83706
    - Research Site
- Indiana
  - Michigan City, Indiana, United States, 46360
    - Research Site
- Kentucky
  - Fort Mitchell, Kentucky, United States, 41017
    - Research Site
  - Louisville, Kentucky, United States, 40215
    - Research Site
- Louisiana
  - Lake Charles, Louisiana, United States, 70601
    - Research Site
  - Zachary, Louisiana, United States, 70791
    - Research Site
- Maryland
  - White Marsh, Maryland, United States, 21162
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Research Site
  - Fall River, Massachusetts, United States, 02721
    - Research Site
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Research Site
  - Flint, Michigan, United States, 48504
    - Research Site
  - Novi, Michigan, United States, 48375
    - Research Site
  - Port Huron, Michigan, United States, 48060
    - Research Site
  - Troy, Michigan, United States, 48085
    - Research Site
- Missouri
  - Saint Louis, Missouri, United States, 63141
    - Research Site
  - Saint Louis, Missouri, United States, 63108
    - Research Site
- Nebraska
  - Lincoln, Nebraska, United States, 68505
    - Research Site
- Nevada
  - Las Vegas, Nevada, United States, 89119
    - Research Site
  - Las Vegas, Nevada, United States, 89106
    - Research Site
- New Jersey
  - Northfield, New Jersey, United States, 08225
    - Research Site
  - Toms River, New Jersey, United States, 08755
    - Research Site
- New York
  - Bronx, New York, United States, 10459
    - Research Site
  - Bronx, New York, United States, 10465
    - Research Site
  - Brooklyn, New York, United States, 11235
    - Research Site
  - New York, New York, United States, 10016
    - Research Site
  - New York, New York, United States, 10032
    - Research Site
  - New York, New York, United States, 10022
    - Research Site
  - New York, New York, United States, 10029
    - Research Site
  - Valhalla, New York, United States, 10595
    - Research Site
- North Carolina
  - Charlotte, North Carolina, United States, 28277
    - Research Site
  - Gastonia, North Carolina, United States, 28054
    - Research Site
  - Winston-Salem, North Carolina, United States, 27104
    - Research Site
- Ohio
  - Cincinnati, Ohio, United States, 45231
    - Research Site
  - Cincinnati, Ohio, United States, 45229
    - Research Site
  - Mayfield Heights, Ohio, United States, 44124
    - Research Site
  - Toledo, Ohio, United States, 43608
    - Research Site
- Oklahoma
  - Edmond, Oklahoma, United States, 73034
    - Research Site
  - Oklahoma City, Oklahoma, United States, 73120
    - Research Site
  - Tulsa, Oklahoma, United States, 74136
    - Research Site
- Oregon
  - Medford, Oregon, United States, 97504
    - Research Site
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15243
    - Research Site
- Rhode Island
  - Warwick, Rhode Island, United States, 02886
    - Research Site
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - Research Site
  - Columbia, South Carolina, United States, 29204
    - Research Site
  - Greenville, South Carolina, United States, 29607
    - Research Site
- Texas
  - Allen, Texas, United States, 75013
    - Research Site
  - Amarillo, Texas, United States, 79106
    - Research Site
  - Boerne, Texas, United States, 78006
    - Research Site
  - Dallas, Texas, United States, 75225
    - Research Site
  - Dallas, Texas, United States, 75230
    - Research Site
  - Lampasas, Texas, United States, 76550
    - Research Site
  - McAllen, Texas, United States, 78504
    - Research Site
  - Plano, Texas, United States, 75093
    - Research Site
  - San Antonio, Texas, United States, 78251
    - Research Site
- Virginia
  - Manassas, Virginia, United States, 20110
    - Research Site
  - Richmond, Virginia, United States, 23220
    - Research Site
  - Richmond, Virginia, United States, 23235
    - Research Site
- Wisconsin
  - Cudahy, Wisconsin, United States, 53110
    - Research Site
  - Madison, Wisconsin, United States, 53792
    - Research Site
Vietnam
- - Ha Noi, Vietnam, 100000
    - Research Site
  - Hanoi, Vietnam, 100000
    - Research Site
  - Hanoi, Vietnam, 10000
    - Research Site
  - Ho Chi Minh, Vietnam, 70000
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tezepelumab Tezepelumab: Tezepelumab subcutaneous injection	Biological: Experimental: Tezepelumab Tezepelumab subcutaneous injection Other Names: Tezepelumab
Placebo Comparator: Placebo Placebo: Placebo subcutaneous injection	Other: Placebo Placebo subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma Time Frame: From randomisation to Study Week 52.	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)	From randomisation to Study Week 52.
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma in Subjects With Baseline Eosinophils < 300 Cells/uL Time Frame: From randomisation to Study Week 52.	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	From randomisation to Study Week 52.

Secondary Outcome Measures

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annual Asthma Exacerbation Rate Associated With Hospitalisations Time Frame: From randomisation to Study Week 52	The annualized exacerbation rate is based on exacerbations reported by the investigator that are associated with hospitalization	From randomisation to Study Week 52
Annual Asthma Exacerbation Rate Using Adjudicated Data Time Frame: From randomisation to Study Week 52	The annualized exacerbation rate is based on exacerbations as defined for the primary endpoint, but any hospitalisation and ER visits which are adjudicated to be asthma related are added, and those adjudicated to not be asthma related are removed from analyses.	From randomisation to Study Week 52
Annual Asthma Exacerbation Rate Associated With Emergency Room (ER) Visit or Hospitalisation Using Adjudicated Data Time Frame: From randomisation to Study Week 52	The annualized exacerbation rate is based on exacerbations associated with hospitalisations or ER visits, where hospitalisation and ER visits adjudicated to be asthma related are added, and those adjudicated to not be asthma related are removed from analyses.	From randomisation to Study Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2017

Primary Completion (Actual)

September 8, 2020

Study Completion (Actual)

November 12, 2020

Study Registration Dates

First Submitted

November 9, 2017

First Submitted That Met QC Criteria

November 17, 2017

First Posted (Actual)

November 20, 2017

Study Record Updates

Last Update Posted (Actual)

November 26, 2021

Last Update Submitted That Met QC Criteria

October 29, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Asthma, Uncontrolled Asthma, Severe Uncontrolled Asthma

Additional Relevant MeSH Terms

Other Study ID Numbers

D5180C00007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

Study Protocol
Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Meyer Children's Hospital IRCCS

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Post Exacerbation Asthma Clinic Telecare Intervention to Reduce Recurrent Exacerbations (PACT)

Asthma Attack | Asthma Acute

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University of Pittsburgh
National Institute of Environmental Health Sciences (NIEHS)

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Pollution Intervention to Impact Kids Asthma Study (PIKAS)

Asthma Exacerbation | Childhood Asthma | Air Pollution, Risk Reduction Behaviors | Asthma Control

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Vanderbilt University Medical Center

Withdrawn

Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations

Asthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; Status

United States
University of California, San Francisco

Completed

User-Friendly Spirometer and Mobile App for Self-Management and Home Monitoring of Asthma Patients

Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic

United States
Columbia University
Children's Hospital of Philadelphia; National Heart, Lung, and Blood Institute... and other collaborators

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Bilevel Positive Airway Pressure (BPAP) for Severe Asthma

Acute Asthma | Pediatric Asthma | Non-invasive Positive Pressure Ventilation | BiPAP

United States
SingHealth Polyclinics

Recruiting

Remote Patient Monitoring Solution for Chronic Respiratory Disease Management

Asthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic

Singapore
Johann Wolfgang Goethe University Hospital

Completed

Exercise Challenge in a Cold Chamber

Exercise-induced Asthma

Germany
Chiesi Slovenija, d.o.o.

Recruiting

Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (STRENGTH) (STRENGTH)

Asthma | Asthma Bronchiale | Asthma Patients

Slovenia
Gümüşhane Universıty

Completed

Effects of Inspiratory Muscle Training Added to a Swimming Program in Children With Asthma (IMT-SWIM-ASTHM)

Asthma | Asthma Chronic | Asthma Control

Turkey (Türkiye)

Clinical Trials on Experimental: Tezepelumab

AstraZeneca
Amgen

Completed

Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma (DIRECTION)

Asthma

Korea, Republic of, Philippines, China
AstraZeneca
Amgen

Completed

Tezepelumab Phase 1 PK Study in Healthy Chinese Subjects (DIRECTION-CK)

Healthy Subjects

China
AstraZeneca
Amgen

Completed

Long-term Safety of Tezepelumab in Japanese Subjects With Inadequately Controlled Severe Asthma (NOZOMI)

Severe Asthma

Japan
AstraZeneca

Recruiting

Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab (TAPER)

Severe Asthma

China
AstraZeneca

Active, not recruiting

Observational Study on the Clinical Profile of Patients With Uncontrolled Severe Asthma Treated With Tezepelumab in Italy (FRONTEDGE)

Asthma

Italy
AstraZeneca

Completed

Patient Characteristics, Treatment Patterns and Outcomes of Patients With Severe Asthma Treated With Tezepelumab in the Real World; a Retrospective, Observational Medical Chart Review Conducted in UK Severe Asthma Centres (TRAILBLAZE)

Severe Asthma

United Kingdom
AstraZeneca

Completed

Study to Evaluate Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma (WAYFINDER)

Asthma

United States, Belgium, United Kingdom, France, Spain, Argentina, Poland, Bulgaria, Germany, Latvia, Mexico
AstraZeneca
Amgen

Completed

Efficacy and Safety of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis (WAYPOINT)

Chronic Rhinosinusitis With Nasal Polyps

United States, Canada, Denmark, Spain, United Kingdom, Germany, Hungary, China, Japan, Poland
Imperial College London
AstraZeneca

Active, not recruiting

Explore the Efficacy and Mechanism of Action of Tezepelumab in Eosinophilic Granulomatosis With Polyangiitis (RACEMATE)

EGPA - Eosinophilic Granulomatosis With Polyangiitis

United Kingdom
Qilu Pharmaceutical Co., Ltd.

Not yet recruiting

Compare the Efficacy and Safety of QL2302 Versus Tezspire® in Severe Asthma

Asthma

Outcome Measure	Measure Description	Time Frame
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) Time Frame: From randomisation to Study Week 52	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.	From randomisation to Study Week 52
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) Time Frame: From randomisation to Study Week 52	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).	From randomisation to Study Week 52
Mean Change From Baseline at Week 52 in Asthma Control Questionnaire-6(ACQ-6) (Key Secondary Endpoint) Time Frame: From randomisation to Study Week 52	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.	From randomisation to Study Week 52
Mean Change From Baseline at Week 52 in Asthma Symptom Diary (Key Secondary Endpoint) Time Frame: From randomisation to Study Week 52	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.	From randomisation to Study Week 52
Time to First Asthma Exacerbation Time Frame: From randomisation to Study Week 52	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.	From randomisation to Study Week 52
Mean Change From Baseline at Week 52 in Clinic Fractional Exhaled Nitric Oxide (FeNO) (Ppb) Time Frame: From randomisation to Study Week 52	Mean change from baseline at Study Week 52 in FeNO (ppb) measured at site	From randomisation to Study Week 52
Mean Change From Baseline in Daily Rescue Medication Use (Weekly Means) at Week 52 Time Frame: From randomisation to Study 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.	From randomisation to Study Week 52
Mean Change From Baseline in Work Productivity Loss Due to Asthma at Week 52 Time Frame: From randomisation to Study 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.	From randomisation to Study Week 52
Mean Change From Baseline in Class Productivity Loss Due to Asthma at Week 52 Time Frame: From randomisation to Study 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.	From randomisation to Study Week 52
Activity Impairment at Week 52 Time Frame: From randomisation to Study 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.	From randomisation to Study Week 52
Pharmacokinetics of Tezepelumab Time Frame: Pre-dose samples at Baseline, Week 4, Week 12, Week 24, Week 36, Week 52, Week 64	Mean serum trough PK concentrations taken pre-dose at each visit	Pre-dose samples at Baseline, Week 4, Week 12, Week 24, Week 36, Week 52, Week 64
Mean Change From Baseline at Week 52 in EQ-5D-5L VAS Time Frame: At Study Week 52	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.	At Study Week 52
Clinicians Global Impression of Change at Week 52 Time Frame: From randomisation to Study 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)	From randomisation to Study Week 52
Patients Global Impression of Change at Week 52 Time Frame: From randomisation to Study 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).	From randomisation to Study Week 52
Patients Global Impression of Severity at Week 52 Time Frame: At Study 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	At Study Week 52
Mean Change From Baseline at Week 52 in Blood Eosinophils (Cells/uL) Time Frame: From randomisation to Study Week 52	Mean change from baseline at Study Week 52 in blood eosinophils (cells/uL)	From randomisation to Study Week 52
Mean Change From Baseline at Week 52 in Total Serum IgE (IU/mL) Time Frame: From randomisation to Study Week 52	Mean change from baseline at Study Week 52 in total serum IgE (IU/mL)	From randomisation to Study Week 52
Number of Participants With Asthma Specific Healthcare Utilization Over 52 Weeks Time Frame: From randomisation to Study Week 52	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	From randomisation to Study Week 52
Mean Change From Baseline in Home Based Morning Peak Expiratory Flow (PEF) at Week 52 (Weekly Means) Time Frame: From randomisation to Study Week 52	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.	From randomisation to Study Week 52
Mean Change From Baseline in Home Based Evening Peak Expiratory Flow (PEF) at Week 52 (Weekly Means) Time Frame: From randomisation to Study Week 52	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.	From randomisation to Study Week 52
Mean Change From Baseline in Night Time Awakenings (Weekly Means) at Week 52 Time Frame: From randomisation to Study 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.	From randomisation to Study Week 52
Immunogenecity of Tezepelumab Time Frame: Baseline, and from time of first dose at Week 0 to end of study at Week 64.	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.	Baseline, and from time of first dose at Week 0 to end of study at Week 64.
Proportion of Subjects Who Had no Asthma Exacerbations Time Frame: From randomisation to Study Week 52	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.	From randomisation to Study Week 52
Annual Asthma Exacerbation Rate Resulting in Emergency Room Visit or Hospitalisation Time Frame: From randomisation to Study Week 52	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)	From randomisation to Study Week 52
Proportion of Subjects With at Least One Asthma Exacerbation Associated With Emergency Room Visit or Hospitalisation Time Frame: From randomisation to Study Week 52	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.	From randomisation to Study Week 52
Proportion of Subjects Who Had no Asthma Exacerbations Associated With Emergency Room or Hospitalisation Time Frame: From randomisation to Study Week 52	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.	From randomisation to Study Week 52

Study to Evaluate Tezepelumab in Adults & 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 (NAVIGATOR)

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Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Asthma

Clinical Trials on Experimental: Tezepelumab

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