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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tezepelumab | Experimental | Tezepelumab: Tezepelumab subcutaneous injection |
|
| Placebo | Placebo Comparator | Placebo: Placebo subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Tezepelumab | Biological | Tezepelumab subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 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. |
| 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Annual Asthma Exacerbation Rate Associated With Hospitalisations | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Menzies-Gow, MD | Royal Brompton Hospital, United Kingdom | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Dothan | Alabama | 36303 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41072729 | Derived | 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. | |
| 40782846 | Derived |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
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.
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.
Of the 1061 randomised, 1059 (99.8%) subjects received treatment. 82 (7.7%) of the subjects randomised and treated were adolescents.
A total of 1061 subjects were randomised at 231 centres in 17 countries to receive treatment with tezepelumab 210mg Q4W or placebo,
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| ID | Title | Description |
|---|---|---|
| FG000 | Tezepelumab 210mg Q4W | Tezepelumab administered every 4 weeks subcutaneously |
| FG001 | Placebo | Placebo administered subcutaneously |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 14, 2020 | Oct 29, 2021 |
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Subjects will be randomized in a 1:1 ratio to either tezepelumab or matching placebo both administered subcutaneously.
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Double-Blind
| Placebo | Other | Placebo subcutaneous injection |
|
| 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). | From randomisation to Study Week 52 |
| 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. | From randomisation to Study Week 52 |
| 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. | From randomisation to Study Week 52 |
| 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. | From randomisation to Study Week 52 |
| 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 | From randomisation to Study Week 52 |
| 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. | From randomisation to Study Week 52 |
| 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. | From randomisation to Study Week 52 |
| 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. | From randomisation to Study Week 52 |
| 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. | From randomisation to Study Week 52 |
| Pharmacokinetics of Tezepelumab | 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 | 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 | 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 | 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 | 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) | 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) | 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 | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
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 | 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 |
| Foley |
| Alabama |
| 36535 |
| United States |
| Research Site | Gilbert | Arizona | 85234 | United States |
| Research Site | Tucson | Arizona | 85724 | United States |
| Research Site | Bakersfield | California | 93301 | United States |
| Research Site | Encinitas | California | 92024 | United States |
| Research Site | Huntington Beach | California | 92647 | United States |
| Research Site | Long Beach | California | 90808 | United States |
| Research Site | Los Angeles | California | 90025 | United States |
| Research Site | Mission Viejo | California | 92691 | United States |
| Research Site | Newport Beach | California | 92663 | United States |
| Research Site | Northridge | California | 91324 | United States |
| Research Site | Palm Desert | California | 92260 | United States |
| Research Site | Rolling Hills Estates | California | 90274 | United States |
| Research Site | Walnut Creek | California | 94598 | United States |
| Research Site | Westminster | California | 92683 | United States |
| Research Site | Denver | Colorado | 80206 | United States |
| Research Site | New Haven | Connecticut | 06520 | United States |
| Research Site | Celebration | Florida | 34747 | United States |
| Research Site | Kissimmee | Florida | 34741 | United States |
| Research Site | Kissimmee | Florida | 34744 | United States |
| Research Site | Orlando | Florida | 32803 | United States |
| Research Site | Orlando | Florida | 32825 | United States |
| Research Site | Panama City | Florida | 32405 | United States |
| Research Site | Port Charlotte | Florida | 33952 | United States |
| Research Site | Sarasota | Florida | 34239 | United States |
| Research Site | Sebring | Florida | 33870 | United States |
| Research Site | St. Petersburg | Florida | 33704 | United States |
| Research Site | St. Petersburg | Florida | 33710 | United States |
| Research Site | St. Petersburg | Florida | 33713 | United States |
| Research Site | Tampa | Florida | 33607 | United States |
| Research Site | Winter Park | Florida | 32789 | United States |
| Research Site | Fayetteville | Georgia | 30214 | United States |
| Research Site | Gainesville | Georgia | 30501 | United States |
| Research Site | Savannah | Georgia | 31406 | United States |
| Research Site | Stockbridge | Georgia | 30281 | United States |
| Research Site | Boise | Idaho | 83706 | United States |
| Research Site | Michigan City | Indiana | 46360 | United States |
| Research Site | Fort Mitchell | Kentucky | 41017 | United States |
| Research Site | Louisville | Kentucky | 40215 | United States |
| Research Site | Lake Charles | Louisiana | 70601 | United States |
| Research Site | Zachary | Louisiana | 70791 | United States |
| Research Site | White Marsh | Maryland | 21162 | United States |
| Research Site | Boston | Massachusetts | 02115 | United States |
| Research Site | Fall River | Massachusetts | 02721 | United States |
| Research Site | Ann Arbor | Michigan | 48109 | United States |
| Research Site | Flint | Michigan | 48504 | United States |
| Research Site | Novi | Michigan | 48375 | United States |
| Research Site | Port Huron | Michigan | 48060 | United States |
| Research Site | Troy | Michigan | 48085 | United States |
| Research Site | St Louis | Missouri | 63108 | United States |
| Research Site | St Louis | Missouri | 63141 | United States |
| Research Site | Lincoln | Nebraska | 68505 | United States |
| Research Site | Las Vegas | Nevada | 89106 | United States |
| Research Site | Las Vegas | Nevada | 89119 | United States |
| Research Site | Northfield | New Jersey | 08225 | United States |
| Research Site | Toms River | New Jersey | 08755 | United States |
| Research Site | Brooklyn | New York | 11235 | United States |
| Research Site | New York | New York | 10016 | United States |
| Research Site | New York | New York | 10022 | United States |
| Research Site | New York | New York | 10029 | United States |
| Research Site | New York | New York | 10032 | United States |
| Research Site | The Bronx | New York | 10459 | United States |
| Research Site | The Bronx | New York | 10465 | United States |
| Research Site | Valhalla | New York | 10595 | United States |
| Research Site | Charlotte | North Carolina | 28277 | United States |
| Research Site | Gastonia | North Carolina | 28054 | United States |
| Research Site | Winston-Salem | North Carolina | 27104 | United States |
| Research Site | Cincinnati | Ohio | 45229 | United States |
| Research Site | Cincinnati | Ohio | 45231 | United States |
| Research Site | Mayfield Heights | Ohio | 44124 | United States |
| Research Site | Toledo | Ohio | 43608 | United States |
| Research Site | Edmond | Oklahoma | 73034 | United States |
| Research Site | Oklahoma City | Oklahoma | 73120 | United States |
| Research Site | Tulsa | Oklahoma | 74136 | United States |
| Research Site | Medford | Oregon | 97504 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15243 | United States |
| Research Site | Warwick | Rhode Island | 02886 | United States |
| Research Site | Anderson | South Carolina | 29621 | United States |
| Research Site | Columbia | South Carolina | 29204 | United States |
| Research Site | Greenville | South Carolina | 29607 | United States |
| Research Site | Allen | Texas | 75013 | United States |
| Research Site | Amarillo | Texas | 79106 | United States |
| Research Site | Boerne | Texas | 78006 | United States |
| Research Site | Dallas | Texas | 75225 | United States |
| Research Site | Dallas | Texas | 75230 | United States |
| Research Site | Lampasas | Texas | 76550 | United States |
| Research Site | McAllen | Texas | 78504 | United States |
| Research Site | Plano | Texas | 75093 | United States |
| Research Site | San Antonio | Texas | 78251 | United States |
| Research Site | Manassas | Virginia | 20110 | United States |
| Research Site | Richmond | Virginia | 23220 | United States |
| Research Site | Richmond | Virginia | 23235 | United States |
| Research Site | Cudahy | Wisconsin | 53110 | United States |
| Research Site | Madison | Wisconsin | 53792 | United States |
| Research Site | Buenos Aires | C1414AIF | Argentina |
| Research Site | CABA | C1056ABJ | Argentina |
| Research Site | CABA | C1425BEN | Argentina |
| Research Site | Ciudad de Buenos Aires | 1425 | Argentina |
| Research Site | Córdoba | X5003DCE | Argentina |
| Research Site | Mendoza | 5500 | Argentina |
| Research Site | Nueve de Julio | B6500EZL | Argentina |
| Research Site | Quilmes | B1878FNR | Argentina |
| Research Site | Campbelltown | 2560 | Australia |
| Research Site | Kent Town | 5067 | Australia |
| Research Site | Melbourne | 3004 | Australia |
| Research Site | Nedlands | 6009 | Australia |
| Research Site | New Lambton | 2310 | Australia |
| Research Site | Spearwood | 6163 | Australia |
| Research Site | Westmead | 2145 | Australia |
| Research Site | Woolloongabba | 4102 | Australia |
| Research Site | Klagenfurt | 9020 | Austria |
| Research Site | Linz | 4020 | Austria |
| Research Site | Salzburg | 5020 | Austria |
| Research Site | Vienna | 1090 | Austria |
| Research Site | Vienna | 1130 | Austria |
| Research Site | Blumenau | 89030-101 | Brazil |
| Research Site | Botucatu | 18618-970 | Brazil |
| Research Site | Curitiba | 80060-900 | Brazil |
| Research Site | Porto Alegre | 9002-060 | Brazil |
| Research Site | Porto Alegre | 90035-074 | Brazil |
| Research Site | Porto Alegre | 90610-000 | Brazil |
| Research Site | Porto Alegre | 90619-900 | Brazil |
| Research Site | Porto Alegre | 91350-200 | Brazil |
| Research Site | Recife | 50070-550 | Brazil |
| Research Site | Salvador | 41940-455 | Brazil |
| Research Site | Santo André | 09080-110 | Brazil |
| Research Site | São Bernardo do Campo | 09750-420 | Brazil |
| Research Site | Sorocaba | 18040-425 | Brazil |
| Research Site | Vitória | 29055-450 | Brazil |
| Research Site | Calgary | Alberta | T2N 4Z6 | Canada |
| Research Site | Sherwood Park | Alberta | T8L 0N2 | Canada |
| Research Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Research Site | Ajax | Ontario | L1S 2J5 | Canada |
| Research Site | Burlington | Ontario | L7N 3V2 | Canada |
| Research Site | Mississauga | Ontario | L5A 3V4 | Canada |
| Research Site | Ottawa | Ontario | K1G 6C6 | Canada |
| Research Site | Windsor | Ontario | N8X 1T3 | Canada |
| Research Site | Montreal | Quebec | H4J 1C5 | Canada |
| Research Site | Québec | Quebec | G1G 3Y8 | Canada |
| Research Site | Saint-Charles-Borromée | Quebec | J6E 2B4 | Canada |
| Research Site | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| Research Site | Brest | 29609 | France |
| Research Site | Grenoble | 38043 | France |
| Research Site | Le Kremlin-Bicêtre | 94275 | France |
| Research Site | Lille | 59037 | France |
| Research Site | Lyon | 69317 | France |
| Research Site | Marseille | 13015 | France |
| Research Site | Montpellier | 34295 | France |
| Research Site | Nantes | 44093 | France |
| Research Site | Paris | 75015 | France |
| Research Site | Paris | 75571 | France |
| Research Site | Paris | 75877 | France |
| Research Site | Pessac | 33604 | France |
| Research Site | Strasbourg | 67091 | France |
| Research Site | Toulouse | 31059 | France |
| Research Site | Bamberg | 96049 | Germany |
| Research Site | Berlin | 10367 | Germany |
| Research Site | Berlin | 10717 | Germany |
| Research Site | Frankfurt | 60596 | Germany |
| Research Site | Frankfurt am Main | 60596 | Germany |
| Research Site | Hamburg | 20354 | Germany |
| Research Site | Hamburg | 22299 | Germany |
| Research Site | Hanover | 30625 | Germany |
| Research Site | Hanover | D-30173 | Germany |
| Research Site | Landsberg | 86899 | Germany |
| Research Site | Leipzig | 04103 | Germany |
| Research Site | Leipzig | 04357 | Germany |
| Research Site | Lübeck | 23552 | Germany |
| Research Site | Mainz | 55131 | Germany |
| Research Site | Ashkelon | 7830604 | Israel |
| Research Site | Haifa | 34362 | Israel |
| Research Site | Jerusalem | 91031 | Israel |
| Research Site | Jerusalem | 91120 | Israel |
| Research Site | Kfar Saba | 49281 | Israel |
| Research Site | Rehovot | 7661041 | Israel |
| Research Site | Bunkyō City | 113-8431 | Japan |
| Research Site | Chūōku | 103-0022 | Japan |
| Research Site | Chūōku | 103-0028 | Japan |
| Research Site | Chūōku | 104-0031 | Japan |
| Research Site | Edogawa-ku | 134-0083 | Japan |
| Research Site | Fujieda-shi | 426-8677 | Japan |
| Research Site | Fukuoka | 810-0001 | Japan |
| Research Site | Fukuoka | 811-1394 | Japan |
| Research Site | Fukuoka | 815-8588 | Japan |
| Research Site | Habikino-shi | 583-8588 | Japan |
| Research Site | Hamamatsu | 431-3192 | Japan |
| Research Site | Higashiibaraki-gun | 311-3193 | Japan |
| Research Site | Himeji-shi | 672-8064 | Japan |
| Research Site | Hitachi-shi | 317-0077 | Japan |
| Research Site | Itabashi-ku | 173-0003 | Japan |
| Research Site | Itabashi-ku | 173-8610 | Japan |
| Research Site | Kagoshima | 890-0073 | Japan |
| Research Site | Kagoshima | 890-8520 | Japan |
| Research Site | Kanazawa | 920-8530 | Japan |
| Research Site | Kanazawa | 920-8641 | Japan |
| Research Site | Kasuga-shi | 816-0813 | Japan |
| Research Site | Kishiwada-shi | 596-8501 | Japan |
| Research Site | Kitakyushu | 802-0052 | Japan |
| Research Site | Koga-shi | 811-3195 | Japan |
| Research Site | Matsusaka-shi | 515-8544 | Japan |
| Research Site | Meguro-ku | 152-0021 | Japan |
| Research Site | Meguro-ku | 152-8621 | Japan |
| Research Site | Minatoku | 105-0003 | Japan |
| Research Site | Minatoku | 105-0004 | Japan |
| Research Site | Minatoku | 108-0014 | Japan |
| Research Site | Mizunami-shi | 509-6134 | Japan |
| Research Site | Nagaoka-shi | 940-2085 | Japan |
| Research Site | Niigata | 951-8520 | Japan |
| Research Site | Ogaki-shi | 503-8502 | Japan |
| Research Site | Ohota-ku | 145-0063 | Japan |
| Research Site | Omuta-shi | 837-0911 | Japan |
| Research Site | Sagamihara-shi | 228-0815 | Japan |
| Research Site | Sapporo | 001-0901 | Japan |
| Research Site | Sapporo | 064-0804 | Japan |
| Research Site | Setagaya-ku | 157-0072 | Japan |
| Research Site | Shibuya-ku | 150-0013 | Japan |
| Research Site | Shinagawa-ku | 140-8522 | Japan |
| Research Site | Shinagawa-ku | 142-8666 | Japan |
| Research Site | Shinjuku-ku | 162-8655 | Japan |
| Research Site | Shinjuku-ku | 162-8666 | Japan |
| Research Site | Sumida-ku | 130-0015 | Japan |
| Research Site | Takamatsu | 761-8073 | Japan |
| Research Site | Toshima-ku | 170-0003 | Japan |
| Research Site | Toshima-ku | 171-0014 | Japan |
| Research Site | Ube | 755-8505 | Japan |
| Research Site | Yokkaichi-shi | 510-8567 | Japan |
| Research Site | Yokohama | 223-0059 | Japan |
| Research Site | Yokohama | 236-0004 | Japan |
| Research Site | Yokohama | 236-0024 | Japan |
| Research Site | Yoshida-gun | 910-1193 | Japan |
| Research Site | Izhevsk | 426035 | Russia |
| Research Site | Moscow | 115093 | Russia |
| Research Site | Moscow | 115522 | Russia |
| Research Site | Saint Petersburg | 193231 | Russia |
| Research Site | Jeddah | 21423 | Saudi Arabia |
| Research Site | Jeddah | 22252 | Saudi Arabia |
| Research Site | Bellville | 7530 | South Africa |
| Research Site | Boksburg North | 1460 | South Africa |
| Research Site | Cape Town | 7570 | South Africa |
| Research Site | Cape Town | 7764 | South Africa |
| Research Site | Durban | 4001 | South Africa |
| Research Site | Durban | 4091 | South Africa |
| Research Site | Durban | 4092 | South Africa |
| Research Site | Durban | 4450 | South Africa |
| Research Site | eMkhomazi | 4170 | South Africa |
| Research Site | Johannesburg | 1724 | South Africa |
| Research Site | Johannesburg | 1829 | South Africa |
| Research Site | Johannesburg | 2113 | South Africa |
| Research Site | Lenasia Ext8 | 1820 | South Africa |
| Research Site | Middelburg | 1055 | South Africa |
| Research Site | Mowbray | 7700 | South Africa |
| Research Site | Parow | 7505 | South Africa |
| Research Site | Pretoria | 0157 | South Africa |
| Research Site | Witbank | 1035 | South Africa |
| Research Site | Bucheon-si | 14584 | South Korea |
| Research Site | Cheongju-si | 28644 | South Korea |
| Research Site | Daegu | 41404 | South Korea |
| Research Site | Daegu | 42415 | South Korea |
| Research Site | Jeju City | 690-767 | South Korea |
| Research Site | Jeonju | 54907 | South Korea |
| Research Site | Seongnam-si | 13620 | South Korea |
| Research Site | Seoul | 02447 | South Korea |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 03312 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Seoul | 06351 | South Korea |
| Research Site | Seoul | 06591 | South Korea |
| Research Site | Seoul | 07985 | South Korea |
| Research Site | Seoul | 08308 | South Korea |
| Research Site | Seoul | 150-713 | South Korea |
| Research Site | Suwon | 16499 | South Korea |
| Research Site | Hsinchu | 300 | Taiwan |
| Research Site | Kaohsiung City | 80756 | Taiwan |
| Research Site | Kaohsiung City | 82445 | Taiwan |
| Research Site | Kaohsiung Hsien | TAIWAN | Taiwan |
| Research Site | Taichung | 40443 | Taiwan |
| Research Site | Tainan | 70403 | Taiwan |
| Research Site | Taipei | 220216 | Taiwan |
| Research Site | Taipei | 235 | Taiwan |
| Research Site | Yilan | 260 | Taiwan |
| Research Site | Ivano-Frankivsk | 76018 | Ukraine |
| Research Site | Kharkiv Region | 61075 | Ukraine |
| Research Site | London | SW3 6NP | United Kingdom |
| Research Site | Hanoi | 100000 | Vietnam |
| Research Site | Hanoi | 10000 | Vietnam |
| Research Site | Hà Nội | 100000 | Vietnam |
| Research Site | Ho Chi Minh City | 70000 | Vietnam |
| 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. |
| 40285963 | Derived | 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. |
| 39514041 | Derived | 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. |
| 39326921 | Derived | 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. |
| 38802635 | Derived | 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. |
| 37772607 | Derived | 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. |
| 37723356 | Derived | 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. |
| 37619779 | Derived | 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. |
| 37263380 | Derived | 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. |
| 37015033 | Derived | 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. |
| 36702146 | Derived | 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. |
| 36253275 | Derived | 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. |
| 33979488 | Derived | 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. |
| 33050934 | Derived | 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. |
| Related Info | View source |
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| ID | Title | Description |
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| BG000 | Tezepelumab 210mg Q4W | Tezepelumab administered every 4 weeks subcutaneously |
| BG001 | Placebo | Placebo administered subcutaneously |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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) | Posted | Least Squares Mean | 95% Confidence Interval | events per year | From randomisation to Study Week 52. |
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| Primary | 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 | Posted | Least Squares Mean | 95% Confidence Interval | events per year | From randomisation to Study Week 52. |
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| Secondary | 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. | Number of participants analyzed is the number of subjects with an observation at Week 52. All subjects from the Full Analysis Set with at least one change from baseline value at any post baseline visit contributes to the analyses. | Posted | Least Squares Mean | Standard Error | Litre | From randomisation to Study Week 52 |
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| Secondary | 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). | Number of participants analyzed is the number of subjects with an observation at Week 52. All subjects from the Full Analysis Set with at least one change from baseline value at any post baseline visit contributes to the analyses. | Posted | Least Squares Mean | Standard Error | Scale of score | From randomisation to Study Week 52 |
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| Secondary | 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. | Number of participants analyzed is the number of subjects with an observation at Week 52. All subjects from the Full Analysis Set with at least one change from baseline value at any post baseline visit contributes to the analyses. | Posted | Least Squares Mean | Standard Error | Scale of score | From randomisation to Study Week 52 |
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| Secondary | 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. | Number of participants analyzed is the number of subjects with a weekly mean at Week 52. All subjects from the Full Analysis Set with at least one change from baseline weekly mean at any post-baseline week contributes to the analyses. | Posted | Least Squares Mean | Standard Error | Scale of score | From randomisation to Study Week 52 |
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| Secondary | 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. | Posted | Count of Participants | Participants | From randomisation to Study Week 52 |
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| Secondary | 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 | Posted | Least Squares Mean | Standard Error | ppb | From randomisation to Study Week 52 |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | weekly mean rescue medication use | From randomisation to Study Week 52 |
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| Secondary | 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. | The work productivity loss is only applicable to subjects who were employed, which is a subset of the study population. | Posted | Mean | Standard Deviation | Percentage of work productivity loss | From randomisation to Study Week 52 |
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| Secondary | 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. | The class productivity loss is only applicable to subjects attending school, which is a subset of the study population. | Posted | Mean | Standard Deviation | Percentage of class productivity loss | From randomisation to Study Week 52 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Percentage of activity impairment | From randomisation to Study Week 52 |
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| Secondary | Pharmacokinetics of Tezepelumab | Mean serum trough PK concentrations taken pre-dose at each visit | Number of subjects who received at least one dose of IP. Number analysed at each timepoint is a subset of this based on subjects who had sample results available at that timepoint. The placebo arm is not applicable since it is not the experimental product. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Pre-dose samples at Baseline, Week 4, Week 12, Week 24, Week 36, Week 52, Week 64 |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | scale of score | At Study Week 52 |
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| Secondary | 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) | Posted | Count of Participants | Participants | From randomisation to Study Week 52 |
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| Secondary | 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). | Posted | Count of Participants | Participants | From randomisation to Study Week 52 |
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| Secondary | 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 | Posted | Count of Participants | Participants | At Study Week 52 |
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| Secondary | 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) | Posted | Least Squares Mean | Standard Error | cells/uL | From randomisation to Study Week 52 |
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| Secondary | 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) | Posted | Least Squares Mean | Standard Error | IU/mL | From randomisation to Study Week 52 |
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| Secondary | 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 | Posted | Number | Participants | From randomisation to Study Week 52 |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | L/min | From randomisation to Study Week 52 |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | L/min | From randomisation to Study Week 52 |
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| Secondary | 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. | Posted | Least Squares Mean | Standard Error | percentage of nights with awakenings | From randomisation to Study Week 52 |
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| Secondary | 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. | Posted | Number | Participants | Baseline, and from time of first dose at Week 0 to end of study at Week 64. |
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| Secondary | 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. | Posted | Number | Percentage | From randomisation to Study Week 52 |
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| Secondary | 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) | Posted | Least Squares Mean | 95% Confidence Interval | events per year | From randomisation to Study Week 52 |
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| Secondary | 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. | Posted | Number | Percentage | From randomisation to Study Week 52 |
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| Secondary | 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. | Posted | Number | Percentage | From randomisation to Study Week 52 |
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| Other Pre-specified | Annual Asthma Exacerbation Rate Associated With Hospitalisations | The annualized exacerbation rate is based on exacerbations reported by the investigator that are associated with hospitalization | Posted | Least Squares Mean | 95% Confidence Interval | events per year | From randomisation to Study Week 52 |
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| Other Pre-specified | Annual Asthma Exacerbation Rate Using Adjudicated Data | 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. | Posted | Least Squares Mean | 95% Confidence Interval | events per year | From randomisation to Study Week 52 |
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| Other Pre-specified | Annual Asthma Exacerbation Rate Associated With Emergency Room (ER) Visit or Hospitalisation Using Adjudicated Data | 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. | Posted | Least Squares Mean | 95% Confidence Interval | events per year | From randomisation to Study Week 52 |
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From first dose of study drug until end of study at Week 64.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tezepelumab 210mg Q4W | Tezepelumab administered every 4 weeks subcutaneously | 0 | 528 | 52 | 528 | 306 | 528 |
| EG001 | Placebo | Placebo administered subcutaneously | 2 | 531 | 73 | 531 | 331 | 531 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic valve stenosis | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Oesophageal achalasia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pancreatitis necrotising | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Herpes zoster oticus | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Lower respiratory tract infection bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bone cyst | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of the oral cavity | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Cubital tunnel syndrome | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Idiopathic generalised epilepsy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myelopathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 23.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Eosinophilic pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cyanosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Muscle necrosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Head | AstraZeneca | +1 302 885 1180 | information.center@astrazeneca.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 22, 2020 | Oct 29, 2021 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000622721 | tezepelumab |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Black of African American |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| American Indian or Alaska Native |
|
| Other |
|
| Not Hispanic or Latino |
|
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| Units | Counts |
|---|
| Participants |
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