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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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A Regional, Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Severe Uncontrolled Asthma
This is a regional, multicentre, randomized, double-blind, placebo controlled, parallel group, phase 3 study designed to evaluate the efficacy and safety of 210 mg Q4W (SC) of tezepelumab in adults with severe, uncontrolled asthma on medium to high-dose ICS and at least one additional asthma controller medication with or without OCS. Approximately 396 participants will be randomized regionally (China/non-China). Participants 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 (AERR) | The annual exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 52 weeks | Randomization to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Pre-dose/Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) at 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. | Randomization to Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nanshan Zhong, Bachelor | Guangzhou institute of Respiratory Disease, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baotou | 14010 | China | |||
| Research Site |
Not provided
| Label | URL |
|---|---|
| D5180C00021-Primary CSR Synopsis Redacted | View source |
| D5180C00021-Final CSR Synopsis Redacted | View source |
Not provided
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 deidentified 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 401 randomized, 400 (99.8%) participants received treatment.
A total of 401 participants were randomized at 74 sites in 3 Asian 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 | Oct 12, 2023 | May 9, 2025 |
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Participants 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 in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score at 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 participants. 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). |
| Randomization to Week 52 |
| Mean Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score at Week 52 | Mean 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. | Randomization to Week 52 |
| Mean Change From Baseline in Weekly Mean Daily Asthma Symptom Diary Score at Week 52 | Mean change from baseline in Asthma Symptom Diary score as compared to placebo at Week 52. 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. A higher value indicates a worse outcome. 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. | Randomization to Week 52 |
| Time to First Asthma Exacerbation | Time to the first occurrence of asthma exacerbation post randomization, presented as number of participants with at least one asthma exacerbation reported in the eCRF | Randomization to Week 52 |
| Mean Change From Baseline in Fractional Exhaled Nitric Oxide at Week 52 | Mean change from baseline in FENO (ppb) at week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on biomarkers | Randomization to Week 52 |
| Number of Participants With Asthma Specific Resource Utilization Over 52 Weeks | Number of participants with asthma specific resource utilization (e.g. unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) over 52 weeks. | Randomization to Week 52 |
| Pharmacokinetics of Tezepelumab | Mean serum trough PK concentrations taken pre-dose at each scheduled visit to evaluate the pharmacokinetics (PK) of tezepelumab | Baseline, Week 24, Week 52, Week 64 |
| Mean Change From Baseline in EQ-5D-5L VAS Score at Week 52 | Mean change from baseline in EQ-5D-5L VAS at week 52. EQ-5D-5L visual analogue scale (VAS) allows participants to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state. | At Week 52 |
| Mean Change From Baseline in Blood Eosinophils (Cells/uL) at Week 52 | Mean change from baseline in blood eosinophil counts at week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on biomarkers. | Randomization to Week 52 |
| Mean Change From Baseline in Total Serum IgE (IU/mL) at Week 52 | Mean change from baseline in IgE at week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on biomarkers. | Randomization to Week 52 |
| Mean Change From Baseline in Night Time Awakenings (Percentage) at Week 52 | Mean change from baseline in night time awakenings due to asthma at Week 52. Night time awakenings percentage is defined as number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with available data and multiplied by 100%. At least 4 out of 7 days of data is required to calculate a weekly mean. | Randomization to Week 52 |
| Immunogenicity 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 to Week 64 |
| 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. | Randomization to Week 52 |
| Mean Change From Baseline in Home Based Morning Peak Expiratory Flow (PEF) at Week 52 | Mean change from baseline in home based morning PEF (L/min) at Week 52. Home PEF testing was performed by participant 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. | Randomization to Week 52 |
| Mean Change From Baseline in Home Based Evening Peak Expiratory Flow (PEF) at Week 52 | Mean change from baseline in home based evening PEF (L/min) at Week 52. Home PEF testing was performed by participant 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. | Randomization to Week 52 |
| Annual Asthma Exacerbation Rate Resulting in Emergency Room Visit or Hospitalization | The annual 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). | Randomization to Week 52 |
| Proportion of Participants Who Had no Asthma Exacerbations | The proportion of participants who had no asthma exacerbations is presented as the percentage of participants with no exacerbations. This is defined as participants who meet both the following criteria: (1) completed the 52 week treatment period and (2) did not report an exacerbation during this period. | Randomization to Week 52 |
| Beijing |
| 1000096 |
| China |
| Research Site | Beijing | 100020 | China |
| Research Site | Beijing | 100029 | China |
| Research Site | Beijing | 100070 | China |
| Research Site | Beijing | 100730 | China |
| Research Site | Beijing | 100853 | China |
| Research Site | Changchun | 130021 | China |
| Research Site | Changsha | 410008 | China |
| Research Site | Changsha | 410011 | China |
| Research Site | Chengdu | 610041 | China |
| Research Site | Chongqing | 400000 | China |
| Research Site | Chongqing | 400016 | China |
| Research Site | Chongqing | 400038 | China |
| Research Site | Fuzhou | 350001 | China |
| Research Site | Guangzhou | 510080 | China |
| Research Site | Guangzhou | 510120 | China |
| Research Site | Guangzhou | 510515 | China |
| Research Site | Guangzhou | China |
| Research Site | Guiyang | 550004 | China |
| Research Site | Haikou | 570311 | China |
| Research Site | Hangzhou | 310020 | China |
| Research Site | Hefei | 133500 | China |
| Research Site | Hengyang | 421001 | China |
| Research Site | Hohhot | 010017 | China |
| Research Site | Hohhot | 10050 | China |
| Research Site | Huzhou | 313003 | China |
| Research Site | Jinan | 250013 | China |
| Research Site | Jinhua | 321000 | China |
| Research Site | Kunming | 650032 | China |
| Research Site | Lanzhou | 730000 | China |
| Research Site | Linhai | 317000 | China |
| Research Site | Linyi | CN-276003 | China |
| Research Site | Nanchang | 330006 | China |
| Research Site | Nanjing | 2100008 | China |
| Research Site | Nanjing | 210009 | China |
| Research Site | Nanjing | 210029 | China |
| Research Site | Nanning | 530007 | China |
| Research Site | Quanzhou | 362000 | China |
| Research Site | Shanghai | 200025 | China |
| Research Site | Shanghai | 200032 | China |
| Research Site | Shanghai | 200050 | China |
| Research Site | Shengyang | 110004 | China |
| Research Site | Shenyang | 110015 | China |
| Research Site | Shenzhen | 518035 | China |
| Research Site | Shijiazhuang | 050000 | China |
| Research Site | Tianjin | 300192 | China |
| Research Site | Ürümqi | 830054 | China |
| Research Site | Weifang | 261041 | China |
| Research Site | Wenzhou | 325027 | China |
| Research Site | Wuhan | 430022 | China |
| Research Site | Wuhan | 430030 | China |
| Research Site | Wuhan | 430033 | China |
| Research Site | Xi'an | 710004 | China |
| Research Site | Xining | 810007 | China |
| Research Site | Xuzhou | 221000 | China |
| Research Site | Xuzhou | 221009 | China |
| Research Site | Yangzhou | 225001 | China |
| Research Site | Zhengzhou | 450000 | China |
| Research Site | Zhuhai | 519099 | China |
| Research Site | Zibo | 255036 | China |
| Research Site | Zunyi | 563100 | China |
| Research Site | Iloilo City | 5000 | Philippines |
| Research Site | Quezon City | 1100 | Philippines |
| Research Site | Cheongju-si | 28644 | South Korea |
| Research Site | Daegu | 42415 | South Korea |
| Research Site | Jeonju | 54907 | South Korea |
| Research Site | Seoul | 03312 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Seoul | 06591 | South Korea |
| Research Site | Suwon | 16499 | South Korea |
| D5180C00021 SAP Redacted | View source |
| D5180C00021 CSP Redacted | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tezepelumab 210mg Q4W | Tezepelumab administered every 4 weeks subcutaneously |
| BG001 | Placebo | Placebo administered subcutaneously |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Annual Asthma Exacerbation Rate (AERR) | The annual exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 52 weeks | Full Analysis Set | Posted | Least Squares Mean | 95% Confidence Interval | Events per year | Randomization to Week 52 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Pre-dose/Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) at 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. | All participants from the Full Analysis Set with at least one change from baseline value at any post-baseline visit contributes to the analysis. | Posted | Least Squares Mean | Standard Error | Litre | Randomization to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score at 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 participants. 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). | All participants from the Full Analysis Set with at least one change from baseline value at any post-baseline visit contribute to the analysis. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Randomization to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score at Week 52 | Mean 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. | All participants from the Full Analysis Set with at least one change from baseline value at any post-baseline visit contribute to the analysis. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Randomization to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Weekly Mean Daily Asthma Symptom Diary Score at Week 52 | Mean change from baseline in Asthma Symptom Diary score as compared to placebo at Week 52. 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. A higher value indicates a worse outcome. 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. | All participants from the Full Analysis Set with at least one change from baseline value at any post-baseline week contribute to the analysis. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Randomization to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Asthma Exacerbation | Time to the first occurrence of asthma exacerbation post randomization, presented as number of participants with at least one asthma exacerbation reported in the eCRF | Posted | Count of Participants | Participants | Randomization to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Fractional Exhaled Nitric Oxide at Week 52 | Mean change from baseline in FENO (ppb) at week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on biomarkers | Posted | Least Squares Mean | Standard Error | ppb | Randomization to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Asthma Specific Resource Utilization Over 52 Weeks | Number of participants with asthma specific resource utilization (e.g. unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) over 52 weeks. | Posted | Number | Participants | Randomization to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics of Tezepelumab | Mean serum trough PK concentrations taken pre-dose at each scheduled visit to evaluate the pharmacokinetics (PK) of tezepelumab | PK Analysis Set: participants who received at least one dose of tezepelumab. The placebo arm is not applicable. Number analyzed at each timepoint is a subset of PK Analysis Set based on participants who had sample results available at that timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Baseline, Week 24, Week 52, Week 64 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in EQ-5D-5L VAS Score at Week 52 | Mean change from baseline in EQ-5D-5L VAS at week 52. EQ-5D-5L visual analogue scale (VAS) allows participants 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 | Scores on a scale | At Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Blood Eosinophils (Cells/uL) at Week 52 | Mean change from baseline in blood eosinophil counts at week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on biomarkers. | Posted | Least Squares Mean | Standard Error | cells/uL | Randomization to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Total Serum IgE (IU/mL) at Week 52 | Mean change from baseline in IgE at week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on biomarkers. | Posted | Least Squares Mean | Standard Error | IU/mL | Randomization to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Night Time Awakenings (Percentage) at Week 52 | Mean change from baseline in night time awakenings due to asthma at Week 52. Night time awakenings percentage is defined as number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with available 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 | Randomization to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Immunogenicity 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 to Week 64 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Inhalations and nebulizers per week | Randomization to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Home Based Morning Peak Expiratory Flow (PEF) at Week 52 | Mean change from baseline in home based morning PEF (L/min) at Week 52. Home PEF testing was performed by participant 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 | Randomization to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Home Based Evening Peak Expiratory Flow (PEF) at Week 52 | Mean change from baseline in home based evening PEF (L/min) at Week 52. Home PEF testing was performed by participant 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 | Randomization to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Annual Asthma Exacerbation Rate Resulting in Emergency Room Visit or Hospitalization | The annual 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 | Randomization to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Who Had no Asthma Exacerbations | The proportion of participants who had no asthma exacerbations is presented as the percentage of participants with no exacerbations. This is defined as participants 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 | Randomization to Week 52 |
|
|
Adverse events is collected from time of signature of the informed consent form until end of study at Week 64.
Not provided
Not provided
| 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 | 201 | 16 | 201 | 114 | 201 |
| EG001 | Placebo | Placebo administered subcutaneously | 2 | 199 | 36 | 199 | 125 | 199 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Salivary gland mass | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Coronavirus pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Connective tissue disorder | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neuroendocrine tumour of the lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Endometrial thickening | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nasal turbinate abnormality | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myocardial bridging | Congenital, familial and genetic disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rhinitis hypertrophic | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Suspected covid-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Head | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 22, 2024 | May 9, 2025 | SAP_001.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 |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
Placebo administered subcutaneously; non-China cohort |
|
|
|
|
|
|
|