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| ID | Type | Description | Link |
|---|---|---|---|
| 05398263 | Registry Identifier | ClinicalTrials.gov | |
| 2023-504648-33 | Other Identifier | EU CT Number | |
| 2023-504648-33-00 | Registry Identifier | CTIS | |
| 2021-006691-17 | EudraCT Number |
Not provided
Not provided
The study was discontinued due to slow recruitment, resulting from evolving clinical practices that reduced the use of maintenance oral corticosteroids for severe asthma treatment. The termination decision was not related to safety concerns.
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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
Not provided
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A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled 28-week Phase 3 Efficacy and Safety Study of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma
This is a multicentre, randomised, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of tezepelumab in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma treated with maintenance OCS in combination with high dose inhaled corticosteroids (ICS) and long-acting β2 agonists (LABA), with or without other asthma controller therapies. Approximately 207 subjects will be randomized globally. Subjects will receive tezepelumab, or placebo, administered via subcutaneous injection using the accessorized pre-filled syringe (APFS), over a 28-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 subcutaneous injection, in an accessorised pre-filled syringe. |
|
| Placebo | Placebo Comparator | Placebo subcutaneous injection, in an accessorised pre-filled syringe. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tezepelumab | Biological | Tezepelumab subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects by Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 Whilst Maintaining Asthma Control. | Proportion of subjects by categorised percent reduction from baseline at Week 28. Percent change from baseline is defined as {final dose-baseline dose)/baseline dose}*100%, and the categories of percent change from baseline in daily OCS dose are defined as: ≥90% to ≤100% reduction, ≥75% to <90% reduction, ≥50% to <75% reduction, >0% to <50% reduction, and, no change or any increase. | Baseline to Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) at Week 28 | Change from baseline in pre-BD FEV1 at Week 28. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration. | Baseline to Week 28 |
| Proportion of Subjects With 100% Reduction From Baseline in Daily OCS Dose at Week 28 |
Not provided
Main inclusion criteria:
Participant must be 18 to 80 years of age.
Documented physician-diagnosed asthma for at least 12 months prior to Visit 1.
Participants must have received a physician-prescribed medium- or high-dose ICS for at least 12 months prior to Visit 1.
Participants must have received physician prescribed LABA and high dose ICS for at least 3 months prior to Visit 1.
Additional maintenance asthma controller medications are allowed. The use of these medications must be documented for at least 3 months prior to Visit 1.
Participants must have received OCS for the treatment of asthma for at least 6 months prior to Visit 1 and on a stable dose of between ≥7.5 to ≤ 30 mg (prednisone or prednisolone) daily or daily equivalent for at least 1 month prior to Visit 1.
Morning pre- bronchodilator (BD) FEV1 must be < 80% predicted normal at Visit 1 or Visit 2.
Evidence of asthma as documented by either:
a)Post-BD responsiveness test result: FEV1 ≥12% and ≥200 mL documented either in the previous 60 months prior to or at Visit 1 or at Visit 2 or at Visit 3; OR b)Airway hyperresponsiveness (methacholine: provocative concentration that causes a positive reaction [PC20] of <8 mg/mL) documented in the 60 months prior to Visit 1.
Blood eosinophils at Visit 1 ≥150 cells/μL or documented EOS ≥300 cells/μL within 12 months prior to Visit 1.
Participants must have a history of at least 1 asthma exacerbation event within 24 months prior to Visit 1.
Participants must have received the optimised OCS dose for at least 2 weeks prior to randomisation.
Other inclusion criteria per protocol apply.
Main exclusion criteria
Other exclusion criteria per protocol apply.
Not provided
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Newport Beach | California | 92663 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42150582 | Derived | Wechsler ME, Brightling CE, Brusselle G, Caminati M, Soler T, Gonzalez EM, Nakwan N, Capala-Szczurko I, Hunter G, Almqvist G, Lal H, Kabelis P, Scrigner P, Matsunaga Y, Molfino N, Ponnarambil SS; SUNRISE study investigators. Efficacy and safety of tezepelumab versus placebo in reducing oral corticosteroid use in adults with severe, oral corticosteroid-dependent asthma (SUNRISE): a multicentre, placebo-controlled, double-blind, phase 3 trial. Lancet Respir Med. 2026 Jun;14(6):481-492. doi: 10.1016/S2213-2600(26)00076-7. Epub 2026 May 18. |
| Label | URL |
|---|---|
| Call center number: 866-914-6996 Email address: az-asthmatrials@careboxhealth.com | 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 evaluatedas 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 datain 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.
Assignment was done by Interactive Voice/Web Response System (IVRS/IWRS). Subjects were randomized in 2:1 ratio for tezepelumab or placebo. Randomization was stratified by region and eosinophil count at Visit 1 (< 150 cells/μL, 150-< 300 cells/μL, ≥ 300 cells/μL).
The study was conducted at 64 centres in 12 countries. Between 9AUG2022 and 29NOV2024, 250 subjects were screened; 125 were randomized and treated, and 125 were not randomized mainly due to screen failures. Four participants (1 tezepelumab, 2 placebo, 1 screen failure) from one site were excluded for quality issues, so 122 randomized participants were analysed. The sponsor terminated the study early due to recruitment challenges.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tezepelumab | Tezepelumab 210 mg administered every 4 weeks subcutaneously |
| FG001 | Placebo | Placebo administered every 4 weeks subcutaneously |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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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 | Mar 28, 2023 | Jun 17, 2026 |
Not provided
Subjects will be randomized in a 2:1 ratio to either tezepelumab or matching placebo both administered subcutaneously.
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Double-Blind
| Placebo |
| Other |
Placebo subcutaneous injection |
|
Proportion of subjects with 100% reduction from baseline in daily OCS dose at Week 28. Percent change from baseline is defined as {(final dose-baseline dose)/baseline dose}*100%. |
| Baseline to Week 28 |
| Proportion of Subjects With Daily OCS Dose ≤5 mg at Week 28 | Proportion of subjects with daily OCS dose ≤5 mg at Week 28. | Week 28 |
| Proportion of Subjects With ≥50% Reduction From Baseline in Daily OCS Dose at Week 28 | Proportion of subjects with ≥50% reduction from baseline in daily OCS dose at Week 28. Percent change from baseline is defined as {(final dose-baseline dose)/baseline dose}*100%. | Baseline to Week 28 |
| Annualised Asthma Exacerbation Rate (AAER) Over 28 Weeks | The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 28 weeks. | Baseline to Week 28 |
| Proportion of Subjects With >= 1 Asthma Exacerbation | Time to first asthma exacerbation, presented as proportion of subjects with at least one asthma exacerbation as reported by the investigator in the eCRF | Baseline to Week 28 |
| Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 28 | Change from baseline in ACQ-6 as compared to placebo at Week 28. 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. | Baseline to Week 28 |
| Change From Baseline in Weekly Mean Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 28 | Change from baseline in weekly mean morning and evening peak expiratory flow (PEF) as compared to placebo at Week 28. 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. Each timepoint is calculated as weekly. | Baseline to Week 28 |
| Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(s)+12) Total Score at Week 28 | Change from baseline in AQLQ(S)+12 as compared to placebo at Week 28. 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). | Baseline to Week 28 |
| Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Score at Week 28 | Change from baseline in SGRQ as compared to placebo at Week 28. The questionnaire is divided into 2 parts: part 1 consists of 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The total score indicates the impact of disease on overall health status. This total score is expressed as a percentage of overall impairment, in which 100 represents the worst possible health status and 0 indicates the best possible health status. | Baseline to Week 28 |
| Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 28 | Change from baseline in fractional exhaled nitric oxide (FeNO) at Week 28. | Baseline to Week 28 |
| Change From Baseline in Peripheral Blood Eosinophils at Week 28 | Change from baseline in blood eosinophil counts at Week 28. | Baseline to Week 28 |
| Change From Baseline in Total Serum Immunoglobulin E (IgE) at Week 28 | Change from baseline in total serum IgE at Week 28. | Baseline to Week 28 |
| PK: Serum Trough Concentrations at Week 0, 12 and 28 | Pharmacokinetics samples are collected at baseline and at Week 12 prior to study intervention administration, and at Week 28 (End of Treatment visit). | Baseline, Week 12 and Week 28 |
| Immunogenicity: Incidence of Anti-drug Antibodies (ADA) at Week 0, 12, 28, and 40 | Immunogenicity samples are collected at baseline and at Week 12 prior to study intervention administration, at Week 28 (End of Treatment visit) and at Week 40 (Follow-up visit). 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 40 |
| Denver |
| Colorado |
| 80206 |
| United States |
| Research Site | Newark | Delaware | 19713 | United States |
| Research Site | Hialeah | Florida | 33016 | United States |
| Research Site | Miami Lakes | Florida | 33014 | United States |
| Research Site | Lincoln | Nebraska | 68510 | United States |
| Research Site | The Bronx | New York | 10459 | United States |
| Research Site | El Paso | Texas | 79902 | United States |
| Research Site | Kingwood | Texas | 77339 | United States |
| Research Site | Botucatu | 18618-686 | Brazil |
| Research Site | Curitiba | 80730-150 | Brazil |
| Research Site | Porto Alegre | 90035074 | Brazil |
| Research Site | Porto Alegre | 91350-200 | Brazil |
| Research Site | Salvador | 40060-330 | Brazil |
| Research Site | São Bernardo do Campo | 09715090 | Brazil |
| Research Site | São Paulo | 01223-001 | Brazil |
| Research Site | Sorocaba | 18040-425 | Brazil |
| Research Site | Ajax | Ontario | L1S 2J5 | Canada |
| Research Site | Québec | Quebec | G1V4G5 | Canada |
| Research Site | Chile | 7770484 | Chile |
| Research Site | Curicó | 3341643 | Chile |
| Research Site | Santiago | 7500010 | Chile |
| Research Site | Santiago | 7500588 | Chile |
| Research Site | Santiago | 7500691 | Chile |
| Research Site | Santiago | 7500698 | Chile |
| Research Site | Santiago | 7750495 | Chile |
| Research Site | Santiago | 8241479 | Chile |
| Research Site | Brno | 625 00 | Czechia |
| Research Site | Hradec Králové | 500 05 | Czechia |
| Research Site | Jindřichův Hradec | 377 01 | Czechia |
| Research Site | Miroslav | 671 72 | Czechia |
| Research Site | Olomouc | 779 00 | Czechia |
| Research Site | Ostrava | 700 30 | Czechia |
| Research Site | Ajmer | 305001 | India |
| Research Site | Kanpur | 208002 | India |
| Research Site | Vadodara | 390022 | India |
| Research Site | Guadalajara | 44100 | Mexico |
| Research Site | Guadalajara | 44130 | Mexico |
| Research Site | Guadalajara | 44200 | Mexico |
| Research Site | Mexico City | 0 3100 | Mexico |
| Research Site | Monterrey | 64460 | Mexico |
| Research Site | San Luis Potosí City | 78250 | Mexico |
| Research Site | Veracruz | 91910 | Mexico |
| Research Site | Lima | 15046 | Peru |
| Research Site | Bialystok | 15-704 | Poland |
| Research Site | Bychawa | 23100 | Poland |
| Research Site | Bydgoszcz | 85-231 | Poland |
| Research Site | Chęciny | 26-060 | Poland |
| Research Site | Grudziądz | 86-300 | Poland |
| Research Site | Ostrowiec Świętokrzyski | 27-400 | Poland |
| Research Site | Poznan | 61-578 | Poland |
| Research Site | Rzeszów | 35-205 | Poland |
| Research Site | Sosnowiec | 41-208 | Poland |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Seoul | 07061 | South Korea |
| Research Site | Seoul | 143-729 | South Korea |
| Research Site | Suwon | 16499 | South Korea |
| Research Site | Bang Kra So | 11000 | Thailand |
| Research Site | Bangkok | 10330 | Thailand |
| Research Site | Hat Yai | 90110 | Thailand |
| Research Site | Ankara | 06620 | Turkey (Türkiye) |
| Research Site | Bursa | 16059 | Turkey (Türkiye) |
| Research Site | Istanbul | 34899 | Turkey (Türkiye) |
| Research Site | Izmir | 35040 | Turkey (Türkiye) |
| D5180C00024\_CSR synopsis\_Redacted | View source |
| D5180C00024\_CSP\_Redacted | View source |
| D5180C00024\_SAP\_Redacted | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tezepelumab | Tezepelumab 210 mg administered every 4 weeks subcutaneously |
| BG001 | Placebo | Placebo administered every 4 weeks 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 | -- Select -- | Mean | Standard Deviation | Years |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | 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 | Proportion of Subjects by Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 Whilst Maintaining Asthma Control. | Proportion of subjects by categorised percent reduction from baseline at Week 28. Percent change from baseline is defined as {final dose-baseline dose)/baseline dose}*100%, and the categories of percent change from baseline in daily OCS dose are defined as: ≥90% to ≤100% reduction, ≥75% to <90% reduction, ≥50% to <75% reduction, >0% to <50% reduction, and, no change or any increase. | Posted | Count of Participants | Participants | Baseline to Week 28 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) at Week 28 | Change from baseline in pre-BD FEV1 at Week 28. 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 a change from baseline value available at Week 28. | Posted | Mean | Standard Deviation | Litre | Baseline to Week 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With 100% Reduction From Baseline in Daily OCS Dose at Week 28 | Proportion of subjects with 100% reduction from baseline in daily OCS dose at Week 28. Percent change from baseline is defined as {(final dose-baseline dose)/baseline dose}*100%. | Posted | Count of Participants | Participants | Baseline to Week 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With Daily OCS Dose ≤5 mg at Week 28 | Proportion of subjects with daily OCS dose ≤5 mg at Week 28. | Posted | Count of Participants | Participants | Week 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With ≥50% Reduction From Baseline in Daily OCS Dose at Week 28 | Proportion of subjects with ≥50% reduction from baseline in daily OCS dose at Week 28. Percent change from baseline is defined as {(final dose-baseline dose)/baseline dose}*100%. | Posted | Count of Participants | Participants | Baseline to Week 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Annualised Asthma Exacerbation Rate (AAER) Over 28 Weeks | The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 28 weeks. | Posted | Number | Events per year | Baseline to Week 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With >= 1 Asthma Exacerbation | Time to first asthma exacerbation, presented as proportion of subjects with at least one asthma exacerbation as reported by the investigator in the eCRF | Posted | Count of Participants | Participants | Baseline to Week 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 28 | Change from baseline in ACQ-6 as compared to placebo at Week 28. 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 a change from baseline value available at Week 28. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Week 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Weekly Mean Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 28 | Change from baseline in weekly mean morning and evening peak expiratory flow (PEF) as compared to placebo at Week 28. 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. Each timepoint is calculated as weekly. | Number of participants analyzed is the number of subjects with a change from baseline value available at Week 28. | Posted | Mean | Standard Deviation | L/min | Baseline to Week 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(s)+12) Total Score at Week 28 | Change from baseline in AQLQ(S)+12 as compared to placebo at Week 28. 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 a change from baseline value available at Week 28. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline to Week 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Score at Week 28 | Change from baseline in SGRQ as compared to placebo at Week 28. The questionnaire is divided into 2 parts: part 1 consists of 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The total score indicates the impact of disease on overall health status. This total score is expressed as a percentage of overall impairment, in which 100 represents the worst possible health status and 0 indicates the best possible health status. | Number of participants analyzed is the number of subjects with a change from baseline value available at Week 28. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline to Week 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 28 | Change from baseline in fractional exhaled nitric oxide (FeNO) at Week 28. | Number of participants analyzed is the number of subjects with a change from baseline value available at Week 28. | Posted | Mean | Standard Deviation | ppb | Baseline to Week 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Peripheral Blood Eosinophils at Week 28 | Change from baseline in blood eosinophil counts at Week 28. | Number of participants analyzed is the number of subjects with a change from baseline value available at Week 28. | Posted | Mean | Standard Deviation | cells/μL | Baseline to Week 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Serum Immunoglobulin E (IgE) at Week 28 | Change from baseline in total serum IgE at Week 28. | Number of participants analyzed is the number of subjects with a change from baseline value available at Week 28. | Posted | Mean | Standard Deviation | IU/mL | Baseline to Week 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PK: Serum Trough Concentrations at Week 0, 12 and 28 | Pharmacokinetics samples are collected at baseline and at Week 12 prior to study intervention administration, and at Week 28 (End of Treatment visit). | The placebo arm is not applicable since it is not the experimental product. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Baseline, Week 12 and Week 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Immunogenicity: Incidence of Anti-drug Antibodies (ADA) at Week 0, 12, 28, and 40 | Immunogenicity samples are collected at baseline and at Week 12 prior to study intervention administration, at Week 28 (End of Treatment visit) and at Week 40 (Follow-up visit). 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 | Count of Participants | Participants | Baseline to Week 40 |
|
From the date of first dose of study intervention throughout the treatment period and including the follow-up period (i.e. up to Week 40).
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 | Tezepelumab 210 mg administered every 4 weeks subcutaneously | 2 | 83 | 7 | 83 | 33 | 83 |
| EG001 | Placebo | Placebo administered every 4 weeks subcutaneously | 1 | 39 | 5 | 39 | 21 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Soft tissue infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 5, 2025 | Jun 17, 2026 | SAP_005.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 |
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| Asian |
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| Black or African American |
|
| Native Hawaiian or other Pacific Islander |
|
| White |
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| Other/Multiple race |
|
| Missing |
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| Not Hispanic or Latino |
|
| >=50% to <75% reduction |
|
| >0% to <50% reduction |
|
| no change or any increase |
|
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|
|
|
|
|
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|
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| Units | Counts |
|---|---|
| Participants |
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