A Phase 3 interventional study of Experimental: Tezepelumab and Placebo in Asthma, sponsored by AstraZeneca. Completed at 289 sites in 18 countries. Open to participants aged 12 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-11-26.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
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Among 28 studies testing tezepelumab in Asthma — 7 open to participants now, 8 under way, 5 of them phase 3. tezepelumab · Asthma.
Among the 28 studies testing tezepelumab in Asthma, this one has the largest enrollment, is the only one that started in 2017, is one of 16 in phase 3, and was the 5th registered.
4,846 studies on the registry are indexed under Asthma; 602 are open to participants now.
Browse Asthma studies →7 of the 28 studies testing tezepelumab in Asthma are open now, in 12 countries. Recruiting first, the newest first:
University of Alberta · Sites in Canada
Ages 18–55
AstraZeneca · Sites in China
Ages 12–80
AstraZeneca · Sites in United States, Argentina, Brazil and 19 more countries
Ages 5–11
Qianfoshan Hospital · Sites in China
Ages 18–75
Qilu Pharmaceutical Co., Ltd.
Ages 18–80
By country, each count listing its studies:
tezepelumab: first FDA approval 2021 (TEZSPIRE), first EMA approval 2022. What it is approved for, and how studies give it, is on its page →
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 146 take children under 18; 104 take healthy volunteers.
This study: 12 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
28 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2017.
This study's enrollment of 1,061 is above the median of 79 across 3,342 interventional studies indexed under Asthma.
Median enrollment 121 across the 28 interventional studies. Of the 19 that completed or were terminated, 15 (79%) have results posted.
This tab as a report to print or save as PDF → With an account.
20 of 28 have an industry lead sponsor. The 10 most frequent:
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
359 studies in Asthma by AstraZeneca: 19 open now, 28 under way, 8 of them phase 3. Of 330 finished, 129 (39%) have results posted.
Among the 359 studies in Asthma by AstraZeneca, this one is the 29th largest by enrollment of the 248 interventional ones that give a count, is one of 13 that started in 2017, is one of 121 in phase 3, and was the 228th registered.
AstraZeneca’s Asthma studies by the year they started, since 1996.
3 of the studies testing tezepelumab in Asthma that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06473779Phase 3AstraZenecaOpen-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma. | 2027-06-25 |
| NCT06705764University of AlbertaTezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA) | 2026-11 |
| NCT07757841Qianfoshan HospitalReal-World Effectiveness of Tezepelumab in Allergic Bronchopulmonary Aspergillosis | 2027-06-30 |
Add all 3 to your calendar (.ics) → With an account.
Among the 28 studies testing tezepelumab in Asthma, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among AstraZeneca’s 359 in Asthma:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tezepelumab: Tezepelumab subcutaneous injection
Biological: Experimental: Tezepelumab
Placebo: Placebo subcutaneous injection
Other: Placebo
Tezepelumab subcutaneous injection
Also known as: Tezepelumab
Placebo subcutaneous injection
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)
Time frame: 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
Time frame: From randomisation to Study Week 52.
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.
Time frame: From randomisation to Study Week 52
Mean Change From Baseline at Week 52 in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score (Key Secondary Endpoint)
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From randomisation to Study Week 52
Pharmacokinetics of Tezepelumab
Mean serum trough PK concentrations taken pre-dose at each visit
Time frame: 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.
Time frame: 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)
Time frame: 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).
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: From randomisation to Study Week 52
Annual Asthma Exacerbation Rate Associated With Hospitalisations
The annualized exacerbation rate is based on exacerbations reported by the investigator that are associated with hospitalization
Time frame: From randomisation to Study Week 52
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.
Time frame: 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.
Time frame: From randomisation to Study Week 52
A total of 1061 subjects were randomised at 231 centres in 17 countries to receive treatment with tezepelumab 210mg Q4W or placebo,
| Milestone | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Started | 529 | 532 |
| Received treatment | 528 | 531 |
| Completed | 513 | 509 |
| Not completed | 16 | 23 |
| Withdrew: Withdrawal by subject | 8 | 15 |
| Withdrew: Death | 0 | 2 |
| Withdrew: Lost to follow-up | 5 | 2 |
| Withdrew: Did not receive treatment / non-compliance with protocol / did not complete safety follow-up visits | 3 | 4 |
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)
| events per year | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma | 0.93 (0.80 to 1.07) | 2.10 (1.84 to 2.39) |
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
| events per year | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma in Subjects With Baseline Eosinophils < 300 Cells/uL | 1.02 (0.84 to 1.23) | 1.73 (1.46 to 2.05) |
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.
| Litre | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| 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) | 0.23 ± 0.018 | 0.10 ± 0.018 |
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).
| Scale of score | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| 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) | 1.48 ± 0.049 | 1.14 ± 0.049 |
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.
| Scale of score | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Mean Change From Baseline at Week 52 in Asthma Control Questionnaire-6(ACQ-6) (Key Secondary Endpoint) | -1.53 ± 0.045 | -1.20 ± 0.046 |
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.
| Scale of score | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Mean Change From Baseline at Week 52 in Asthma Symptom Diary (Key Secondary Endpoint) | -0.70 ± 0.027 | -0.59 ± 0.027 |
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.
| Participants | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Time to First Asthma Exacerbation | 231 | 319 |
Mean change from baseline at Study Week 52 in FeNO (ppb) measured at site
| ppb | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Mean Change From Baseline at Week 52 in Clinic Fractional Exhaled Nitric Oxide (FeNO) (Ppb) | -17.29 ± 1.156 | -3.46 ± 1.165 |
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.
| weekly mean rescue medication use | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Mean Change From Baseline in Daily Rescue Medication Use (Weekly Means) at Week 52 | -2.53 ± 0.137 | -2.36 ± 0.137 |
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.
| Percentage of work productivity loss | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Mean Change From Baseline in Work Productivity Loss Due to Asthma at Week 52 | -20.16 ± 30.31 | -16.58 ± 29.46 |
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.
| Percentage of class productivity loss | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Mean Change From Baseline in Class Productivity Loss Due to Asthma at Week 52 | -14.03 ± 33.00 | -24.72 ± 26.48 |
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.
| Percentage of activity impairment | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Activity Impairment at Week 52 | -20.0 ± 28.6 | -17.9 ± 27.1 |
Mean serum trough PK concentrations taken pre-dose at each visit
| ug/mL | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Baseline | 0 ± 0 | — |
| Week 4 | 10.1573 ± 74.51 | — |
| Week 12 | 18.7396 ± 48.53 | — |
| Week 24 | 20.1924 ± 51.77 | — |
| Week 36 | 19.5246 ± 55.58 | — |
| Week 52 | 19.8894 ± 70.04 | — |
| Week 64 | 1.7675 ± 171.86 | — |
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.
| scale of score | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Mean Change From Baseline at Week 52 in EQ-5D-5L VAS | 14.64 ± 0.708 | 11.86 ± 0.712 |
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)
| Participants | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Very much improved | 96 | 60 |
| Much improved | 199 | 132 |
| Minimally improved | 98 | 131 |
| No change | 77 | 130 |
| Minimally worse | 11 | 19 |
| Much worse | 2 | 4 |
| Very much worse | 0 | 1 |
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).
| Participants | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Very much improved | 255 | 182 |
| Much Improved | 103 | 94 |
| Minimally improved | 71 | 76 |
| No change | 39 | 99 |
| Minimally worse | 6 | 8 |
| Much worse | 4 | 6 |
| Very much worse | 1 | 1 |
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
| Participants | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| No symptoms | 118 | 78 |
| Very mild symptoms | 138 | 128 |
| Mild symptoms | 110 | 128 |
| Moderate symptoms | 99 | 111 |
| Severe symptoms | 14 | 19 |
| Very severe symptoms | 0 | 2 |
Mean change from baseline at Study Week 52 in blood eosinophils (cells/uL)
| cells/uL | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Mean Change From Baseline at Week 52 in Blood Eosinophils (Cells/uL) | -170.02 ± 9.222 | -40.15 ± 9.254 |
Mean change from baseline at Study Week 52 in total serum IgE (IU/mL)
| IU/mL | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Mean Change From Baseline at Week 52 in Total Serum IgE (IU/mL) | -164.38 ± 34.414 | 43.61 ± 34.542 |
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
| Participants | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Hospitalisation | 17 | 37 |
| Emergency Room visit | 23 | 50 |
| Unscheduled visit to specialist | 187 | 231 |
| Home visit | 9 | 10 |
| Telephone call | 101 | 133 |
| Ambulance transport | 4 | 12 |
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.
| L/min | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Mean Change From Baseline in Home Based Morning Peak Expiratory Flow (PEF) at Week 52 (Weekly Means) | 34.57 ± 3.051 | 18.01 ± 3.074 |
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.
| L/min | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Mean Change From Baseline in Home Based Evening Peak Expiratory Flow (PEF) at Week 52 (Weekly Means) | 23.87 ± 3.075 | 9.01 ± 3.094 |
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.
| percentage of nights with awakenings | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Mean Change From Baseline in Night Time Awakenings (Weekly Means) at Week 52 | -33.51 ± 1.381 | -30.22 ± 1.387 |
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.
| Participants | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| ADA positive at baseline and/or post-baseline | 26 | 44 |
| Any baseline ADA positive | 17 | 25 |
| Only baseline ADA positive | 14 | 8 |
| Any post-baseline ADA positive | 12 | 36 |
| Both baseline and >= 1 post-baseline ADA positive | 3 | 17 |
| Treatment induced ADA positive | 9 | 18 |
| Treatment boosted ADA positive | 1 | 2 |
| Treatment emergent ADA positive | 10 | 20 |
| ADA persistently positive | 4 | 18 |
| ADA transiently positive | 8 | 18 |
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.
| Percentage | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Proportion of Subjects Who Had no Asthma Exacerbations | 54.2 | 38.6 |
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)
| events per year | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Annual Asthma Exacerbation Rate Resulting in Emergency Room Visit or Hospitalisation | 0.06 (0.04 to 0.09) | 0.28 (0.20 to 0.39) |
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.
| Percentage | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Proportion of Subjects With at Least One Asthma Exacerbation Associated With Emergency Room Visit or Hospitalisation | 4.7 | 12.2 |
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.
| Percentage | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Proportion of Subjects Who Had no Asthma Exacerbations Associated With Emergency Room or Hospitalisation | 92.4 | 85.1 |
The annualized exacerbation rate is based on exacerbations reported by the investigator that are associated with hospitalization
| events per year | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Annual Asthma Exacerbation Rate Associated With Hospitalisations | 0.03 (0.01 to 0.06) | 0.19 (0.12 to 0.30) |
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.
| events per year | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Annual Asthma Exacerbation Rate Using Adjudicated Data | 0.94 (0.81 to 1.09) | 2.14 (1.88 to 2.44) |
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.
| events per year | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| Annual Asthma Exacerbation Rate Associated With Emergency Room (ER) Visit or Hospitalisation Using Adjudicated Data | 0.08 (0.05 to 0.12) | 0.31 (0.22 to 0.42) |
Collected over From first dose of study drug until end of study at Week 64.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tezepelumab 210mg Q4W | 0/528 (0%) | 52/528 (9.8%) | 306/528 (58%) |
| Placebo | 2/531 (0.4%) | 73/531 (13.7%) | 331/531 (62.3%) |
| Event | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 14/528 | 39/531 |
| Cardiac failure congestiveCardiac disorders | 2/528 | 0/531 |
| Pneumonia bacterialInfections and infestations | 2/528 | 2/531 |
| Ligament ruptureInjury, poisoning and procedural complications | 2/528 | 0/531 |
| Malignant melanoma in situNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/528 | 0/531 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 2/528 | 0/531 |
| CellulitisInfections and infestations | 0/528 | 2/531 |
| GastroenteritisInfections and infestations | 0/528 | 2/531 |
| Lower respiratory tract infection bacterialInfections and infestations | 0/528 | 2/531 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/528 | 2/531 |
| Event | Tezepelumab 210mg Q4W | Placebo |
|---|---|---|
| NasopharyngitisInfections and infestations | 113/528 | 114/531 |
| Upper respiratory tract infectionInfections and infestations | 58/528 | 88/531 |
| HeadacheNervous system disorders | 43/528 | 45/531 |
| SinusitisInfections and infestations | 19/528 | 40/531 |
| BronchitisInfections and infestations | 25/528 | 33/531 |
| Bronchitis bacterialInfections and infestations | 24/528 | 17/531 |
| HypertensionVascular disorders | 23/528 | 22/531 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 14/528 | 23/531 |
| Urinary tract infectionInfections and infestations | 22/528 | 22/531 |
| Influenza like illnessGeneral disorders | 19/528 | 22/531 |
| Age, Categorical(Participants) | Tezepelumab 210mg Q4W | Placebo | Total |
|---|---|---|---|
| <=18 years | 41 | 41 | 82 |
| Between 18 and 65 years | 391 | 416 | 807 |
| >=65 years | 96 | 74 | 170 |
| Age, Continuous(Years) | Tezepelumab 210mg Q4W | Placebo | Total |
|---|---|---|---|
| Mean | 49.9 ± 16.3 | 49.0 ± 15.9 | 49.5 ± 16.1 |
| Sex: Female, Male(Participants) | Tezepelumab 210mg Q4W | Placebo | Total |
|---|---|---|---|
| Female | 335 | 337 | 672 |
| Male | 193 | 194 | 387 |
| Race/Ethnicity, Customized(Participants) | Tezepelumab 210mg Q4W | Placebo | Total |
|---|---|---|---|
| White | 332 | 327 | 659 |
| Black of African American | 30 | 31 | 61 |
| Asian | 146 | 149 | 295 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| American Indian or Alaska Native | 0 | 1 | 1 |
| Other | 19 | 23 | 42 |
| Race/Ethnicity, Customized(Participants) | Tezepelumab 210mg Q4W | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 83 | 81 | 164 |
| Not Hispanic or Latino | 445 | 450 | 895 |
Showing the first 100 of 289 sites across 18 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
Ran from Nov 2017 to primary completion in Sep 2020, 33 months.
Results were first posted in Nov 2021, 1 year 2 months after primary completion.
Of 173 industry-sponsored phase 3 interventional studies under Asthma, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 41. This study's 33 months is above that.
Counting every sponsor, half of 205 studies reached it within 27 months; a quarter within 14 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tezepelumab