A Phase 3 interventional study of Tezepelumab and Placebo in Asthma, sponsored by AstraZeneca. Completed at 60 sites in 7 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-12-09.
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 is the 13th largest by enrollment, is one of 2 that started in 2018, is one of 16 in phase 3, and was the 6th 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: 18 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. 2 started in 2018.
This study's enrollment of 150 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 130th largest by enrollment of the 248 interventional ones that give a count, is one of 8 that started in 2018, is one of 121 in phase 3, and was the 234th 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.
Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma
A Multicentre, Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma
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:
Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
Affect the safety of the subject throughout the study Influence the findings of the study or the interpretation Impede the subject's ability to complete the entire duration of study
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tezepelumab subcutaneous injection
Biological: Tezepelumab
Placebo subcutaneous injection
Other: Placebo
Tezepelumab subcutaneous injection
Placebo subcutaneous injection
Categorized Percent Reduction From Baseline in the Daily OCS Dose While Not Losing Asthma Control
Categorized percent reduction from baseline at Week 48. 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.
Time frame: Baseline to Week 48
Annualised Asthma Exacerbation Rate (AAER)
The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 48 weeks.
Time frame: Baseline to Week 48
Proportion of Subjects With 100% Reduction From Baseline in Daily OCS Dose at Week 48
Proportion (expressed as a percentage) of subjects with 100% reduction from baseline in daily OCS dose at Week 48. Percent change from baseline is defined as {(final dose-baseline dose)/baseline dose}\*100.
Time frame: Baseline to Week 48
Proportion of Subjects With Daily OCS Dose ≤5 mg at Week 48
Proportion (expressed as a percentage) of subjects with daily OCS dose ≤5 mg at Week 48.
Time frame: Week 48
Proportion of Subjects With ≥50% Reduction From Baseline in Daily OCS Dose at Week 48
Proportion (expressed as a percentage) of subjects with ≥50% reduction from baseline in daily OCS dose at Week 48. Percent change from baseline is defined as {(final dose-baseline dose)/baseline dose}\*100.
Time frame: Baseline to Week 48
Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1)
Change from baseline in pre-BD FEV1 at Week 48. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
Time frame: Baseline to Week 48
Change From Baseline in Weekly Mean Daily Asthma Symptom Score Via the Daily Asthma Symptom Diary
Change from baseline in Asthma Symptom Diary score at Week 48. 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: Baseline to Week 48
Change From Baseline in Weekly Mean Rescue Medication Use
Change from baseline in weekly mean rescue medication use at Week 48. 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 \[number of day nebulizer times\]. Each timepoint is calculated as weekly means based on daily diary data.
Time frame: Baseline to Week 48
Change From Baseline in Weekly Mean Home Peak Expiratory Flow (PEF) (Morning and Evening)
Change from baseline in weekly mean morning and evening peak expiratory flow (PEF) at Week 48. 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 means using at least 4 of the 7 days of PEF data.
Time frame: Baseline to Week 48
Change From Baseline in Weekly Mean Number of Night-time Awakening Due to Asthma
Change from baseline in weekly mean number (expressed as a percentage) of night time awakenings at Week 48. 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: Baseline to Week 48
Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score
Change from baseline in ACQ-6 at Week 48. 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: Baseline to Week 48
Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(s)+12) Total Score
Change from baseline in AQLQ(S)+12 as compared to placebo at Week 48. 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: Baseline to Week 48
Change From Baseline in European Quality of Life - 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) Score
Change from baseline in EQ-5D-5L at Week 48. The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no/slight/moderate/severe/extreme problems) that reflect increasing levels of difficulty. The EQ-5D-5L scores are converted into a single index-based value (Health State Valuation), using the UK population-based weights. The Helth State Valuation is scored between 0 to 1, where higher score indicates a better health state.
Time frame: Baseline to Week 48
Number of Participants With Asthma Specific Resource Utilizations
Number of participants with asthma specific resource utilizations (e.g. unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) over 48 weeks.
Time frame: Baseline to Week 48
Change From Baseline in Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questionnaire (WPAI+CIQ) Score
Change from baseline in WPAI+CIQ score at Week 48. The WPAI+CIQ consists of 10 questions about how asthma and asthma related issues impact a subject's ability to work, attend classes, and perform regular daily activities. Work (Class) productivity loss is derived by sum of percentage of missed work (class hours) due to asthma and product of percentage of actual working hours (class) times degree of asthma affecting work (class) productivity while working. Percentage of missed work (class hours) due to asthma is calculated by number of hours missed work (class) due to asthma divided by total number of hours missed work (class) plus number of hours actually worked (in class). 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: Baseline to Week 48
Change From Baseline in FENO
Change from baseline in fractional exhaled nitric oxide (FeNO) at week 48.
Time frame: Baseline to Week 48
Change From Baseline in Peripheral Blood Eosinophils
Change from baseline in blood eosinophil counts at week 48.
Time frame: Baseline to Week 48
Change From Baseline From Total Serum IgE
Change from baseline in total serum IgE at week 48.
Time frame: Baseline to Week 48
PK: Serum Trough Concentrations
Serum trough concentrations at each scheduled visit.
Time frame: Pre-dose samples at Baseline, Week 4, Week 12, Week 24, Week 40, Week 48, Week 60
Immunogenicity: Incidence of Anti-drug Antibodies (ADA)
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 to Week 60
The study was conducted at 60 centres in 7 countries. A total of 243 subjects were screened between 5MAR2018 and 27SEP2019, of which 150 were randomized and treated. 93 subjects were screen failures mainly due to exclusion criteria met and/or inclusion criteria not met. Assignment was done by Interactive Voice/Web Response System(IVRS/IWRS).
| Milestone | Tezepelumab | Placebo |
|---|---|---|
| Started | 74 | 76 |
| Completed | 68 | 73 |
| Not completed | 6 | 3 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Withdrawal by subject | 5 | 2 |
Categorized percent reduction from baseline at Week 48. 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.
| Participants | Tezepelumab | Placebo |
|---|---|---|
| >=90% to <=100% reduction | 40 | 35 |
| >=75% to <90% reduction | 5 | 4 |
| >=50% to <75% reduction | 10 | 14 |
| >0% to <50% reduction | 5 | 9 |
| no change or any increase | 14 | 14 |
The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 48 weeks.
| Events per year | Tezepelumab | Placebo |
|---|---|---|
| Annualised Asthma Exacerbation Rate (AAER) | 1.38 (0.98 to 1.95) | 2.00 (1.46 to 2.74) |
Proportion (expressed as a percentage) of subjects with 100% reduction from baseline in daily OCS dose at Week 48. Percent change from baseline is defined as {(final dose-baseline dose)/baseline dose}\*100.
| Percentage of participants | Tezepelumab | Placebo |
|---|---|---|
| Proportion of Subjects With 100% Reduction From Baseline in Daily OCS Dose at Week 48 | 54.1 | 46.1 |
Proportion (expressed as a percentage) of subjects with daily OCS dose ≤5 mg at Week 48.
| Percentage of participants | Tezepelumab | Placebo |
|---|---|---|
| Proportion of Subjects With Daily OCS Dose ≤5 mg at Week 48 | 71.6 | 72.4 |
Proportion (expressed as a percentage) of subjects with ≥50% reduction from baseline in daily OCS dose at Week 48. Percent change from baseline is defined as {(final dose-baseline dose)/baseline dose}\*100.
| Percentage of participants | Tezepelumab | Placebo |
|---|---|---|
| Proportion of Subjects With ≥50% Reduction From Baseline in Daily OCS Dose at Week 48 | 74.3 | 69.7 |
Change from baseline in pre-BD FEV1 at Week 48. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
| Litre | Tezepelumab | Placebo |
|---|---|---|
| Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) | 0.21 ± 0.046 | -0.04 ± 0.046 |
Change from baseline in Asthma Symptom Diary score at Week 48. 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.
| Score on a scale | Tezepelumab | Placebo |
|---|---|---|
| Change From Baseline in Weekly Mean Daily Asthma Symptom Score Via the Daily Asthma Symptom Diary | -0.36 ± 0.071 | -0.26 ± 0.068 |
Change from baseline in weekly mean rescue medication use at Week 48. 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 \[number of day nebulizer times\]. Each timepoint is calculated as weekly means based on daily diary data.
| Weekly mean rescue medication use | Tezepelumab | Placebo |
|---|---|---|
| Change From Baseline in Weekly Mean Rescue Medication Use | -0.85 ± 0.280 | -0.37 ± 0.268 |
Change from baseline in weekly mean morning and evening peak expiratory flow (PEF) at Week 48. 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 means using at least 4 of the 7 days of PEF data.
| L/min | Tezepelumab | Placebo |
|---|---|---|
| morning PEF | 13.29 ± 5.653 | -9.71 ± 5.435 |
| evening PEF | 10.05 ± 5.980 | -11.37 ± 5.749 |
Change from baseline in weekly mean number (expressed as a percentage) of night time awakenings at Week 48. 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 | Placebo |
|---|---|---|
| Change From Baseline in Weekly Mean Number of Night-time Awakening Due to Asthma | -15.71 ± 3.482 | -12.79 ± 3.317 |
Change from baseline in ACQ-6 at Week 48. 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.
| Score on a scale | Tezepelumab | Placebo |
|---|---|---|
| Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score | -0.87 ± 0.125 | -0.51 ± 0.123 |
Change from baseline in AQLQ(S)+12 as compared to placebo at Week 48. 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).
| Score on a scale | Tezepelumab | Placebo |
|---|---|---|
| Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(s)+12) Total Score | 0.94 ± 0.124 | 0.58 ± 0.123 |
Change from baseline in EQ-5D-5L at Week 48. The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no/slight/moderate/severe/extreme problems) that reflect increasing levels of difficulty. The EQ-5D-5L scores are converted into a single index-based value (Health State Valuation), using the UK population-based weights. The Helth State Valuation is scored between 0 to 1, where higher score indicates a better health state.
| Score on a scale | Tezepelumab | Placebo |
|---|---|---|
| Change From Baseline in European Quality of Life - 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) Score | 0.07 ± 0.026 | 0.00 ± 0.027 |
Number of participants with asthma specific resource utilizations (e.g. unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) over 48 weeks.
| Participants | Tezepelumab | Placebo |
|---|---|---|
| Hospitalisation | 5 | 10 |
| Emergency room visit | 4 | 7 |
| Unscheduled visit to specialist | 29 | 41 |
| Home visit | 1 | 2 |
| Telephone call | 26 | 43 |
| Ambulance transport | 0 | 1 |
Change from baseline in WPAI+CIQ score at Week 48. The WPAI+CIQ consists of 10 questions about how asthma and asthma related issues impact a subject's ability to work, attend classes, and perform regular daily activities. Work (Class) productivity loss is derived by sum of percentage of missed work (class hours) due to asthma and product of percentage of actual working hours (class) times degree of asthma affecting work (class) productivity while working. Percentage of missed work (class hours) due to asthma is calculated by number of hours missed work (class) due to asthma divided by total number of hours missed work (class) plus number of hours actually worked (in class). 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 | Tezepelumab | Placebo |
|---|---|---|
| Work productivity loss | -6.27 ± 25.30 | -9.66 ± 36.63 |
| Class productivity loss | -10.00 ± 0 | — |
| Activity impairment | -13.2 ± 29.3 | -7.8 ± 26.4 |
Change from baseline in fractional exhaled nitric oxide (FeNO) at week 48.
| ppb | Tezepelumab | Placebo |
|---|---|---|
| Change From Baseline in FENO | -11.71 ± 2.757 | -1.40 ± 2.774 |
Change from baseline in blood eosinophil counts at week 48.
| cells/μL | Tezepelumab | Placebo |
|---|---|---|
| Change From Baseline in Peripheral Blood Eosinophils | -83.79 ± 17.078 | 33.38 ± 16.605 |
Change from baseline in total serum IgE at week 48.
| IU/mL | Tezepelumab | Placebo |
|---|---|---|
| Change From Baseline From Total Serum IgE | -80.66 ± 36.253 | 37.77 ± 35.621 |
Serum trough concentrations at each scheduled visit.
| μg/mL | Tezepelumab | Placebo |
|---|---|---|
| Baseline | 0 ± 0 | — |
| Week 4 | 10.3298 ± 42.31 | — |
| Week 12 | 17.9626 ± 57.85 | — |
| Week 24 | 18.9210 ± 55.83 | — |
| Week 40 | 16.7095 ± 181.44 | — |
| Week 48 | 13.9224 ± 352.35 | — |
| Week 60 | 3.5591 ± 177.36 | — |
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 | Placebo |
|---|---|---|
| ADA positive at baseline and/or post-baseline (ADA prevalence) | 3 | 2 |
| Any baseline ADA positive | 2 | 2 |
| Only baseline ADA positive | 1 | 1 |
| Any post-baseline ADA positive | 2 | 1 |
| Both baseline and at least one post-baseline ADA positive | 1 | 1 |
| Treatment-induced ADA positive | 1 | 0 |
| Treatment-boosted ADA positive | 0 | 0 |
| TE-ADA positive (ADA incidence) | 1 | 0 |
| ADA persistently positive | 1 | 1 |
| ADA transiently positive | 1 | 0 |
Collected over Baseline to Week 60. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tezepelumab | 1/74 (1.4%) | 12/74 (16.2%) | 35/74 (47.3%) |
| Placebo | 0/76 (0%) | 16/76 (21.1%) | 48/76 (63.2%) |
| Event | Tezepelumab | Placebo |
|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 4/74 | 8/76 |
| PneumoniaInfections and infestations | 1/74 | 2/76 |
| Cardiac arrestCardiac disorders | 1/74 | 0/76 |
| Cardiac failureCardiac disorders | 1/74 | 0/76 |
| Supraventricular tachycardiaCardiac disorders | 1/74 | 0/76 |
| Inguinal herniaGastrointestinal disorders | 1/74 | 0/76 |
| Intervertebral discitisInfections and infestations | 1/74 | 0/76 |
| Septic shockInfections and infestations | 1/74 | 0/76 |
| Incisional herniaInjury, poisoning and procedural complications | 1/74 | 0/76 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/74 | 0/76 |
| Event | Tezepelumab | Placebo |
|---|---|---|
| NasopharyngitisInfections and infestations | 12/74 | 19/76 |
| Upper respiratory tract infectionInfections and infestations | 9/74 | 8/76 |
| HeadacheNervous system disorders | 3/74 | 8/76 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 6/74 | 8/76 |
| Bronchitis bacterialInfections and infestations | 6/74 | 7/76 |
| HypertensionVascular disorders | 2/74 | 6/76 |
| Influenza like illnessGeneral disorders | 0/74 | 5/76 |
| SinusitisInfections and infestations | 1/74 | 5/76 |
| BronchitisInfections and infestations | 4/74 | 3/76 |
| Oral candidiasisInfections and infestations | 4/74 | 4/76 |
| Age, Continuous(years) | Tezepelumab | Placebo | Total |
|---|---|---|---|
| Mean | 53.5 ± 12.1 | 53.4 ± 11.9 | 53.4 ± 12.0 |
| Sex: Female, Male(Participants) | Tezepelumab | Placebo | Total |
|---|---|---|---|
| Female | 49 | 45 | 94 |
| Male | 25 | 31 | 56 |
| Race/Ethnicity, Customized(Participants) | Tezepelumab | Placebo | Total |
|---|---|---|---|
| White | 62 | 64 | 126 |
| Black or African American | 1 | 0 | 1 |
| Asian | 11 | 11 | 22 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| American Indian or Alaska Native | 0 | 0 | 0 |
| Other | 0 | 1 | 1 |
| Race/Ethnicity, Customized(Participants) | Tezepelumab | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 14 | 24 |
| Not Hispanic or Latino | 64 | 62 | 126 |
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 refer 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 Mar 2018 to primary completion in Sep 2020, 30 months.
Results were first posted in Dec 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 30 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 Nov 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tezepelumab