A Phase 3 interventional study of Tezepelumab and Placebo in Asthma, sponsored by AstraZeneca. Recruiting at 147 sites in 22 countries. Open to participants aged 5 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.
This is a phase-3 multicentre, double-blind, parallel-group placebo-controlled, randomised study.
The study will comprise of:
Participants will be randomised 2:1 to receive either tezepelumab or placebo administered by (SC) Subcutaneous injections for 52 weeks (double-blind Treatment period).
There will then be a 12-week off-treatment Follow-up period for participants who do not continue in the optional open-label Active Treatment Extension period.
An optional open-label Active Treatment Extension will allow all eligible participants the opportunity to receive active treatment with tezepelumab. The Active Treatment Extension period of the study will start following the 52-week double-blind Treatment period and will consist of a 104-week open-label Treatment period prior to the 12-week post-treatment Follow-up period.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 231 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Supportive evidence of asthma as documented by one of the following:
Post-BD (albuterol/salbutamol) responsiveness of ≥ 10% during Screening (15 to 30 min after administration of 4 puffs of albuterol/salbutamol with a maximum of 12 puffs of reliever medication only if tolerated by the participant) at either Visit 1 or Visit 2.
If (a) is not achieved at Visit 1 or Visit 2, historical documentation by any of the below prior to Visit 1:
Evidence of uncontrolled asthma, with at least 1 of the below criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Participants will be receiving tezepelumab subcutaneous injection
Biological: Tezepelumab
Participants will be receiving placebo through a subcutaneous injection
Other: Placebo
Participants will be receiving subcutaneous injection of tezepelumab
Also known as: MEDI9929 and AMG157
Participants will be receiving subcutaneous injection of matching placebo
Annualized severe asthma exacerbation rate (AAER)
To assess the effect of tezepelumab on severe asthma exacerbations in children 5 to \< 12 years old with severe uncontrolled asthma compared with placebo.
Time frame: From Baseline to Week 52
Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) percent predicted normal (PN)
To assess the effect of tezepelumab on pulmonary function (FEV1) in children with severe uncontrolled asthma compared with placebo. Pre-bronchodilator FEV1% PN will be determined by spirometry at the clinic visit.
Time frame: From Baseline to Week 52
AAER associated with allergic asthma
AAER will be assessed in association with both allergic asthma (defined by a positive perennial allergen using serum specific IgE \[FEIA\]).
Time frame: From Baseline to Week 52
Time to first severe asthma exacerbation
Time to first severe asthma exacerbation will be assessed.
Time frame: From Baseline to Week 52
Proportion of participants with ≥ 1 severe asthma exacerbation
Proportion of participants with ≥ 1 severe asthma exacerbation will be assessed.
Time frame: From Baseline to Week 52
AAER associated with ER visit or hospitalisation
AAER will be assessed in association with ER visits or hospitalisations.
Time frame: From Baseline to Week 52
Cumulative exposure to systemic corticosteroids for treatment of severe asthma exacerbations
Cumulative exposure to systemic corticosteroids for treatment of severe asthma exacerbations over the 52 week double-blind treatment period
Time frame: From Baseline to Week 52
Change from baseline in Paediatric Asthma Quality of Life Questionnaire (PAQLQ-(S)-IA) total score
Change from baseline of PAQLQ-(S)-IA total score will be assessed. The PAQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with asthma. The PAQLQ-(S)-IA has 23 questions in 3 domains (symptoms, activity limitation, and emotional function). Participants are asked to think about how they have been during the previous week and respond to each question on a 7-point scale (1 = extremely bothered to 7 = not bothered at all or 1 = all of the time to 7 = none of the time). There are 2 coloured cards (green and blue), which list sets of response options appropriate to different questions. The appropriate card should be used by the participant during completion of each question and then taken back when it is no longer required. The overall PAQLQ-(S)-IA score is the mean of all 23 responses, and the individual domain scores are the means of the items in those domains.
Time frame: From Baseline to Week 52
Change from baseline in weekly mean daily Paediatric Asthma Symptom Observer (PASO) score
Change from baseline in PASO score will be assessed. The PASO questionnaire will be completed by the caregiver each day from the evening of Treatment period. Caregivers in this study will complete 4 items from the morning assessment capturing night-time asthma symptoms, rescue medication use, night-time awakenings, and maintenance asthma medication use. The evening assessment will capture daytime asthma symptoms, rescue medication use, activity limitation and change in asthma.
Time frame: From Baseline to Week 52
Change from baseline in Asthma Control Questionnaire - Interviewer Administered (ACQ-IA) score
Change from baseline in ACQ-IA score will be assessed. The ACQ-IA will only be completed for participants ≥ 6 years old at Screening. The ACQ-IA is administered by trained individuals according to standardised instructions to help the child understand concepts like symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, and wheezing) and use of SABA during the past week using a 7-point scale. The ACQ-IA score is calculated by taking the mean of the 6 equally weighted items and ranges from 0 (well controlled) to 6 (extremely poorly controlled). The estimated minimal clinically important difference is 0.5
Time frame: From Baseline to Week 52
Change from baseline in weekly mean rescue medication use
Change from baseline in weekly mean rescue medication use will be assessed.
Time frame: From Baseline to Week 52
Change from baseline in weekly mean number of night-time awakenings
Change from baseline in weekly mean number of night-time awakenings will be assessed.
Time frame: From Baseline to Week 52
Change from baseline in blood eosinophil count
Change from baseline in blood eosinophil count will be assessed.
Time frame: From Baseline to Week 52
Change from baseline in fractional exhaled nitric oxide (FeNO)
Change from baseline in FeNO will be assessed.
Time frame: From Baseline to Week 52
Change from baseline in total serum IgE
Change from baseline in total serum IgE will be assessed.
Time frame: From Baseline to Week 52
Change from baseline in pre-bronchodilator (pre-BD) peak expiratory flow (PEF)
The effect of tezepelumab on pulmonary function compared with placebo will be assessed using spirometry.
Time frame: From Baseline to Week 52
Number of asthma--related healthcare resource utilization (HRU)
Mean number and type of Asthma specific HRU (eg, unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) will be assessed.
Time frame: From Baseline to Week 52
Number of participant/caregiver health-related absences
Mean number of participant/caregiver health-related absences from work/school due to asthma will be assessed.
Time frame: From Baseline to Week 52
Serum concentrations of tezepelumab
To evaluate the pharmacokinetics of tezepelumab.
Time frame: At Baseline, Week 4, Week 24, and Week 52
Incidence of anti-drug antibodies (ADAs)
To evaluate the immunogenicity of tezepelumab.
Time frame: At Baseline, and from time of first dose at Week 0 to end of study at week 64
Incidence of neutralising antibodies (nAbs)
To evaluate the immunogenicity of tezepelumab.
Time frame: At Baseline, and from time of first dose at Week 0 to end of study at week 64
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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 Vivli.org. All requests 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 approved.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA 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 anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Tezepelumab