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Looking for participantsPhase3

A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma

Sponsor: AstraZeneca

NCT ID: NCT06023589

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Tezepelumab (biological), Placebo (other)
How long the study runs
Study runs about 84 months (dates as stated)
About the drug or intervention
Tezepelumab — biological: Participants will be receiving subcutaneous injection of tezepelumab · Placebo — other: Participants will be receiving subcutaneous injection of matching placebo
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
5 Years to 11 Years
Who
All
Number of participants
231
Started
2023-08-24
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for asthma
  • • Phase3 - 231 participants
  • • 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

Who can take part?

  • • Ages 5 Years to 11 Years
  • • Diagnosed with asthma

Where?

  • • Birmingham - Research Site
  • • Bradford - Research Site
  • • Bristol - Research Site
  • • Glasgow - Research Site
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

This is a phase-3 multicentre, double-blind, parallel-group placebo-controlled, randomised study. The study will comprise of: 1. Screening/Run-in period of 4 to 6 weeks, 2. 52-week double-blind Treatment period, 3. Post-treatment Follow-up period of 12 weeks. 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.

Asthma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 5 Years - 11 Years
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ according to local guidelines and standard of care

What the study is looking for

  • ✓Participants must be 5 to \< 12 years of age, at the time of signing the assent form (as applicable per local...
  • ✓Documented physician diagnosis of severe asthma confirmed and evaluated for at least 6 months prior to Visit 1.
  • ✓Documented physician-prescribed treatment with a total daily dose of either medium or high dose, for at least 3...
  • ✓Supportive evidence of asthma as documented by one of the following:
  • ✓If (a) is not achieved at Visit 1 or Visit 2, historical documentation by any of the below prior to Visit 1:

Who cannot take part

  • ✗History of vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal...
  • ✗Change in ICS dose within 1 month prior to Visit 1.
  • ✗History of a life-threatening asthma exacerbation resulting in a hypoxic seizure or requiring intubation.
See the full criteria
Inclusion Criteria: 1. Written informed consent from (ICF) at least one parent/caregiver (as per local guidelines) and accompanying informed assent from the participant (where the participant is able to provide assent) prior to admission to the study. 2. Participants must be 5 to \< 12 years of age, at the time of signing the assent form (as applicable per local guidelines) and their caregivers signing the ICF and at Visit 3. 3. Documented physician diagnosis of severe asthma confirmed and evaluated for at least 6 months prior to Visit 1. 4. Documented physician-prescribed treatment with a total daily dose of either medium or high dose, for at least 3 months with stable dose ≥ 1 month prior to Visit 1. 5. Documented treatment with at least one additional maintenance asthma controller medication is required according to local guidelines and standard of care; (long-acting beta agonist, leukotriene receptor antagonist, long-acting muscarinic antagonist) for at least 3 months with stable dose ≥ 1 month prior to Visit 1. 6. Supportive evidence of asthma as documented by one of the following: 1. Post-BD (albuterol/salbutamol) responsiveness of FEV1 ≥ 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: 2. Post-BD responsiveness of FEV1 ≥ 10%. 3. Positive methacholine challenge defined as provocative concentration (PC20) of ≤ 16 mg/mL. 4. PEF average daily diurnal variability \> 13% over a 2-week period. 5. Variability of FEV1 ≥ 12% between any two clinical visits. 6. Positive exercise challenge test (defined as a fall in FEV1 of \> 12%). 7. FeNO ≥ 20 ppb despite confirmed ICS maintenance therapy. 7. History of at least 2 severe asthma exacerbation events OR 1 severe asthma exacerbation event resulting in hospitalisation within 12 months prior to Visit 1. 8. Pre-BD FEV1 \>50% and ≤ 95%PN OR FEV1/forced vital capacity (FVC) ratio ≤ 0.85 at either Visit 1 or Visit 2. 9. Evidence of uncontrolled asthma, with at least 1 of the below criteria: 1. ACQ-IA score ≥ 1.5 at least once during Screening/Run-in, including Visit 3 (prior to Randomisation) for participants ≥ 6 years old at Screening. 2. Use of reliever medication, other than as a preventive for exercise induced bronchospasm, on 3 or more days per week for at least 1 week during the Screening/Run-in period. 3. Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening/Run-in period. 4. Asthma symptoms 3 or more days per week in at least 1 week during the Screening/Run-in period. 10. Body weight ≥ 16 kg at Visit 1 (Screening) and Visit 3 (Randomisation). Exclusion Criteria: 1. History of vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyposis. 2. History of any clinically significant disease or disorder other than asthma which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study. 3. History of a clinically significant deterioration in asthma or asthma exacerbation including those requiring use of systemic corticosteroids or increase in the maintenance dose of oral corticosteroids within 30 days prior to Visit 1. 4. Change in ICS dose within 1 month prior to Visit 1. 5. History of a life-threatening asthma exacerbation resulting in a hypoxic seizure or requiring intubation.

Where Is This Study? (8 UK sites)

Research Site

Birmingham B4 6NH, United Kingdom

Recruiting

Research Site

Bradford BD9 6RJ, United Kingdom

Recruiting

Research Site

Bristol BS2 8BJ, United Kingdom

Recruiting

Research Site

Glasgow G3 8SJ, United Kingdom

WITHDRAWN

Research Site

Leicester LE1 5WW, United Kingdom

Recruiting

Research Site

London SE5 9RS, United Kingdom

Recruiting

Research Site

Nottingham NG7 2UH, United Kingdom

Recruiting

Research Site

Stoke-on-Trent ST4 6QG, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10