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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
Where Is This Study? (8 UK sites)
Research Site
Birmingham B4 6NH, United Kingdom
Research Site
Bradford BD9 6RJ, United Kingdom
Research Site
Bristol BS2 8BJ, United Kingdom
Research Site
Glasgow G3 8SJ, United Kingdom
Research Site
Leicester LE1 5WW, United Kingdom
Research Site
London SE5 9RS, United Kingdom
Research Site
Nottingham NG7 2UH, United Kingdom
Research Site
Stoke-on-Trent ST4 6QG, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
