Tests tezepelumab against placebo in children with severe asthma
Tests tezepelumab against a placebo in children aged 5 to 11 with severe asthma.
Plain-language title generated from the registry record
Registry title: A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
Key facts
- Where
- Debrecen, Szeged, and Szigetvár, HungarySee the 3 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children aged 5 to under 12 with severe asthma that is not under control despite regular asthma medicines.
- Age
- 5 to under 12 years
- Sex
- Boys and girls
- Disease stage
- Severe uncontrolled asthma, diagnosed by a doctor for at least 6 months, with at least 2 severe asthma attacks (or 1 that needed hospital care) in the past 12 months.
- Earlier treatment
- Must have taken a medium or high dose of inhaled corticosteroid for at least 3 months, plus at least one other daily asthma controller medicine for at least 3 months. Doses must be stable for at least 1 month.
- Biomarker or test result
- Lung tests showing asthma, such as FEV1 improving by at least 10% after a reliever medicine, or FeNO of 20 ppb or more. Body weight at least 16 kg (35 lb).
Main reasons for not taking part
- Vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyps
- Another serious illness that could put the child at risk or affect the results
- Asthma worsening or attack needing steroid tablets or injections within 30 days before the first visit
- Change in inhaled corticosteroid dose within 1 month before the first visit
- Past life-threatening asthma attack with a hypoxic seizure or a breathing tube
Read by machine on 11 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 5 and 11 years old?
Source: NCT06023589, who can take part
Where in Hungary
- DebrecenHospital not named in the registryNo longer taking part
- SzegedHospital not named in the registryTaking people
- SzigetvárHospital not named in the registryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06023589
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
A Multicentre, Randomised, Double-Blind, Parallel-Group Placebo-Controlled, Phase 3, Efficacy and Safety Study of Tezepelumab in 5 to < 12 Year Old Children With Severe Uncontrolled Asthma (HORIZON)
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.
Inclusion: 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; 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; 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 months with stable dose ≥ 1 month prior to Visit 1; 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; Supportive evidence of asthma as documented by one of the following:; 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:; Post-BD responsiveness of FEV1 ≥ 10%; Positive methacholine challenge defined as provocative concentration (PC20) of ≤ 16 mg/mL; PEF average daily diurnal variability > 13% over a 2-week period; Variability of FEV1 ≥ 12% between any two clinical visits; Positive exercise challenge test (defined as a fall in FEV1 of > 12%); FeNO ≥ 20 ppb despite confirmed ICS maintenance therapy; 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; Pre-BD FEV1 >50% and ≤ 95%PN OR FEV1/forced vital capacity (FVC) ratio ≤ 0.85 at either Visit 1 or Visit 2; Evidence of uncontrolled asthma, with at least 1 of the below criteria:; 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; 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; Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening/Run-in period; Asthma symptoms 3 or more days per week in at least 1 week during the Screening/Run-in period; Body weight ≥ 16 kg at Visit 1 (Screening) and Visit 3 (Randomisation).
Exclusion: 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; Change in ICS dose within 1 month prior to Visit 1; History of vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyposis; 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; History of a life-threatening asthma exacerbation resulting in a hypoxic seizure or requiring intubation.