A study to investigate the efficacy and safety of tezepelumab compared with placebo in children 5 to < 12 years old with severe asthma

Trial details

Who runs it

AstraZeneca AB

Trial code

EU 2022-502984-39-00

Record updated

2026. augusztus 17.

Original description

To assess the effect of tezepelumab on severe asthma exacerbations in children 5 - < 12 years old with severe uncontrolled asthma compared with placebo.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 effect of tezepelumab on severe asthma exacerbations in children 5 - < 12 years old with severe uncontrolled asthma compared with placebo.

Inclusion: Documented physician-prescribed treatment with a total daily dose of either medium or high dose ICS, and additional asthma controller medication (i.e., long-acting β2 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: (a) 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: (b) Post-BD responsiveness of FEV1 ≥ 10%. (c) Positive methacholine challenge defined as provocative concentration (PC20) of ≤ 16 mg/mL. (d) PEF average daily diurnal variability > 13% over a 2-week period. (e) Variability of FEV1 ≥ 12% between any two clinical visits. (f) Positive exercise challenge test (defined as a fall in FEV1 of > 12%). (g) FeNO ≥ 20 ppb despite confirmed ICS maintenance therapy; History of at least 2 severe asthma exacerbation events resulting in treatment with a systemic corticosteroid (oral or parenteral) OR 1 severe asthma exacerbation event resulting in hospitalization within 12 months prior to Visit 1; Pre-BD FEV1 >50% and ≤ 95%PN OR FEV1/FVC ratio ≤ 0.85 at either Visit 1 or Visit 2; Evidence of uncontrolled asthma, with at least 1 of the below criteria: (a) ACQ-IA score ≥ 1.5 at least once during Screening/Run-in, including Visit 3 (prior to Randomisation) for participants ≥ 6years old at Screening (b) 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 (c) Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening/Run-in period (d) 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); 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.

Exclusion: 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.

EU CTIS 2022-502984-39-00