Last updated 9 days ago
A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
231 patients around the world
Available in Spain, Colombia, United States, Mexico, Argentina
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.
AstraZeneca
7Research sites
231Patients around the world
This study is for people with
Asthma
Childhood asthma
Requirements for the patient
To 11 Years
All Gender
Medical requirements
- 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 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.Evidence of asthma as documented by one of the following:Documented historical BD responsiveness of FEV1 ≥ 10% in the previous 12 months prior to Visit 1 ORDocumented historical methacholine challenge result of ≤ 16 mg/mL in the previous 12 months prior to Visit 1 ORPost-BD (albuterol/salbutamol) responsiveness of FEV1 ≥ 10% during Screening (15 to 30 min after administration of 4 puffs of albuterol/salbutamol) at either Visit 1 or Visit 2.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 FEV-1 >50% and ≤ 95%PN OR FEV1/forced vital capacity (FVC) ratio ≤ 0.8 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 ScreeningUse 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 periodSleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening/Run-in periodAsthma symptoms 3 or more days per week in at least 1 week during the Screening/Run-in periodBody weight ≥ 16 kg at Visit 1 (Screening) and Visit 3 (Randomisation).
- History of 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 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 a life-threatening asthma exacerbation resulting in a hypoxic seizure or requiring intubation or mechanical ventilation.
Sites
CEMLO Centro de Especialidades Médicas Lobos
Recruiting
Centro Respiratorio Quilmes - Buenos Aires
Recruiting
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Centro de Investigaciones Médicas Lanús - Buenos Aires
Recruiting
Fundación CIDEA - Buenos Aires
Recruiting
CEMER Centro Médico de Enfermedades Respiratorias - Vicente Lopez
Recruiting
Instituto INSARES - Mendoza
Recruiting
StudyHORIZON
SponsorAstraZeneca
Study typeInterventional
Conditions
Childhood asthma
Requirements
To 11 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06023589
