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Clinical Trials in the UK / NCT06023589
Recruiting Phase 3

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

NCT06023589 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2023-08-24
Last updated
2026-09-11

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

TezepelumabPlacebo

Tezepelumab: Participants will be receiving subcutaneous injection of tezepelumab

Placebo: Participants will be receiving subcutaneous injection of matching placebo

Study summary

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.

Eligibility

Sex
ALL
Min age
5 Years
Max age
11 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (147)

FacilityCityRegionStatus
Research Site Montgomery Alabama Recruiting
Research Site Phoenix Arizona Recruiting
Research Site Little Rock Arkansas Withdrawn
Research Site La Jolla California Recruiting
Research Site Long Beach California Recruiting
Research Site Orange California Withdrawn
Research Site San Diego California Recruiting
Research Site Atlanta Georgia Recruiting
Research Site Savannah Georgia Terminated
Research Site Baltimore Maryland Recruiting
Research Site Boston Massachusetts Recruiting
Research Site Boston Massachusetts Recruiting
Research Site Ann Arbor Michigan Terminated
Research Site Detroit Michigan Recruiting
Research Site Northfield New Jersey Recruiting
Research Site Hawthorne New York Recruiting
Research Site Schenectady New York Withdrawn
Research Site Staten Island New York Recruiting
Research Site Chapel Hill North Carolina Recruiting
Research Site Cincinnati Ohio Recruiting
Research Site Cleveland Ohio Recruiting
Research Site Toledo Ohio Recruiting
Research Site Oklahoma City Oklahoma Recruiting
Research Site Columbia South Carolina Withdrawn
Research Site Coppell Texas Terminated
Research Site Dallas Texas Recruiting
Research Site Frisco Texas Withdrawn
Research Site Houston Texas Recruiting
Research Site San Antonio Texas Recruiting
Research Site Temple Texas Withdrawn
Research Site Buenos Aires Argentina Recruiting
Research Site Buenos Aires Argentina Recruiting
Research Site Buenos Aires Argentina Recruiting
Research Site CABA Argentina Terminated
Research Site Florida Argentina Recruiting
Research Site Lanus Argentina Recruiting
Research Site Lobos Argentina Recruiting
Research Site Mendoza Argentina Recruiting
Research Site Quilmes Argentina Terminated
Research Site Rosario Argentina Recruiting

+ 107 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06023589 on ClinicalTrials.gov ↗ ← All trials in the UK