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Compares treatment options for Asthma
Official title A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
ClinicalTrials.gov ID: NCT06023589
What this study is testing
What is Tezepelumab?
Tezepelumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for asthma.
Also referred to as MEDI9929 and AMG157.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 11
You may be able to join if
- Written informed consent from (ICF) at least one parent/caregiver (as per local guidelines) and accompanying informed assent from the participant...
- 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...
- 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...
- Documented treatment with at least one additional maintenance asthma controller medication is required according to local guidelines and standard of...
You likely can't join if
- 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...
- History of a clinically significant deterioration in asthma or asthma exacerbation including those requiring use of systemic corticosteroids or...
- 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 eligibility criteria
- 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...
- 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...
- 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...
- 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).
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Montgomery, Alabama, United States
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- La Jolla, California, United States
- Long Beach, California, United States
- Orange, California, United States
- San Diego, California, United States
- Atlanta, Georgia, United States
- Savannah, Georgia, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Northfield, New Jersey, United States
- Hawthorne, New York, United States
- Schenectady, New York, United States
- Staten Island, New York, United States
- Chapel Hill, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
+ 107 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montgomery, Alabama, United States; Phoenix, Arizona, United States; Little Rock, Arkansas, United States; La Jolla, California, United States; Long Beach, California, United States; Orange, California, United States and 121 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.