Asthma study: Tezepelumab
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 injectable medicine being studied as a potential treatment for severe uncontrolled asthma in children. It is designed to block thymic stromal lymphopoietin (TSLP), a protein that helps trigger airway inflammation.
Also referred to as MEDI9929, 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
- The study aims to find out if tezepelumab is safe and helps control severe asthma better than a placebo (a fake treatment).
- Who it's for
- The study is looking for children between 5 and 11 years old who have severe asthma that is not well controlled by their current daily inhalers.
- What's involved
- Participants will receive either the new medicine or a placebo, along with their usual asthma treatments, and will have regular check-ups and tests to monitor their health.
- Time commitment
- The study involves regular visits over a set period to track how the child’s asthma responds to the treatment.
- 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
- 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.
- 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 is enrolling
- Montgomery, Alabama, United States
- Phoenix, Arizona, United States
- Long Beach, California, United States
- San Diego, California, United States
- Atlanta, Georgia, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Northfield, New Jersey, United States
- Hawthorne, New York, United States
- Staten Island, New York, United States
- Chapel Hill, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Toledo, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Buenos Aires, Argentina
+ 88 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Montgomery, Alabama, United States; Phoenix, Arizona, United States; Long Beach, California, United States; San Diego, California, United States; Atlanta, Georgia, United States; Baltimore, Maryland, United States and 102 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.