BridgeMD
A study to investigate the efficacy and safety of tezepelumab compared with placebo in children 5 to < 12 years old with severe asthma
EU CTIS ID: 2022-502984-39-00
What this study is testing
To assess the effect of tezepelumab on severe asthma exacerbations in children 5 - < 12 years old with severe uncontrolled asthma compared with placebo.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
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 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.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Philippines
- United States
- Turkey
- South Africa
- Ukraine
- Argentina
- United Kingdom
- Brazil
- Thailand
- Japan
- Mexico
- China
- Korea, Republic of
- Canada
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 - 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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philippines; United States; Turkey; South Africa; Ukraine; Argentina and 8 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 EU CTIS; the study team decides eligibility.