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Efficacy and safety of subcutaneous dupilumab in participants with asthma/asthmatic wheeze aged 2 to <6 years
EU CTIS ID: 2023-504331-41-00
What this study is testing
Part A: To assess the efficacy of dupilumab in reducing the annualized rate of severe asthma exacerbations at Week 52 compared to placebo Part B: Safety and tolerability of dupilumab in children aged 2 to <6 years old with uncontrolled asthma and/or recurrent severe asthmatic during Part B
- 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
- Participant must be 2 to <6 years of age
- Diagnosis of asthma or recurrent severe asthmatic wheeze that is not controlled with chronic ICS for at least 3 months with stable use of at least low dose ICS for ≥1 month prior to Screening Visit 1 with evidence of uncontrolled asthma and/or recurrent severe asthmatic wheeze.
- At least one additional major criterion from the modified asthma predictive index: a) Physician diagnosed Atopic Dermatitis, b) Allergic sensitization to at least 1 aeroallergen (with a positive serum IgE defined as a value ≥0.35 kU/L). OR 2 minor critieria: c) Wheezing unrelated to colds, d) Peripheral blood eosinophilia ≥4%, e) Allergic sensitization to milk, eggs, or peanuts (defined by serum specific IgE >0.35 kU/L.
- Parent(s)/caregiver(s)/legal guardian(s) willing and able to comply with clinic visits and study-related procedures.
- Parent(s)/caregiver(s)/legal guardian(s) able to understand the study requirements.
- Participants/parent(s)/caregiver(s)/legal guardian(s), as appropriate, must be able to understand and complete study-related questionnaires
You likely can't join if
- Severe asthma with the need for chronic oral/systemic corticosteroid use (>1 month continuous) at the time of screening enrollment.
- History of a systemic hypersensitivity reaction or anaphylaxis to biologic therapy, including any excipient.
- History of prematurity (<34 weeks gestation).
- Any other chronic lung disease that would impair lung function (eg, cystic fibrosis, bronchopulmonary dysplasia) or chronic lung disease of prematurity or need for oxygen for more than 5 days in the neonatal period.
- History of life-threatening asthma (eg, requiring intubation).
See the full eligibility criteria
- Participant must be 2 to <6 years of age
- Diagnosis of asthma or recurrent severe asthmatic wheeze that is not controlled with chronic ICS for at least 3 months with stable use of at least low dose ICS for ≥1 month prior to Screening Visit 1 with evidence of uncontrolled asthma and/or recurrent severe asthmatic wheeze.
- At least one additional major criterion from the modified asthma predictive index: a) Physician diagnosed Atopic Dermatitis, b) Allergic sensitization to at least 1 aeroallergen (with a positive serum IgE defined as a value ≥0.35 kU/L). OR 2 minor critieria: c) Wheezing unrelated to colds, d) Peripheral blood eosinophilia ≥4%, e) Allergic sensitization to milk, eggs, or peanuts (defined by serum specific IgE >0.35 kU/L.
- Parent(s)/caregiver(s)/legal guardian(s) willing and able to comply with clinic visits and study-related procedures.
- Parent(s)/caregiver(s)/legal guardian(s) able to understand the study requirements.
- Participants/parent(s)/caregiver(s)/legal guardian(s), as appropriate, must be able to understand and complete study-related questionnaires
- Body weight at screening and randomization >5 kg and <30 kg.
- Parents or caregivers or legal guardian capable of giving signed informed consent.
- Severe asthma with the need for chronic oral/systemic corticosteroid use (>1 month continuous) at the time of screening enrollment.
- History of a systemic hypersensitivity reaction or anaphylaxis to biologic therapy, including any excipient.
- History of prematurity (<34 weeks gestation).
- Any other chronic lung disease that would impair lung function (eg, cystic fibrosis, bronchopulmonary dysplasia) or chronic lung disease of prematurity or need for oxygen for more than 5 days in the neonatal period.
- History of life-threatening asthma (eg, requiring intubation).
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- Argentina
- United Kingdom
- Canada
- United States
- Brazil
- Japan
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 Mexico; Argentina; United Kingdom; Canada; United States; Brazil and 1 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.