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Tests treatment safety and results for Wheezing
Official title Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
ClinicalTrials.gov ID: NCT06191315
What this study is testing
What is Dupilumab?
Dupilumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for wheezing.
Also referred to as SAR231893, Dupixent.
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
- This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to \<6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze. The study will be conducted in 2 parts.
- 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 2 to 5
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...
- At least one additional major criterion from the modified asthma predictive index:
- Physician diagnosed Atopic Dermatitis,
- Allergic sensitization to at least 1 aeroallergen (with a positive serum IgE defined as a value ≥0.35 kU/L). OR 2 minor criteria:
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply:
- 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...
- History of life-threatening asthma (eg, requiring intubation). The above information is not intended to contain all considerations relevant to a...
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...
- At least one additional major criterion from the modified asthma predictive index:
- Physician diagnosed Atopic Dermatitis,
- Allergic sensitization to at least 1 aeroallergen (with a positive serum IgE defined as a value ≥0.35 kU/L). OR 2 minor criteria:
- Wheezing unrelated to colds,
- Peripheral blood eosinophilia ≥4%,
- 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.
- Participants are excluded from the study if any of the following criteria apply:
- 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 above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Destin, Florida, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Owensboro, Kentucky, United States
- Rochester, Minnesota, United States
- Buffalo, New York, United States
- Hawthorne, New York, United States
- Chapel Hill, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- Boerne, Texas, United States
- Houston, Texas, United States
- Rosario, Santa Fe Province, Argentina
- Buenos Aires, Argentina
- Corrientes, Argentina
- Córdoba, Argentina
- Mendoza, Argentina
- Porto Alegre, Rio Grande do Sul, Brazil
+ 48 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 - 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, 2 years to 5 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Destin, Florida, United States; Miami, Florida, United States; Chicago, Illinois, United States; Owensboro, Kentucky, United States; Rochester, Minnesota, United States and 62 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.