What is dupilumab studying for asthma and severe asthmatic wheeze in young children?

Dupilumab is being studied to evaluate its effects on controlling asthma and recurrent severe asthmatic wheeze in children aged 2 to under 6 years. This trial aims to assess how well the treatment works and its long-term safety. The study is sponsored by Sanofi to better understand treatment options for young children with these conditions.

Who may be eligible for this asthma clinical trial?

Children aged 2 to under 6 years with a diagnosis of asthma or recurrent severe asthmatic wheeze not controlled by inhaled corticosteroids may be eligible. Participants must weigh between 5 and 30 kilograms and have certain allergic conditions. There are no gender restrictions. Please review eligibility criteria for more details.

Is there any cost to participate in this asthma clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants and families should plan accordingly for any travel costs.

Actively Recruiting

Phase 3

Age: 2Years - 5Years

All Genders

ID06191315

Study of Dupilumab Injection for Children Ages 2 to Under 6 With Uncontrolled Asthma or Severe Wheezing

Led by Sanofi · Updated on 2026-03-20

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of dupilumab treatment on children aged 2 to under 6 years with uncontrolled asthma andor recurrent severe asthmatic wheeze. This Phase 3 study aims to assess both the efficacy and long-term safety of dupilumab compared to a placebo. The study is conducted in two parts to thoroughly evaluate treatment outcomes and safety over an extended period. In Part A, children will be randomly assigned to receive either dupilumab or a matching placebo through subcutaneous injections over a 52-week treatment period following a 4-week screening phase. After this, there is a 12-week follow-up to monitor any ongoing effects. Participants who qualify may choose to enter Part B, an optional open-label extension where all receive dupilumab for an additional 52 weeks, followed by another 12-week safety follow-up. Throughout the study, participants will be regularly assessed for asthma exacerbations, medication use, symptom control, quality of life, and medication safety. Caregivers will complete diaries and questionnaires about asthma symptoms and control. Blood tests will monitor eosinophil levels, immune responses, and drug concentrations. The total time in the study can be up to 120 weeks, allowing researchers to observe long-term treatment effects and safety.

CONDITIONS

Brief Title

Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)

Who Can Participate

Age: 2Years - 5Years

All Genders

Eligibility Criteria

You may qualify if you...

Child aged 2 to under 6 years
Diagnosis of asthma or recurrent severe asthmatic wheeze not controlled with inhaled corticosteroids for at least 3 months
Stable use of at least low dose inhaled corticosteroids for 1 month prior to screening
Evidence of uncontrolled asthma and/or recurrent severe asthmatic wheeze
At least one major criterion from modified asthma predictive index: physician diagnosed atopic dermatitis or allergic sensitization to at least one aeroallergen
Or two minor criteria: wheezing unrelated to colds, peripheral blood eosinophilia ≥4%, or allergic sensitization to milk, eggs, or peanuts
Parent(s)/caregiver(s) willing and able to comply with study visits and procedures
Ability to understand and complete study questionnaires
Body weight between 5 kg and 30 kg at screening and randomization
Signed informed consent by parent(s), caregiver(s), or legal guardian(s)

You will not qualify if you...

Need for chronic oral/systemic corticosteroid use for more than 1 month at screening
History of systemic hypersensitivity reaction or anaphylaxis to biologic therapy
History of prematurity before 34 weeks gestation
Other chronic lung diseases affecting lung function (e.g., cystic fibrosis, bronchopulmonary dysplasia)
Chronic lung disease of prematurity or need for oxygen more than 5 days in neonatal period
History of life-threatening asthma requiring intubation

Research Team

Trial Transparency email recommended (Toll free for US & Canada)

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Study of Dupilumab Injection for Children Ages 2 to Under 6 With Uncontrolled Asthma or Severe Wheezing

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria