Home › Trials › NCT06191315

Evaluating Dupilumab for Young Children with Uncontrolled Asthma

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Longterm Safety of Dupilumab in Children 2 to <6 Years of Age With Uncontrolled Asthma and/or Recurrent Severe Asthmatic Wheeze

Phase 3 Interventional Sanofi · NCT06191315

This study is testing if a new asthma medication can help young children aged 2 to under 6 who have trouble controlling their asthma and wheezing.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment90 (estimated)
Ages2 Years to 5 Years
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsdupilumab
Locations74 sites (Phoenix, Arizona and 73 other locations)
Trial IDNCT06191315 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial assesses the efficacy and long-term safety of dupilumab in children aged 2 to less than 6 years who suffer from uncontrolled asthma or recurrent severe wheezing. The study consists of two parts: a 52-week randomized, double-blind, placebo-controlled phase followed by an optional open-label extension phase for those who qualify. Participants will undergo a screening period, treatment, and post-treatment follow-up to evaluate the drug's effectiveness and safety over a total duration of up to 120 weeks. The trial aims to provide insights into managing asthma in this young population.

Who should consider this trial

Good fit: Ideal candidates are children aged 2 to less than 6 years with uncontrolled asthma or recurrent severe wheezing despite low-dose inhaled corticosteroids.

Not a fit: Patients who have well-controlled asthma or do not meet the specific diagnostic criteria for severe wheezing may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve asthma control and quality of life for young children suffering from severe wheezing.

How similar studies have performed: Previous studies have shown promising results with dupilumab in older populations, suggesting potential success in this younger demographic.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion 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:

  1. Physician diagnosed Atopic Dermatitis,
  2. Allergic sensitization to at least 1 aeroallergen (with a positive serum IgE defined as a value ≥0.35 kU/L).

     OR 2 minor criteria:
  3. Wheezing unrelated to colds,
  4. Peripheral blood eosinophilia ≥4%,
  5. 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.

Exclusion Criteria:

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.

Where this trial is running

Phoenix, Arizona and 73 other locations

+24 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions WheezingAsthma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.