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Study on the Effects and Safety of Dupilumab for Children Aged 2 to Under 6 with Uncontrolled Asthma or Severe Asthmatic Wheeze

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called dupilumab in young children aged 2 to less than 6 years who have asthma or experience frequent severe wheezing. Asthma is a condition that affects the airways in the lungs, making it difficult to breathe. The study aims to understand how well dupilumab works in reducing severe asthma attacks and to assess its safety over a long period. Participants in the study will receive either dupilumab or a placebo, which is a substance with no active medication, to compare the effects.

The study will be conducted over a period of 52 weeks, during which the children will receive regular injections of dupilumab in a pre-filled syringe. The study will monitor the frequency of severe asthma attacks and any side effects that may occur. The goal is to see if dupilumab can help reduce the number of asthma attacks and improve the overall health and quality of life for these young children.

In addition to dupilumab, the study will also consider other medications that the children might be using, such as ipratropium bromide, salbutamol, beclometasone, fluticasone, montelukast, and salmeterol. These medications are commonly used to manage asthma symptoms and will help provide a comprehensive understanding of how dupilumab fits into the treatment plan for children with asthma. The study will help determine the best ways to manage asthma in young children and improve their breathing and overall well-being.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant is confirmed to be between 2 to less than 6 years old with a diagnosis of asthma or severe wheezing that is not controlled with regular medication.

    The participant's parent or guardian must provide consent and agree to comply with study procedures.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the participant's current health status and asthma control.

    This includes a review of medical history and current medications.

  3. Step 3

    Treatment phase part A

    The participant receives either dupilumab or a placebo through a solution for injection in a pre-filled syringe.

    The treatment is administered over a 52-week period to assess the reduction in severe asthma attacks.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to track the participant's response to the treatment.

    This includes checking for any adverse effects and measuring the concentration of dupilumab in the blood.

  5. Step 5

    Treatment phase part B

    The safety and tolerability of dupilumab are assessed in children with uncontrolled asthma or severe wheezing.

    The participant continues to receive the treatment for another 52 weeks.

  6. Step 6

    Final evaluation

    A final evaluation is conducted to assess the overall effectiveness and safety of the treatment.

    The participant's asthma control and quality of life are measured and compared to the baseline.

Who can join the trial?

8 criteria

  • The child must be between 2 and less than 6 years old.
  • The child must have a diagnosis of asthma or severe wheezing that is not controlled with regular use of inhaled medications for at least 3 months.
  • The child must meet at least one major criterion from the modified asthma predictive index, such as having a doctor-diagnosed skin condition called Atopic Dermatitis or being allergic to something in the air, shown by a specific blood test result. Alternatively, the child can meet two minor criteria, such as wheezing not related to colds, having a certain type of white blood cell called eosinophils at a level of 4% or more, or being allergic to milk, eggs, or peanuts, shown by a specific blood test result.
  • The parent(s), caregiver(s), or legal guardian(s) must be willing and able to attend clinic visits and follow study procedures.
  • The parent(s), caregiver(s), or legal guardian(s) must be able to understand what the study involves.
  • The child and their parent(s), caregiver(s), or legal guardian(s) must be able to understand and complete study-related questionnaires.
  • The child's body weight must be more than 5 kg and less than 30 kg at the time of screening and randomization.
  • The parent(s), caregiver(s), or legal guardian(s) must be able to give signed informed consent, which means they agree to let the child participate in the study after understanding what it involves.

Who cannot join the trial?

8 criteria

  • Children who are not between the ages of 2 and less than 6 years old.
  • Children who do not have uncontrolled asthma or do not experience frequent severe asthma attacks.
  • Children who have other serious health conditions that might interfere with the study.
  • Children who are taking medications that could affect the study results.
  • Children who have had a recent illness or infection that could impact their participation.
  • Children who have a history of severe allergic reactions to medications.
  • Children who are participating in another clinical trial at the same time.
  • Children whose parents or guardians do not agree to follow the study procedures.
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Investigated drugs

Dupilumab is a medication being studied for its ability to help children aged 2 to under 6 years old who have uncontrolled asthma or experience frequent severe asthma attacks. The trial aims to see if this medication can reduce the number of severe asthma episodes over a year and to ensure it is safe and well-tolerated by young children.

What is already known about the treatment

Dupilumab – Dupilumab is administered as an injection under the skin, typically in the upper arm, thigh, or abdomen. It is currently being studied in clinical trials for its effectiveness and safety in treating young children with uncontrolled asthma and severe wheezing. The medication is primarily used to manage respiratory conditions like asthma by targeting specific proteins in the immune system to reduce inflammation. Dupilumab is classified as a monoclonal antibody, which works by blocking the action of interleukin-4 and interleukin-13, proteins involved in the inflammatory response associated with asthma.

Investigated diseases

  • Wheezing

    Wheezing is a high-pitched whistling sound made while breathing, often associated with difficulty in breathing. It occurs when air flows through narrowed breathing tubes, typically during exhalation. This condition is commonly seen in respiratory infections, asthma, or allergic reactions. Wheezing can vary in intensity and may be accompanied by other symptoms like coughing or shortness of breath. It can be a temporary condition or a sign of a chronic respiratory issue. The frequency and severity of wheezing episodes can change over time.

  • Asthma

    Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. Symptoms include wheezing, coughing, chest tightness, and shortness of breath, which can vary in severity and frequency. Asthma attacks can be triggered by allergens, exercise, cold air, or stress. The condition often begins in childhood but can occur at any age. Asthma is a long-term condition that can fluctuate, with periods of exacerbation and remission. The progression of asthma can be influenced by environmental factors and individual health conditions.

Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-504331-41-00Protocol codeEFC14771Estimated enrolment146 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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