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Enrolling by invitationPhase 3

Tests dupilumab injections in young children with asthma or severe wheezing

Tests dupilumab against placebo in children aged 2 to 5 with uncontrolled asthma.

Key facts

Who runs it
Sanofi
Where
Milan, Naples, Padova, Pavia, and Rome, ItalySee the 5 sitesAlso in 15 other countries, 69 sites
Trial code
Registry title
Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
Status
Enrolling by invitation
Phase
Phase 3
People taking part
90 people, planned
Started
3 Jan 2024
Expected to end
21 Dec 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Dupilumab
  • Placebo
Record updated
13 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children aged 2 to under 6 years with asthma or repeated severe asthma wheezing that is not controlled with inhaled steroid treatment.

Age
2 to under 6 years (2 to 5 years)
Sex
Boys and girls can both join.
Disease stage
Asthma or repeated severe asthmatic wheeze that is not controlled, despite regular inhaled steroids (ICS) for at least 3 months.
Earlier treatment
Stable use of at least a low dose of inhaled steroids (ICS) for at least 1 month before screening.
Biomarker or test result
Besides asthma, the child needs at least one more major sign from the modified asthma predictive index: doctor-diagnosed atopic dermatitis, or allergy to at least 1 airborne allergen (serum IgE ≥0.35 kU/L). Or 2 minor signs: wheezing not linked to colds, blood eosinophils ≥4%, or allergy to milk, eggs or peanuts (serum specific IgE >0.35 kU/L).

Main reasons for not taking part

  • Severe asthma needing long-term steroids by mouth or injection (more than 1 month in a row)
  • Past severe allergic reaction or anaphylaxis to a biologic therapy or its ingredients
  • Born before 34 weeks of pregnancy
  • Another long-term lung disease (for example cystic fibrosis or bronchopulmonary dysplasia) or oxygen for more than 5 days as a newborn
  • Past life-threatening asthma, for example needing a breathing tube

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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:; 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

Who cannot take part

  • 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
  • Participants are excluded from the study if any of the following criteria apply:

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 2 and 5 years old?

Where in Italy

Also in 15 other countries, 69 sites

  • ASST Fatebenefratelli SaccoMilan, ItalyNo longer taking part
  • Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, ItalyNo longer taking part
  • Azienda Ospedaliera di PadovaPadova, ItalyNo longer taking part
  • Fondazione IRCCS Policlinico San MatteoPavia, ItalyNo longer taking part
  • Ospedale Pediatrico Bambino GesùRome, ItalyNo longer taking part

About the trial

What the trial wants to find out

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. Part A will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to <6 years old with uncontrolled asthma and/or recurrent severe asthmatic wheeze. At the end of Part A, all eligible participants will be offered participation in Part B, an optional open-label extension phase.

Read full original descriptionShow less

Study details include:

Part A:

The study duration of part A will be up to 68 weeks consisting of a 4-week Screening, a 52week treatment period, and a 12-week post-treatment follow-up period. For participants who will chose to participate in Part B, the study duration will be up to 120 weeks (additional 52-week treatment period).

Part B:

For participants who will choose to participate in Part B, the study duration will be up to 120 weeks (Part A [4-week Screening and a 52-week treatment period] plus additional 52-week treatment period and a 12-week post-treatment follow-up period).

The 2 groups in the trial

  • Dupilumab (double-blind period)Treatment being tested

    Dupilumab subcutaneous injection as per protocol

    Treatment: Dupilumab

  • PlaceboPlacebo, for comparison

    Placebo matching dupilumab subcutaneous injection as per protocol

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests dupilumab injections in young children with asthma or severe wheezingGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06191315, who can take part
Record updated
13 August 2026