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WheezingPhase 3NCT06191315

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

A Phase 3 study testing Dupilumab in people with Wheezing and Asthma, run by Sanofi at 74 sites in 16 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 2 to 5 years
Conditions the study is for
Wheezing, Asthma
What is being tested?
Dupilumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
74 sitesin 16 countries
Study dates
3 Jan 2024to 21 Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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:
Show all 14Show fewer
  • 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 join

  • 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.

Trial locations and contacts

74 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

74 sites in 16 countries

United States14 sites

  • South Texas Medical Research Institute - TTS Research- Site Number : 8400022

    Boerne, Texas, 78006

  • UBMD Pediatrics- Site Number : 8400013

    Buffalo, New York, 14203

  • UNC Children's Hospital- Site Number : 8400005

    Chapel Hill, North Carolina, 27514

  • Ann & Robert H. Lurie Children's Hospital of Chicago- Site Number : 8400011

    Chicago, Illinois, 60611

  • Cincinnati Children's Hospital Medical Center- Site Number : 8400004

    Cincinnati, Ohio, 45229

  • University Hospitals Cleveland Medical Center- Site Number : 8400015

    Cleveland, Ohio, 44106

  • Allervie Clinical Research - Destin- Site Number : 8400016

    Destin, Florida, 32541

  • Boston Children's Health Physicians - Hawthorne- Site Number : 8400010

    Hawthorne, New York, 10532

  • Texas Children's Hospital- Site Number : 8400027

    Houston, Texas, 77030

  • EMDA Clinical Research- Site Number : 8400026

    Miami, Florida, 33126

  • Vanderbilt University Medical Center- Site Number : 8400024

    Nashville, Tennessee, 37232

  • Allergy and Asthma Specialist- Site Number : 8400002

    Owensboro, Kentucky, 42301

  • Phoenix Children's Hospital- Site Number : 8400001

    Phoenix, Arizona, 85016

  • Mayo Clinic in Rochester - Minnesota- Site Number : 8400008

    Rochester, Minnesota, 55905

Other trials in United States

Argentina8 sites

  • Investigational Site Number : 0320008

    Buenos Aires, 1028

  • Investigational Site Number : 0320003

    Buenos Aires, 1121

  • Investigational Site Number : 0320002

    Buenos Aires, 1122

  • Investigational Site Number : 0320001

    Buenos Aires, 1414

  • Investigational Site Number : 0320006

    Córdoba, 5003

  • Investigational Site Number : 0320009

    Corrientes, 3400

  • Investigational Site Number : 0320004

    Mendoza, 5500

  • Investigational Site Number : 0320005

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Spain7 sites

  • Investigational Site Number : 7240001

    Barcelona, Barcelona [Barcelona], 08035

  • Investigational Site Number : 7240007

    Esplugues de Llobregat, Barcelona [Barcelona], 08950

  • Investigational Site Number : 7240006

    Jerez de la Frontera, Cádiz, 11407

  • Investigational Site Number : 7240005

    Madrid, 28009

  • Investigational Site Number : 7240002

    Sabadell, Barcelona [Barcelona], 08208

  • Investigational Site Number : 7240003

    Santiago de Compostela, A Coruña [La Coruña], 15706

  • Investigational Site Number : 7240004

    Valencia, 46026

Other trials in Spain

Canada6 sites

  • Investigational Site Number : 1240008

    Burlington, Ontario, L7L 6W6

  • Investigational Site Number : 1240002

    Edmonton, Alberta, T6G 2B7

  • Investigational Site Number : 1240007

    Hamilton, Ontario, L8S 1G5

  • Investigational Site Number : 1240006

    Montreal, Quebec, H3T 1C5

  • Investigational Site Number : 1240005

    Sherbrooke, Quebec, J1H 5N4

  • Investigational Site Number : 1240001

    Vancouver, British Columbia, V6H 3N1

Other trials in Canada

France5 sites

  • Investigational Site Number : 2500005

    Créteil, 94010

  • Investigational Site Number : 2500001

    Lille, 59000

  • Investigational Site Number : 2500004

    Nice, 06200

  • Investigational Site Number : 2500002

    Paris, 75019

  • Investigational Site Number : 2500003

    Paris, 75571

Other trials in France

Italy5 sites

  • Buzzi Children's Hospital - Investigational Site Number : 3800003

    Milan, Lombardy, 20154

  • AOU Luigi Vanvitelli - Investigational Site Number : 3800004

    Naples, 80131

  • Investigational Site Number : 3800005

    Padua, Padova, 35128

  • Fondazione IRCCS Policlinico San Matteo - Investigational Site Number : 3800001

    Pavia, 27100

  • Ospedale Pediatrico Bambino Gesù - Investigational Site Number : 3800002

    Rome, Roma, 00165

Other trials in Italy

Japan5 sites

  • Investigational Site Number : 3920002

    Fukuoka, 811-1394

  • Investigational Site Number : 3920001

    Fukuoka, 813-0017

  • Investigational Site Number : 3920006

    Isehara, Kanagawa, 259-1193

  • Investigational Site Number : 3920004

    Tsu, Mie-ken, 514-0125

  • Investigational Site Number : 3920003

    Ureshino, Saga-ken, 843-0393

Other trials in Japan

Hungary4 sites

  • Investigational Site Number : 3480005

    Budapest, 1085

  • Investigational Site Number : 3480004

    Debrecen, 4032

  • Investigational Site Number : 3480002

    Székesfehérvár, 8000

  • Investigational Site Number : 3480001

    Szigetvár, 7900

Other trials in Hungary

United Kingdom4 sites

  • Investigational Site Number : 8260003

    Birmingham, England, B4 6NH

  • Investigational Site Number : 8260004

    Bradford, BD9 6RJ

  • Investigational Site Number : 8260002

    Leicester, Leicestershire, LE1 5WW

  • Investigational Site Number : 8260001

    London, London, City of, SE5 9RL

Other trials in United Kingdom

Brazil3 sites

  • Hospital Ernesto Dornelles- Site Number : 0760004

    Porto Alegre, Rio Grande do Sul, 90160-093

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760001

    São Paulo, 05403-000

  • Clinica de Alergia Martti Antila- Site Number : 0760002

    Sorocaba, São Paulo, 18040-425

Other trials in Brazil

Germany3 sites

  • Investigational Site Number : 2760002

    Düsseldorf, 40217

  • Investigational Site Number : 2760004

    Frankfurt, 60590

  • Investigational Site Number : 2760001

    Leipzig, 04103

Other trials in Germany

Mexico3 sites

  • Investigational Site Number : 4840004

    Durango, 34000

  • Investigational Site Number : 4840001

    San Juan del Río, Querétaro, 76800

  • Investigational Site Number : 4840002

    Veracruz, 91900

Other trials in Mexico

Poland3 sites

  • Investigational Site Number : 6160001

    Lodz, Lódzkie, 93-509

  • Investigational Site Number : 6160004

    Tarnów, Lesser Poland Voivodeship, 33-100

  • Investigational Site Number : 6160003

    Warsaw, Masovian Voivodeship, 02-091

Other trials in Poland

Greece2 sites

  • Investigational Site Number : 3000001

    Athens, 115 27

  • Investigational Site Number : 3000003

    Athens, 152 36

Other trials in Greece

Czechia1 site

  • Investigational Site Number : 2030001

    Prague, 190 00

Other trials in Czechia

Netherlands1 site

  • Investigational Site Number : 5280001

    Rotterdam, 3015 CE

Other trials in Netherlands

About this study

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

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.

Study details include:

Read more

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).

Read the detailed description

The duration per participant is up to 120 Weeks.

Conditions
Wheezing, Asthma
Being tested
Dupilumab, Placebo
Medical subject headings
Respiratory Sounds, Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DupilumabDrug

    Also called SAR231893, Dupixent

    Pharmaceutical form: Injection solution Route of administration: Subcutaneous

  • PlaceboDrug

    Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Study groups in NCT06191315
Study groupRoleWhat they receive
Dupilumab (double-blind period)ExperimentalDupilumab subcutaneous injection as per protocol
Receives: Drug: Dupilumab
PlaceboPlacebo comparatorPlacebo matching dupilumab subcutaneous injection as per protocol
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Annualized rate of severe asthma exacerbations during the 52-week treatment period

    Annualized rate of severe asthma exacerbations during the 52-week treatment period.

    Measured: Baseline through Week 52

  2. Part B: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and AEs leading to permanent treatment discontinuation

    Incidence of TEAEs, SAEs, AESIs, and AEs leading to permanent treatment discontinuation.

    Measured: Week 52 through Week 116

Secondary outcomes (21)

  1. Part A: Annualized rate of hospitalization, ER or urgent care visit for asthma exacerbation during the 52week treatment period.

    Measured: Baseline through Week 52

  2. Part A: Annualized rate of moderate asthma exacerbations during the 52-week treatment period

    Annualized rate of moderate asthma exacerbations during the 52-week treatment period.

    Measured: Baseline through Week 52

  3. Part A: Cumulative ICS dose during the 52-week treatment period

    Measured: Baseline through Week 52

  4. Part A: Change from baseline in weekly average use of reliever medication during the 52-week treatment period

    Measured: Baseline to Week 52

  5. Part A: Mean number of days without asthma symptoms (DWAS) using the Pediatric Asthma Caregiver Diary (PACD) during the 52-week treatment period

    A day without asthma symptoms (DWAS) is defined as a day without any asthma symptoms, β-agonist use, oral steroid use, or need for urgent asthma care. The PACD consists of a daytime and overnight record. The daytime asthma symptom questions are scored on a 6-point scale from 0 (no symptoms/interference) to 5 (very severe symptoms/interference). The overnight questions are scored on a 5-point scale from 0 (no overnight cough and caregiver not disturbed at all) to 4 (coughed all night and disturbed all night).

    Measured: Baseline through Week 52

  6. Part A: Change from baseline to Week 52 in daytime symptom score using the daytime record of PACD

    The PACD consists of a daytime and overnight record. The daytime asthma symptom questions are scored on a 6-point scale from 0 (no symptoms/interference) to 5 (very severe symptoms/interference).

    Measured: Baseline to Week 52

  7. Part A: Incidence of TEAEs, SAEs, AESIs, and AEs leading to permanent treatment discontinuation

    Measured: Baseline through Week 52

  8. Part A: Change from baseline to Week 52 in Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Scale

    PedsQL measures health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. Scores range 0-100 with higher scores indicate better HRQOL.

    Measured: Baseline to Week 52

  9. Part A: Caregiver Global Impression of Change in their child's asthma control (CGI-change in asthma control) at Week 52

    CGI-change in asthma control is a 1-item questionnaire that asks the caregiver to provide the overall assessment of change of their child's asthma control on a 7-point scale, compared to just before he/she started taking the study treatment. Response choices are: 0 = "Very much better", 1 ="Moderately better", 2 = "A little better", 3 = "No change", 4 = "A little worse", 5 = "Moderately worse", 6 = "Very much worse".

    Measured: Week 52

  10. Part A: Physician Global Assessment of Change of the child's asthma control (PGA-change in asthma control) at Week 52

    The Physician Global Assessment of Change of Asthma (PGA-change in asthma control) is a 1 item questionnaire that asks the physician to provide the overall assessment of change in the child's asthma control on a 7-point scale, compared to just before he/she started taking the study treatment. Response choices are: 0 = "Very much better", 1 = "Moderately better", 2 ="A little better", 3 = "No change", 4 = "A little worse", 5 = "Moderately worse", 6 = "Very much worse".

    Measured: Week 52

  11. Part A: Change from baseline to Week 52 in Caregiver Global Impression of their child's asthma control (CGI-asthma control)

    The Caregiver Global Impression of asthma control (CGI-Asthma Control) is a 1-item questionnaire that asks caregiver to provide the assessment of their child's asthma control over the past 7 days, on a 4-point scale for the past week. Response choices are: 1 = "Not controlled", 2 = "Somewhat controlled", 3 = "Moderately controlled", 4 = "Well controlled".

    Measured: Baseline to Week 52

  12. Part A: Change from baseline to Week 52 in Caregiver Global Impression of their child's asthma severity (CGI-asthma severity)

    The Caregiver Global Impression of asthma severity (CGI-Asthma Severity) is a 1-item questionnaire that asks caregivers to provide the assessment of their child's asthma control over the past 7 days, on a 4-point scale for the past week. Response choices are: 1 = "None", 2 = "Mild", 3 = "Moderate", 4 = "Severe".

    Measured: Baseline to Week 52

  13. Part A: Change from baseline to Week 52 in Physician Global Assessment of the child's asthma control (PGA-asthma control).

    The Physician Global Assessment of asthma control is a 1-item questionnaire that asks physicians to assess the control of the child's asthma in the past 7 days on a 4 point scale for the past week. Response choices are: 1 = "Not controlled", 2 = "Somewhat controlled", 3 = "Moderately controlled", 4 = "Well controlled".

    Measured: Baseline to Week 52

  14. Part A: Change from baseline to Week 52 in Test for Respiratory and Asthma Control in Kids (TRACK)

    TRACK is a validated questionnaire for caregiver completion for preschool aged children with symptoms consistent with asthma. The total score range of 0 to 100. Higher scores indicated better asthma control.

    Measured: Baseline to Week 52

  15. Part A: Change from baseline in blood eosinophil level at Weeks 24 and 52

    Measured: Baseline to Week 24 and 52

  16. Part A: Concentration of dupilumab in serum over time during the 52-week treatment period

    Measured: Baseline through Week 52

  17. Part A: Incidence of treatment-emergent anti-drug antibody (ADA) against dupilumab over time

    Measured: Baseline through Week 52

  18. Part A: IgG response to any vaccination for tetanus, diphtheria and pertussis and antibody for influenza (HAI antibody titers) vaccine administered according to vaccination schedule during the 52-week treatment period

    Measured: Baseline through Week 52

  19. Part B: Annualized rate of severe asthma exacerbations events during the 52-week Part B treatment period

    Annualized rate of severe asthma exacerbations events during the 52-week Part B treatment period.

    Measured: Week 52 through Week 104

  20. Part B Concentration of dupilumab in serum over time during the 52-week Part B treatment period

    Measured: Week 52 through Week 104

  21. Part B: Incidence of treatment-emergent anti-drug antibodies (ADAs) against dupilumab over time

    Measured: Week 52 through Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2024
  2. Study start3 Jan 2024
  3. Primary completion21 Dec 2028 (estimated)
  4. Study completion21 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06191315
Sponsor's protocol ID
EFC14771
Other IDs
2023-504331-41, U1111-1246-7432, 2023
Status last verified
Aug 2026
First submitted
19 Dec 2023
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dupilumab in people with Wheezing and Asthma, run by Sanofi at 74 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Argentina, Spain, Canada, France and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Annualized rate of severe asthma exacerbations during the 52-week treatment period (time frame: Baseline through Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06191315.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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