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Could a new shot help toddlers breathe easier?

NCT ID NCT06191315

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study tests if dupilumab, an injected drug, can help control asthma and severe wheezing in children aged 2 to 6. About 90 kids will receive either dupilumab or a placebo for a year, with an option to continue treatment. The goal is to see if it reduces serious asthma attacks and is safe long-term.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dupilumab (Dupixent)
What this could lead to
If successful, this could provide a new treatment option to better control asthma and reduce severe wheezing attacks in young children.
What could go wrong
This is a Phase 3 trial, but results may not apply to all children. Side effects are possible, and the long-term benefits are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 5 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

asthma Respiratory Sounds

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma Wheezing

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    74 sites in 16 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Luigi Vanvitelli - Investigational Site Number : 3800004

    Naples, 80131, Italy

  • Allergy and Asthma Specialist- Site Number : 8400002

    Owensboro, Kentucky, 42301, United States

  • Allervie Clinical Research - Destin- Site Number : 8400016

    Destin, Florida, 32541, United States

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

    Chicago, Illinois, 60611, United States

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

    Hawthorne, New York, 10532, United States

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

    Milan, Lombardy, 20154, Italy

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

    Cincinnati, Ohio, 45229, United States

  • Clinica de Alergia Martti Antila- Site Number : 0760002

    Sorocaba, São Paulo, 18040-425, Brazil

  • EMDA Clinical Research- Site Number : 8400026

    Miami, Florida, 33126, United States

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

    Pavia, 27100, Italy

  • Hospital Ernesto Dornelles- Site Number : 0760004

    Porto Alegre, Rio Grande do Sul, 90160-093, Brazil

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

    São Paulo, 05403-000, Brazil

  • Investigational Site Number : 0320001

    Buenos Aires, 1414, Argentina

  • Investigational Site Number : 0320002

    Buenos Aires, 1122, Argentina

  • Investigational Site Number : 0320003

    Buenos Aires, 1121, Argentina

  • Investigational Site Number : 0320004

    Mendoza, 5500, Argentina

  • Investigational Site Number : 0320005

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320006

    Córdoba, 5003, Argentina

  • Investigational Site Number : 0320008

    Buenos Aires, 1028, Argentina

  • Investigational Site Number : 0320009

    Corrientes, 3400, Argentina

  • Investigational Site Number : 1240001

    Vancouver, British Columbia, V6H 3N1, Canada

  • Investigational Site Number : 1240002

    Edmonton, Alberta, T6G 2B7, Canada

  • Investigational Site Number : 1240005

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Investigational Site Number : 1240006

    Montreal, Quebec, H3T 1C5, Canada

  • Investigational Site Number : 1240007

    Hamilton, Ontario, L8S 1G5, Canada

  • Investigational Site Number : 1240008

    Burlington, Ontario, L7L 6W6, Canada

  • Investigational Site Number : 2030001

    Prague, 190 00, Czechia

  • Investigational Site Number : 2500001

    Lille, 59000, France

  • Investigational Site Number : 2500002

    Paris, 75019, France

  • Investigational Site Number : 2500003

    Paris, 75571, France

  • Investigational Site Number : 2500004

    Nice, 06200, France

  • Investigational Site Number : 2500005

    Créteil, 94010, France

  • Investigational Site Number : 2760001

    Leipzig, 04103, Germany

  • Investigational Site Number : 2760002

    Düsseldorf, 40217, Germany

  • Investigational Site Number : 2760004

    Frankfurt, 60590, Germany

  • Investigational Site Number : 3000001

    Athens, 115 27, Greece

  • Investigational Site Number : 3000003

    Athens, 152 36, Greece

  • Investigational Site Number : 3480001

    Szigetvár, 7900, Hungary

  • Investigational Site Number : 3480002

    Székesfehérvár, 8000, Hungary

  • Investigational Site Number : 3480004

    Debrecen, 4032, Hungary

  • Investigational Site Number : 3480005

    Budapest, 1085, Hungary

  • Investigational Site Number : 3800005

    Padua, Padova, 35128, Italy

  • Investigational Site Number : 3920001

    Fukuoka, 813-0017, Japan

  • Investigational Site Number : 3920002

    Fukuoka, 811-1394, Japan

  • Investigational Site Number : 3920003

    Ureshino, Saga-ken, 843-0393, Japan

  • Investigational Site Number : 3920004

    Tsu, Mie-ken, 514-0125, Japan

  • Investigational Site Number : 3920006

    Isehara, Kanagawa, 259-1193, Japan

  • Investigational Site Number : 4840001

    San Juan del Río, Querétaro, 76800, Mexico

  • Investigational Site Number : 4840002

    Veracruz, 91900, Mexico

  • Investigational Site Number : 4840004

    Durango, 34000, Mexico

  • Investigational Site Number : 5280001

    Rotterdam, 3015 CE, Netherlands

  • Investigational Site Number : 6160001

    Lodz, Lódzkie, 93-509, Poland

  • Investigational Site Number : 6160003

    Warsaw, Masovian Voivodeship, 02-091, Poland

  • Investigational Site Number : 6160004

    Tarnów, Lesser Poland Voivodeship, 33-100, Poland

  • Investigational Site Number : 7240001

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7240002

    Sabadell, Barcelona [Barcelona], 08208, Spain

  • Investigational Site Number : 7240003

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

  • Investigational Site Number : 7240004

    Valencia, 46026, Spain

  • Investigational Site Number : 7240005

    Madrid, 28009, Spain

  • Investigational Site Number : 7240006

    Jerez de la Frontera, Cádiz, 11407, Spain

  • Investigational Site Number : 7240007

    Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain

  • Investigational Site Number : 8260001

    London, London, City of, SE5 9RL, United Kingdom

  • Investigational Site Number : 8260002

    Leicester, Leicestershire, LE1 5WW, United Kingdom

  • Investigational Site Number : 8260003

    Birmingham, England, B4 6NH, United Kingdom

  • Investigational Site Number : 8260004

    Bradford, BD9 6RJ, United Kingdom

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

    Rochester, Minnesota, 55905, United States

  • Ospedale Pediatrico Bambino Gesù - Investigational Site Number : 3800002

    Rome, Roma, 00165, Italy

  • Phoenix Children's Hospital- Site Number : 8400001

    Phoenix, Arizona, 85016, United States

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

    Boerne, Texas, 78006, United States

  • Texas Children's Hospital- Site Number : 8400027

    Houston, Texas, 77030, United States

  • UBMD Pediatrics- Site Number : 8400013

    Buffalo, New York, 14203, United States

  • UNC Children's Hospital- Site Number : 8400005

    Chapel Hill, North Carolina, 27514, United States

  • University Hospitals Cleveland Medical Center- Site Number : 8400015

    Cleveland, Ohio, 44106, United States

  • Vanderbilt University Medical Center- Site Number : 8400024

    Nashville, Tennessee, 37232, United States

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Other studies related to the condition(s) this trial covers.